Coronavirus Update – New FAQs and Toolkits for Telehealth, Telemedicine & Medicare Provider Enrollment

(March 27, 2020): Liles Parker published an article covering CMS’ blanket waiver of certain telehealth requirements on March 16, 2020, with an updated version posted March 17, 2020.[1] This article covers developments since March 17, 2020 related to CMS telehealth requirements and provider enrollment activities in response to the COVID-19 public health emergency, as well as the Drug Enforcement Administration’s recent waiver permitting practitioners to prescribe controlled substances via telemedicine.

We recommend providers carefully review the CMS and DEA guidance specific for each service or activity for complete details or contact a Liles Parker attorney for more information.

I.   Medicare Telehealth Waiver:

On March 17, 2020, CMS announced a waiver of certain telehealth coverage requirements so that Medicare beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility.[2]Since then, the agency has published toolkits for general and ESRD providers that answer a number of key questions.[3]

The initial announcement regarding the blanket waiver published March 17, 2020 included the following key takeaways:

• Effective for services starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to patients in all areas of the country in all settings.
• During this period, Medicare will make payment for Medicare telehealth services furnished to beneficiaries in any healthcare facility and in their home.
• The Medicare coinsurance and deductible would generally apply to these services. However, the HHS Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.
• To the extent the 1135 waiver requires an established relationship, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency.
• HHS’ Office of Civil Rights will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency.[4]

Note that the waiver does not restrict coverage to patients with coronavirus or symptoms of coronavirus. Any service that a provider can safely deliver via telehealth and is on CMS’ list of approved telehealth services[5] will be permitted under the new waiver. This waiver of Medicare program and HIPAA requirements will last for the duration of the COVID-19 public health emergency.

II.   Medicare Telehealth FAQs

CMS updated its COVID-19 FAQs after publishing the March 17, 2020 telehealth waiver notice.[6] The FAQs answer several key questions we have received from clients in the last several days, including the following:

• Question: For purposes of the statutory requirement that a patient have a face-to-face encounter with a physician or an allowed non-physician practitioner in order to qualify for Medicare home health care, can this encounter occur via telehealth during a pandemic outbreak of an infectious disease?

Answer: The face-to-face encounter, as described at 1814(a)(2)(C) and 1835(a)(2)(A) of the Social Security Act, can be performed via telehealth in accordance with the requirements under 1834(m)(4)(C) of the Social Security Act. Under the expansion of telehealth under the 1135 waiver, beneficiaries are able to use telehealth technologies with their doctors and practitioners from home (or other originating site) for the face-to-face encounter to qualify for Medicare home health care.

• Question: Can the distant site practitioner furnish Medicare telehealth services from their home? Or do they have to be in a medical facility?

Answer: There are no payment restrictions on distant site practitioners furnishing Medicare telehealth services from their home. Individual providers may use their MAC hotline number to verbally update their practice location over the phone and would be effective immediately so practitioners could continue providing care without a disruption.

Liles Parker recommends that if a distant site practitioner intends to provide telehealth services and does not have their home listed on the enrollment file as a practice location, he or she should call their Medicare Administrative Contractor (MAC) to add it. Please also see the additional information below on CMS provider enrollment waivers.

We note that CMS’ telehealth waiver does not relax or remove incident to supervision requirements. We recently reviewed whether a distant site practitioner (for example, a clinical psychologist), and someone under their supervision who is not enrolled in the Medicare program (for example, a licensed counselor), could collaborate via telemedicine to care for a Medicare patient. The scenario would involve the licensed counselor providing individual therapy services via telemedicine technology. The patient would be an established patient with a plan of care established by the clinical psychologist. The psychologist and licensed counselor would not be in the same location. As of the publication of this update, CMS has not relaxed or waived the supervision requirements for incident to services; therefore, this telehealth service would not be covered unless the supervising psychologist and licensed counselor are in the same location. We will continue to monitor CMS’ FAQs and other guidance for any changes.

III.   State Medical Board Telehealth and Other Waivers:

We recommend that you check with your State licensing board to verify state requirements for telemedicine if you are unfamiliar with what is permitted in your state and the State in which you wish to provide telehealth services. The Federation of State Medical Boards (FSMB) is maintaining a list of state actions that include waivers of licensure requirements, license renewal requirements, and other state medical board actions in response to the COVID-19 public health emergency.[7] Many of these waivers address physicians from out-of-state rendering telehealth and/or telemedicine services in states where they are not licensed. Keep in mind that a physician must meet the licensing requirements both in the state where he or she is licensed and in the state where the patient being seen via telemedicine is located.

Liles Parker has advised numerous clients with regard to telemedicine services and is ready to assist you in understanding both Medicare and relevant state law during this unprecedented public health emergency.

IV.   DEA Waiver to Regarding Controlled Substance Prescribing via Telemedicine

DEA is doing its part to support enhanced telemedicine services during the COVID-19 public health emergency as well. In a recently posted FAQ,[8] DEA informed the healthcare community that while a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency, as Secretary Azar did on January 31, 2020.

On March 16, 2020, the Secretary of HHS, with the concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States. Accordingly, as of March 16, 2020, and continuing for as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:

• The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;

• The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and

• The practitioner is acting in accordance with applicable Federal and State laws.

Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently permitted, including electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.

DEA clarified that the term “practitioner” includes a physician, dentist, veterinarian, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he or she practices, to prescribe controlled substances in the course of his/her professional practice.

V.   Additional Details on Medicare Provider Enrollment Waivers:

CMS issued a blanket waiver related to provider enrollment requirements[9] on March 13, 2020. That waiver included the following, as further explained the new FAQs published by CMS as of March 22, 2020:[10]

• For Physicians and Non-Physician Practitioners:
  • Establishes toll-free hotlines for non-certified Part B suppliers, physicians and nonphysician practitioners to enroll and receive temporary Medicare billing privileges
  • Waives the following screening requirements:
    • Application Fee – 42 C.F.R § 424.514
    • Criminal background checks associated with fingerprint-based criminal background checks – 42 C.F.R § 424.518
    • Site visits – 42 C.F.R § 424.517
    • Postpones all revalidation actions 

• For All other providers and suppliers (including DMEPOS):
  • Expedites any pending or new applications from providers
    • All clean web applications will be processed within 7 business days and all clean paper applications in 14 business days.
  • Waives the following screening requirements for all applications received after March 1, 2020:
    • Application Fee – 42 C.F.R § 424.514
    • Criminal background checks associated with fingerprint-based criminal background checks – 42 C.F.R § 424.518
    • Site visits – 42 C.F.R § 424.517
    • Postpones all revalidation actions;

CMS’ new FAQs include a list of the toll-free hotline numbers for each Medicare Administrative Contractor where physicians and non-physician practitioners[11] can call to receive immediate, temporary billing privileges in a jurisdiction where they are not already enrolled, or to add new practice locations to an existing enrollment. Callers should be prepared to provide the Legal Name of the enrolling practitioner, National Provider Identifier (NPI), Social Security Number, a valid in-state or out-of-state license, address information and contact information (telephone number). If basic screening criteria are met, the MAC will advise the physician or non-physician practitioner during the call that provisional billing privileges have been granted and will follow-up with a letter. If you need a retroactive effective date, the MACs may backdate your provisional enrollment as far as March 1, 2020. Individuals who receive these provisional privileges will be asked to file initial enrollment applications after the public health emergency declaration is lifted.

Note that for physicians enrolling in a MAC jurisdiction where they are not currently licensed, CMS is permitting this under its waiver authority so long as the following conditions are met:

1. The physician or non-physician practitioner must be enrolled as such in the Medicare program.
2. The physician or non-physician practitioner must possess a valid license to practice in the State which relates to his or her Medicare enrollment.
3. The physician or non-physician practitioner is furnishing services – whether in person or via telehealth – in a State in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity.
4. The physician or non-physician practitioner is not affirmatively excluded from practice in the State or any other State that is part of the 1135 emergency area.

CMS’ provider enrollment waiver does not supersede State or local licensing requirements. As we mentioned above, many States are waiving out-of-state licensing requirements or streamlining their process to get a temporary license. As stated above, we recommend that you check with your State licensing board to verify state requirements both in the state where the physician or non-physician practitioner is licensed and in the State where he or she wishes to render services either in-person, or via telehealth or telemedicine.[12]

Liles Parker provides assistance to all types of providers seeking to enroll in the Medicare program.

V.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

Jennifer Papapanagiotou is a Partner at Liles Parker, Attorneys & Clients at Law.  She has decades of experience representing health care providers and suppliers around the country in connection with a wide range of regulatory actions.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Jennifer for a free consultation.  She can be reached at:  1 (800) 465-1906.

[1] See the March 16, 2020 article (updated March 17, 2020) here.

[2] Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, can be found here. Frequently Asked Questions expanding on the fact sheet and giving more details on implementation can be found here.

[3] The CMS General Provider Telehealth and Telemedicine Tool Kit can be found here. The ESRD Provider Telehealth and Telemedicine Tool Kit can be found here.

[4] HHS’s Office of Civil Rights is maintaining a website with more information on this topic here.

[5] You can find CMS’ list of approved telemedicine services here.

[6] The updated FAQs from CMS last updated on March 23, 2020 can be accessed here.

[7] The FSMB list of state licensing board actions related to the COVID-19 public health emergency can be found here.

[8] DEA’s FAQ can be found here.

[9] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   Provider enrollment waivers of certain requirements are outlined in the guidance.

[10] The CMS 2019-Novel Coronavirus (COVID-19) Medicare Provider Enrollment Relief Frequently Asked Questions (FAQs) can be accessed here.

[11] Other provider types will need to file an enrollment application via PECOS or a paper application with the appropriate Medicare Administrative Contractor; however, the MACs will be expediting processing of all applications as indicated in the FAQs.

[12] The Federation of State Medical Boards list of state licensing board actions related to the COVID-19 public health emergency can be found here.

DOJ is Aggressively Investigating Allegations of Wrongdoing Related to COVID-19 Fraud and the Current National Emergency

(March 27, 2019):  We live in trying times.  As the coronavirus disease (COVID-19) has spread both globally and throughout the United States, the government has taken a number of steps to address the current pandemic.  On March 13, 2020, President Donald Trump officially declared that the COVID-19 outbreak constitutes a national emergency.[1]  Within 72 hours of the issuance of President Trump’s declaration,  William Barr, the Attorney General of the United States, determined it was necessary to issue a memorandum to the 94 U.S. Attorney’s Offices around the country stressing the fact that Department of Justice (DOJ) prosecutors must remain diligent in their efforts to detect, investigate and prosecute wrongdoing related to the COVID-19 crisis.  This article examines the various COVID-19 fraud concerns that DOJ has already raised and sets out steps you can take to reduce your level of regulatory risk.

I.   Overview of DOJ Guidance of COVID-19 Fraud and Related Wrongdoing:

As mentioned above, on March 16, 2020, the Attorney General issued guidance[2] to the 94 U.S. Attorney’s Office around the country noting that it is essential that the justice system remain functioning throughout the national emergency.  It is also worth noting that U.S. Attorney’s Offices has been “directed to prioritize the detection, investigation, and prosecution of all criminal conduct related to the current pandemic.”

Less than a week after issuing this initial guidance, the DOJ announced on Sunday, March 22, 2020, that it had filed its first enforcement action in the Western District of Texas related to COVID-19 fraud.  As set out in the Civil Complaint filed by the government, the defendants have been alleged to have engaged in a “wire fraud scheme seeking to profit from the confusion and widespread fear surrounding COVID-19” through the company’s sale of World Health Organization (WHO) vaccine kits.  As the government notes, at this time, there are no legitimate COVID-19 vaccines and the WHO is not distributing such a vaccine.  As Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division stated at the time:

“The Department of Justice will not tolerate criminal exploitation of this national emergency for personal gain . . . We will use every resource at the government’s disposal to act quickly to shut down these most despicable of scammers, whether they are defrauding consumers, committing identity theft, or delivering malware.”[3]

Even more recently, on March 25, 2020, the U.S. Attorney’s Office for the Central District of California announced that it had filed a criminal complaint against an individual who allegedly solicited investments in a company that was marketing pills that would prevent coronavirus infections.  The defendant’s company was also supposedly marketing an injectable cure for individuals battling COVID-19. The complaint charges the individual with a single count of attempted wire fraud. [9]

II.   Specific Guidance Issued by Deputy Attorney Rosen on COVID-19 Fraud:

Shortly thereafter, on March 25, 2020, Deputy Attorney General, Jeffrey A. Rosen issued guidance titled “Department of Justice Enforcement Actions Related to COVID-19.” [4]  As the guidance notes, there are a number of specific statutory authorities that Federal prosecutors may find applies to assert if COVID-19 fraud or wrongdoing is identified.  These statutory authorities include, but are not limited to:

Specific examples of possible COVID-19 fraud schemes that might be perpetrated were set out in Deputy Attorney General Rosen’s memorandum.  These examples included:

• Robocalls making fraudulent offers to sell respirator masks with no intent of delivery. 18 U.S.C. § 1343 (Wire Fraud). The crime of “wire fraud” occurs when someone voluntarily and intentionally uses makes an interstate telephone call or another electronic communication (such as e-mail) in furtherance of a fraud scheme. Notably, the elements of wire fraud are very similar to those of mail fraud statute except that it speaks of communications transmitted by wire.

• Fake COVID-19-related apps and websites that install malware or ransomware. 18 U.S.C. § 1343 (Wire Fraud) or 18 U.S.C. § 1030 (Computer Fraud). The crime of wire fraud is described above.  The crime of computer fraud occurs when someone knowingly causes the transmission of a “program, information, code or command” and intentionally damages (without authorization) a protected computer.   

• Phishing emails asking for money or presenting malware. 18 U.S.C. § 1030 (Computer Fraud). One of the forms of computer fraud is set out above. Additional examples are also discussed under 18 U.S.C. § 1030.[5]  

• Social media scams fraudulently seeking donations or claiming to provide stimulus funds if the recipient enters his or her bank account number. 18 U.S.C. §§ 1028-1028A (Identity Theft) or 18 U.S.C. § 1343 (Wire Fraud).  Notably, the government has extensive experience prosecuting individuals and entities who are alleged to have set up fake charities and have effectively taken advantage of a national disaster or tragedy.  The perpetrators of this type of fraud are almost always caught and the courts have levied heavy jail sentences and fines on bad actors found guilty of engaging in this type of wrongdoing.

• Sales of fake testing kits, cures, “immunity” pills, and protective equipment. 21 U.S.C. 333 (Introduction of Misbranded or Adulterated Drug or Device Into Interstate Commerce) or 15 U.S.C. § 2068 (Violation of the Consumer Product Safety Act). Federal prosecutors and regulators for the Food and Drug Administration (FDA) handle these types of cases on an ongoing basis and are experienced in shutting down fraudsters hawking fake cures and treatments.

• Fraudulent offers for free COVID-19 testing in order to obtain Medicare beneficiary information that is used to submit false medical claims for unrelated, unnecessary, or fictitious testing or services. 18 U.S.C. §§ 1028-1028A (Identification Fraud and Aggravated Identity Theft).  This type of fraud has been occurring law before the inception of the COVID-19 fraud cases we are now seeing.  Most recently, Medicare beneficiary information has been misused by a number of telemarketing companies and durable medical equipment companies.  Federal prosecutors are currently in the middle of several prosecutions involving this type of conduct. 

• Prescription drug schemes involving the submission of medical claims for unnecessary antiretroviral treatments or other drugs that are marketed as purported cures for COVID19. 18 U.S.C. § 1347 (Healthcare Fraud) or 15 U.S.C. § 2068 (Violation of the Consumer Product Safety Act). These common schemes are now being seen in connection with COVID-19 fraud cases around the country.  Health care providers should exercise caution before entering into business relationships with laboratories, pharmacies  and other ancillary service providers who are marketing purported cures or treatment regimens for COVID-19.

• Robberies of patients departing from hospitals or doctor offices. 18 U.S.C. § 2118 (Robberies and Burglaries Involving Controlled Substances). Although not discussed in Deputy Attorney General Rosen’s memorandum, it is a Federal crime to take, or attempt to take, by force or violence or by intimidation, any quantity of a controlled substance from any person (including a patient) on the business premises or property of a person registered with the Drug Enforcement Administration.  In addition, to this Federal statute, there are a host of robbery statutes that would implicated under State law. 

• Threats of violence against mayors and other public officials. 18 U.S.C. § 875 (Interstate Communications) or 18 U.S.C. § 876 (Mailing Threatening Communications). Using the internet to convey an interstate threat of violence or injury to any person would be a crime under 18 U.S.C. § 875.  Similarly, using the mails to threaten someone with violence or injury would be a crime under 18 U.S.C. § 876.  

• Threats to intentionally infect other people. 18 U.S.C. § 2332a (Use of Weapons of Mass Destruction). Of the examples discussed in Deputy Attorney General Rosen’s guidance, this is perhaps the most interesting.  As the memorandum reflects, Federal prosecutors may view “Threats or attempts to use COVID-19 as a weapon against Americans”  as a violation of 18 U.S.C. § 2332a since COVID-19 arguably meets the statutory definition of a “biological agent” [6]and therefore could implicate our country’s terrorism-related statutes.

III.   Reducing Your Level of Regulatory Risk During the Current National Emergency:

Although the health, societal and business impact of the current COVID-19 emergency is unprecedented (at least in our lifetime), the fact that bad actors will readily take advantage of this situation is to be expected.  In fact, with the exception of the terroristic threat conduct discussed above, the types of wrongdoing encountered in COVID-19 fraud cases is pretty run-of-the-mill.  In addition to the concerns raised in Deputy Attorney General Rosen’s memorandum, several additional areas of risk to be considered by health care providers and suppliers include the following:

• Exercise Due Diligence Before Accepting the Assertions of Medicare Coverage by a Vendor’s Sales Representative. There are a wide variety of medical devices and pharmaceutical products that have not been properly vetted through the FDA approval process in order to qualify for coverage and payment by Medicare.  Don’t assume that sales pitches asserting that a medical device or pharmaceutical product is correct.   In recent years, we have represented multiple providers who were talked into buying expensive equipment and other products based on a sales representatives promises that the item or service to be billed qualifies for Medicare coverage and payment.  In once case we handled, when our client was audited, the company that sold the medical device at issue had long since gone out of business and had been sued by other providers for misrepresenting that the services performed with the medical device could be properly billed to Medicare.
• Take Care if You Seek a Bank or Small Business Administration (SBA) Loan as a Result of the COVID-19 Crisis. In an effort to help businesses deal with the current national emergency, the government has streamlined the SBA loan process for small businesses. Two recent articles[7]covering these developments have been placed on our website.  Should you decide to seek a bank or SBA backed business loan, you must exercise care when completing these applications.  While the documentation and approval timeframes may have been simplified, should you make a misstatement on the application or fail to disclose relevant information, your actions may constitute a crime.
• Government Waivers of Certain Requirements (Such as those Associated with Telehealth / Telemedicine Services) are Always Limited. To its credit, the Centers for Medicare and Medicare Services (CMS) have been quick to address many of the patient access, diagnostic and treatment concerns expressed by health care providers and patients alike that have arisen because of the current COVID-19 outbreak.  For example, CMS maintains a list of services that are normally furnished in-person that it will now permit providers to furnish by Medicare telehealth.  As CMS wrote in recent guidance[8] it issued on March 17, 2020:  “Under the emergency declaration and waivers, these services may be provided to patients by professionals regardless of patient location.”  Don’t assume that the relaxation of Medicare’s telehealth / telemedicine rules are an indication that this area is no longer under extreme scrutiny by law enforcement and by CMS program integrity contractors such as Unified Program Integrity Contractors (UPICs).  Once our country has effectively dealt with the current national emergency, government investigators and CMS contractors will undoubtedly resume their review and audit of these historically-problematic claims.  For a more detailed discussion of the government’s enforcement efforts in this regard, please see our article from February 17, 2020, titled “Telemedicine Audits of Evaluations by Referring Physicians are Increasing.”

While CMS is continuing to identify additional ways that it can better facilitate the provision of patient care, health care providers need to remember that specific waivers recently approved by CMS are likely to be short-term in nature.  More importantly, all other coverage and payment requirements remain in effect.  First and foremost, were the services medically necessary?  Were the services properly documented (in accordance with CMS, State Medical Board and Industry Standards)?  Were the services properly coded and billed?  And finally, was the reimbursement you received accurate?

Once the current national emergency is over, health care providers and suppliers should expect to see significant upswings in program integrity audits by Unified Program Integrity Contractors (UPICs), Supplemental Medical Review Contractors (SMRCs) and Comprehensive Error Rate Testing (CERT) contractors.  As this health crisis continues, it is also important to keep in mind that State and Federal law enforcement agencies are actively soliciting reports of COVID-19 fraud and other related wrongdoing.  Attorney General Barr has urged the public to report any and all COVID-19 fraud schemes that are identified to the National Center for Disaster Fraud (NCDF) hotline.  As a result, it is imperative that you continue to ensure that your regulatory compliance efforts are both ongoing and up-to-date (in terms of your obligations under the law).

Have you received a document request from the OIG, a UPIC, a SMRC or another CMS contractor?  Are you currently facing a government audit or investigation of your claims billed to Medicare, Medicaid or another Federal health benefit program?  Call us for a free consultation.  We can be reached at: (202) 298-8750 or toll-free 1 (800) 475-1906.

Robert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with claims audits and investigation.  Is your health care practice, home health agency or hospice being audited? Give us a call.  For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

[1] “Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak,”dated March 13, 2020.  A copy of the declaration can be found the following link.

[2] DOJ’s Memorandum, “COVID-19 – Department of Justice Priorities,” March 16, 2020.  A copy can be found at the following link.

[3] A copy of DOJ’s Press Release is available at this link.

[4] DOJ’s Memorandum, “Department of Justice Enforcement Actions Related to COVIF-19,” March 24, 2020. A copy can be found at the following link.

[5] 18 U.S.C. § 1030 (Fraud and Related Activity in Connection with Computers). A link to the statute can be found here.

[6] See 18 U.S.C. § 175.

[7] Our article titled “Small Business Administration Releases Express Bridge Loan Pilot Program for COVID-19,” dated March 26, 2020, can be found here.   An earlier article titled “COVID-19 SBA Loan Support May be Available for Qualified Health Care Providers,” dated March 25, 2020, can be found here.

[8] CMS guidance titled “Medicare Telehealth Frequently Asked Questions (FAQs),” dated March 17, 2020, can be found here.

[9]  A copy of the Press Release can be found here.

Small Business Administration Releases Express Bridge Loan Pilot Program for COVID-19

(March 26, 2020): The Small Business Administration (“SBA”) announced an Express Bridge Loan Pilot Program on March 25, 2020.[1]   The Express Bridge Loans are available to businesses, including health care providers, to provide economic relief for businesses impacted by the Coronavirus Disease (COVID-19) while they await long-term disaster financing.[2]

I.   Background:

The Express Bridge Loan Pilot Program was released by the SBA in October 2017 and was created to supplement the SBA’s ability to grant direct disaster loans.[3]  The program provides “expedited guaranteed bridge loan financing for disaster-related purposes” to any small business that is located in a Presidentially-declared disaster area[4] while the business awaits long-term financing, regardless of whether the long-term financing is sought through the SBA disaster loan program.  The Express Bridge Loan Program includes a “streamlined underwriting process” and is designed to “minimize the burden” of applying for a small business loan.[5]

II.   COVID-19 Expansion of the Express Bridge Loan Program:

The SBA expanded its Express Bridge Loan Program, effective March 25, 2020,[6] to include all small businesses impacted by COVID-19 Emergency Declaration.[7] This proclamation includes all states, U.S. Territories, and the District of Columbia. Express Bridge Loans can be approved for health care providers through March 13, 2021.

Express Bridge Loans may be granted at a maximum amount of $25,000 for a loan term of 7 years.  The maximum allowable interest rate is 6.5% over the Prime rate, regardless of the maturity of the loan.[8] A lender may charge an applicable fee of 2% of the loan amount (or $250), whichever is greater.[9] Lenders are not required to take collateral for Express Bridge Loans. The minimum accepted credit score is a FICO Small Business Scoring Service Score of 130.

a. Who is Eligible for an Express Bridge Loan?

Any small business located in any U.S. state, territory, or the District of Columbia that was operational on March 13, 2020.

b. How Does a Health Care Provider Qualify for an Express Bridge Loan?

A health care provider interested in applying for an Express Bridge Loan must demonstrate that it does not have credit available elsewhere.[10]  This can be achieved by having a lender[11] certify on a Lender’s Application for Loan Guaranty Form (SBA Form 1920) that the provider does not have the ability to obtain some or all of the requested loan amount from a non-Federal source, including from the lender completing the form, without SBA assistance.  The lender must also document that the provider / applicant had an operating business located in a disaster area on March 13, 2020, which was adversely impacted by COVID-19.

The provider / applicant must also complete the SBA 7(a) Borrower Information Form (SBA Form 1919). This form should be submitted to the provider’s lender. The form requires information about each of the applicant’s principals, which includes:

• Sole proprietors;
• For a general partnership: all general partners and all limited partners owning 20% or more of the equity of the business; or any partner that is involved in the management of the business;
• For a corporation: all owners of 20% or more of the corporation, and each officer and director;
• For limited liability companies: all members owning 20% or more of the company, each officer, director, and managing member;
• Any person hired by the business to management day-to-day operations (“key employees”); and
• Any Trustor (if the business is owned by a trust).

A separate SBA Form 1919 should be completed and signed by each of the above principals.[12] Finally, the lender must a signed IRS Form 4506-T to obtain an IRS transcript before it disburses the loan.[13]

C. How Soon Will a Provider Receive an Express Bridge Loan Payment?

The first disbursement of an Express Bridge Loan “should occur” within 45 days of the lender’s receipt of an SBA loan number. Disbursement must occur within 90 days of receipt of an SBA loan number or the loan will be cancelled.[14]  The SBA “endeavors” to provide loan numbers within one business day of receipt of the application (if filed through the SBA’s electronic transmission system, “E-Tran”).

III.   Conclusion:

The Federal Government is working with the SBA to make emergency funds available as quickly as possible to providers affected by COVID-19. Liles Parker attorneys are closely monitoring the available programs and are available to assist health care providers with the loan process and to answer any other concerns in response to this National Emergency.

Ashley Morgan is a Senior Associate at the health law firm, Liles Parker, PLLC.  Ms. Morgan represents health care providers and suppliers around the country in a wide variety of regulatory matters.  These include but are not limited to Medicare revocation, suspension and deactivation actions, prepayment reviews, postpayment claims audits, and State Board licensure matters.  Ms. Morgan is also assisting health care providers and suppliers adversely affected by COVID-19 with the completion and submission of SBA business loans.  For a free consultation regarding your needs, please give Ms. Morgan a call.  She can be reached at (202) 298-8750 or toll-free at 1 (800) 475-1906.

[1] Express Bridge Loan Pilot Program Guide, Small Business Administration, https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[2] COVID-19 SBA Loan Support May be Available for Qualified Health Care Providers, Liles Parker PLLC (Mar. 25, 2020) https://www.lilesparker.com/2020/03/25/covid-19-sba-loan/ (last accessed Mar. 26, 2020).

[3] 82 Fed. Reg. 47958, Express Bridge Loan Pilot Program; Modification of Lending Criteria (Oct. 16, 2017) (codified at 13 CFR Part 120).

[4] Current Declared Disasters, Small Business Administration, https://disasterloan.sba.gov/ela/Declarations (last accessed Mar. 26, 2020).

[5] Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 3, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[6] According to the SBA the expansion of the Express Bridge Loan Program will be published in the Federal Register. Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 3, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[7] This Emergency Declaration was issued by President Trump on March 13, 2020. Donald Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, The White House, Mar. 13, 2020, https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/ (last accessed Mar. 26, 2020).

[8] Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 7-8, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[9] An SBA Form 159 must be completed and signed by the applicant and lender if the lender charges an application fee. Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 11, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[10] 42 C.F.R. § 120.101.

[11] The lender must have an existing banking relationship with the provider/applicant as of the date of the applicable disaster. Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 9, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[12] SBA 7(a) Borrower Information Form, Small Business Administration (SBA Form 1919) (OMB Control No. 3245-0348) (Exp. Date July 31, 2020).

[13] Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 11-12, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

[14] Express Bridge Loan Pilot Program: Program Guide v.2, Small Business Administration, Mar. 25, 2020, p. 12, available at: https://www.sba.gov/document/support–express-bridge-loan-pilot-program-guide (last accessed Mar. 26, 2020).

Lab Testing Guidance for COVID-19

(Updated March 31, 2020): On March 13, 2020, President Trump declared a National Emergency[1] related to the current Coronavirus / COVID-19 outbreak.  The declaration gives Secretary Alex Azar of the U.S. Department of Health & Human Services (HHS) the power to waive certain Federal requirements in Medicare, Medicaid and CHIP in order to address the outbreak. The President’s declaration was preceded by Secretary Azar’s determination on January 31, 2020[2] that a public health emergency exists.  Since these pronouncements, Liles Parker attorneys have received numerous calls asking for clarification on these waivers and other guidance from HHS and the Centers for Medicare and Medicaid Services (CMS).  Our clients have also asked that we provide a listing of useful links and other available resources.  This article will detail the information related to lab operations and billing for COVID-19 diagnostic tests to CMS, as well as billing for COVID-19 diagnostic tests for private payors.

I.   Authorization for Use of COVID-19 Testing:

On February 6, 2020, CMS provided guidance permitting laboratories to use the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel Assay for use in CDC qualified laboratories.  At that time, testing was limited to the CDC developed test and could only be performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.[3] Since then, the FDA has approved a number of laboratory-developed tests being performed by private companies throughout the United States.[4]

II.   Billing for CMS:

On March 5, 2020, CMS announced new HCPCS codes for laboratories to bill Medicare for diagnostic tests for coronavirus.  There are two new HCPCS codes: U0001 and U0002.

• U0001: This code is to be used only for the test developed by the Centers for Disease Control and Prevention (CDC) for 2019-nCoV/SARS-CoV-2.
• U0002: This code is to be used for non-CDC developed laboratory tests for 2019-nCoV/SARS-CoV-2.

Starting April 1, 2020, Medicare claims processing systems will be able to accept these codes for dates of service on or after February 4, 2020.[5]

The following are the current COVID-19 Test Pricing as of March 12, 2020[6]:

On March 31, 2020, CMS published new specimen collection codes for laboratories billing for COVID-19 testing.  To identify and reimburse specimen collection for COVID-19 testing, CMS established two Level II HCPCS codes, effective with line item date of service on or after March 1, 2020:

• G2023 – Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source.

• G2024 – Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source.

These codes are billable by clinical diagnostic laboratories. (See MLN Connects, “COVID-19: Regulatory Changes, Telehealth Billing, and Specimen Collection Codes.” Published March 31, 2020).

III.   Billing for COVID-19 Diagnostic Testing to Private Payors:

Private payors are also taking measures to encourage COVID-19 diagnostic testing of their beneficiaries.  The following are the measures taken by five of the largest national payors in relation to COVID-19 diagnostic testing.[7]

• Aetna[8]
  • Aetna will waive co-pays for all diagnostic testing related to COVID-19.
• Anthem[9]
  • Anthem will cover the cost of coronavirus testing with no out-of-pocket cost.
  • Anthem also confirms that prior authorization is not required for diagnostic services related to COVID-19 testing.
  • Anthem’s affiliated plans will continue to waive copays, coinsurance and deductibles for diagnostic tests for COVID-19, and extending this to include waiver of copays, coinsurance, and deductibles for visits associated with in-network COVID-19 testing, whether the care is received in a doctor’s office, urgent care center or emergency department.
• Blue Cross Blue Shield (General Association)[10]
  • BCBS announced that its network of 36 independent and locally operated companies will:
    • waive prior authorizations for diagnostic tests and covered services for COVID-19, and
    • cover those tests at no cost share to members.
  • This applies to fully insured, individual, and Medicare Advantage plan members, and plans are working with state Medicaid and CHIP agencies to ensure people have access to needed testing and services.
• Cigna[11]
  • Cigna is covering the cost of coronavirus testing and waiving all co-pays or cost-shares for fully insured plans, including employer-provided coverage, Medicare Advantage, Medicaid, and individual market plans available through the Affordable Care Act.
  • Cigna also announced it will waive customers’ out-of-pocket costs for COVID-19 testing-related visits with in-network providers, whether at a doctor’s office, urgent care clinic, emergency room or via telehealth, through May 31, 2020.
• UnitedHealthcare[12]
  • UHC is waiving costs for COVID-19 testing provided at approved locations in accordance with the CDC guidelines, as well as waiving copays, coinsurance and deductibles for visits associated with COVID-19 testing.
  • This coverage is not dependent on whether the care is received in a physician’s office, an urgent care center or an emergency department.
  • This coverage applies to Medicare Advantage and Medicaid members as well as commercial members.
  • UHC is also expanding provider telehealth access and waiving member cost sharing for COVID-19 testing-related visits.

IV.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

Mary Soule Culter is an Associate Attorney at Liles Parker’s Washington, DC office.  She focuses her practice on regulatory health care compliance matters, fraud and abuse, and reimbursement issues. Questions regarding the Lab Testing Guidance for COVID-19?  Call Liles Parker, PLLC for a free consultation.  We can be reached at:  1 (800) 465-1906.

[1] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020, available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

[2] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020, available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.

[3] CMS, “Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories,” available at https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/notification-surveyors-authorization-emergency-use-cdc-2019-novel-coronavirus-2019-ncov-real-time-rt.

[4] Readers can monitor the list of FDA Emergency Use Authorizations for SARS-CoV-2 tests on the FDA’s website available at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.

[5] CMS, “Press Release: CMS Develops Additional Code for Coronavirus Lab Tests”, available at https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests.

[6] CMS, “Fact Sheet: Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF)”, available at https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf.

[7] Visit America’s Health Insurance Plans’ (AHIP) website for more payors’ plans related to COVID-19 diagnostic testing.  See AHIP, “Health Insurance Providers Respond to Coronavirus (COVID-19)”, available at https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/?fbclid=IwAR019orl2bXznUeWbmrldExyyrdt-dZ614xaowUgoc9IHXsOg0efo-iAwoA.

[8] CVS Health, “CVS Health announces COVID-19 resources for Aetna members”, available at https://cvshealth.com/newsroom/press-releases/cvs-health-announces-covid-19-resources-aetna-members.

[9] Anthem, “Anthem Issues Updates Regarding COVID-19 Testing and Care to Support Affiliated Health Plan Members”, available at https://ir.antheminc.com/news-releases/news-release-details/anthem-issues-updates-regarding-covid-19-testing-and-care?field_nir_news_date_value[min]=.

[10] BlueCross BlueShield, “Blue Cross and Blue Shield Companies Announce Coverage of Coronavirus Testing for Members and Other Steps to Expand Access to Coronavirus Care”, available at https://www.bcbs.com/press-releases/blue-cross-and-blue-shield-companies-announce-coverage-of-coronavirus-testing.

[11] Cigna, “Cigna Covers Cost Of Coronavirus Tests For Customers”, available at https://www.cigna.com/newsroom/news-releases/2020/cigna-covers-cost-of-coronavirus-tests-for-customers.

[12] UnitedHealthcare, “UnitedHealthcare Expands Access to Care, Support and Resources to Help People and Families Address COVID-19”, available at https://newsroom.uhc.com/news-releases/UnitedHealthcare-COVID-19.html.

Section 1135 Waiver Issues and COVID-19

(March 25, 2020):  On January 31, 2020, Secretary Alex Azar, of the US Department of Health & Human Services (HHS), used his authority under the Public Health Service Act to declare a public health emergency in the United States.[1] Secretary Azar determined that a public health emergency had existed nationwide since January 27, 2020. Subsequently, President Trump declared a National Emergency[2] on March 13, 2020 related to the current COVID-19 outbreak. When the HHS Secretary has declared a public health emergency and the President of the United States has declared a disaster or emergency under the Stafford Act or National Emergencies Act, the HHS Secretary is authorized to grant certain waivers or modifications in order to address the outbreak (referred to as a Section 1135 Waiver). Due to these two declarations, Secretary Azar has now been granted the power to waive certain Federal requirements in Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) to ensure that sufficient health care items and services are available to meet the needs of enrolled individuals. This authority was granted March 15, 2020 with a retroactive effective date of March 1, 2020.

I.  State Medicaid Agencies Must Request a Section 1135 Waiver:

CMS has the authority to grant state and territorial Medicaid agencies a wider range of flexibilities under Section 1135 waivers. However, a Section 1135 Waiver is  not automatically granted. Each state or territory must assess their individual needs and file a request with CMS for specific waivers. In March 2020, CMS created an 1135 Medicaid & CHIP Checklist to assist states during emergencies.[3] This checklist includes some of the temporary flexibilities available to CMS. For example, the following Medicaid Authorizations can be requested:

• Suspend Medicaid fee-for-service prior authorization requirements. Section 1135(b)(1)(C) allows for a waiver or modification of pre-approval requirements if prior authorization processes are outlined in detail in the State Plan for particular benefits

• Require fee-for-service providers to extend pre-existing authorizations through which a beneficiary has previously received prior authorization through the termination of the emergency declaration

These are examples of the types of flexibilities that a state / territory can request but is not all inclusive. The 1135 waiver authority only applies to Federal requirements and does not apply to any State requirements for licensure or conditions of participation.[4] In addition, these waivers typically end no later than the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless the Secretary extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period.

CMS also has the authority to grant a “blanket” waiver or modification to a Medicare, Medicaid, or CHIP requirement. A blanket waiver is made when a determination has been made that all similarly situated providers in an emergency area need such a waiver or modification. A decision regarding a blanket waiver or modification is made based on the need and frequency of requests for specific waivers or modifications in response to the disaster or emergency.

As of March 24, 2020, CMS has issued the following guidance, directives and waivers, related to Medicaid and CHIP programs. We recommend providers carefully review the HHS, CMS, and / or CDC guidance specific to each service, discipline or facility type for complete details and keep in mind that due to the rapidly evolving nature of this public health emergency, guidance will need to be constantly updated.

II.  Section 1135 Waiver Opportunities:

On March 22, 2020, CMS announced a new Section 1115 demonstration opportunity to aid states with addressing the public health emergency. The COVID-19, Section 1115 waiver demonstration opportunity is effective retroactively to March 1, 2020 and will allow states to select from a variety of options to deliver the most effective care to their beneficiaries in light of the COVID-19 public health emergency.[5] This demonstration will allow states to extend home and community-based service (HCBS) flexibilities to beneficiaries receiving long-term supports and services (LTSS) or could be used by states to accept self-attestations of applicant resources to assist Medicaid agencies in making more streamlined eligibility determinations. Any section 1115 demonstrations approved pursuant to this opportunity are time limited and will expire no later than 60 days after the end of the public health emergency.

• 1915(c) Appendix K Template

 CMS developed Appendix K as a standalone appendix to be utilized by states during emergency situations to request amendments to approved 1915(c) waivers. Appendix K includes actions that states may take under the existing Section 1915(c) home and community-based waiver authority in order to respond to an emergency. Appendix K may be completed retroactively as needed by the state. CMS has drafted a template and instructions to assist with the drafting of this appendix. As of this date, Pennsylvania, Washington, and West Virginia have applied for Appendix K waivers and received approvals from CMS.[6]

• Medicaid Disaster State Plan Amendment Template

Each Medicaid program has a state plan which describes the state’s rules related to eligibility, benefits and payments. CMS created a Disaster State Plan Amendment (SPA) template to allow states to submit one combined request for all temporary changes that states may wish to make to their programs. CMS also released instructions to assist states in completing the SPA and in responding to the COVID-10 national emergency.[7]

III.  Florida 1135 Waivers:

On March 13, 2020, Florida became the first state to file a request for a 1135 waiver to address the challenges posed by COVID-19. On March 16, 2020, CMS filed a response to Florida’s 1135 waiver requests.[8] CMS granted a number of waiver requests to help Florida combat this emerging crisis.

•  Florida Provider Enrollment Changes:

In general, a state Medicaid agency must enroll furnishing providers. However, Florida is not required to create a temporary provisional enrollment for providers who are enrolled with another state Medicaid agency or Medicare. Under current CMS policy, Florida may reimburse otherwise payable claims from an out-of-state provider not currently enrolled in Florida’s Medicaid program if five criteria have been met.

• The item or service is furnished by an institutional provider, individual practitioner, or pharmacy at an out-of-state/territory practice location– i.e., located outside the geographical boundaries of the reimbursing state/territory’s Medicaid plan,
• The National Provider Identifier (NPI) of the furnishing provider is represented on the claim,
• The furnishing provider is enrolled and in an “approved” status in Medicare or in another state/territory’s Medicaid plan,
• The claim represents services furnished, and;
• The claim represents either: A single instance of care furnished over a 180-day period, OR  Multiple instances of care furnished to a single participant, over a 180-day period[9]

For the duration of the Section 1135 waiver, CMS has agreed to waive the fifth criteria listed above. Therefore, providers may furnish care to more than one beneficiary and may treat multiple instances of care over a 180-day period as long as the other four criteria have been met.

Florida has also been granted the ability to perform an expedited enrollment for an out-of-state facility for a certified provider who is enrolled in Medicare or with another state Medicaid program in order to accommodate participants who were displaced by the emergency.

For providers not currently enrolled with Medicare or a state Medicaid agency, CMS has agreed to waive four screening requirements to allow Florida to provisionally, temporarily enroll providers. Specifically, the following screening requirements may be waived:

1. Payment of the application fee – 42 C.F.R. 455.460.
2. Criminal background checks associated with Fingerprint-based Criminal Background Checks – 42 C.F.R. 455.434.
3. Site visits – 42 C.F.R. 455.432.
4. In-state/territory licensure requirements – 42 C.F.R. 455.412.

However, CMS is still requiring Florida to meet a number of minimum documentation requirements before enrolling providers to ensure the safety of patients.  Finally, Florida may temporarily cease revalidation of providers who are located in Florida or who are directly impacted by the emergency. These provider enrollment emergency relief efforts also apply to CHIP.

• Waiver of Service Prior Authorization (PA) Requirements:

CMS has agreed to waive any prior authorization processes outlined in the State of Florida’s state plan.  This waiver applies to services provided on or after March 1, 2020 through the termination of the emergency declaration for beneficiaries with a permanent residence in the geographic area of the public health emergency.

• Waiver for Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

For Medicaid-certified nursing facilities, Level 1 and Level 2 assessments have been waived for 30 days. All new admissions can be treated like exempted hospital discharges. After 30 days, any new admissions with mental illness or intellectual disability should receive a Resident Review as soon as resources become available.

• Waiver to Allow Evacuating Facilities to Provide Services in Alternative Settings, such as a Temporary Shelter When a Provider’s Facility is Inaccessible:

Facilities such as nursing facilities, intermediate care facilities for individuals with intellectual and developmental disabilities, psychiatric residential treatment facilities, and hospitals nursing facilities are to be fully reimbursed for services rendered during an emergency evacuation to an unlicensed facility (where an evacuating facility continues to render services). After the initial 30 days, CMS would require that the unlicensed facility either seek licensure or the evacuating facility would need to seek new placement for the individuals.

• State Fair Hearing Requests and Appeal Deadlines:

CMS has granted Florida the authority to modify the timeframes associated with appeals and fair hearings. Specifically, CMS granted three modifications to the state fair hearing and decision-making process:

1. CMS has authorized the state to modify the timeframe for managed care plans to resolve appeals to zero days. If the state uses this authority, it would mean that all appeals filed between March 1, 2020 and June 29, 2020 are deemed to immediately satisfy the exhaustion requirement in 42 CFR 438.408(f)(1) and allow enrollees to proceed directly to the state fair hearing.
2. Managed care enrollees have 120 days to exercise their appeal rights and file for a fair hearing under 42 CFR 438.408(f)(2). Any managed care enrollee for whom the 120 day deadline would have occurred between March 1, 2020 through June 29, 2020 is granted an extension to request a state fair hearing. An enrollee can be allowed up to an additional 120 days to make this request, however, all requests must be made no later than June 29, 2020.
3. Modification of the timeframes in 42 CFR 431.221(d) to allow beneficiaries to have more than 90 days to request a state fair hearing for eligibility or fee-for-service issues.

CMS also granted a number of flexibilities the state can utilize in operating their appeals and fair hearing process:

• The state may suspend adverse actions for individuals for whom the state has completed a determination but either: 1) has not yet sent the notice; or 2) who the state believes likely did not receive the notice.
• The state may delay scheduling fair hearings and issuing fair hearing decisions.
• The state may offer to continue benefits to individuals who are requesting a fair hearing if the request comes later than the date of the action.

IV.  Washington 1135 Waivers:

On March 15, 2020, Washington state submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 19, 2020, CMS filed a response to Washington’s 1135 waiver requests.[10] CMS granted a number of waiver requests to help Washington combat this emerging crisis.

• Provider Enrollment; Waiver of Service Prior Authorization (PA) Requirements; Waiver for Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days; Waiver to Allow Evacuating Facilities to Provide Services in Alternative Settings, such as a Temporary Shelter When a Provider’s Facility is Inaccessible; and State Fair Hearing Requests and Appeal Deadlines:

The same 1135 waivers regarding provider enrollment, waiver of service prior authorization (PA) requirements; waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments for 30 Days; waiver to allow evacuating facilities to provide services in alternative settings, such as a temporary shelter when a provider’s facility is inaccessible; and state fair hearing requests and appeal deadlines were granted to Washington as were previously granted in Florida (see above).

In addition, Washington state requested a waiver of Drug Enforcement Administration’s (DEA) requirements around medications. However, CMS stated that it was unable to waive relief from the DEA requirements. However, CMS stated that it would consult with DEA to determine if these requirements could be waived during the public health emergency.

• Public Notice and Tribal Consultation:

CMS has also granted Washington a partial waiver of public notice. For public notice for state plan amendments (SPAs) that only provide or increase beneficiary access to items and services related to COVID-19 (such as cost sharing waivers, payment rate increase, or amendments to ABPs adding services or providers) and would not be a restriction or limitation on payment or services or otherwise burden beneficiaries and providers, and that are temporary, with a specified sunset date related to COVID-19, CMS approves the state’s request to waive public notice requirements. However, CMS has encouraged Washington to make all relevant information available to the public. Similarly, the state has flexibility in modifying their tribal consultation timeframe, including shortening the number of days before submission or conducting consultation after submission of the SPA.

V.  Alabama 1135 Waivers:

On March 18, 2020, Alabama submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Alabama’s 1135 waiver requests.[11] CMS granted a waiver to help Alabama to combat this emerging crisis.

• Waiver for Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same Section 1135 waiver regarding pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments for 30 Days was granted to Alabama as was previously granted in Florida (see above).

 VI.  Arizona 1135 Waivers:

On March 17, 2020, Arizona submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Arizona’s 1135 waiver requests.[12] CMS granted a number of waiver requests to help Arizona combat this emerging crisis.

• Provider Enrollment and Waiver for Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments for 30 Days were granted to Arizona as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

CMS has also granted Arizona the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

 VII.  California 1135 Waivers:

On March 16, 2020 and March 19, 2020, California submitted a request for a 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to California’s Section 1135 waiver requests.[13] CMS granted a number of waiver requests to help California combat this emerging crisis.

• Provider Enrollment:

The same 1135 waivers regarding provider enrollment were granted to California as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

 CMS has also granted California the ability to suspend, waive, or modify prior authorization requirements.

• State Fair Hearing Requests and Appeal Deadlines:

CMS has granted California the authority to modify the timeframes associated with appeals and fair hearings. Specifically, CMS granted three modifications to the state fair hearing and decision-making process:

1. CMS has authorized the state to modify the timeframe for managed care plans to resolve appeals to no less than one day. If the state uses this authority, it would mean that all appeals filed between March 1, 2020 and the end of the public health emergency are deemed to satisfy the exhaustion requirement in 42 CFR 438.408(f)(1) after one day (or more if that is the timeline elected by the state) and allow enrollees to file an appeal to the state fair hearing level.
2. Managed care enrollees have 120 days to exercise their appeal rights and file for a fair hearing under 42 CFR 438.408(f)(2). Any managed care enrollee for whom the 120-day deadline would have occurred between March 1, 2020 through the end of the public health emergency, are granted an extension to request a state fair hearing. An enrollee can be allowed up to an additional 120 days to make this request.
3. Modification of the timeframes in 42 CFR 431.221(d) to allow beneficiaries to have more than 90 days, up to an additional 120 days to request a fair hearing for an eligibility or fee for service appeal.

• Provision of Services in Alternative Settings:

Facilities such as nursing facilities, intermediate care facilities for individuals with intellectual and developmental disabilities, psychiatric residential treatment facilities, and hospitals nursing facilities are to be fully reimbursed for services rendered to an unlicensed facility provided that the State makes a reasonable assessment that the facility meets minimum standards, consistent with reasonable expectations in the context of the current public health emergency, to ensure the health, safety and comfort of beneficiaries and staff. This arrangement would be effective for the duration of the Section 1135 waiver.

 VIII.  Illinois 1135 Waivers:

On March 19, 2020, Illinois submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Illinois’ 1135 waiver requests.[14] CMS granted a number of waiver requests to help Illinois combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same Section 1135 waivers regarding provider enrollment and pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to Illinois as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

CMS has also granted Illinois the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same Section 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to Illinois as were previously granted in California (see above).

 IX.  Louisiana 1135 Waivers:

On March 17, 2020, Louisiana submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Louisiana’s 1135 waiver requests.[15] CMS granted a number of waiver requests to help Louisiana combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to Louisiana as were previously granted in Florida (see above).

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to Louisiana as were previously granted in California (see above).

X.  Mississippi 1135 Waiver Issues:

On March 18, 2020, Mississippi submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Mississippi’s 1135 waiver requests.[16] CMS granted a number of waiver requests to help Mississippi combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to Mississippi as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

CMS has also granted Mississippi the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to Mississippi as were previously granted in California (see above).

XI.  New Hampshire 1135 Waivers:

On March 18, 2020, New Hampshire submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to New Hampshire’s 1135 waiver requests.[17] CMS granted a number of waiver requests to help New Hampshire combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to New Hampshire as were previously granted in Florida (see above). However, New Hampshire was not granted the ability to temporarily cease revalidation of providers.

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

 CMS has also granted New Hampshire the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to New Hampshire as were previously granted in California (see above).

XII.  New Mexico 1135 Waivers:

On March 19, 2020, New Mexico submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to New Mexico’s 1135 waiver requests.[18] CMS granted a number of waiver requests to help New Mexico combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to New Mexico as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

 CMS has also granted New Mexico the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines were granted to New Mexico as were previously granted in California (see above).

XIII.  New Jersey 1135 Waivers:

On March 20, 2020, New Jersey submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to New Jersey’s 1135 waiver requests.[19] CMS granted a number of waiver requests to help New Jersey combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to New Jersey as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

CMS has also granted New Jersey the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to New Jersey as were previously granted in California (see above).

XIV.  North Carolina 1135 Waiver:

On March 17, 2020, North Carolina submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to North Carolina’s 1135 waiver requests.[20] CMS granted a number of waiver requests to help North Carolina combat this emerging crisis.

• Provider Enrollment and Suspend Pre-Admission Screening and Annual Resident Review (PASRR) Level I, Level II Assessments for 30 Days:

The same 1135 waivers regarding provider enrollment and waiver for pre-admission screening and annual resident review (PASRR) Level I, Level II Assessments were granted to North Carolina as were previously granted in Florida (see above).

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements:

 CMS has also granted North Carolina the ability to suspend prior authorization requirements.

• State Fair Hearing Requests and Appeal Timelines and the Provision of Services in Alternative Settings:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines and the provision of services in alternative settings were granted to North Carolina as were previously granted in California (see above).

XV.  Virginia 1135 Waivers:

On March 16, 2020, Virginia submitted a request for a Section 1135 waiver to address the challenges posed by COVID-19. On March 23, 2020, CMS filed a response to Virginia’s 1135 waiver requests.[21] CMS granted a number of waiver requests to help Virginia combat this emerging crisis.

• Temporarily Suspend Medicaid Fee-for-Service Prior Authorization Requirements and Extend Pre-Existing Authorizations for which a Beneficiary has Previously Received Prior Authorization Through the End of the Public Health Emergency:

CMS has granted Virginia the ability to suspend prior authorization requirements and permitted services approved to be provided on or after March 1, 2020 to continue to be provided without a requirement for a new or renewed prior authorization, through the termination of the public health emergency.

• State Fair Hearing Requests and Appeal Timelines:

The same 1135 waivers regarding the state fair hearing requests and appeal timelines were granted to Virginia as were previously granted in California (see above).

XVI.  Conclusion:

CMS has reiterated their commitment to continue to expeditiously review and approve as appropriate all Section 1135 waivers and other requests received by the agency to provide states with the maximum amount of flexibility possible to care for their Medicaid beneficiaries during this public health emergency. This commitment has been demonstrated by the quick review and approval of multiple 1135 waiver requests. As additional Section 1135 waivers are approved by CMS, they will be posted on the CMS and Medicaid.gov website.[22] It is expected that additional 1135 waivers will be requested in the coming days / weeks.

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available.  For an overview on additional CMS initiatives to assist health care providers, you may wish to review our article dated March 27, 2020, titled “Coronavirus Update — New FAQs and Toolkits for Telehealth, Telemedicine & Medicare Provider Enrollment.”  Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

Meaghan McCormick is an Associate at Liles Parker, Attorneys & Clients at Law.  She has experience representing health care providers and suppliers around the country in connection with a wide range of health law matters.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Liles Parker, PLLC for a free consultation.  We can be reached at:  1 (800) 465-1906.

[1] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020.  A link to the determination can be found here.

[2] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020.  A link to the declaration can be found here.

[3] Access to the 1135 Medicaid & CHIP Checklist can be accessed here.

[4] CMS guidance regarding the 1135 waivers can be accessed here.

[5] Information regarding the COVID-19: 1115 Waiver Demonstrations including an application template can be accessed here.

[6] Information regarding Appendix K including the templates, instructions, and CMS approval letters can be accessed here.

[7] Information regarding the Medicaid State Plan Disaster Relief SPA including the template and instructions can be accessed here.

[8] A copy of CMS’ response to Florida’s request for 1135 flexibilities can be accessed here.

[9] Medicaid Provider Enrollment Compendium can be accessed here.

[10] A copy of CMS’ response to Washington’s request for 1135 flexibilities can be accessed here.

[11] A copy of CMS’ response to Alabama’s request for 1135 flexibilities can be accessed here.

[12] A copy of CMS’ response to Arizona’s request for 1135 flexibilities can be accessed here.

[13] A copy of CMS’ response to California’s request for 1135 flexibilities can be accessed here.

[14] A copy of CMS’ response to Illinois’ request for 1135 flexibilities can be accessed here.

[15] A copy of CMS’ response to Louisiana’s request for 1135 flexibilities can be accessed here.

[16] A copy of CMS’ response to Mississippi’s request for 1135 flexibilities can be accessed here.

[17] A copy of CMS’ response to New Hampshire’s request for 1135 flexibilities can be accessed here.

[18] A copy of CMS’ response to New Mexico’s request for 1135 flexibilities can be accessed here.

[19] A copy of CMS’ response to Florida’s request for 1135 flexibilities can be accessed here.

[20] A copy of CMS’ response to North Carolina request for 1135 flexibilities can be accessed here.

[21] A copy of CMS’ response to Virginia’s request for 1135 flexibilities can be accessed here.

[22] Access to all CMS 1135 approval letters can be accessed here.

COVID-19 Outbreak Update – Two Recent Updates From CMS Affecting Relief From Quality Reporting Requirements, And New Targeted Plan For Healthcare Facility Inspections Including Provider-Self Assessment Tool For Infection Control

(March 25, 2020): As our clients and all members of the health care community are acutely aware, the challenges raised by the Coronavirus /  COVID-19 outbreak are critical and widespread.  Because of these challenges, the Centers for Medicare and Medicaid Services (CMS) and other principal operating components of the United States Department of Health and Human Services (HHS) are issuing frequent guidance to our community.

Additionally, Congress is currently working on the third and large piece of legislation to address both the health care and economic impact of this outbreak.  Over the last two weeks, our attorneys have posted a variety of helpful articles on our Firm’s website that are directly responsive to these activities.  This article provides an update to two pieces of guidance that the CMS recently issued.

I.     COVID-19 Outbreak Relief From Certain Quality Reporting Requirements for Clinicians, Providers, Hospitals and Facilities:

On Sunday, March 22, in response to the COVID-19 outbreak, CMS announced that it was granting exceptions from reporting requirement and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submissions for these programs.  The Press Release states that “[s]pecifically CMS is implementing … extreme and uncontrollable circumstances policy exceptions and extensions for upcoming measure reporting and data submission deadlines for the following CMS programs:”

The Press Release further states:

1. Submission of data for those programs with submission deadlines in April and May 2020 will be optional based on the facility’s choice to report; and
2. CMS will not use data reflecting services provided from January 1, 2020 through June 30, 2020 in calculations for the Medicare quality reporting and value-based purchasing programs.

The Press Release indicates that these actions are being undertaken to reduce data collection and reporting burdens on providers while they are responding to the COVID-19 outbreak pandemic and also because data furnished during this period my not be reflective or certain performance measures during this time, and as a result “seeks to hold organizations harmless for not submitting data during this period.”

The entirety of the Press Release can be found at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.             

II.     New Targeted Plan for Health Facility Inspections:

A.  CMS guidance on a short-term re-focusing of the inspection process.

As a result of the recent COVID-19 outbreak, CMS has recognized the increasing stress of the workload being placed on front line clinicians as they care for patients and residents.  This is especially true for nursing facilities which face unique and critical challenges in caring for their patients, and where the shortage of supplies of personal protective gear, while true throughout many sectors of the health care system, is especially acute in these facilities.  Therefore, on Monday, March 23, CMS released guidance that streamlines the survey process for these and facilities and other providers.

The guidance states that as of the date of publication, according to the Centers for Disease Control and Prevention (CDC), 147 nursing facilities across 27 states have at least one resident diagnosed positive as a result of the COVID-19 outbreak.  CMS will be reviewing data as it comes in from the CDC, using that information to identify areas where the virus is likely to strike next and will be targeting inspections accordingly.

B.  Overall general framework of the process.

The guidance stresses three action areas:

1. CMS will continue responsiveness to immediate jeopardy situations;
2. CMS will work with the CDC to identify areas of risk of COVID-19 outbreak spread to ensure that providers are compliant with federal infection control requirements; and
3. the guidance contains two tools/protocols which inspectors will use for infection control during this period, and that CMS strongly encourages providers to use as a voluntary self-assessment tool to review their own compliance with federal infection control requirements – one for nursing facilities and one for hospitals and continuing care.

C.  Specific actions.

During the next three weeks “only,” federal inspections will be prioritized as follows:

*Complaint inspections. These will be conducted for complaints and facility-reported incidents at the immediate jeopardy level, including allegations such as physical or sexual abuse, neglect, or other conditions that are at the IJ level.  Inspectors will use a streamlined Infection Control review tool regardless of the IJ allegation.

*Targeted Infection Control Inspections.  Federal and state inspectors will be conducting targeted infection control inspections for providers identified by CMS in collaboration with the CDC using a streamlined review checklist.  The guidance states that providers will receive immediate feedback to enable them to address shortcomings.

*Self-Assessment.  The guidance includes an infection control checklist to allow for self-assessments in this area.

Additionally, the guidance states that:

*Standard inspections of nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices and revisit inspections not associated with Immediate Jeopardy will not be conducted.

*CMS will prioritize IJ investigations over recertification surveys for CLIA laboratories.

*Absent IJ, CMS will utilize enforcement discretion.

*Initial inspections will be conducted with current guidance and prioritization.

During this period, CMS has also delayed certain enforcement activities as set forth in the quoted section from the CMS guidance document, below:

“ 4.a. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit survey to verify substantial compliance, and a per day civil money penalty (CMP), or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for noncompliance that occurred prior to the prioritization date of surveys: These remedies will be suspended (stopped) as of the start of the survey prioritization date. In other words, the CMP will stop accruing and the DPNA/SPNA will end as of the suspension date. Additionally, CMS will not impose any new remedies to address noncompliance that occurred prior to the start of the survey prioritization period. NOTE: This does not apply to unremoved IJs. Enforcement actions will proceed as usual per the SOM for unremoved IJ deficiencies. CMS will issue guidance on how to reconcile these actions in the next few weeks.

b. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit survey to verify substantial compliance, and for pending enforcement cycles with new noncompliance cited after the issuance of this memo, and a per day CMP, or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for IJ level noncompliance (where the IJ has not been removed): Surveyors will follow normal policies and procedures for removing the IJ. CMS will also follow normal policies and procedures for imposing enforcement remedies for remediating the noncompliance. For example, for noncompliance cited at the IJ level, that has not been removed at the time of the survey exit, the CMS Office will impose an enforcement remedy (e.g., CMP, 23 day termination), and the state surveyors will conduct a revisit survey. On the revisit survey, surveyors will either verify substantial compliance, or cite noncompliance at a lower level if warranted.

i. If the IJ noncompliance is reduced and cited at level 3 (LTC) or condition level (non-LTC), an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. CMS will issue guidance on how to impose enforcement and verify compliance with these in the next few weeks (see 2.c. [elsewhere in the full CMS guidance document]).

ii. If the IJ noncompliance is reduced and cited at level 2 (LTC) or standard level (non-LTC), facilities and survey agencies would verify compliance through normal procedures through a desk review (see 2.d. [elsewhere in the CMS guidance document]). However, CMS should not impose remedies during the prioritization period for any noncompliance that was identified before or after the start of the survey prioritization period, unless the noncompliance is an unremoved IJ.

c. The three-month mandatory DPNA and six-month mandatory termination (nursing homes) for not being in substantial compliance (for nursing homes and HHAs) will not take place, and be deferred for an evaluation at a later date. However, enforcement actions related to IJ remain and continue under normal procedures.

d. If CMS has previously imposed an alternative sanction (e.g., SPNA, CMP) on a HHA for noncompliance identified prior to the suspension, the six-month mandatory termination will not take place, and be deferred for an evaluation at a later date.

e. For existing CLIA enforcement cases where a civil money penalty (CMP) per day of non-compliance was imposed, accrual of CMP will stop as of the survey COVID-19 suspension date. CMS will issue guidance on how to reconcile these actions in the next few weeks. Other CLIA enforcement actions that have been initiated will be handled on a case-by-case basis with consultation DCLIQ managers and staff.

Due to its breadth, we have provided the following links to CMS guidance:

*Fact Sheet:  https://www.cms.gov/newsroom/fact-sheets/kirkland-washington- update-and-survey-prioritization-fact-sheet

*Full Guidance Document, including Infection Control Self-Assessment Tools: https://www.cms.gov/files/document/qso-20-20-allpdf.pdf-0

D. Other activity involving state Medicaid programs.

Additionally, on March 24, CMS granted 11 states’ Medicaid requests for 1135 waivers that allow greater flexibility in the administration of their programs.  We expect to provide a more detailed discussion of this event shortly; however, in the interim, we strongly suggest that all health care entities participating in the Medicaid program check with the states in which they operate to determine whether those states have received such a waiver, and if so, review the waiver to determine any impact that it might have on them.  As we all know, as the full scope of the COVID-19 outbreak develops, both Federal and State regulators will be actively monitoring the adverse impact that this national emergency is having on health care providers and suppliers.

III.     Conclusion — Responding to the COVID-19 Outbreak:

As a final remark, we wish to emphasize our awareness that the COVID-19 outbreak is a highly stressful situation that changes almost minute by minute.  We also wish to emphasize that as a society, we are all in this together and that we will get through this.  Right now, we need to do everything in our power to protect our residents, patents, and staff (and our loved ones and selves).  At Liles Parker, we will do our utmost to help you in this process by keeping you up to date of major developments and are available to respond to your inquiries during this period.

Michael Cook is a Partner and Co-chair for the Health Care Group at Liles Parker PLLC.  He has more than 40 years representing virtually every form of health care entity in a wide variety of matters across this country, currently is a member of the Board that oversees Virginia’s Medicaid program by appointment of the Governor, has advised a number of candidates for public office at both the state and national levels on health care issues, and has served on health care transition teams for several Governors.  Anyone with questions on the issues discussed in this paper should feel free to contact Michael.  He can be reached at either (202) 298-8750 (office) or (202) 361-2508 (cell) or [email protected].

COVID-19 SBA Loan Support May be Available for Qualified Health Care Providers

(March 25, 2020):  The Small Business Administration (SBA) offers loans to small businesses through community lenders.  The SBA acts as guarantor for these loans. In addition to the traditional lending, the SBA is also authorized to offer disaster assistance to businesses, renters, and homeowners who are located in regions with “declared disasters.”[1]  Small businesses impacted by Coronavirus (COVID-19) are eligible to apply for Disaster Loan Assistance from the SBA.[2]  As of January 31, 2020, individual states and the District of Columbia have been declared disaster areas.[3] These Economic Injury Disaster Loans (Disaster Loans or COVID-19 SBA loans) may be used by businesses to pay “fixed debts, payroll, accounts payable and other bills that can’t be paid because of the disaster’s impact.”[4]  The SBA may offer up to $2 million in Disaster Loan assistance with repayment options up to 30 years at an interest rate of no more than 3.75% for small businesses without credit available elsewhere.[5] If a business is a major source of employment, then SBA may waive the $2 million statutory limit.[6]

How can you apply for COVID-19 SBA loan?  The SBA utilizes a three-step process to administer disaster loans (such as those related to COVID-19 losses).  First, an applicant must submit an application for a Disaster Loan.  The SBA encourages online applications, but paper forms are available.[7] Second, the SBA will review the applicant’s credit and eligibility.  Third, the SBA will prepare and send loan closing documents and make an initial disbursement.  The initial disbursement for economic injuries is $25,000.[8]

Small businesses must complete several forms and provide the following information to apply for a Disaster Loan / COVID-19 SBA Loan [9]:

• A Disaster Loan Application (SBA Form 5) must be filed.

• A Tax Information Authorization (IRS Form 4506T) must be completed and signed by each applicant, each person owning 20 percent or more of the business, each general partner or managing member, and, any owner who has greater than 50 percent ownership in an affiliate business.

  • Affiliates include, but are not limited to, business parents, subsidiaries, and / or other businesses with common ownership or management.

• The applicant must provide complete copies (including all schedules) of the business’s most recent Federal income tax return. An explanation may be submitted if a copy of the income tax return is not available.

• A Personal Financial Statement (SBA Form 413) must be completed, signed, and dated by: (1) the applicant, (2) each principal owning 20% or more of the applicant business, and (3) each general partner or managing member.

Each form requires detailed information and it is critical to accurately complete the forms to avoid delays in processing or requests for additional information. Liles Parker attorneys are available to assist health care providers with the SBA Disaster Loan application process and to answer any other concerns in response to this National Emergency and your possible eligibility for a COVID-19 SBA loan.  For a free consultation, call Ashley Morgan at (202) 298-8750 or toll-free at 1 (800) 475-1906.

[An updated article dated March 26, 2020, titled “Small Business Administration Releases Express Bridge Loan Pilot Program for COVID-19” is available at this link.]

Ashley Morgan is a Senior Associate at the health law firm, Liles Parker, PLLC.  Ms. Morgan represents health care providers and suppliers around the country in a wide variety of regulatory matters.  These include but are not limited to Medicare revocation, suspension and deactivation actions, prepayment reviews, postpayment claims audits, and State Board licensure matters.  Ms. Morgan is also assisting health care providers and suppliers adversely affected by COVID-19 with the completion and submission of SBA business loans.  For a free consultation regarding your needs, please give Ms. Morgan a call.  She can be reached at (202) 298-8750 or toll-free at 1 (800) 475-1906.

[1] Disaster Assistance, Small Business Administration, https://www.sba.gov/funding-programs/disaster-assistance (last accessed Mar. 25, 2020).

[2] Economic Injury Disaster Loans, Small Business Administration, https://disasterloan.sba.gov/ela/Information/EIDLLoans (last accessed Mar. 25, 2020).

[3] A list of Declared Disasters is available on the SBA website. Current Declared Disasters, Small Business Administration, https://disasterloan.sba.gov/ela/Declarations (last accessed Mar. 25, 2020).

[4] SBA to Provide Disaster Assistance Loans for Small Businesses Impacted by Coronavirus (COVID-19), Release No. 20-24, Small Business Administration, Mar. 12, 2020, https://www.sba.gov/about-sba/sba-newsroom/press-releases-media-advisories/sba-provide-disaster-assistance-loans-small-businesses-impacted-coronavirus-covid-19 (last accessed Mar. 25, 2020).

[5] The interest rate for non-profits is 2.75%. Id.

[6] U.S. Small Business Administration Fact Sheet – Economic Injury Disaster Loans – Texas Declaration #16381: Incident: Coronavirus (COVID-19), Small Business Administration, available at: https://disasterloan.sba.gov/ela/Declarations/DeclarationDetails?declNumber=6064043&direct=false (last accessed Mar. 25, 2020).

[7] The online application portal for disaster loans, where you can also access paper applications is available here.

[8] Three Step Process: Disaster Loans, Small Business Administration, https://www.sba.gov/sites/default/files/files/Three_Step_Process_SBA_Disaster_Loans.pdf (last accessed Mar. 25, 2020).

[9] The SBA Schedule of Liabilities form (SBA Form 2202) may be used to identify all fixed debts to assist applicants in completing these forms.

Coronavirus Update – HHS & CMS Guidance, Directives and Waivers with Respect to Telemedicine, Provider Enrollment Regulations, Claim Appeals, the Suspension of Non-Emergency Survey Inspections, Nursing Homes, Home Health Agencies, Dialysis Facilities and DME Suppliers.

UPDATED (March 17, 2020): CMS just announced a waiver of certain telehealth coverage requirements so that Medicare beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. The article below has been updated to address these key takeaways.

(March 16, 2020): On March 13, 2020, President Trump declared a National Emergency[1] related to the current Coronavirus / COVID-19 outbreak. The declaration gives Secretary Alex Azar of the US Department of Health & Human Services (HHS) the power to waive certain Federal requirements in Medicare, Medicaid and CHIP in order to address the outbreak. The President’s declaration was preceded by Secretary Azar’s determination on January 31, 2020[2] that a public health emergency exists.  Since these pronouncements, Liles Parker attorneys have received numerous calls asking for clarification on these waivers and other guidance from HHS and the Centers for Medicare and Medicaid Services (CMS).  Our clients have also asked that we provide a listing of useful links and other available resources.

As a result of President Trump’s declaration of a national emergency, HHS now has broad authority to make temporary adjustments including:

1. Applying flexibilities that are already available under normal business rules;
2. Waiver or modification of policy or procedural norms by the Administrator of the Center for Medicare and Medicaid Services (CMS) under his or her authority; and
3. Waiver or modification of certain Medicare requirements pursuant to waiver authority under § 1135 of the Social Security Act.

As of March 16, 2020, CMS has issued the following guidance, directives and waivers, specifically with regard to the coronavirus outbreak. We recommend providers carefully review the HHS, CMS and/or CDC guidance specific to each service, discipline or facility type for complete details.

I.   Impact of the Coronavirus on Telehealth / Telemedicine Regulations:

The Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020[3] signed by President Trump on March 6, 2020 included a specific provision addressing Medicare coverage and telehealth services. HB 6074 grants certain powers to the Secretary of Health and Human Services to waive some of the telehealth coverage requirements under the Medicare program. Unfortunately, the new law requires Secretary Azar to issue a waiver addressing any temporary changes to current Medicare telehealth coverage requirements. As of the publication of this article, a waiver has not been released, although CMS Administrator Seema Verma indicated during her remarks on March 13, 2020,[4] that more information would be forthcoming very soon. H.B. 6074 permits Secretary Azar to relax telehealth coverage requirements for all services CMS has approved to be provided via telemedicine as follows:

• To relax the originating site requirements to include patient homes;
• To waive the rural HPSA/non-MSA county geographic location requirement so that patients in any geographic location can receive covered telemedicine services; and,
• To permit phone only telehealth services so long as the phone used has audio and video capabilities (i.e., most smartphones).

The law imposes certain restrictions, even under a waiver from Secretary Azar. Importantly, the relaxed coverage requirements would only extend to services provided by a physician or practitioner (or another physician or practitioner in that provider’s group practice) to an established patient, meaning an individual the provider has seen during the 3-year period before a telehealth service is furnished. We will update this article when a specific waiver is issued.

UPDATE (3/17/2020): CMS just announced a waiver of certain telehealth coverage requirements so that Medicare beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. Here are the key takeaways from this important announcement:

• Effective for services starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to patients in broader circumstances.
• These visits are considered the same as in-person visits and are paid at the same rate as regular, in-person visits.
• Starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings.
• While they must generally travel to or be located in certain types of originating sites such as a physician’s office, skilled nursing facility or hospital for the visit, effective for services starting March 6, 2020 and for the duration of the COVID-19 Public Health Emergency, Medicare will make payment for Medicare telehealth services furnished to beneficiaries in any healthcare facility and in their home.
• The Medicare coinsurance and deductible would generally apply to these services. However, the HHS Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.
• To the extent the 1135 waiver requires an established relationship, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency.
• HHS’ Office of Civil Rights will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency.[18]

Note that the waiver does not restrict coverage to patients with coronavirus or symptoms of coronavirus. Any service that a provider can safely deliver via telemedicine and is on CMS’ list of approved telemedicine services[19] will be permitted under the new waiver. This waiver of Medicare program and HIPAA requirements will last for the duration of the COVID-19 Public Health Emergency. We do recommend that you check with your State licensing board to verify state requirements for telemedicine if you are unfamiliar with what is permitted in your state. Liles Parker has advised numerous clients with regard to telemedicine services.

In the meantime, CMS has reminded providers of the following options to provide covered non-face to face services to Medicare patients:

• Medicare pays for “virtual check-ins” for patients to connect with their doctors without going to the doctor’s office. These brief, virtual check-in services are for patients with an established relationship with a physician or certain practitioners where the communication is not related to a medical visit within the previous 7 days and does not lead to a medical visit within the next 24 hours (or soonest appointment available). The patient must verbally consent to using virtual check-ins and the consent must be documented in the medical record prior to the patient using the service. The Medicare coinsurance and deductible would apply to these services. Doctors and certain practitioners may bill for these virtual check-in services furnished through several communication technology modalities, such as telephone (HCPCS code G2012) or captured video or image (HCPCS code G2010).
• Medicare also pays for patients to communicate with their doctors without going to the doctor’s office using online patient portals. The individual communications, like the virtual check ins, must be initiated by the patient; however, practitioners may educate beneficiaries on the availability of this kind of service prior to patient initiation. The communications can occur over a 7-day period. The services may be billed using CPT codes 99421-99423 and HCPCS codes G2061-G206, as applicable. The Medicare coinsurance and deductible would apply to these services.
• In addition, Medicare beneficiaries living in rural areas may use telehealth technology to have full visits with their physicians. The patient must be present at an approved telehealth originating site and must receive services using a real-time audio and video communication system at the site to communicate with a remotely located doctor or certain other types of practitioners. Medicare pays for many medical visits through this telehealth benefit. The Medicare coinsurance and deductible would apply to these services. For additional information on this benefit, please see CMS’s Telehealth resource page [5] for additional details and requirements.
• Medicare Advantage Plans were given the authority to expand their telehealth coverage through enhanced benefit packages last year, but coverage still varies from plan to plan. CMS also issued a waiver on March 10, 2020 permitting (but not requiring) Medicare Advantage Plans to expand access to certain telehealth services. We recommend checking with the plans with which you contract for specific details or contact Liles Parker for assistance.
• Many State Medicaid programs already cover telehealth/telemedicine services provided to patients in their homes. Liles Parker can assist in determining what your State Medicaid program covers.

II.   Impact of the Coronavirus on Medicare Provider Enrollment Regulations:

CMS has issued a blanket waiver related to provider enrollment requirements[6] to do the following:

• Establish a toll-free hotline for non-certified Part B suppliers, physicians and nonphysician; practitioners to enroll and receive temporary Medicare billing privileges;
• Waive the following screening requirements:
  • Application Fee – 42 C.F.R § 424.514
  • Criminal background checks associated with FCBC – 42 C.F.R § 424.518
  • Site visits – 42 C.F.R § 424.517
• Postpone all revalidation actions;
• Allow licensed providers to render services outside of their state of enrollment; and,
• Expedite any pending or new applications from providers.

Liles Parker provides assistance to all types of providers seeking to enroll in the Medicare program.

III.   Impact of the Coronavirus on Medicare Claim Appeals:

CMS has issued a blanket waiver applicable to fee-for-service Medicare, Medicare Advantage and Medicare Part D claim appeals.[7]  The blanket waiver provides for the following relief:

• Extensions to file an appeal
• Waiving timeliness for requests for additional information to adjudicate the appeal;
• Processing the appeal even with incomplete Appointment of Representation forms but communicating only to the beneficiary;
• Processing requests for appeal that don’t meet the required elements using information that is available.
• Utilizing all flexibilities available in the appeal process as if good cause requirements are satisfied.

IV.   Suspension of Non-Emergency Survey Inspections Due to Coronavirus:

On March 4, 2020, CMS issued a Memorandum[8] advising that it is temporarily suspending non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse. Specifically, survey activity is limited to the following (in Priority Order):

• All immediate jeopardy complaints (cases that represents a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death or harm) and allegations of abuse and neglect;
• Complaints alleging infection control concerns, including facilities with potential COVID-19 or other respiratory illnesses;
• Statutorily required recertification surveys (Nursing Home, Home Health, Hospice, and ICF/IID facilities);
• Any re-visits necessary to resolve current enforcement actions;
• Initial certifications;
• Surveys of facilities/hospitals that have a history of infection control deficiencies at the immediate jeopardy level in the last three years;
• Surveys of facilities/hospitals/dialysis centers that have a history of infection control deficiencies at lower levels than immediate jeopardy.

CMS is maintaining a website[9] with consolidated guidance to surveyors related to coronavirus and infection control in hospitals, nursing homes, hospices, home health, and dialysis facilities.

V.   Nursing Homes:

CMS issued a revised Memorandum[10] on March 13, 2020 with specific guidance to nursing homes, including:

• Directing nursing homes to temporarily restrict all visitors and nonessential personnel with a few exceptions such as end-of-life situations, and to cancel all communal dining and group activities.
• Screening their staff and outside healthcare providers using CDC guidelines for restricting access to health care workers.
• Notifying their local health department if a resident is suspected of having COVID-19. Facilities that can follow the infection prevention and control practices recommended by CDC may or may not need to transfer the patient, depending on the severity of the patient’s symptoms. If a resident must be transferred to a hospital, careful coordination with EMS and the receiving facility must be performed, including placing a facemask on the patient during transfer.
• Accepting patients diagnosed with COVID-19 and still under Transmission-Based Precautions for COVID-19 as long as the facility can follow CDC guidance;
• Accepting patients who are not diagnosed with COVID-19 from hospitals or other locations where a case of COVID-19 was/is present; and,
• Obligations to maintain appropriate PPE and alcohol-based hand rub supply levels, while assuring facilities they will not be cited by surveyors so long as they can demonstrate they are having difficulty obtaining the supplies for reasons outside their control. Nursing homes are advised to contact with their local and state public health agency to notify them of any shortage, follow national guidelines for optimizing their current supply, and identify the next best option to care for their residents.

CMS also exercised its authority to waive certain coverage requirements for skilled nursing services on March 13, 2020, including the following:

• CMS is waiving the 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay for those people who need to be transferred as a result of the coronavirus emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period.
• Second, CMS is waiving 42 CFR 483.20 to provide relief to SNFs on the timeframe requirements for Minimum Data Set assessments and transmission.

VI.   Home Health Agencies:

CMS has issued a blanket waiver[11] to provide relief to home health agencies (HHAs) on the timeframes related to OASIS Transmission. The waiver also allows Medicare Administrative Contractors to extend the auto-cancellation date of Requests for Anticipated Payment (RAPs) during emergencies. Please consult with your home health MAC for specific guidance.

Additionally, on March 10, 2020, CMS issued guidance [12] on addressing potential and confirmed COVID-19 cases and mitigating transmission including screening, treatment, and transfer to higher level care (when appropriate).

• Importantly, agencies are instructed to continue caring for patients with known or suspected COVID-19 in their homes depending on the severity of their symptoms and as long as the individual with support of the HHA can follow the infection prevention and control practices recommended by CDC.
• Specific instruction is also included for agencies to follow CDC Interim Guidance for Public Health Personnel Evaluating Persons Under Investigation (PUIs) and Asymptomatic Close Contacts of Confirmed Cases at Their Home or Non-Home Residential Settings when visiting the home of a patient suspected of COVID-19 exposure or confirmed exposure.
• HHAs are obligated to maintain appropriate PPE and alcohol-based hand rub supply levels, while assuring facilities they will not be cited by surveyors so long as they can demonstrate they are having difficulty obtaining the supplies for reasons outside their control. HHAs are advised to contact with their local and state public health agency to notify them of any shortage, follow national guidelines for optimizing their current supply, and identify the next best option to care for their residents.

VII.   Hospitals:

On March 4, 2020, CMS issued guidance[13] regarding infection control and prevention related to COVID-19 cases.  In addition, CMS has issued blanket waivers applicable to hospitals[14] addressing a number of issues.[17] Some of the most significant include:

• CMS is waiving the requirements that Critical Access Hospitals limit the number of beds to 25, and that the length of stay be limited to 96 hours.
• CMS is waiving requirements to allow acute care hospitals to house acute care inpatients in excluded distinct part units, where the distinct part unit’s beds are appropriate for acute care inpatient.
• CMS is waiving to allow acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit.
• CMS is waiving requirements to allow acute care hospitals with excluded distinct part inpatient Rehabilitation units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit.

VIII.   Coronavirus Related Waivers Issued by CMS to DME Suppliers:

A blanket waiver[15] has been issued by CMS as of March 13, 2020 to address lost, destroyed, irreparably damaged or otherwise unusable Durable Medical Equipment (DME).  DME Medicare Administrative Contractors (MACs) will have the flexibility to waive replacement requirements such that the face-to-face requirement, a new physician’s order, and new medical necessity documentation are not required. Suppliers must still include a narrative description on the claim explaining the reason why the equipment must be replaced and are reminded to maintain documentation indicating that the DMEPOS was lost, destroyed, irreparably damaged or otherwise rendered unusable or unavailable as a result of the emergency. Please check your DME MAC website for more information or contact Liles Parker for assistance.

IX.   Dialysis Facilities:

On March 10, 2020, CMS issued guidance[16] addressing potential and confirmed COVID-19 cases and mitigating transmission including screening, treatment, and transfer to higher level care (when appropriate).

X.   Conclusion:

Liles Parker attorneys and staff are closely monitoring HHS, CMS and CDC guidance and will update this article as new information becomes available. Please contact us with questions or for assistance with your response to this unprecedented National Emergency.

Jennifer Papapanagiotou is a Partner at Liles Parker, Attorneys & Clients at Law.  She has decades of experience representing health care providers and suppliers around the country in connection with a wide range of regulatory actions.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Jennifer for a free consultation.  She can be reached at:  1 (800) 465-1906.

[1] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, Issued on March 13, 2020.  A link to the declaration can be found here.

[2] Determination that a Public Health Emergency Exists, issued by Secretary Azar on January 31, 2020.  A link to the determination can be found here.

[3] ‘‘Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020.”  H.B. 6074

[4] Emergency Declaration Press Call Remarks by CMS Administrator Seema Verma, delivered March 13, 2020.  A link to the remarks can be found here.

[1] Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, can be found here. Frequently Asked Questions expanding on the fact sheet and giving more details on implementation can be found here.

[2] HHS’s Office of Civil Rights is maintaining a website with more information on this topic here.

[3] You can find CMS’ list of approved telemedicine services here.

[5] CMS’s telehealth resource page can be found here.  

[6] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here. Provider enrollment waivers of certain requirements are outlined in the guidance.

[7] Ibid. Waivers to the administrative claims appeals process are outlined on page 3 of the document.

[8] Memorandum titled “Suspension of Survet Activities,” dated March 4, 2020.  A copy of the Memorandum can be found here.

[9] CMS guidance titled “Updates for State Surveyors and Accrediting Organizations” can be found here.  

[10]CMS Memorandum titled Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED),” can be found here.

[11] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   Home health agency guidance is on page 3 of the Fact Sheet.

[12] CMS Memorandum titled Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs), was issued on March 10, 2020, and can be found here.

[13] CMS Memorandum titled Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” dated March 4, 2020, can be found here.  

[14] COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   Hospital guidance is on pages 1-3 of the Fact Sheet.

[15]COVID-19 Emergency Declaration Health Care Providers Fact Sheet, dated March 13, 2020, can be found here.   DME related guidance is on page 1 of the Fact Sheet.

[16] CMS issued guidance on March 10, 2020

[17]  Medicare Telemedicine Health Care Provider Fact Sheet, dated March 17, 2020, can be found here. Frequently Asked Questions expanding on the fact sheet and giving more details on implementation can be found here. 

[18] HHS’s Office of Civil Rights is maintaining a website with more information on this topic here.

[19] You can find CMS’ list of approved telemedicine services here.

[20]

Responding to a Medicare Revocation Action Effective Prior to November 4, 2019

(UPDATE:  March 9, 2020):  A Medicare revocation action can destroy the financial viability of your practice.  Moreover, effective November 4, 2019, the reasons for which a health care provider or supplier may have its Medicare billing privileges revoked have greatly expanded. Our article titled “42 CFR Sec. 424.535(a) Medicare Revocation Actions — Your Medicare Billing Privileges Can be Revoked For a Host of New Reasons. Are You Facing a Medicare Revocation Action? If so, You Must Act Fast to Preserve Your Appeal Rights,” discusses these revocation reasons in much more detail).  After reviewing the materials below, we strongly recommend that you also review the updated article linked above. 

The information in this article only applies to a Medicare revocation action with an effective of November 3, 2019 or earlier.  During 2015, more than 1.2 million non-institutional health care providers participated in the Medicare program. [1]  Over the last year, a number of these providers have unexpectedly found themselves in a difficult situation where their Medicare number has been either “deactivated” or “revoked.”  While Medicare deactivation actions remain somewhat rare, over the past year, the number of Medicare revocation actions taken by Medicare Administrative Contractors (MACs) appears to have greatly increased. Both of these actions will effectively suspend a provider’s ability to bill for services rendered to Medicare beneficiaries. In order to receive reimbursement for services rendered to Medicare beneficiaries, a provider must properly enroll in the Medicare program and remain compliant with all of its conditions of enrollment and participation requirements. [2] The purpose of this article is discuss the differences between these two types of adverse actions and possible remedial steps that you can take if your Medicare number is deactivated or revoked.

I.  What is a Medicare Revocation Action?

 When a health care provider’s Medicare number is revoked, its billing privileges are terminated.  Notably, the associated provider agreement is also automatically terminated. There are a wide variety of bases upon which a revocation action can be initiated.  The two primary reasons for revocation we have addressed in recent months have included licensure-based actions and those resulting from a provider’s failure to report an adverse action or change in location.

• Noncompliance. 

Unfortunately, if a physician, falls out of compliance with applicable enrollment requirements, his or her Medicare billing privileges may be revoked. Typically, revocation actions associated with this reason result from a determination by a Medicare contractor that a physician or his / her practice no longer meets all of the necessary registration requirements.  When this occurs, the contractor notifies the CMS Provider Enrollment & Oversight Group with the pertinent provider information and its recommendation that a revocation action be authorized.

For instance, Medicare requires that physician services be furnished by a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the state in which he or she practices. The Medicare Program Integrity Manual (MPIM) further elaborates on this basis for revocation in cases where a physician is not appropriately licensed: “…situations in which § 424.535(a)(1) may be used a revocation reason include [where]…[t]he provider or supplier is not appropriately licensed.” MPIM Ch. 15 § 15.27.2(A)(1)(c).

This basis for revocation is especially pertinent in a large state like Texas, where the Texas Medical Board remains active with respect to disciplinary actions.  At its June 10, 2016 meeting, the Texas Medical Board disciplined 78 licensed physicians and issued one cease and desist order. A significant number of these disciplinary actions resulted in licensure revocation or suspension.  Each of these adverse disciplinary actions would likely result in the revocation of a physician’s billing privileges.

• Failure to Report.

Should a provider fail to comply with its reporting requirements under 42 C.F.R. 424.516(d)(1)(ii) and (iii), which include “any adverse legal action” and / or “a change in location,” CMS may revoke the provider’s billing privileges.  Additional reasons for revocation we have seen also include:

• Provider or Supplier Conduct.

 Under this regulatory provision, if a provider (or supplier), or an owner, managing employee, authorized or designated official, medical director, supervising physician or other health care personnel of the provider (or supplier) is excluded from the Medicare, Medicare or other federal health care program, the provider’s Medicare number can be revoked and its billing privileges terminated.  This basis for revocation is especially harsh – it can be imposed based on the fact that a provider has failed to adequately screen out employees, staff and contractors that have been excluded from participation in one or more federal health benefit programs.  Debarment or suspension from federal procurement and nonprocurement programs can also result in revocation.

• Felonies.

If a provider (or supplier) or any owner or managing partner of the provider (or supplier) has been convicted of a federal or state felony within the past 10 years and CMS determines that the offense is detrimental to the best interest of the Medicare program, the agency may revoke the provider’s Medicare number.

• False or Misleading Information.

If a provider or supplier has certified as “true” false or misleading information on an enrollment application, its Medicare number may be revoked.  Importantly, such an action may also constitute a violation of criminal law due to the submission of a “false statement” to the government.

• On-Site Review.

If a program integrity contractor (such as a Unified Program Integrity Contractor (UPIC)) visits your office and makes a determination that your practice or agency is no longer operational or fails to meet another Medicare enrollment requirement, the UPIC will recommend to CMS that your Medicare billing privileges be revoked.  This often occurs when a provider moves offices and either fails to notify Medicare of the move in a timely fashion OR a Medicare contractor claims that it never received notice of the change in location.  Importantly, it isn’t merely enough for a provider to be able to show that notice of the change in location was actually sent – you need to be able to prove that the Medicare contractor RECEIVED the notice.

• Misuse of Billing Number. 

If a provider knowingly sells its billing number or allows another individual or entity to use its billing number, CMS can revoke the provider’s billing privileges.  Exceptions are permitted for a valid reassignment of benefits or a change of ownership.

• Abuse of Billing Privileges.

Should CMS determine that a provider has engaged in abusive billing practices, it can revoke the provider’s billing privileges.  Examples cited in the regulation include:

Billing for services provided to a Medicare beneficiary that is deceased.

Billing for services when either the physician or the beneficiary is not in the state or the country when the service was supposedly rendered.

Billing for services that require certain testing equipment when that equipment was not available at the location where the services were allegedly rendered.

CMS may also revoke a provider’s billing privileges if it determines there is a pattern or practice of submitting claims that fail to meet Medicare’s requirements.  When considering this basis for revocation, CMS considers:

The percentage of claims that were denied.

The reasons for claims denials.

Whether or not the provider has a history of previous final adverse actions.

The length of time over which a pattern or practice or improper billing has taken place.

How long the provider has been enrolled in the Medicare program.

Any other information that CMS feels is relevant in its determination of whether a pattern or practice of improper billing has occurred.

II.  What is the Effect of the Revocation of a Provider’s Billing Privileges?

The revocation of a provider’s billing privileges can destroy the provider’s practice.  A provider will be barred from participating in the Medicare program for a minimum of one to three years, depending on the basis for revocation and the facts in a particular case.  Once this period has expired, a provider will be required to submit a new enrollment application to CMS for its review and consideration.

III.  Responding to Medicare Revocation Action:

What actions should you take if your Medicare billing privileges have been revoked?  While a provider may choose to represent themselves in the appeal of a revocation action, we recommend that you engage experienced legal counsel to assist you with this process. A well written letter telling your side of the story is unlikely to persuade a reviewer at reconsideration that your billing privileges should be restored.  Successful defenses of revocation actions typically require a careful analysis of both the facts and the law.  Liles Parker attorneys have represented a wide variety of health care providers and suppliers in Medicare revocation actions.  Please give me a call for a free consultation on your case.

Robert W. Liles, M.B.A., M.S., J.D., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law. Liles Parker is a boutique health law firm, with offices in Washington DC, Houston TX, and Baton Rouge LA. Robert represents physicians and other health care providers around the country in connection with Medicare revocation actions. Our firm also represents health care providers in connection with federal and state regulatory reviews and investigations. For a free consultation, call Robert at: 1 (800) 475-1906.

[1] https://www.cms.gov/fastfacts/

[2]     42 C.F.R. § 424.505; MPIM Ch. 15 § 15.1.

42 CFR Sec. 424.535(a) Medicare Revocation Actions — Your Medicare Billing Privileges Can be Revoked For a Host of New Reasons. Are You Facing a Medicare Revocation Action? If so, You Must Act Fast to Preserve Your Appeal Rights.

(March 9, 2020):   Last September, the Centers for Medicare and Medicaid Services (CMS) published a Final Rule titled “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process.”  The Final Rule under 42 CFR Sec. 424.535(a) was published in order to implement sections 1866(j)(5) and 1902(kk)(3) of the Social Security Act (as amended by the Affordable Care Act).

As we discussed in earlier articles[1], the Final Rule is quite expansive. It implements a wide range of new enrollment, affiliation, revocation and denial authorities.  As a reminder, here’s an overview of the timeline we are concerned with:

• November 4, 2019: Purported effective date of the expanded revocation bases outlined in the Final Rule. 

• September 10, 2019: CMS published the Final Rule titled “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process.” in the Federal Register. [2]  The Final Rule sets out the expanded reasons for revocation or denial of a provider’s or supplier’s billing authority.  

• March 1, 2016: CMS published a Proposed Rule titled “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process.”[3] This Proposed Rule set out the enrollment revocation and denial changes CMS planned to implement in an effort to address long-standing program integrity risks that have previously been exploited in the past.

Within hours of the purported[4] effective date of the Final Rule, CMS Medicare Administrative Contractors (MACs) began issuing revocation letters to participating Medicare providers and suppliers who had been identified as slated to have their Medicare billing privileges revoked (based on one or more of the expanded revocation letters set out in the Final Rule).  This updated article focuses on one aspect of the Final Rule – the expanded Medicare billing privilege revocation authorities now exercised by CMS.

I.   Implementation of Medicare’s Expanded Billing Privilege Revocation Authorities Under 42 CFR Sec. 424.535(a):

Prior to the issuance of the Final Rule, under 42 CFR Sec. 424.535(a), CMS exercised the authority to revoke the Medicare billing privileges of a currently-enrolled provider or supplier (along with any related provider or supplier agreement) based on fourteen reasons.  Under the Final Rule, the number of reasons upon which revocation could be based grew to 22.[5]  Moreover, the scope of several of the original fourteen reasons for revocation was expanded under the Final Rule, primarily due to implementation of new requirements with respect to “Affiliations,” “Disclosable Events,” and “Uncollected Debts.”  Over the last few months, since the expanded bases for revocation have been implemented, we have seen a significant increase in the number of revocation actions being pursued by Medicare MACs around the country. Moreover, as discussed in Section III below, CMS is now typically imposing a 10-year reenrollment bar (rather than the previous 3-year reenrollment bar) when pursuing a revocation action. An overview of the expanded list of reasons upon which a provider’s Medicare billing privileges can be revoked is provided below:

1. Noncompliance. Under 42 CFR Sec. 424.535(a) (1), CMS can revoke Medicare billing privileges if it has determined that a provider or supplier is not in compliance with its enrollment requirements (as set out in the appropriate enrollment application) AND has not submitted an appropriate plan of correction, CMS may revoke the Medicare billing privileges.

2. Provider or supplier conduct. Under 42 CFR Sec. 424.535(a) (2), CMS can revoke Medicare billing privileges if a provider, supplier or any owner, managing employee, delegated official, medical director, supervising physician or other health care personnel of the provider or supplier has been excluded from participation in a Federal health care program OR has been disbarred, suspended, otherwise excluded from participating in any other Federal procurement program. 

3. Felonies.  Under 42 CFR Sec. 424.535(a) (3), CMS can revoke Medicare billing privileges if a provider, supplier or any owner or managing employee was convicted of a Federal or State felony (within the preceding 10 years) that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries. 

4. False or misleading information. Under 42 CFR Sec. 424.535(a) (4), CMS can revoke Medicare billing privileges if a provider or supplier certified as “true” information on the enrollment application that is misleading or false. As the regulation is quick to point out, the false certification action can also lead to fines and imprisonment. 

5. On-site review. Under 42 CFR Sec. 424.535(a) (5), CMS can revoke Medicare billing privileges if when conducting an “on-site review” at the purported address of the provider or supplier, it finds that the site is no longer operational OR the on-site review shows that the provider has moved and did not update their address appropriately. In recent years, this revocation reason is typically cited when a Unified Program Integrity Contractor (UPIC) conducts an unannounced, on-site visit of a practice, home health agency, hospice or other provider, based on the location listed in PECOS.  If a provider has moved offices and has failed to update CMS Form 855B and the Provider Enrollment, Chain, and Ownership System (PECOS), the CMS contractor will recommend that a provider’s billing privileges be revoked. 

6. Grounds related to provider or supplier screening requirements. Under 42 CFR Sec. 424.535(a) (6),  CMS can revoke the Medicare billing privileges of an institutional provider[6] that fails to submit an application fee or hardship exception request with their Medicare revalidation application.

7. Misuse of billing number.  Under 42 CFR Sec. 424.535(a) (7), CMS can revoke Medicare billing privileges if a provider or supplier knowingly sells to or allows another individual or entity to use its billing number (other than in the case of a valid reassignment of benefits). 

8. Abuse of billing privileges. Under 42 CFR Sec. 424.535(a) (8), CMS can revoke the Medicare billing privileges of a provider or supplier: 

• • Submits a claim for services that have not been furnished to a specific individual on the date of service. Examples provided under 42 CFR scc. 424.535(a) (8) include situations where beneficiary is deceased, situations where the directly physician or beneficiary is not in the state or country when the serves were allegedly furnished, OR when the equipment necessary for testing is not present when the testing is said to have taken place.
  • Has a pattern or practice of submitting claims that fail to meet Medicare requirements.[7]

9. Failure to report[8]. Under 42 CFR Sec. 424.535(a) (9), can revoke the Medicare billing privileges if a provider or supplier: 

• • Failed to comply with its reporting requirements under 42 CFR Se. 516(d), such as changes in ownership or control, any other changes in enrollment within 90 days, any revocation or suspension of a Federal or State license within 30 days; OR
  • Failed to comply with its reporting requirements under 42 CFR Sec. 33(g)(2), such as changes in ownership, changes of location, changes in general supervision, and adverse legal actions must be reported to the Medicare fee-for-service contractor on the Medicare enrollment application within 30 calendar days of the change. All other changes to the enrollment application must be reported within 90 days. As a recent letter to a provider from CMS contractor Novitas Solutions stated:

 “An undeliverable records request sent to the provider’s Medicare 855 correspondence address constitutes a failure to provide CMS access to documentation in violation of 42 U.S. Code Sec. 424.516(1).”  

            OR

• •  Failed to comply with its reporting requirements under 42 CFR Sec. 424.57(c)(2), such as changes in information on a provider’s application for billing privileges within 30 days of the change. 

10. Failure to document or provide CMS access to documentation. Under 42 CFR Sec. 424.535(a) (10), CMS can revoke the Medicare billing privileges if a provider or supplier has failed to comply with the documentation or CMS access requirements. Under 42 CFR Sec. 516(f), a provider or supplier is required to maintain documentation for 7 years from the date of services, AND upon the request of CMS or Medicare contractors, provide access to that documentation. 

11. Initial reserve operating funds. Under 42 CFR Sec. 424.535(a) (11), CMS can revoke the Medicare billing privileges of a home health agency if within 30 days of CMS or a Medicare contractor request, the home health agency cannot furnish supporting documentation verifying that the home health agency  meets the initial reserve operating funds requirement found in 42 CFR Sec. 489.28(a). 

12. Other program termination. Under 42 CFR Sec. 424.535(a) (12), CMS can revoke Medicare billing privileges if a provider or supplier is terminated, revoked or otherwise barred from participation in a State Medicaid program or any other Federal health care program. This represents a significant change.

13. Prescribing authority. Under 42 CFR Sec. 424.535(a) (13), CMS can revoke Medicare billing privileges if a physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration is revoked or suspended; OR a State licensing body suspends or revokes the ability of a physician or other eligible professional to prescribe drugs.

14. Improper prescribing practices. Under 42 CFR Sec. 424.535(a) (14), CMS can revoke Medicare billing privileges of a physician or other eligible professional if it determines that there has been a pattern or practice of prescribing Part B or Part D drugs that is:

• • Abusive or represents a threat to the health and safety of Medicare beneficiaries or both; OR
  • Fails to meet Medicare requirements.

15. Reserved.

16. Reserved.

17. NEW — Debt referred to the United States Department of Treasury. Under 42 CFR Sec. 424.535(a) (17), CMS can revoke Medicare billing privileges if a provider or supplier has an existing debt that CMS appropriately refers to the United States Department of Treasury.[9]

18. NEW — Revoked under different name, numerical identifier or business identity. Under 42 CFR Sec. 424.535(a) (18) CMS can revoke the Medicare billing privileges if a provider or supplier is currently revoked under a different name, numerical identifier, or business identity, and the applicable reenrollment bar period has not expired. [10]

19. NEW — Affiliation that poses an undue risk. Under 42 CFR Sec. 424.535(a) (19), CMS may revoke the Medicare billing privileges if it determines that the provider or supplier has or has had an affiliation under 42 CFR Sec. 424.519 that poses an undue risk of fraud, waste, or abuse to the Medicare program.

20. NEW — Billing from a non-compliant location. Under 42 CFR Sec. 424.535(a) (20), CMS may revoke the Medicare billing privileges of a provider or supplier, even if all of the practice locations associated with a particular enrollment comply with Medicare enrollment requirements, if the provider or supplier billed for services performed at or items furnished from a location that it knew or should have known did not comply with Medicare enrollment requirements.[11]

21. NEW Abusive ordering, certifying, referring, or prescribing of Part A or B services, items or drugs. Under 42 CFR Sec. 424.535(a) (21), CMS may revoke the Medicare billing privileges if it determines that a physician or eligible professional has a pattern or practice of ordering, certifying, referring, or prescribing Medicare Part A or B services, items, or drugs that are abusive, represents a threat to the health and safety of Medicare beneficiaries, or otherwise fails to meet Medicare requirements.[12]

22. NEW — Patient Harm. Under 42 CFR Sec. 424.535(a) (22), CMS may revoke the Medicare billing privileges if it determines that a physician or eligible professional has been subject to prior action from a State oversight board, Federal or State health care program, Independent Review Organization (IRO) determination(s), or any other equivalent governmental body or program that oversees, regulates, or administers the provision of health care with underlying facts reflecting improper physician or other eligible professional conduct that led to patient harm.[13]

As the above expanded list of revocation authorities reflects, CMS now has the express ability to revoke the Medicare billing privileges of a health care provider or supplier for serious violations of law (such as conviction of a felony or patient abuse).  However, it also has the authority to revoke Medicare billing privileges for conduct that may only amounts to an administrative error or mistake by a provider or supplier.  Perhaps even more troubling is the fact that the past or current “affiliations” of a provider or supplier may lead to a revocation action if CMS determines that the affiliation represents an undue risk to the Medicare program or its beneficiaries.

A hundred years ago, the U.S. Supreme Court stated in the case Rock Island Arkansas & Louisiana R. Co v. United States[14]:

“Men must turn square corners when they deal with the government“

That statement still rings true in today’s world.  Health care providers and suppliers are permitted to apply to participate in the Medicare and Medicaid programs.  Participation isn’t a “right.”  It is a privilege.  When you complete your enrollment paperwork, you expressly agree to comply with the terms of the Form 855 Enrollment Application.  Should you fail to comply with each of the obligations set out in that agreement, CMS reserves the right to revoke your Medicare billing privileges. Now, more than ever, it is essential that you have an effective Compliance Program in place and that you periodically review your practices to ensure that you and your staff are fully complying with applicable Medicare regulatory, statutory and legal requirements.

II.   Length of Time a Provider’s Medicare Billing Privileges May be Revoked Under 42 CFR Sec. 424.535(c):

The Final Rule significantly modified 42 CFR Sec. 424.535(c). This regulatory provision sets out the potential reenrollment bar time limits that may imposed by CMS when initiating a Medicare revocation action.  If this is the first time that a provider’s Medicare billing privileges are being revoked, the minimum reenrollment bar is 1 year, and the maximum reenrollment bar is 10 years.[15]  If CMS determines that a provider attempted to “circumvent its existing reenrollment bar by enrolling in Medicare under a different name, numerical identifier or business identity,” the agency can further tack on up to 3 additional years onto the reenrollment bar it has imposed.[16] As a final point in this regard, Moreover, under if a provider or supplier is being revoked from Medicare a second time, CMS may choose to impose a reenrollment bar of up to 20 years.[17]

III.   Responding to a Medicare Revocation Action:

If you receive notice that CMS is intending to revoke your Medicare billing privileges, it is essential that you engage experienced health law counsel to represent you in the appeal process.  This is especially critical given the fact that recent revocation actions initiated by CMS have all sought to impose of reenrollment bar of 10 years, rather than the 3-year bar that was typically imposed prior to November 4, 2019.  Unfortunately, a Medicare revocation action can trigger a number of other secondary adverse actions by law enforcement, private payors and a provider’s State Medical Board. If your Medicare billing privileges are being revoked, please feel free to give us a call for a free consultation.  Liles Parker attorneys have extensive experience representing health care providers around the country in Medicare revocation actions.  We can be reached at:  1 (800) 475-1906.

Robert W. Liles is a former Federal prosecutor and has more than 25 years of health law experience.  Mr. Liles and the other attorneys at Liles Parker have extensive experience representing providers and suppliers in the appeal of proposed Medicare revocation actions. Questions?  Give Robert Liles a call.  For a free consultation, he can be reached at:  1 (800) 475-1906.

[1] September 2019 article titled “Medicare, Medicaid and CHIP Enrollment Revocation and Denial Authorities Have Expanded.  What Steps are You Taking to Reduce Your Level of Risk?”

and our December 2017 article titled “Revocation of Your Medicare Billing Privileges.”

[2] 84 FT 47794 (September 10, 2019). https://www.govinfo.gov/content/pkg/FR-2019-09-10/pdf/2019-19208.pdf

[3] 81 FR 10720.

[4] We are in currently in the process of challenging the purported effective date of November 4, 2019.  CMS failed to provide the proper notice requirements mandated under the Congressional Review Act.  This failure thereby delays the effective date of the expanded revocation authorities.

[5] Slots have been placed in reserve for revocation reasons number 15 and 16 which would likely be assigned by CMS in the future and would presumably go through the rulemaking process.

[6] Under 42 CFR Sec. 424.502, the term “Institutional Provider” means any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and nonphysician practitioner organizations), CMS-855S, CMS-20134, or an associated Internet-based PECOS enrollment application.

[7] Under 42 CFR Sec. 424.535(a) (8), when making this determination, CMS considers:

• The percentage of submitted claims that were denied;
• The reasons for the denials; whether the provider has a history of final adverse actions (and the nature of these actions;
• The length of time over which the pattern has continued; how long the provider has been enrolled in Medicare; and
• Any other information that CMS deems relevant to its determination of whether the provider or supplier has or has not engaged in the pattern or practice identified.

[8] Under 42 CFR Sec. 424.535(a)) (9), when determining whether a revocation under this paragraph is appropriate, CMS considers the following factors:

(i) Whether the data in question was reported.

(ii) If the data was reported, how belatedly.

(iii) The materiality of the data in question.

(iv) Any other information that CMS deems relevant to its determination.

[9] Under 42 CFR Sec. 424.535(a) (17), when determining whether a revocation under this paragraph is appropriate, CMS is supposed to consider:

• The reason(s) for the failure to fully repay the debt (to the extent this can be determined).
• Whether the provider or supplier has attempted to repay the debt (to the extent this can be determined).
• Whether the provider or supplier has responded to CMS’ requests for payment (to the extent this can be determined).
• Whether the provider or supplier has any history of final adverse actions or Medicare or Medicaid payment suspensions.
• The amount of the debt. (vi) Any other evidence that CMS deems relevant to its determination.

[10] Under 42 CFR Sec. 424.535(a) (18), when determining whether a provider or supplier is a currently revoked provider or supplier under a different name, numerical identifier, or business identity, CMS investigates the degree of commonality by considering the following factors:

• Owning and managing employees and organizations (regardless of whether they have been disclosed on the Form CMS–855 application).
• Geographic location.
• Provider or supplier type.
• Business structure.
• Any evidence indicating that the two parties are similar or that the provider or supplier was created to circumvent the revocation or reenrollment bar.

[11]  Under 42 CFR Sec. 424.535(a) (20), when determining whether and how many of the provider’s or supplier’s enrollments, involving the non-compliant location or other locations, should be revoked, CMS considers the following factors:

• The reason(s) for and the specific facts behind the location’s noncompliance.
• The number of additional locations involved.
• Whether the provider or supplier has any history of final adverse actions or Medicare or Medicaid payment suspensions.
• The degree of risk that the location’s continuance poses to the Medicare Trust Funds.
• The length of time that the noncompliant location was non-compliant.
• The amount that was billed for services performed at or items furnished from the non-compliant location.
• Any other evidence that CMS deems relevant to its determination.

[12] Under 42 CFR Sec. 424.535(a) (21), when making its determination as to whether such a pattern or practice exists, CMS considers the following factors:

(i) Whether the physician’s or eligible professional’s diagnoses support the orders, certifications, referrals or prescriptions in question.

(ii) Whether there are instances where the necessary evaluation of the patient for whom the service, item or drug was ordered, certified, referred, or prescribed could not have occurred (for example, the patient  was deceased or out of state at the time of the alleged office visit).

(iii) The number and type(s) of disciplinary actions taken against the physician or eligible professional by the licensing body or medical board for the state or states in which he or she practices, and the reason(s) for the action(s).

(iv) Whether the physician or eligible professional has any history of final adverse action (as that term is defined in Sec. 424.502).

(v) The length of time over which the pattern or practice has continued.

(vi) How long the physician or eligible professional has been enrolled in Medicare.

(vii) The number and type(s) of malpractice suits that have been filed against the physician or eligible professional related to ordering, certifying, referring or prescribing that have resulted in a final judgment against the physician or eligible professional or in which the physician or eligible professional has paid a settlement to the plaintiff(s) (to the extent this can be determined).

(viii) Whether any State Medicaid program or any other public or private health insurance program has restricted, suspended, revoked, or terminated the physician’s or eligible professional’s ability to practice medicine, and the reason(s) for any such restriction, suspension, revocation, or termination.

[13] Under 42 CFR Sec. 424.535(a) (21), when determining whether a revocation is appropriate, CMS considers the following factors:

(A) The nature of the patient harm.

(B) The nature of the physician’s or other eligible professional’s conduct.

(C) The number and type(s) of sanctions or disciplinary actions that have been imposed against the physician or other eligible professional by the State oversight board, IRO, Federal or State health care program, or any other equivalent governmental body or program that oversees, regulates, or administers the provision of health care. Such actions include, but are not limited to in scope or degree:

(1) License restriction(s) pertaining to certain procedures or practices.

(2) Required compliance appearances before State medical board members.

(3) License restriction(s) regarding the ability to treat certain types of patients (for example, cannot be alone with members of a different gender after a sexual offense charge).

(4) Administrative or monetary penalties.

(5) Formal reprimand(s).

(D) If applicable, the nature of the IRO determination(s).

(E) The number of patients impacted by the physician’s or other eligible professional’s conduct and the degree of harm thereto or impact upon.

[14] 254 U.S. 141, 143 (1920).

[15] 42 CFR Sec. 424.535(c)(1)(i).

[16] 42 CFR Sec. 424.535(c)(2)(i).

[17] 42 CFR Sec. 424.535(c)(3),

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