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We Defend Healthcare Providers Nationwide in Audits & Investigations.

Chiropractor Owned Multidisciplinary Practices are at a Higher Risk of Audit

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(January 13, 2021):  Over the last few years, we have noted a significant increase in the number of audits initiated against Chiropractor owned multidisciplinary practices.  Typically, these integrated medical practices and clinics employ at least one Chiropractor (typically in an ownership or managerial capacity), along with multiple Doctors of Medicine (MDs), Doctors of Osteopathy (DOs). Physician-extenders such as Nurse Practitioners (NPs) and Physician Assistants (PAs) are also commonly employed in these multidisciplinary practices and clinics.

The purpose of this article is to examine Chiropractor owned multidisciplinary practices which employ MDs, DOs and physician extenders in order to provide a wide range of care and treatment services.  While there are a number of benefits to such a model, both State regulatory entities and Federally-contracted Unified Program Integrity Contractors (UPICs) working for the Centers for Medicare and Medicaid services (CMS) have shown their concern regarding these organizations.  Depending on the jurisdiction, a number of State regulatory entities have questioned the appropriateness of the model itself.  UPICs and other CMS Medicare contractors have initiated (or, in some cases, are in the process of initiating) a review or audit of various claims submitted to Medicare for coverage and payment.

I. Why have Chiropractors Worked to Integrate Other Medical Services Into Their Practice?

While you may disagree, it has been our observation that many Chiropractors have an entrepreneurial spirit.  This has manifested itself in a growing number of Chiropractor owned multidisciplinary practices which provide health care services other than merely those associated with chiropractic care.  Depending on the State, integrating other medical services into a chiropractic practice isn’t always easy – there are often a number of statutory and / or regulatory barriers to be overcome. Examples of the Chiropractor owned multidisciplinary practices we have recently seen have included:

  • Pain management clinics.
  • Multidisciplinary clinics which also offer complimentary and alternative medicine therapy options.
  • Industrial medicine clinics (often focusing on Workman’s Compensation cases).
  • Orthopedic clinics focusing on back injuries, spinal compression problems and victims of automobile accidents.

Chiropractic practices choosing to transition over to a multidisciplinary model have often found that they are better equipped to address the health problems of their patients.  This is often due to the fact that an integrated DC / MD practice typically greatly expands the scope of care and treatment services available to patients. This multidisciplinary approach provides patients with a convenient one-stop care and treatment option.

From a financial standpoint, Chiropractor owned multidisciplinary practices have also found that this business model opens up a number of previously-unavailable opportunities.  As you are aware, only a few chiropractic services qualify for coverage and payment under Medicare.  While private payor plans typically cover a somewhat wider scope of services, many Chiropractors have essentially built their business on cash-pay patients.  The addition of MDs, DOs and physician extenders has permitted integrated practices to expand their scope of medically-reimbursable services, many of which now qualify for coverage and payment by Medicare and  private payor programs.  While there are both patient-care and financial benefits to the integrated, multi-disciplinary model, there are also a number of challenges you should consider prior to setting up this type of practice or clinic.

II.  Challenges to be Considered:

A.     State Regulatory Considerations.

Depending on the State, it may be illegal for anyone other than a medical physician to own a medical practice.  For example, many jurisdictions still prohibit the “Corporate Practice of Medicine.” In such States, it is illegal for a corporation to practice medicine.  Moreover, a corporation cannot employ a physician to provide medical care and treatment services.

Although every State is different, if your State prohibits the Corporate Practice of Medicine, it may be against the law for a corporation or for a non-physician individual (including a Chiropractor) to own or control a physician practice or clinic which provides professional physician services.  Therefore, we strongly recommend that prior to setting up a Chiropractor-owned, multidisciplinary practice or clinic, you should contact a qualified health lawyer to assist you maneuvering through the myriad statutory and regulatory requirements governing this complex area of law.  As a final point in this regard, should you choose to set up an integrated practice or clinic, it is essential that you have a full understanding of both your State’s Chiropractic Practice Act and the Medical Practice Act governing the physicians you intend to employ.

B.    Current Audit Challenges.

Over the last few years, many providers, including Chiropractor owned multidisciplinary practices, have been advised that their claims are being placed on prepayment review or that their prior-paid claims are being be subjected to a postpayment audit by a “Unified Program Integrity Contractor (UPIC), such as Qlarant, Safeguard Services or CoventBridge. [1]  Most of these CMS program integrity contractor audit actions have been generated as a result of data-mining.  Other reasons for audit and / or review have included: patient complaints, competitor complaints and referrals from State Medical Boards.  Regardless of the reason for audit, if your integrated practice or clinic is audited, it is essential that you engage qualified health law counsel to advise you on your options for responding to an inquiry by a UPIC.  For a detailed discussion of the current UPIC audit environment, please see our article titled “A UPIC Audit is Serious Business — Is Your Office Prepared?”  [2]

Prepayment Reviews:  Unlike postpayment overpayment assessments, there is not an effective administrative overpayment process for health care providers placed on prepayment review.  We recommend that you consult with legal counsel if your practice is placed on prepayment review.  There are three points to keep in mind in such cases:

(1) It is often in your best interest to continue to submit claims for review and not hold them.  Even if they are denied, at least you can initiate the postpayment appeals process as soon as possible and hopefully begin to restore cash flow;

(2) It is often helpful to engage qualified health law counsel to review your claims and generate a report that can be sent to the UPIC, pointing out that the claims do, in fact, qualify for coverage and payment.

(3) Think outside of the box—no provider can survive on prepayment review over a long period if a significant portion of their payor mix is Medicare.  Contact your health law counsel to discuss possible options for seeking remedial action to have the prepayment review lifted.

Postpayment Audits: Over the last decade, program integrity contractors (such as UPICs) have aggressively pursued alleged Medicare overpayments from Chiropractors, Physicians and other health care providers around the country.  Specific actions taken have included:

(1)  Using statistical sampling and extrapolation.  While the Medicare Program Integrity Manual sets out the basic requirements for a UPIC to conduct a statistical sampling, these contractors have been known to have deviated from the sampling methodologies proscribed by CMS.

(2)  UPIC reviews have often alleged significant claims coverage concerns.  Identified error rates of 100% by UPICs are not uncommon.  They then seek a full refund of all claims submitted by an individual provide.

(3)  Multiple errors often identified. Due to the massive amount of minute technical requirements imposed on providers, UPICs are often able to identify and allege multiple technical and substantive errors in many of the claims which they review.

Medicare Revocation Actions:  Over the last year, we have seen a sharp increase in the number of Medicare revocation actions taken.  The reasons for revocation have varied but have typically been associated with alleged violations of a health care provider’s participation agreement.  In some cases, the UPIC contractors found that the provider had moved addresses and had not properly notified Medicare.  In other cases, a health care provider was alleged to have not been cooperative or refused to participate in a site visit.  As a participating provider in the Medicare program, your organization must fully meet each of its obligations under the agreement in order to remain in the program.

UPIC Referrals for Civil and Criminal Enforcement:  UPICs are actively referring health care providers to law enforcement agencies such as the Office of Inspector General (OIG) and the  Department of Justice (DOJ) for possible civil and / or criminal enforcement) when a case appears to entail more than a mere overpayment.  However, just because a referral is made doesn’t mean that it will be prosecuted.  In many instances, OIG and / or DOJ will decline to open a case for a variety of reasons (such as lack of evidence, insufficient damages, etc.). 

What Sources of Coding / Billing Data are used by UPICs?  UPICs are required to use a variety of proactive and reactive techniques to identify and confront any potentially improper or fraudulent practices.  As set out in Chapter 2 of the Medicare Integrity Policy Manual (MIPM), UPICs have  utilize a wide variety of data sources. 

III.  Final Thoughts:

Chiropractor-owned multidisciplinary practices and clinics currently appear to be under the proverbial microscope While there is little, if any, action that can reduce your likelihood of being targeted for an audit due to data-mining, there are a number of effective steps that you can reduce your risk of liability if an audit or investigation is initiated.  The design, implementation and adherence to provisions set out in an effective compliance plan can greatly improve your efforts to fully meet your statutory and regulatory requirements under the law.

Healthcare LawyerRobert W. Liles, JD, MBA, MS, CPC, serves as Managing Partner at the health law firm of Liles Parker, Attorneys and Counselors at Law.  Robert represents Chiropractors and other health care providers around the country in connection with UPIC audits, DOJ investigations, State Medical Board disciplinary, and other health law related issues.  Please give Robert a call for free consultation.  He can be reached at:  1 (800) 475-1906.


[1] Qlarant, Safeguard Services and CoventBridge are the current program integrity contractors that have been awarded contracts as Unified Program Integrity Contractors (UPICs) by the Centers for Medicare and Medicaid Services (CMS).

[2]  A copy of this article can be found at the following link.

[3] CMS, Medicare Program Integrity Manual, § 2, available at this link.

Preparing for a UPIC Audit? Examine These Eight Claim Elements

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Preparing for a UPIC Audit(Updated January 9, 2021):  Each year, our attorneys and paralegals review and assess literally thousands of Medicare claims which have been audited (and denied) by Unified Program Integrity Contractors (UPICs) and other contractors working for the Centers for Medicare and Medicaid Services (CMS).  Are you preparing for a UPIC audit?  If your Medicare or Medicaid claims haven’t already been audited by a UPIC, chances are that it will eventually happen. As UPIC audits increase during 2021, it is essential that health care providers and suppliers review their processes to better ensure that services and supplies billed to Medicare and Medicare fully comply with applicable coverage, coding and billing requirements.  While defending physicians and other health care providers in UPIC audits and government reviews, we have identified a relatively straight-forward approach for determining whether a particular claim qualifies for coverage and payment.  Generally, we refer to this approach as an examination of the “Eight Elements of a Payable Claim.Notably, this has proven to be extremely helpful tool when developing an effective Compliance Plan for a client.  As set out below, physicians and other non-hospital health care providers can often use this approach to determine whether specific services billed to the Medicare and Medicaid programs.

I.  Assessing Your Claims — Preparing for a UPIC Audit:

A discussion of the eight elements which must be carefully assessed for each and every claim is provided below.  This is especially when you are preparing for a UPIC audit of the medical services or supplies you have billed to the Medicare and Medicaid programs.

Element #1: Medical Necessity — In addressing this element, a treating health care provider should ask the following question: Were the services administered medically necessary?”

Just because a certain treatment regime is medically necessary does not mean that it will be covered by Medicare or Medicaid.  We believe that this element constitutes the most important question to be answered by a provider.  Government payors only cover medically necessary services and supplies.

Element #2: Services Were Provided The second issue addressed is whether the services at issue were actually provided.

As you can imagine, regardless of the fact that services ordered were medically necessary, the services must actually be provided in order for those services to be billed and paid.  When you are preparing for a UPIC audit, as part of your internal auditing and monitoring, should you find instances where you cannot show that a medical service or piece of durable medical equipment was provided, you must return any funds that have been received.  Equally important, medical services must actually be provided at a level of quality consistent with Medicare’s expectations or the expectations of the covering payor.

Element #3 No Statutory Violations Are the services “tainted” by any statutory or regulatory violation, such as the Stark Law, Federal Anti-Kickback or a False Claims Act violation?

Remember, a UPIC is specifically instructed to detect and refer instances of fraud, waste and abuse. [1]  When you are preparing for a UPIC audit, your review of claims should not be limited to merely a review of the documentation.  You need to also examine your organization’s business relationship and business practices.  For example, is there any evidence that the service or supplies are linked in any way to a breach of the Federal Anti-Kickback Statute or Stark’s prohibition against improper self-referrals?  Similarly, is the service or claim associated with a possible violation of the civil False Claims Act? In recent years, we have see an increasing number of cases where otherwise payable claims were tainted due to the fact that the referring or servicing provider was excluded from participation in the Medicare or Medicaid programs. [2]  The bottom line is fairly straight-forward: it is insufficient to merely show that a claim appears to meet the government payor’s basic medical necessity, billing and coding rules. You need to also verify that the way the business was generated or referred was proper and not due to a statutory violation.

Element #4:  Meets all Coverage Rules – Do the services meet Medicare’s coverage requirements?

The next point to be addressed when auditing a claim is to determine whether or not it is covered by Medicare or Medicaid.  It is important to keep in mind that a medical service or supplies can be medically necessary yet still not qualify for coverage and payment.   Ultimately, every service or claim, regardless of whether the beneficiary is a Medicare or a Medicaid plan participant, must be examined to see if it qualifies for coverage.

Element #5Full and Complete Documentation – Have the services rendered been properly and fully documented?

It is essential that you pull each and every regulatory issuance, along with any guidance issued by the state which sets out the documentation requirements associated with a particular service or claim.  After auditing literally thousands of claims, we have found that over a majority of the health care providers we have audited have never fully researched and reviewed applicable  documentation requirements.  As UPIC clinical reviewers of both Medicare and Medicaid claims are quick to state in hearings before an Administrative Law Judge (ALJ), “If it isn’t documented, it didn’t happen.”   When made during an ALJ hearing by a UPIC, this point is quite effective—it is extremely difficult for a provider to prove that a service was provided if there is insufficient documentation of the work conducted in the patient’s medical records.  Therefore, research, review, and confirm the precise documentation requirements to be met, then ensure that you take the time to fully and accurately document the work you have performed.

UPIC auditors are excellent at identifying one or more ways in which your claims do not meet applicable coverage requirements.  While you may very well disagree with their assessments, especially in “medical necessity” determinations (when you file a request for redetermination appeal and later, a request for reconsideration appeal), you will find that your Medicare Administrative Contractor (MAC) and your Qualified Independent Contractor (QIC) agree with the UPIC’s denial decision.  Rather than endure significant costs and stress when defending against an overpayment assessment, you need to take steps to avoid a denial in the first place.  To that end, health care providers should ensure that clinical staff members are fully trained and educated regarding Medicare’s documentation, coding, and billing processes.  It is very important that you show your clinicians that UPICs  enforce a strict application of Medicare’s documentation and coverage requirements.

Element #6: Proper Coding – Were the services rendered correctly coded?

Unfortunately, even if the foregoing rules have been met, it is quite simple to make a coding mistake, therefore invalidating the claim.  The coding rules are both complicated and dynamic, potentially changing from year to year.  We recommend that you either engage a qualified third-party billing company to assist you with coding and billing or ensure that your in-house staff members handling these duties are experienced and provided regular opportunities for updated training.

Element #7: Proper Billing Practices – Were the services rendered correctly billed to Medicare?

As a final requirement, health care providers must ensure that the services or claims performed fully meet Medicare or Medicaid;s billing rules.  Once again, you need to ensure that your staff is properly trained to handle the organization’s billing responsibilities. As you review your billing practices, you should abide by the following:  First, “If it doesn’t belong to you, give it back.” [3] Conversely, if you don’t owe the money, don’t automatically throw in the towel.  Discuss these claims with our attorneys to determine if there may be other arguments in support of payment that may be asserted.  

II.  Final Considerations — UPIC Audits:

The likelihood that your practice or organization will be subjected to a Medicare or Medicaid audit is increasing every day.  As a participating provider in one or more Federal health care programs, you have an affirmative obligation to ensure that your claims are properly provided, documented, coded, and billed.  Unfortunately, many health care providers have never researched and reviewed the proper rules covering the care and treatment services they provide.  When conducting a “GAP Analysis” [4] of your organization, a sample of your claims is an important proactive step you can take to help ensure that your current practices are fully compliant with applicable laws and regulations; such analyses do not have to be statistically significant.  Should you identify deficiencies, remedial steps should be taken (immediately) so that future claims for care and treatment will meet all applicable requirements.  Keep in mind—any identified overpayments must be repaid promptly to the government in order to avoid possible False Claims Act liability.

Healthcare LawyerRobert W. Liles represents health care providers in UPIC Medicare and Medicaid audits. In addition, Robert counsels clients on regulatory compliance issues, performs GAP analyses, conducts internal reviews, and trains healthcare professionals on various legal and compliance issues Do you need help preparing for a UPIC audit? Call Robert for a free consultation: 1 (800) 475-1906.


[1] A detailed discussion of the UPIC audit process can be found at the following link.

[2]  For an overview of the impact of an “exclusion” action, please see Paul Wiedenfeld’s article titled “A Provider’s Guide to OIG Exclusions.”

[3] A detailed discussion of a provider’s repayment obligations when an overpayment has been identified can be found at this link.

[4]  For a detailed discussion on how to conduct a “GAP Analysis” of your health care claims, please see our page titled: “How to Conduct a GAP Analysis of Your Health Care Practice.”

Audits of Respiratory (CPT Code 87633) / Gastro (CPT Code 87507) Panels are Ongoing.

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(January 3, 2021):  In recent months, we have seen a significant rise in the number of Medicare and Medicaid audits focusing on the medical necessity of certain outpatient Respiratory Viral Panels (CPT Code 87633) and Gastrointestinal Pathogen Panels (CPT Code 87507).  Unfortunately, many of these audits seem to be merely the latest example where payors have conflated the issues of “Medical Necessity” and “Coverage.”  In this article, we examine a number of the laboratory tests currently being audited by Medicare and Medicaid payors and we discuss why the government’s crack-down on respiratory and gastrointestinal testing may be ill-advised.  Specific outpatient respiratory tests currently being scrutinized include:

CPT Code 87631 (Respiratory Virus Panel.  3-5 Targets)

CPT Code 87632 (Respiratory Virus Panel. 6-12 Targets)

CPT Code 87633 (Respiratory Virus Panel.  12-20 Targets)

Specific outpatient gastrointestinal tests currently being audited include:  

CPT Code 87505 (Infectious agent detection by nucleic acid (DNA or RNA) Gastrointestinal Pathogen Panel (PCR).  3-5 Targets)

CPT Code 87506 (Infectious agent detection by nucleic acid (DNA or RNA) Gastrointestinal Pathogen Panel (PCR).  6-11 Targets)

CPT Code 87507 (Infectious agent detection by nucleic acid (DNA or RNA) Gastrointestinal Pathogen Panel (PCR).  12-25 Targets)

I.  Clinical Laboratory Testing for Viral Respiratory Infections:

Prior to the development of low-cost, outpatient multiplex laboratory testing technologies, clinicians diagnosed viral respiratory track infections with the assistance of direct fluorescent-antibody assay (DFA) and culture testing.  With this approach, clinicians were able to detect only a little more than a handful of commonly seen respiratory viruses.  DFA testing was labor intensive, required qualified laboratory staff and specific monoclonal antibodies. As technology has advanced, the ability to detect new respiratory viruses also increased.  From 2000 to 2007, five new human respiratory viruses were discovered. The emergence of five new respiratory viruses since 2000, including metapneumovirus (MPV), severe acute respiratory syndrome coronavirus (SARS-CoV), avian influenza virus H5N1, CoVs NL63 and HKU1, and human bocavirus really amplified the limitations of relying on DFA and culture testing. It became more important than ever that clinicians have the ability to readily detect both traditional and emerging respiratory viruses. [1]

Since 2000, a number of laboratory polymerase chain reaction (PCR) testing technologies were developed that enabled the rapid processing of 20 or more respiratory tests simultaneously, using a single sample.  As this technology has developed, the use of these multiplex testing systems has grown.  Today, a number of physician practices and clinics have integrated multiplex PCR testing systems into their outpatient practices.  The benefits of using multiplex PCR respiratory viral panel tests are well established and are discussed below.

II.  Benefits of Outpatient Multiplex PCR Respiratory Viral Panels — CPT Code 87631, CPT Code 87632 and CPT Code 87633:

The specific respiratory lab tests being audited include: CPT Code 87631, CPT Code 87632 and CPT Code 87633.  As you would expect, payors are quite concerned with the proliferation of CPT Code 87633, which involves the testing and billing for 12-20 targets. Despite these concerns, proponents of broad respiratory testing can point to a wide variety of benefits that have been realized through the use of multiplex PCR respiratory viral panel systems.  These benefits include, but are not limited to:

PCR testing platforms cover a broader scope of viral agents. PCR respiratory viral panel testing platforms can automatically process 22 (or more) viral tests at one time. DFA testing systems were typically limited to conducting 6 or 7 concurrent tests.

PCR test results are faster. PCR respiratory viral panel test results are typically available within an hour.  In contrast, old-school DFA and culture testing is both labor intensive and more time consuming.

PCR respiratory viral panels have been shown to significantly reduce ICU days.[2]

PCR respiratory viral panels have been shown to reduce the duration of a patient’s antibiotic use. [3]

Perhaps most importantly, PCR respiratory viral panels just work better.

PCR respiratory viral panels identified significantly more pathogens than traditional testing platforms. Christine Ginocchio, Ph.D.[4] presented a poster at the recent Seasonal and Pandemic Influenza meeting in Washington, DC, that emphasized the assay’s reproducibility and its ability to detect mixed infections.  “Overall, we detected a variety of respiratory viruses in 29 percent of specimens tested by direct immunofluorescence [DFA], in 49.9 percent of the specimens by rapid viral culture using R-Mix cells [Diagnostic Hybrids, Athens, Ohio], and in 64 percent of the specimens by the RVP [respiratory viral panel] assay,” she says. “The increase in identifying specimens positive for a respiratory virus was due to the fact that we are detecting viruses we normally do not culture for or grow routinely in the laboratory—the rhinoviruses, parainfluenza, and coronaviruses.”

Despite the fact that the benefits to using multiplex testing are numerous, a number of payors have taken a hard line when it comes to covering these tests.  Several of the payors concerns are discussed below.

III.  Problems with Multiplex PCR Respiratory Viral Panels:

Testing platform manufacturers have programmed their machines to test for organisms that are not common. One the one hand, manufacturers have covered their bases when it comes to commonly identified viral infections.  However, as the number of emerging respiratory viral organisms has grown, the manufacturers have expanded the scope of testing to include these organisms, despite the fact that they infrequently seen.

Testing platforms have a “fixed” testing protocol. For example, one of the more common PCR respiratory viral panel testing platforms is set up to test for 22 different organisms using a single sample, regardless of whether the ordering physician believes that a patient should be tested for all 22 of these viral organisms.

Medicare takes the position that multiplex PCR respiratory platforms do not meet the payor’s “reasonable and necessary” requirements. Essentially, Medicare takes the position that fixed testing platforms, where a sample is automatically tested for 22 organisms, regardless of whether or not they are needed, does not meet the payor’s reasonable and necessary requirements.  As such, checking for organisms where there is no identified need for testing would be medically unnecessary.  As Palmetto has argued “The multiplex PCR respiratory viral panels are effectively a ‘one size fits all’ diagnostic approach, and do not meet Medicare’s ‘reasonable and necessary’ criteria. Non-coverage of these multiplex PCR respiratory viral panels does not deny patient access because appropriate clinician directed testing is available.”

The Emergence of COVID-19 has Heightened the Government’s Concerns Regarding Multiplex Testing.   Earlier this year, the OIG added “COVID-19 Add-on Testing” to its list Work Plan projects.  As the OIG noted at the time, the OIG has program integrity concerns related to add-on tests in conjunction with COVID-19 testing, particularly related to potentially fraudulent billing for associated respiratory pathogen panel (RPP) tests, allergy tests, or genetic tests.

IV.  Coverage Concerns with Respect to Outpatient Gastrointestinal Multiplex Testing — CPT Code 87505, CPT Code 87506 and CPT Code 87507:

The specific gastrointestinal lab tests being audited include: CPT Code 87505, CPT Code 87506 and CPT Code 87507.  As you would expect, payors are quite concerned with the proliferation of CPT Code 87507, which involves the testing and billing for 12-25 targets.  Proponents of broad, multiplex testing can point to a number of benefits that have been identified in connection with this approach.  Several of these benefits include:

(a) Reduced antibiotic use.[5]

(b) Reduced time to antimicrobial therapy.[6]

(c) Led to more targeted therapy.[7]

(d) Reduced downstream procedures such as endoscopies and abdominal imaging.[8]

Medicare, Medicaid and private payors have approached both respiratory and gastrointestinal multiplex testing in a similar fashion.  For example, Noridian has issued Local Coverage Determination guidance providing that it would only cover multiplex gastrointestinal pathogen molecular assays in limited circumstances:

“In immune competent beneficiaries, coverage is limited to no more than 5 bacterial targets (when not testing for Clostridium difficile). Testing for 6-11 pathogens is covered when there is a clinical concern for Clostridium Difficile colitis, and Clostridium difficile is one of the pathogens being tested.

Testing for 12 or more organisms will only be covered in critically ill or immunosuppressed patients.”[9]

V.  Responding to an Audit of Outpatient Respiratory and Gastrointestinal Multiplex Laboratory Tests:

Arguably, there has been a disconnect between the technology being developed by industry and payor policies. A number of the multiplex lab testing technologies currently being sold are not set up to test for only a limited number of specified pathogens.  When conducting outpatient respiratory and gastrointestinal multiplex tests, these machines may automatically test the maximum number of targets.  In other words, a provider can’t use some of these machines to only test for 3-5 targets even if that is all the provider wanted to test.  While payors like to base their denials of higher level multiplex testing on lack of medical necessity grounds, there have been a number of studies which suggest that in the long run, it is both better for the patient and more economical to conduct broad-based multiplex testing.  In any event, you cannot bill a payor for respiratory viral or gastrointestinal pathogen tests that were not medically necessary.  Should you identify that you have received an overpayment, you have an affirmative obligation to return it to the appropriate payment.  For more information on your duty to return overpayments, please see our page on the subject.

If your respiratory and / or gastrointestinal laboratory testing practices are audited (especially CPT Code 87633 and CPT Code 87507), you will need to be able to show that the level of testing billed was medical necessary and appropriate given the clinical profile of each patient.

NATIONWIDE REPRESENTATION:  Call for Free Consultation. 1 (800) 475-1906

Robert W. Liles, JD, MS, CPC, serves as Managing Partner at Liles Parker.  Liles Parker health law attorneys [10] are experienced in defending claims audits of this type.  In addition to being experienced health lawyers, many of our attorneys have also achieved recognition as Certified Professional Coders (CPCs).  Are your laboratory claims for CPT Code 87633 and CPT Code 87507 being audited?  Give us a call for a free consultation:  1 (800) 475-1906.

Robert W. Liles represents providers in audits of CPT Code 87633 and CPT Code 87507 claims

[1] Journal of Clinical Microbiology, Development of a Respiratory Virus Panel Test for Detection of Twenty Human Respiratory Viruses by Use of Multiplex PCR and a Fluid Microbead-Based Assay Sept. 2007, p. 2965–2970.

[2] Martinez R, et al. Clinical Virology Symposium, Poster #C-368, May 2016.

[3] Rogers B, et al. Arch. Path. & Lab. Med. 2015;139(5): 636-41.

[4] CGinocch@NSHS.edu

[5] Axelrad JE, Freedberg DE, Whittier S, Greendyke W, Lebwohl B, Green DA. Impact of Gastrointestinal Panel Implementation on Healthcare Utilization and Outcomes. J of Clin. Microbiology. 2019; 27;57(3). e01775-18.

[6] Cybulski R, Bateman A, Bourassa L, Bryan A, Beail B, Matsumoto J, Cookson B, Fang FC; Clinical impact of a Multiplex Gastrointestinal PCR Panel in Patients with Acute Gastroenteritis. 2018. Clinical Infectious Diseases, ciy357, https://doi.org/10.1093/cid/ciy357.

[7] Id.

[8] Axelrad JE, Freedberg DE, Whittier S, Greendyke W, Lebwohl B, Green DA. Impact of Gastrointestinal Panel Implementation on Healthcare Utilization and Outcomes. J of Clin. Microbiology. 2019; 27;57(3). e01775-18.

[9] Noridian Local Coverage Article: Billing and Coding: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) (A56711)

Medicare Revocation Actions Resulting from Telemedicine Evaluations are on the Rise!

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Medicare Revocation Actions are Increasing Around the Country(September 25, 2020):  In recent years, many individuals (especially younger members of our work force) have embraced the chance to supplement their income through short-term engagements in the “gig economy.”  Notably, both professionals and non-professionals alike have found flexible, part-time opportunities online, allowing them to work remotely as independent contractors.  A number of physicians, nurse practitioners and physician assistants have taken advantage of the chance to participate in the gig economy, working virtually and providing telemedicine services for patients.  Unfortunately, many of these licensed professionals have conducted little or no due diligence into the companies engaging them to conduct evaluations by phone, video or asynchronously.  In some cases, the company engaging these licensed professionals to provide telemedicine evaluations has been alleged to have illegally funneled prescriptions issued by these professionals to third-party durable medical equipment (DME) suppliers.  Associated physicians, nurse practitioners and physician assistants (collectively referred to as “Telemedicine Providers”) have then found themselves subject to administrative sanctions, civil liability, and, in some case, criminal prosecution.  This article examines the Medicare revocation actions that have resulted from a Telemedicine Provider’s failure to provide access to documentation related to telemedicine services that are currently being pursued by Medicare Administrative Contractors (MACs) around the country.

I.  Overview of Statutory and Regulatory Concerns When Providing Telemedicine Evaluations:

With the advent of COVID, both governmental and private payors alike have supported the expansion of telehealth / telemedicine services.  Coverage and payment rules have been expanded by most payors and patients have welcomed the opportunity to be evaluated remotely by their caregiver.  Generally, the current wave of telemedicine related enforcement actions has been unrelated to the coverage expansions resulting from the spread of COVID.  The vast majority of Medicare revocation actions associated with improper telemedicine business practices have been related to pre-COVID conduct.   An overview of these improper telemedicine cases is provided below:

  • Intermediary marketing companies.  Over the last few years, licensed providers with prescribing authority have been actively recruited by an intermediary company[1] OR have responded to an online advertisement seeking to hire physicians, nurse practitioners or physician assistants to perform remote telemedicine evaluations. These companies essentially serve as middlemen – they are not typically participating providers or suppliers in the Medicare program.
  • Lists of beneficiaries to be evaluated remotely are assembled by the intermediary marketing companies. Using a variety of patient recruiting and screening methods, representatives of the intermediary marketing company will work to assemble a list of prospective beneficiaries who have expressed an interest in being evaluated for DME.  The intermediary marketing company then provides these beneficiary lists to Telemedicine Providers who have been engaged to conduct remote assessments and evaluations[2] of these individuals. After completing an evaluation, the Telemedicine Provider then decides whether it is medically necessary and appropriate to order DME for the beneficiary. Typically, the licensed providers have been paid a fixed amount of $25 — $30 for each telemedicine evaluation conducted.
  • Beneficiaries have no control of where an order or prescription is referred.  In the cases we have handled, orders for DME have NOT been issued to a supplier, pharmacy or testing laboratory selected by the patient.  Instead, the order has been directed by the intermediary marketing company to a particular supplier, pharmacy or testing laboratory with whom the company has a business relationship.[3]
  • Unified Program Integrity Contractors (UPICs) are using data mining to identify potentially fraudulent telemedicine business relationships.  Through an analysis of billing data, UPICs have noted that some DME suppliers have billed Medicare for items based on orders issued by a physician, nurse practitioner or physician assistant who did NOT bill Medicare for an associated Evaluation and Management (E/M) service, either directly or through an appropriate reassignment relationship.
  • UPIC requests for medical records have often gone unanswered or unfulfilled.  Both UPICs and a variety of state and federal law enforcement agencies around the country have been investigating questionable telemedicine related business relationships.  One of the essential steps in investigating the propriety of these claims has included an assessment of the beneficiary’s medical records, along with the telemedicine evaluation conducted.  These medical records and intake documents are often maintained by the intermediary marketing company and have not been downloaded or maintained by the ordering physician, nurse practitioner or physician assistant. Moreover, the contracts between the parties often prohibit the physician from retaining copies of documents. In several cases we have handled, the licensed provider’s relationship with the intermediary marketing company was terminated long ago and the provider no longer has access to the beneficiary records now being requested.
  • Telemedicine providers are often unaware that a marketing company is engaging in illegal kickback activities.  Licensed providers are not usually privy to the terms of any business relationship between an intermediary marketing company and an associated DME supplier.  Both UPICs and law enforcement agencies around the country are investigating these telemedicine related business relationships.

II. Medicare Revocation Actions Based on a Provider’s Failure to Provide Access to Documents are Being Pursued by CMS Around the Country:

The failure to respond or comply with a UPIC request for records is one of the many bases[4] that CMS may assert to revoke a provider’s enrollment in the Medicare program, along with any corresponding provider agreement. As provided by 42 C.F.R. § 424.535(a)(10):

Ҥ 424.535 РRevocation of enrollment in the Medicare program.

(10) Failure to document or provide CMS access to documentation. (i) The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f). . .”

As 42 C.F.R. § 424.516(f) provides:

  • 424.516 – Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program.

“(f) Maintaining and providing access to documentation. (1)(i) A provider or a supplier that furnishes covered ordered, certified, referred, or prescribed Part A or B services, items or drugs is required to –

(A) Maintain documentation (as described in paragraph (f)(1)(ii) of this section) for 7 years from the date of service; and

(B) Upon the request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(1)(ii) of this section).

(ii) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions, and requests for payments for Part A or B services, items or drugs.

(2)(i) A physician or, when permitted, an eligible professional who orders, certifies, refers, or prescribes Part A or B services, items or drugs is required to

(A) Maintain documentation (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and

(B) Upon request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(ii) of this section).

(ii) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs.” (emphasis added).

III.  Medicare Revocation Actions for the Failure to Provide Medical Records Have Typically Sought a 10-Year Re-Enrollment Bar.

CMS extended the maximum re-enrollment bar that can be applied after a revocation from three years to ten years through a Final Rule, which was published on September 10, 2019 and became effective November 4, 2019.[5]  Although a 10-year re-enrollment bar is supposed to be reserved for cases involving serious misconduct, CMS has been actively seeking a 10-year re-enrollment bar in cases where the basis for exclusion is the failure to provide access to documentation.[6]

  • What is the impact of a Medicare revocation action?  The imposition of a 10-year re-enrollment bar can effectively destroy a health care provider’s practice.  Moreover, it will likely limit a provider’s employment options.  Additional potential consequences of having your Medicare enrollment revoked are discussed below.
  • Depending on the facts, the role you played in a telemedicine fraud case may result in a referral to the U.S. Department of Justice (DOJ) for investigation and possible prosecution. Since 1994, CMS has participated in an interagency agreement with the DOJ which allows CMS program integrity contractors (in this case, UPICs) to send health care fraud referrals directly to the DOJ without having to first route the referral through the Office of Inspector General (OIG).  Your involvement in a telemedicine related fraud case will be carefully evaluated.  For instance, did you actually conduct evaluations by phone, video or asynchronously OR did you perform an evaluation based solely on the medical information and intake documents provided to you by an intermediary marketing company?
  • You will be likely be barred from enrolling in the Medicare program for a period of 10 years. In light of the cases we have handled since the issuance of the November 4th Final Rule, it appears to be CMS’s policy to seek to impose a 10-year enrollment bar in revocation cases based on a violation of 42 C.F.R. § 424.535(a)(10).
  • You will likely be placed on Medicare’s “Preclusion List.” Individuals and entities that have been revoked from Medicare, are under an active reenrollment bar, AND CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program may qualify to be placed on the Medicare Preclusion List.  The Preclusion list is made available to Medicare Advantage and Part D plans.   If placed on the Preclusion List, an individual or entity will not be permitted to enroll in the Medicare Part C or Part D programs.
  • A Medicare revocation action may result in the revocation of your enrollment as a provider in your state’s Medicaid program. Using Texas as an example, Rule § 371.1703(a) of the Texas Administrative Code provides that:

“(a) The OIG may terminate the enrollment or cancel the contract of a person by debarment, suspension, revocation, or other deactivation of participation, as appropriate. The OIG may terminate or cancel a person’s enrollment or contract if it determines that the person committed an act for which a person is subject to administrative actions or sanctions. . . .

(b)(7) a provider that is terminated or revoked for cause, excluded, or debarred under Title XVIII of the Social Security Act or under the Medicaid program or CHIP program of any other state;[7]

  • A Medicare revocation action will result in a report being sent to the National Practitioner Databank (NPDB). As the NPDB Guidebook[8] notes, “formal or official actions such as revocation of suspension of a license, certification agreement, or contract for participation in government health care programs; reprimand; censure; or probation,” is considered to be a final adverse action and must be reported by a Federal agency.
  • A report to the NPDB may result in an investigation by your State Medical Board. A revocation action based on your failure to provide records to a UPIC may generate a collateral investigation by your state licensing board since you are likely required to maintain adequate patient records.  For instance, under Rule § 165.1(a) of the Texas Administrative Code, a licensed physician is required to maintain an “adequate medical record” for each patient that is complete, contemporaneous and legible.  Your failure to maintain a copy of the records you reviewed when making a telemedicine evaluation may constitute a violation of your obligations under the Texas Medical Practice Act. As such, you may be subject to disciplinary action.
  • A Medicare revocation of your billing privileges may result in the termination of your hospital credentialing. Many hospitals require that a physician, nurse practitioner or physician assistant be enrolled in the Medicare program (or at the very least, be eligible to enroll in the Medicare program), in order to be credentialed and granted privileges.  If you have been barred from enrollment in Medicare, you may not be eligible to obtain privileges at a hospital.
  • Termination from commercial payor agreements. Unfortunately, Medicare revocation actions are often used by commercial payors as a basis for terminating a provider from their plan.
  • Loss of employment. The collateral consequences of a Medicare revocation action can greatly limit your ability to work for a practice or entity that treats Medicare and Medicaid patients.   As a result, you may be terminated from employment.

IV.  Responding to a UPIC Request for Records:

We cannot overemphasize the seriousness of a UPIC request for records, especially when those records are related to your telemedicine evaluation of a patient’s DME needs.  Remember – UPICs are tasked with identifying suspected cases of fraud and abuse being committed against the Medicare and Medicaid programs.   Should you fail to provide records requested by a UPIC, the proposed revocation of your Medicare billing privileges may be the least of your problems.  Therefore, it is essential that you engage qualified health law counsel to represent you and guide you through this administrative process.  Liles Parker attorneys have extensive knowledge of the Medicare revocation process and have successfully represented multiple physicians and nurse practitioners in the appeal of a proposed revocation action, including those involving failure to respond to a records request.  For a free consultation, give us a call.  We can be reached at: (202) 298-8750.

Robert W. Liles defends health care providers in Medicare auditsRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent physicians, NPs and PAs in connection with Medicare revocation actions, administrative audits (UPIC audits / private payor audits), civil False Claims Act cases, and criminal violations of the Federal Anti-Kickback Statute and EKRA.  Are you currently being audited or under investigation?  We can help.  For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

[1]  Often the companies identify themselves as “locum tenens” agencies, or “telemedicine providers.” Most have a contract the physician signs that (1) doesn’t permit the physician to retain any patient records, and (2) requires the physician to agree not to file any claims or bill the patient.

[2] A variety of telemedicine compliance issues arise at this stage of the agreement.  Many times, the physician does not directly speak with the patient.  The physician’s agreement with the intermediary may say that the physician is supposed to conduct their telemedicine services “in compliance with their state licensing law” but most physicians have no idea what their state law requires.

[3] Licensed providers are not usually privy to the terms of any business relationship between a telemedicine marketing company and an associated DME supplier, compound pharmacy or testing laboratory.

[4] For an overview of the various reasons that a provider’s Medicare enrollment and billing privileges may be revoked, please see 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.(March 9, 2020).

[5] See Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process, 84 Fed. Reg. 47794 (Sep. 10, 2019).

[6] See 42 C.F.R. § 424.535(a)(10).

[7] Title 1, Part 15, Rule § 371.1703(a) of the Texas Administrative Code, “Termination of Enrollment or Cancellation of Contract.”

[8] NPDB Guidebook (October 2018), (Page E-81).

Sober Home and Recovery Residence Fraud Enforcement Efforts are on the Increase – Are Your Sober Home Business Practices Legal?

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(September 12, 2020):  This has been a rough year for sober home and recovery residence owners, operators and their health care business partners. Literally everyone has been adversely impacted by the public health crisis generated by the rapid spread of COVID-19. While most health care and providers obtained a temporary reprieve from, Medicare, Medicaid and private payor administrative audits[1], many state and federal law enforcement agencies (such as the Federal Bureau of Investigation (FBI), the Department of Health and Human Services, Office of Inspector General (OIG), state Medicaid Fraud Control Units (MFCUs) have continued to investigate allegations of wrongdoing against sober home and recovery residence owners, operators, managers and their health care business partners.  Moreover, these investigative agencies have continued to make referrals to federal and state prosecutors for possible civil and / or criminal enforcement.  This article provides a review of the government’s sober home and recovery residence prosecution efforts and examines the current enforcement landscape.

I.  Alcohol and Drug Addiction Treatment Industry Overview:

The care and treatment of individuals with alcohol and drug abuse issues is estimated to cost $42 billion in 2020.  More than 14,000 treatment and aftercare facilities current treat more than 3.7 million individuals in the United States.[2]  With the expansion of insurance eligibility under the Affordable Care Act,[3] the number of individuals who covered by health insurance has continued to grow over the last decade.

A broad continuum of care is available to individuals seeking treatment for alcohol and drug addiction and dependency issues.  The most intensive level of care is typically provided in an inpatient setting.  Patients residing in inpatient treatment centers are often still dependent on alcohol or drugs and need the intensive level of care to complete a supervised detoxification (detox) program.[4]  After successfully completing a supervised detox program, these individuals are typically discharged from an inpatient treatment facility to a lower level of care such as afforded in a Partial Hospitalization Program (PHP), Intensive Outpatient Program (IOP),[5] or Outpatient Program (OP).  Individuals being treated on an outpatient basis (whether PHP, IOP or OP) often elect to live in a drug and alcohol-free group home or similar facility with other individuals going through recovery.  These supportive, drug and alcohol-free facilities are often referred to as a:

  • Sober Home.
  • Halfway House.
  • Recovery Residence.

In this article, we will collectively refer to the three recovery facilities listed above as a sober home or recovery residence. These facilities are primarily group homes and residential facilities comprised of individuals with a shared history of alcohol or drug abuse who are now in recovery.  Individuals who reside in a sober homes or a recovery residence typically pay rent to live in this supportive, group setting.

II.  Sober Home and Recovery Residence Business Relationships Can Lead to Violations of the Anti-Kickback Statute or the Eliminating Kickbacks in Recovery Act:

Living in a sober home or recovery residence has traditionally served as an essential step in the drug and alcohol recovery process.  While most sober homes do not directly provide and bill insurance for clinical services, the residents of a sober home or recovery residence have a number of ongoing primary care and drug screening needs that must be met.  For instance, recurrent laboratory testing may be needed to verify that a resident is, in fact, remaining alcohol and drug free.  A number of sober homes have therefore engaged a licensed physician to serve as the facility’s Medical Director to oversee and order periodic drug screening tests to verify an individual’s compliance with the rules.[6]  Drug screening tests (such as a urinalysis) conducted on insured patients are then billed by the testing In addition to engaging a Medical Director, a sober home may also establish a business relationship with a testing laboratory and with other types of medical providers (such therapists, counselors, DME suppliers).  When a sober home’s Medical Director orders drug screening for residents, it isn’t unusual for a favored testing laboratory to collect blood and urine samples from residents at their sober home.   Physicians, testing laboratories and other health care providers and suppliers would then bill a sober home resident’s insurance company (such as Medicare, Medicaid, TriCare, FEHBP, Railroad Retirement or a private payor).[7]   Unfortunately, this is where the sober home business model typically runs afoul of state and federal regulatory and statutory requirements. Depending on the facts, the conduct could represent a violation of the federal Anti-Kickback Statute.

Kickbacks arrangements between referring sober homes / recovery residences and testing laboratories are problematic even if only private payors are affected by the improper conduct.  Under the Eliminating Kickbacks in Recovery Act (EKRA)(covered in section 8122 of “The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” (SUPPORT Act)), it is unlawful to solicit, receive or pay any remuneration (including any kickback, bribe or rebate) directly or indirectly, in return for referring a patient or patronage to a recovery home, clinical treatment facility or laboratory. This is intended to address a number of opioid related issues and it extends these prohibitions to services covered by a private payers as Medicare, Medicaid and other government programs. In addition, since the language of the act is very broad and the term laboratory is not limited to just those laboratories associated with substance abuse services, enforcement actions under EKRA could potentially reach laboratories outside the scope of substance abuse treatment. It could also implicate sales and marketing procedures that have been standard components of many laboratory business models and criminal sanctions under EKRA include fines up to $200,000 and up to 10 years imprisonment for kickbacks with respect to services covered by any type of health care benefit program in or affecting interstate or foreign commerce.

III. Sober Home / Recovery Home Risk Areas:

In recent years, federal auditors have dedicated considerable resources to their assessment of sober homes and recovery residence.  As the Government Accountability Office (GAO) found, the national prevalence of sober homes (referred to as “recovery residences” in GAO’s report) is unknown because there is not comprehensive data that can be relied on to arrive at this figure.[8] The GAO found that four of the five states it reviewed had conducted (or were in the process of conducting) law enforcement investigation of:

“unscrupulous behavior and potential insurance fraud related to recovery homes and outcomes of some of these investigations included criminal charges and changes to health insurance policies.”[9]

While not exhaustive, there are a number of common regulatory fraud risk areas that have been identified by state and federal investigators and prosecutors when investigating treatment centers, sober homes and recovery residences.  For example:

Fraudulent Coding. (Massachusetts Medicaid False Claims Act — M.G.L.c. 118E, § 21A ET SEQ.).  In this Massachusetts case, a physician and his addiction treatment clinic have been indicted for allegedly committing health care fraud against MassHealth, the state’s Medicaid program.  One of the allegations is that the physician billed for the administration of Vivitrol and was able to circumvent the limits on Vivitrol reimbursement by coding some of the Vivitrol treatments as chemotherapy treatments rather than as a treatment to prevent a relapse associated with alcohol or drug abuse.   The government has not detailed how the defendants were able to get past the Medicaid payment restrictions.

Patient Brokering. (Massachusetts “All-Payor” State Anti-Kickback Statute — G.L.c. 175H, §3)(Federal Anti-Kickback Violations — 42 U.S.C. § 1320a-7b(b)(1)(A): When investigating allegations of “patient brokering,” a representative of the Massachusetts Attorney General’s Office testified before Congress that the AG’s Office had been receiving reports that state residents have been lured to out-of-state addiction treatment providers by paid recruiters who promised them free travel to an addiction treatment center in a warm-weather state. When the patients discovered that the treatment they were to receive was low quality or nonexistent, they were often left thousands of miles from home with no health insurance, no access to the medical care they needed, and no resources to return home. In the most tragic cases, these young people suffered fatal overdoses following their continued opioid use without treatment.”[10]  As a result, the Massachusetts AG’s Office opened criminal investigations into addiction treatment fraud and issued a Consumer Advisory, alerting patients and their families that they should be wary of unsolicited offers for free out-of-state addiction treatment.

Illegal Business Relationships (Involving Claims Submitted to Federal / State Payors). (Federal Anti-Kickback Violations — 42 U.S.C. § 1320a-7b(b)(1)(A)).[11]: Generally, sober home and recovery residences do not qualify as health care providers or suppliers and are unable to be credentialed and participate in health benefits programs.  As a result, they cannot bill insurance payors. Some sober home and recovery residence owners and operators have entered into unscrupulous, often illegal referral business relationships with physicians, nurse practitioners, physician assistants, testing laboratories, and others. In exchange for the referral of their residents for medical and clinical services (often in the form of drug screen testing), sober home and recovery home owners, operators (and affiliated Medical Directors) have received a “referral fee” or kickback from the servicing health care provider or supplier who then bills the resident’s insurance company for payment.

Illegal Business Relationships (Involving Submitted to Private Payors).  (Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories — 18 U.S.C. § 220): Despite the fact that EKRA has now been in place for almost two years,  only a handful of cases have been prosecuted under EKRA.  While illegal sober home conduct was not cited, a recent EKRA case out of the District of New Jersey did allege that a drug treatment center illegally paid a marketing company for patient referrals. To identify patients, the marketing company used a nationwide network of recruiters who were instructed to identify individuals addicted to alcohol or drugs AND were covered under a health care benefit program.  The drug treatment center allegedly paid the marketing company approximately $5,000 for each referral.  The marketing company then supposedly paid a percentage of the referral funds received to its recruiters.  Notably, the government alleged that the drug treatment facility tried to disguise the kickbacks as a “monthly fee” paid to the marketing company.  

Business Relationships Resulting in the Violation of the Health Care Fraud and Anti-Kickback Statutes. (Conspiracy to Commit Health Care Fraud — 18 U.S.C. §1349).[12] In this recent case a multi-agency task force[13] investigated the business practices of a Florida osteopathic physician in his role as “Medical Director” for more than 50 addiction treatment facilities and sober homes.  Unlike most relationships where a physician has been engaged to serve as Medical Director, the physician in this case was paid only a nominal salary.  Instead, federal prosecutors have alleged that the physician benefited from the relationship by getting access to a “stable” of insured addiction treatment patients residing in sober homes and addiction treatment centers.   As Medical Director, the physician in this case is alleged to have signed more than 136 standing orders for medically unnecessary urinalysis tests.  These urinalysis tests were processed by testing laboratories that sometimes paid kickbacks to referring sober homes and addiction treatment centers.  As the Criminal Complaint states:  “In addition, the entire referral network made possible by [Medical Director] authorizing such false and fraudulent testing for these addiction treatment centers, sober homes, and testing laboratories by his signing of standing orders often facilitated kickback relationships between these parties and individual recruiters or brokers for these entities, as the sober home and treatment center owners (through these brokers) received kickbacks from the owners and operators of the laboratories in return for sending specimens their way for testing.”  Ultimately, the government has further alleged the standing orders signed by the government resulted in the improper billing of hundreds of millions of dollars of medically unnecessary urinalysis tests and other fraudulent treatments.  Finally, prosecutors have claimed that the defendant Medical Director did not meaningfully review the results of the tests he ordered.  The government has estimated that the fraudulent conduct resulted in approximately $681 million for urinalysis laboratory tests and other medical services billed to the Medicare program and to private payors.  Of this total, approximately $121 million was paid to government and private payors.  The defendant physician (serving as Medical Director) is currently charged with Conspiracy to Commit Health Care Fraud and Wire Fraud (18 U.S.C. §1349).  The government has also filed a Criminal Forfeiture (18 U.S.C. §982(a)(7) count against the physician in an effort to recover to losses incurred by federal health care benefit programs due to the fraud.

Ordering of Medically Unnecessary Controlled Substances.Distributing Controlled Substances Without a Legitimate Medical Purpose. (21 U.S.C. § 841(a)(1).[14]  In a recent Florida case, an internal medicine physician and a licensed mental health counselor were indicted for their roles[15] in the distribution of controlled substances that were not medically necessary and had no legitimate medical purpose.  As the indictment statement, the defendant physician knowingly and intentionally distribute and dispense outside the scope of professional practice and not for a legitimate medical purpose, a controlled substance.”

Aiding or Abetting in the Performance of Illegal Conduct(Principals — 18 U.S.C. § 2).  In the same Florida case discussed above, a licensed mental health counselor was implicated in the illegal dispensing conduct of the principal offender, the ordering physician.

Wrongfully Prescribing Controlled Substances After a Medical License or Controlled Substance Registration has been Suspended(Conspiracy to Unlawfully Distribute a Schedule III Controlled Substance — 21 U.S.C. 846).[16]   In one case, a physician employed as the Medical Director at a substance abuse treatment center was charged by indictment with one count of conspiracy to distribute controlled substances in relation to his employment at the center. While serving as Medical Director, his medical license was suspended.  Nevertheless, the physician continued to prescribe controlled substances for individuals at the treatment center over a five-month period.

IV.  Conclusion:

The business practices of sober homes and recovery residences are under microscope.  It is therefore essential that you carefully review your business relationships and practices to ensure that you are complying with state and federal regulations and statutes.  Steps you can take include, but are not limited to:

Develop and implement an effective Compliance Program for your sober home / recovery residence.

Properly train your staff on their duties and obligations under the law.

Exercise caution before entering into any business relationships with drug treatment centers, physicians, DME companies, and other entities to whom your sober home / recovery residence may make referrals.  Additionally, watch our for marketing companies who may want to send you possible patient referrals.  Contact your attorney before entering into these relationships! 

Conduct a GAP analysis of your business practices.

DOJ is holding owners, operators and management officials to a level of responsibility consistent with their position in the organization.

Educate your owners, operators and managers regarding the “Yates Memo” and DOJ’s interest in individual accountability.

Have your contracts and agreements reviewed by health law counsel before executing the documents.

Finally, if you or your sober home / recovery residence is ever investigated, it is critical that you engage qualified health law counsel to represent your interests. Need assistanceGive us a call for a free consultation:  1 (800) 475-1906.

Robert W. LilesRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent individuals and entities around the country in connection with administrative audits (UPIC audits / private payor audits), civil False Claims Act cases, and criminal violations of the Federal Anti-Kickback Statute and EKRA.  Are you currently being audited or under investigation?  We can help.  For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

[1] On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) suspended most Medicare Fee-For-Service (FFS) medical reviews because of the COVID-19 pandemic. Many private payors also curtailed their audit activities for several months.

[2] The U.S. Addiction Rehab Industry (January 2020).  A summary of this report can be found at: https://www.marketresearch.com/Marketdata-Enterprises-Inc-v416/Addiction-Rehab-12943155/?progid=91619

[3] The Affordable Care Act was enacted on March 23, 2010. Pub. L. 111- 148.

[4] When an individual stops using drugs or taking alcohol, detoxification (commonly referred to a “detox”) occurs.  Detox is essentially the process of allowing drugs and alcohol to be removed or flushed out of an individual’s body.  Inpatient detox programs are designed to medical and mental support to an individual while he / she goes through the withdrawal process.

[5] Under the guidelines issued by U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment (SAMHSA) and the American Society of Addiction Medicine (ASAM), Intensive Outpatient Programs (IOPs) are formal abuse treatment programs that are required to be overseen by a qualified medical professional, and to have a formal treatment plan to be used in the patient’s care.

[6] A sober home’s Medical Director may also offer primary care services to residents.

[7] Both governmental and private payor health plans qualify as “health care benefit programs” under 18 U.S.C. §24(b).

[8] Government Accountability Office (GAO) report entitled “SUBSTANCE USE DISORDER – Information on Recovery Housing Prevalence, Selected States’ Oversight, and Funding.” (GAO-18-315) (March 2018, Page 6).  https://www.gao.gov/assets/700/690831.pdfA representative of GAO was subsequently asked to testify before the Committee on Finance, United States Senate on October 24, 2019 (GAO-20-214T). GAO’s report on this testimony is available at:  https://www.gao.gov/assets/710/702271.pdf

[9] GAO-18-315, page 7.

[10] Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, Testimony of Eric M. Gold. Serial No. 115-87, (December, 12, 2017).

[11] Federal Anti-Kickback Violations, 42 U.S.C. § 1320a-7b(b)(1)(A.

[12] Attempt and Conspiracy, 18 U,S,C, §1349.

[13] Comprised of the FBI, the Drug Enforcement Administration (DEA), and the Internal Revenue Service – Investigative and Forensic Service (IRS).

[14] See 21 U.S.C. § 841(a)(1).

[15] In this case, the licensed mental health counselor was implicated in the illegal dispensing conduct through the operation of 18 U.S.C. §2.  As the statutory provision provides:

“(a) Whoever commits an offense against the United States or aids, abets, counsels, commands, induces or procures its commission, is punishable as a principal. 

(b) Whoever willfully causes an act to be done which if directly performed by him or another would be an offense against the United States, is punishable as a principal.”

Aider and abettor liability is distinct from accessory after the fact under 18 U.S.C. § 3. An aider and abettor, unlike an accessory after the fact, is punishable as a principal.

[16] See 21 U.S.C. 846

Medicaid After-Hours Claims Audits (CPT 99050 & CPT 99051) by State Medicaid Regulators are Continuing.  Are Your Medicaid After-Hours Claims Compliant?

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Medicaid After-Hours Claims Audits(June 3, 2020):  By 2027, national health spending is expected to exceed $6 trillion.  Notably, health spending will rise from a share of approximately 17.9% of the Gross National Product (GNP) to 19.4% during this time period.[1]  Understandably, Medicare and Medicaid program officials have ramped up their efforts to reign-in the costs of these government payor programs.  One of the continuing areas of concern that has contributed to the high cost of Medicaid services is the use of hospital emergency room services by Medicaid recipients for the care of non-urgent medical issues.  In response, many State Medicaid plans (especially Medicaid Advantage plans) have taken steps to make it easier for plan beneficiaries to obtain care by their primary care provider after normal business hours rather than be forced have to seek significantly more expensive hospital emergency room assistance during evenings, weekends and holidays, when their primary caregiver’s offices would normally be closed. This article reviews the billing of Medicaid after-hours claims (CPT 99050, CPT 99051) in more detail and discusses the types of deficiencies that have been noted by regulators when auditing these services.

I.  Background of the Medicaid After-Hours Claims Issue:

The non-emergency use of hospital emergency room services by Medicaid participants has been a long-standing problem of almost four decades.  As early as 1983, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) noted that there was a high rate of hospital emergency room misuse by Medicaid recipients who would utilize high-cost emergency rooms for the care and treatment of non-emergency medical issues. At that time, it was estimated that over one-half to two-thirds of Medicaid emergency room visits” were non-emergent.[2] As the OIG’s 1983 report further noted, Medicaid recipients were found to be visiting hospital emergency rooms for non-urgent care largely because other sources of care [were] either unavailable or inaccessible to the them.”  The OIG concluded that at least half of Medicaid beneficiary emergency room visits could have been more appropriately treated in community care settings. Notably, the root cause of the problem was clearly understood by the government long ago:

The use of emergency rooms for non-urgent care results primarily from the recipient’s lack of access to primary care during or after office hours.  Often the Medicaid recipient does not have a doctor that they see on a regular basis.  Recipients may not live near a participating physician or may lack transportation to get to the physician’s office.  A recipient may not be able to go to the physician’s office during normal office hours, and may have difficulty reaching the physician after hours.[3] (emphasis added).

II. State Medicaid Coverage Issues of CPT Code 99050 and CPT Code 99051:

If a participating provider treats a Medicaid recipient after normal business hours, a number of State Medicaid plans now permit a participating provider to bill an appropriate Evaluation and Management (E/M) code AND bill CPT 99050 or CPT 99051 as an additional charge to reflect the fact that after-hours care was provided.  As the 2019 American Medical Association Current Procedural Terminology manual reflects, CPT 99050 and CPT 99051 are defined as follows:

  • CPT 99050Service(s) provided in the office at times other than regularly scheduled office hours, or days when the office is normally closed (i.e., holidays, Saturday or Sunday), in addition to basic service.
  • CPT 99051Service(s) provided in the office during regularly scheduled evening, weekend, or holiday office hours, in addition to basic service.

The Office of Inspector General provided the following example to demonstrate proper billing of CPT 99050:

“[A] physician’s office may be open from 9 a.m. to 5 p.m., Monday through Friday. A physician treating a beneficiary in that office at 7 p.m. on a Thursday may bill for CPT code 99050 in addition to the evaluation and management code for the visit.[4]  

With the incorporation of these codes into their payment schemes, State Medicaid plans have effectively encouraged primary care providers to make themselves, and / or members of their staff, available beyond regularly scheduled office hours, and weekends, to care for Medicaid patients.  The expanded availability of these Medicaid providers has therefore made it less likely that Medicaid patients would seek care for non-emergent medical conditions from hospital emergency rooms.  Unfortunately, the coding and billing requirements applied by State Medicaid regulators often unwritten and / or in direct contradiction of what a Medicaid provider has been told by one or more Medicaid Advantage payor plans.  As a result, the billing of CPT 99050 and CPT 99051 has led to a number of State investigations and audits of these codes.

III.  Overview of CPT 99050 and CPT 99051 Medicaid After Hours Claims Audit Enforcement Efforts:

A number of State Medicaid regulatory authorities have been actively auditing the claims practices of physicians and other providers who have been billing for after-hours services using CPT 99050 and CPT 99051.  While the audit findings have varied from one state to another, the government has generally argued that providers have incorrectly billed for after-hours services when such services did not qualify for coverage and payment.  Examples of state Medicaid after-hours claims audit initiatives include the following:

Texas

  • Despite the fact that Texas physicians and practices have seen dramatic drops in revenues since March 2020 due to the COVID-19 crisis, the Texas Health and Human Services Commission, Office of Inspector General (HHSC-OIG) have continued to aggressively audit CPT 99050 claims billed by Medicaid providers. Notably, many of these audits have focused on physician practices in the Rio Grande Valley.  As of May 2020, Medicaid after-hours claims audits remain ongoing throughout Texas.
  • Last year, HHSC-OIG reached a settlement with a physician in Pharr, Texas for $297,549 for the alleged improperly billing of Medicaid after-hours claims. Government investigators claimed that the provider was improperly reimbursed for Medicaid after-hours services, in contravention to the billing requirements set out in the provider’s Medicaid managed care contract and HHSC program policy.[5]
  • That same month, the government regulators reached a similar settlement with a physician practice in Mission, Texas in the amount of $61,310. [6]
  • Notably, Texas has recently upped-the-ante, so to speak, by issuing a “Clarification Statement” meant to further explain its coverage of Medicaid after-hours claims. Effective February 1, 2020, Texas Medicaid & Healthcare Partnership (TMHP)[7] now takes the position that:“After-hours procedures are limited to one per day, same provider.” [8]

What is meant by this “Clarification Statement”?  Great question.  At this time, TMHP has not issued any additional guidance setting out the parameters of this new rule.

New Jersey

  • In this case, the New Jersey Office of the Comptroller, Medicaid Fraud Division, (New Jersey Comptroller) alleged that one of its Medicaid providers had improperly billed 99050 for services which it provided during “regular office hours.”[9] In its decision, the New Jersey Comptroller argued that because CPT 99050 was an add-on code, it should not be utilized and billed frequently, and that the provider’s frequent use of the code indicated improper usage.
  • To determine the practice’s regular business hours, the New Jersey Comptroller reviewed the hours of operation that were listed in the credentialing documents which the provider submitted to enroll in the payor’s managed care network, and the hours of operation listed on the payor’s online provider portal. The New Jersey Comptroller then compared these times against the times and dates of service which were listed in the claims submitted by the provider to determine whether the provider regularly treated patients on weekends and federal holidays (July 4th, Labor Day, Thanksgiving, Christmas, New Year’s Day, Easter, and Memorial Day).  After completing this analysis, the New Jersey Comptroller argued that dates and times which were submitted with the Medicaid provider’s claims showed that the Medicaid provider regularly operated during weekends and federal holidays, and that these times were considered regular office hours for purposes of the after-hours code.
  • The New Jersey Comptroller concluded that the Medicaid provider had improperly used CPT 99050 despite the fact that the Medicaid payor had reassured the provider that it was properly billing the code, and had awarded the Medicaid provider a $100,000 bonus for saving the payor over $600,000 in emergency room visits. Although the New Jersey Comptroller acknowledged the provider’s receipt of this award, it concluded that the practice’s receipt of this award did not overcome the practice’s allegedly improper use of CPT 99050.

Alabama

  • Although not as recent as the cases currently being pursued in Texas and New Jersey, it is worth noting that a Federal case out of the Northern District of Alabama held that a healthcare provider had improperly used the after-hours billing code for weekend visits when the clinic’s normal business hours, as advertised on the clinic’s website and written to all insurance companies, were 7 days a week from 8:00 am to 6:00 pm.[10]

South Carolina

  • The South Carolina Department of Health & Human Services advised that providers with regular scheduled evening and weekend office hours should not use CPT 99050 for services provided during those times or for treating patients whose visits lasted longer than the facility’s posted hours.[11]

Connecticut

  • A Connecticut Medicaid pediatric practice, agreed to pay $65,378 to settle allegations that it violated the False Claims Act by improperly billing after-hours billing code CPT 99050.[12] The U.S. Attorney’s Office for the District of Connecticut alleged that the practice had improperly billed the after-hours code when the practice was open for business and regularly scheduling patients for same-day sick visits.

IV.  Responding to an Audit of Your Medicaid After-Hours Claims:

While the basic rules for the billing of after-hours codes are well established, the way that coverage and payment requirements are being interpreted by State Medicaid regulators widely vary from one jurisdiction to another.  Some of the problems we are seeing include, but are not limited to the following:

  • State Regulators Don’t Always Go By Your Agreements with the Medicaid Advantage Plans. Medicaid providers typically negotiate what constitutes after-hours with each Medicaid Advantage payor plan. The negotiated understanding of what constitutes after-hours is often expressly defined in the provider’s contract.  It is not uncommon for the definition of after-hours to differ from one Medicaid Advantage plan to another.  Despite the fact that a provider may have reached an agreement with a provider, State Medicaid regulators conducting audits of CPT 99050 and CPT 99051 have often disregarded the definition set out in the contract and denied payment of these claims, citing a number of reasons why the claims don’t qualify for coverage and payment.
  • Incomplete Documentation. A number of the cases we have reviewed have involved health care practices who have failed to keep and / or maintain records of when a patient arrived and left their offices.  The failure to keep proper records will inevitably lead to denials of CPT 99050 and CPT 99051.
  • Failure to Maintain a Patient Signature Sheet. Even if your practice electronically checks in a patient when they arrive at your office, it is important to also obtain a patient signature which reflects when the patient arrived.
  • Inconsistent Posting of Office Hours. Regardless of what your Medicaid Advantage provider contract may state with respect to what constitutes after-hours, you may find that signage, online posts, and / or a practice’s “Google Your Business” listing indicates that a practice is supposedly open at a time that is consider after-hours by a Medicaid Advantage plan.   In the event of Medicaid claims audit, the government may try to argue that since an online listing indicated that a time was within your regular business hours, the practice cannot be paid for CPT 99050 and CPT 99051.

Ultimately, the way these cases are being handled appears to vary from state to state.  How should you respond if your Medicaid after-hours claims are audited?  We recommend you immediately contact experienced health law counsel to assist with the defense of these claims. For a free consultation, call:  1 (800) 475-1906.

Robert W. LilesRobert 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.  Are your “After-Hours” claims being audited by State Medicaid Regulators?  Give us a call.  For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

 

 

 

 

[1] CMS Office of the Actuary Releases 2018-2027 Projections of National Health Expenditures, February 20, 2019.  https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/ForecastSummary.pdf

[2] Testimony of Michael Mangano, Deputy Inspector General, before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, on February 28 and March 26, 1992. (See page 422).  During his testimony, Mr. Mangano cited OIG’s September 1983 report entitled “Non-Emergency Use of Hospital Emergency Departments by Medicaid and Medicare Beneficiaries.”  https://archive.org/stream/medicaidprogrami00unit/medicaidprogrami00unit_djvu.txt

[3] Ibid, page 424.

[4] Id.

[5] See OIG Medicaid Program Integrity recovers $14 million in third quarter, OIG HHSC (July 12, 2019), https://oig.hhsc.texas.gov/latest-news/oig-medicaid-program-integrity-recovers-14-million-third-quarter

[6]    Id.

[7] The Texas Medicaid & Healthcare Partnership (TMHP) is the claims administrator for Texas Medicaid under contract with the Texas Health and Human Services Commission.

[8] TMHP is still in the process of adding this language to Texas Medicaid Provider Procedures Manual, Medical and Nursing Specialists, Physicians, and Physician Assistants Handbook, and the Children with Special Health Care Needs (CSHCN) Services Program Provider Manual.

[9] Final Audit Report – Ocean County Internal Med. Assoc., P.C.’s Use of AMA’s CPT Code 99050, N.J. Office of Comptroller (July 11. 2018), at 11-12, https://www.nj.gov/comptroller/news/docs/ocima_far.pdf.

[10] No. CV 5:10-cv-2843-IPJ, 2014 U.S. Dist. LEXIS 195885, at *6 (N.D. Ala. July 29, 2014), aff’d, United States ex rel. Salters v. Family Care, Inc., No. 5:10-cv-2843-LSC, 2016 U.S. Dist. LEXIS 173433 (N.D. Ala. Dec. 15, 2016).

[11] See Provider Perspective, 1 S.C. Dep’t of Health and Hum. Serv., at 1 (2008), at https://www.scdhhs.gov/internet/pdf/provider%20newsletterfinal.pdf.

[12] See Pediatric Practice Pays $65,378 to Settle Allegations Under the False Claims Act, FBI (May 27, 2010), https://archives.fbi.gov/archives/newhaven/press-releases/2010/nh052710.htm.

The Coronavirus Aid, Relief and Economic Security (CARES) Act: Provisions Relevant to Healthcare Providers

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By Michael Cook, Jennifer Papapanagiotou & Andy Lynch –  Partners at Liles Parker, PLLC.

(March 31, 2020):  On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act[1] passed the House of Representatives by a voice vote. The President then signed the bill into law. The bill is the third round of federal government support in the wake of the coronavirus public health crisis and associated economic fallout, succeeding the $8.3 billion in public health support passed two weeks ago and the Families First Coronavirus Response Act.  Liles Parker has published a series of articles highlighting the waivers and other actions taken by the Centers for Medicare & Medicaid Services and other Federal and State agencies to ease the burden on healthcare providers during the COVID-19 public health emergency.[2]  This article is the first in a two-part series that will highlight some of the more significant provisions of the Cares Act.

I.   Support for Healthcare Providers

  • Section 3211, Supplemental Awards for Health Centers: The CARES Act provides for supplemental awards for FY 2020 for federally qualified health centers, including an additional $1,320,000,000 for the prevention, diagnosis, and treatment of COVID-19 or the detection of SARS-CoV-2.
  • Sections 3212 – 3213, Reauthorizations of HRSA Rural Development and Telehealth Network Grant Programs: The Act reauthorizes HRSA’s Rural Health Care Services Outreach, Rural Health Network Development and Small Health Care Provider Quality Improvement grant programs, as well as the Telehealth Network and Telehealth Resource Center grant programs.
  • Section 3214, Modernization of the Public Health Service: The legislation creates a Ready Reserve Corps to ensure that there are enough doctors and nurses ready to respond to public health emergencies like COVID-19.
  • Section 3215, Limitation of Liability for Volunteer Health Professionals During COVID-19 Emergency Response: This section holds harmless from liability under federal or state law, health care professionals who volunteer their service during the public health emergency for the COVID-19 pandemic declared by the Secretary of HHS.  There are a number of conditions that must be satisfied for this limitation of liability to be effective.

Among these, the limitation of liability covers only professionals who are truly volunteers and who do not receive compensation in the course of providing health care services in the diagnosis or treatment of COVID-19.  The professional must be acting within the scope of her/his license, registration, or certification under the State of licensure/certification, and may not exceed the scope of the license/certification of similar professionals in the State in which the action or omission occurs.  The limitation of liability does not cover willful or criminal misconduct, gross negligence and other similar types of flagrant misconduct.

The provision applies only to conduct that occurs on or after the date of enactment of the CARES Act and is only in effect during the period of the public health emergency declared by the Secretary during the pandemic.

  • Section 3216, Flexibility for Members of the National Health Service Corps During the Emergency Period: During the period of the emergency declaration, this provision allows the Secretary to temporarily re-assign members of the National Health Services Corps to provide service outside of the areas to which they have been assigned to respond to the COVID-19 pandemic. The assignment would need the member’s voluntary agreement and would need to be “within a reasonable distance” of the original assignment, and the member would need to maintain the number of hours originally required of her/him.    

II.   Provisions Affecting Coverage and Payment Under the Medicare & Medicaid Programs

  • Section 3701, Health Savings Accounts for Telehealth Services: This section allows a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services prior to a patient reaching the deductible, increasing access for patients who may have the COVID-19 virus and protecting other patients from potential exposure.
  • Section 3702, Over-the-Counter Medical Products without Prescription: This section allows patients to use funds in HSAs and Flexible Spending Accounts for the purchase of over-the-counter drugs and menstrual care products without a prescription from a physician. This section appears to reverse the ACA and makes permanent the over-the-counter drug changes during the 2020 plan year and after.
  • Section 3703, Expanding Medicare Telehealth Flexibilities: This section eliminates the requirement included in the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (Public Law 116-123) that limits the Medicare telehealth expansion authority during the COVID-19 emergency period to situations where the physician or other professional has treated the patient in the past three years. This enables beneficiaries to access telehealth, including in their home, from a broader range of providers, reducing COVID-19 exposure for the duration of the public health emergency.
  • Section 3704, Allowing Federally Qualified Health Centers and Rural Health Clinics to Furnish Telehealth in Medicare: This section allows, during the COVID-19 emergency period, Federally Qualified Health Centers and Rural Health Clinics to serve as a distant site for telehealth consultations. A distant site is where the practitioner is located during the time of the telehealth service. This section will allow FQHCs and RHCs to furnish telehealth services to beneficiaries in their home. Medicare will reimburse for these telehealth services based on payment rates similar to the national average payment rates for comparable telehealth services under the Medicare Physician Fee Schedule. It will also exclude the costs associated with these services from both the FQHC prospective payment system and the RHC all-inclusive rate calculation.
  • Section 3705, Expanding Medicare Telehealth for Home Dialysis Patients: This section eliminates a requirement during the COVID-19 emergency period that a nephrologist conduct some of the required periodic evaluations of a patient on home dialysis face-to-face, allowing these vulnerable beneficiaries to get more care in the safety of their home.
  • Section 3706, Allowing for the Use of Telehealth during the Hospice Care Recertification Process in Medicare: Under current law, hospice physicians and nurse practitioners cannot conduct recertification encounters using telehealth. This section allows, during the COVID-19 emergency period, qualified providers to use telehealth technologies in order to fulfill the hospice face-to-face recertification requirement.
  • Section 3707, Encouraging the Use of Telecommunications Systems for Home Health Services in Medicare: This section requires the Department of Health and Human Services (HHS) to issue clarifying guidance encouraging the use of telecommunications systems, including remote patient monitoring, to furnish home health services consistent with the beneficiary care plan during the COVID-19 emergency period.
  • Section 3708, Improving Care Planning for Medicare Home Health Services: This provision enables nurse practitioners, clinical nurse specialists, and physician assistants to order home health services, and certify and recertify patients for home health care. These changes also apply to Medicaid and become effective when HHS publishes implementing regulations, which must be within six months of the enactment of the CARES Act.  Unlike many of the provision of the Act, this provision is permanent and survives the end of the emergency.
  • Section 3709, Adjustment of Sequestration:  The CARES Act suspends the mandatory 2% global reductions under the sequestration order for the period May 1 through the remainder of calendar year 2020.
  • Section 3710, Medicare Hospital IPPS Add-On Payment for COVID-19 Patients During Emergency Period: The Act increases DRG weights by 20% for patients diagnosed with COVID-19 during the emergency period.
  • Section 3711, Increasing Access to Post-Acute Care During the Emergency Period: The Act waives certain requirements for inpatient rehabilitation facilities (IRFs) and long-term acute care hospitals (LTCHs).  For IRFs, the provision waives the requirement that a patient receive at least 15 hours of therapy per week.  For LTCHs, the provision waives the requirement of a payment adjustment where an LTCH does not have a discharge percentage of 50% of patients who would meet the eligibility requirements during the emergency period.  The provision also waives the site-neutral payment rate for discharges occurring during the emergency period that are in response to the public health emergency.
  • Section 3712, Revising Payment Rates for DME Under Medicare During the Emergency Period: This Section prohibits scheduled payment reductions in Medicare DME during 2020 and the emergency period.
  • Section 3715, Providing Home and Community-Based Services in Acute Care Hospitals:  A number of waivers under sections 1915 and 1115 of the Social Security Act provide for home and community-based services for individuals who otherwise would require care in a hospital, nursing facility, or ICF/MR.  This provision allows states to cover these services to individuals under certain of these waivers while they are in an acute care hospital if they meet certain conditions, including that they are identified in the individual’s care plan, not provided through the hospital, not a substitute for services that the hospital is otherwise required to provide, and are designed to ensure a smooth transition to the community and preserve the individual’s functional abilities.
  • Section 3719, Expansion of Medicare Hospital Accelerated Payment Program During COVID-19 Public Health Emergency: During the period of the emergency, this provision expands the accelerated hospital payment program by allowing acute care hospitals, cancer hospitals, children’s hospitals, and critical access hospitals (CAHs) to apply for up to 6-months’ advance payment of up to 100%, and for CAH’s 125%, of anticipated payments.  The provision also provides for 120 days before claims are offset to recoup these payments and not less than 12 months after the date of the first accelerated payment before the outstanding balance must be paid in full.

Administrative Implementation to Encompass All Providers:  On March 28, 2020, CMS published a press release and a Fact Sheet that expanded the availability of the accelerated advance payment program to all Medicare participating health care providers and suppliers.  These advance payments will be based on historical payments.  The Press Release states that “… [t]he payments can be requested by hospitals, doctors, durable medical equipment suppliers and other Medicare Part A and Part B providers and suppliers.”  The applicants must: have billed Medicare for claims within 180 days of the request; not be in bankruptcy; not be under active medical review or program integrity investigations; and not have delinquent Medicare overpayments.  Applications are made to the MACs, and CMS anticipates that payments will be issued within seven days of a request.  Providers described in the legislation, above, can request payments for an amount for up to a six-month period, while other types of providers can request up to a three-month period.  The Fact Sheet provides further instructions on the process.[3]

  • Section 3720, Delaying Requirements for Enhanced FMAP to Enable State Legislation Necessary for Compliance: The The Families First Coronavirus Relief Act increases State Federal assistance matching percentages (FMAP) percentages by 6.2% during the calendar quarters that encompass the emergency period if the State meets certain conditions, one of which was that it did not increase premiums in excess of what they were on January 1, or impose new premiums, during this period.  This provision gives any state that has raised or imposed such premiums since January 1, a thirty-day delay in the enforcement of that requirement – presumably to provide the State an opportunity to come into compliance without losing the increased matching rate.

III.   Health and Human Services Extenders

  • Section 3811, Extension of Money Follows the Person Rebalancing Demonstration: The CARES Act extends and provides funds for the demonstration through November 30, 2020.
  • Section 3812, Extension of Spousal Impoverishment Protections: This section of the Act extends certain protections from spousal impoverishment through November 30, 2020 to help a spouse of an individual who qualifies for nursing home care to live at home in the community.
  • Section 3813, Delay of DSH Reductions: The CARES Act delays Medicaid DSH reductions that were to begin on May 23, 2020, to begin, instead, on December 1, 2010.

IV.   Economic Stabilization and Assistance to Severely Distressed Sectors of the United States Economy

Title IV of the Act provides $500 billion in funding for loans and financial assistance to mid-size and large businesses, states and municipalities and non-profits.  $46 billion of these funds are specially allocated to the airline industry and industries critical to national security.  Assistance to airlines and national security industries will be via direct U.S. Department of Treasury loans and investments.

The remaining $454 billion is available to assist other businesses, states and municipalities and non-profits. The financial assistance will be made available via a Federal Reserve Act Section 13(3) program to provide financing through banks and other lenders.  This assistance targets businesses employing between 500 and 10,000 employees.  The assistance is contemplated primarily as low interest loans (interest rate not exceeding 2% per annum) with payments of principal and interest deferred for the first six months or longer.

The Act provides conditions on eligibility and terms and conditions of loans, including:  (i) economic conditions make the loan necessary to support ongoing operations, (ii) funds will be utilized to retain or restore at least 90% of workforce, (iii) prohibitions on dividends and stock buybacks while the loan is outstanding, and (iv) restrictions on offshoring jobs and a requirement that a majority of employees are based in the U.S. Other requirements, terms and conditions for loans and assistance will be determined and set forth in the Department of Treasury and Federal Reserve guidelines.  Title IV assistance does not provide for future loan forgiveness.

Application procedures and guidelines for the Title IV program are to be published shortly by the Department of Treasury and the Federal Reserve.

V.   HHS – Public Health and Social Services Emergency Fund

The CARES Act establishes a $100 billion “Public Health and Social Services Emergency Fund” to reimburse eligible providers for health care related expenses or lost revenues that are attributable to the coronavirus.  The Act further defines eligible health care providers to be public entities, Medicare or Medicaid enrolled suppliers and providers, and other entities that the Secretary includes that provide diagnosis, testing, or care for individuals with possible or actual cases of COVID-19.  These funds are available for building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity.  To be eligible, providers are required to apply to HHS.

VI.   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.

CARES ActCARES ActCARES Act

 

 

 

 

 

Michael Cook, Jennifer Papapanagiotou and Andy Lynch are Partners at Liles Parker, PLLC.  They each have decades of experience representing health care providers and suppliers and other businesses around the country in connection with a wide range of matters.  Questions regarding the impact of recent coronavirus guidance on your organization?  Call Liles Parker for a free consultation.  We can be reached at:  1 (800) 475-1906.

[1] See this link for a full copy of the CARES Act.

[2] For a collection of all articles written by Liles Parker attorneys related to the COVID-19 public health emergency, please visit our webpage at this link.

[3] The CMS Press Release on the Accelerated and Advanced Payment process can be accessed here and the Fact Sheet can be accessed here.

Operating a Medical Practice in Texas during the COVID-19 Pandemic

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Texas SNF Providers are Under Audit(March 30, 2020): The COVID-19 pandemic is unprecedented and has resulted in President Trump declaring a National Emergency[1] and Secretary Alex Azar, of the US Department of Health & Human Services (HHS) to declare a public health emergency[2] for the nation. The effects of this pandemic have been felt across the country, and understandably, numerous disruptions to clinic operations have occurred. These uncertainties have left providers questioning the types of procedures that can be completed during the pandemic.  This article examines COVID-19 related guidance from the Texas Governor’s Office, the Texas Medical Board (Board}, and the Texas Attorney General’s Office with respect to medical clinics in Texas. However, this review is not exhaustive. It should be kept in mind that due to the rapidly evolving nature of this public health emergency, that any guidance would need to be constantly updated. Therefore, it is strongly recommended that a practice consult with legal counsel to address any concerns specific to their practice.

I.    The Impact of COVID-19 on Telemedicine Laws in Texas:

When possible, it is highly advisable that practices conduct visits through telemedicine or postpone visits that are able to be completed at a later date. During the pandemic, some Medicare telemedicine laws have been relaxed to expand coverage.[3] In addition, some states have expanded access to telemedicine as well. Texas is one of the states that has expanded access to telemedicine services.

  • Expansion of Telemedicine.

On March 14, 2020, the Governor of the State of Texas, Greg Abbott, approved the Board’s request to temporarily suspend Texas Occupation Code 111.005 (a)-(b) and Title 22, Chapter 174.6 (a)(2)-(3) of the Texas Administrative Code. Pursuant to these suspensions, Texas has approved phone only consults as telemedicine. Specifically, the Board has advised: “Telemedicine, including the use of telephone only, may be used to establish a physician-patient relationship. This expanded use of telemedicine may be used for diagnosis, treatment, ordering of tests, and prescribing for all conditions. The standard of care must be met in all instances.” These suspensions are in effect until the March 13, 2020 disaster declaration is lifted or expires or they are terminated by the Office of the Governor.[4] It is important to note that only encounters that are initiated by a patient, or the patient’s proxy decision maker, are allowed to qualify as telemedicine under these rule changes.[5]

  • Telemedicine for Chronic Pain.

On March 19, 2020, Governor Abbott approved the Board’s request to temporarily suspend 22 TAC § 174.5(e)(2)(A). This law previously stated, “Treatment of chronic pain with schedule drugs through the use of telemedicine medical services is prohibited.”[6] According to the Board, this “waiver allows telephone refill(s) of a valid prescription for treatment of chronic pain by a physician with an established chronic pain patient. Due to the seriousness of the opioid crisis and the need to ensure there is proper oversight of chronic pain management, this suspension is only in effect until April 10, 2020.”[7] The Board also added however, that the physician “remains responsible for meeting the standard of care and all other laws and rules related to the practice of medicine. The standard of care must still be maintained related to the treatment of chronic pain patients.” This order opens up the possibility of continuing to treat some chronic pain patients via telemedicine which previously was not possible.

However, there are still many instances that telemedicine cannot adequately address the needs of a patient. Therefore, providers in Texas need to be aware of the new limitations placed on them when completing non-urgent elective procedures or surgeries.

II.   Executive Order GA-09:

On March 22, 2020, the Governor Abbott, issued Executive Order No. GA-09. Executive Order GA-09 ordered that:

[A]ll licensed health care professionals and all licensed health care facilities shall postpone all surgeries and procedures that are not immediately medically necessary to correct a serious medical condition of, or to preserve the life of, a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician;

PROVIDED, however, that this prohibition shall not apply to any procedure that, if performed in accordance with the commonly accepted standard of clinical practice, would not deplete the hospital capacity or the personal protective equipment needed to cope with the COVID-19 disaster.

GA-09 applies to the entire state of Texas and is currently in full force and effect until 11:59 p.m. on April 21, 2020 unless the order is modified, amended, rescinded, or suspended by the governor.[8]

  • Related Texas Attorney General Guidance.

On March 23, 2020, Texas Attorney General, Ken Paxton, warned all licensed health care professionals and all licensed health care facilities, including abortion providers, that they must postpone all surgeries and procedures that are not immediately medically necessary. It was clarified that this prohibition applies to all surgeries and procedures that are not immediately medically necessary, “including routine dermatological, ophthalmological, and dental procedures, as well as most scheduled healthcare procedures that are not immediately medically necessary such as orthopedic surgeries or any type of abortion that is not medically necessary to preserve the life or health of the mother.”[9] Attorney General Paxton noted that the failure to comply with the executive order can result in penalties of up to $1,000 or 180 days of jail time.[10]

  • Related CDC Guidance.

The CDC recommends that elective surgeries at inpatient facilities be rescheduled as necessary and recommends that urgent inpatient diagnostic and surgical procedures be moved to outpatient settings when feasible. In addition, any non-urgent outpatient visits should be rescheduled.[11]

  • Related CMS Guidance.

 CMS has issued guidelines regarding “Adult Elective Surgery and Procedure Recommendations: Limit all non-essential planned surgeries and procedures, including dental, until further notice.” CMS also included a tiered framework with guidance regarding the types of procedures that should be completed or postponed.[12]

  •  Texas Medical Board Emergency Rules and Guidance.

On March 24, 2020, the Texas Medical Board (Board) issued guidance stating that it will enforce Executive Order GA-09 and passed emergency Board rules to enforce the “Executive Order’s prohibition against performing surgeries or medical procedures that are not immediately medically necessary through April 21, 2020.”[13]

A.  Board Emergency Rules.

On March 23, 2020, the Board adopted emergency rules to enforce Executive Order GA-09. These rules allow the Board to quickly act if it is determined that a licensee is in violation of the Executive Order. The emergency rules have amended 22 TAC § 187.57(c) and 22 TAC § 178.4(d). The Board updated 22 TAC § 187.57(c) to amend the current definition of “Continuing Threat to the Public Welfare” to include the “performance of a non-urgent elective surgery or procedure.”[14] The Board also amended 22 TAC § 178.4(d) to require immediate reporting of “any physician scheduling to perform, preparing to perform, performing, or  who has performed a non-urgent elective surgery or procedure.”[15]

B.  Board Guidance and Answers to Frequently Asked Questions (FAQs):

The Board has recognized that there are different levels of need for “elective” surgeries. These levels of need can be distinguished by terms such as “urgent,” “emergent,” “or acuity.” Despite the differences in terminology used, the Board has stated that the physician must determine “if these types of procedures are delayed or canceled, will a patient be at risk for serious adverse medical consequences or death.”[16]

Due to the changes in 22 TAC § 187.57(c), the Board defined procedures that are “urgent or elective urgent” as “a surgery or procedure is scheduled where there is a risk of patient deterioration of disease progression that is likely to occur if the procedure is not undertaken immediately and/or the surgery or procedure is significantly delayed. The resulting decline in the patient’s health could make them more vulnerable to COVID-19 and other issues.”[17]

As Executive Order GA 09 and 22 TAC § 187.57(c) provides that this prohibition does not apply to a procedure that, if performed in accordance with the commonly accepted standard of clinical practice, would not deplete the hospital capacity or the personal protective equipment (PPE) needed to cope with the COVID-19 disaster. What does this mean?  As the Board’s guidance reflects:

“Executive Order GA O9 stated that PPE and hospital capacity needed to fight COVID-19 should not be depleted. Because PPE and hospital capacity are a critical need, procedures under this section of Executive Order GA 09 and 22 TAC § 187.57(c) must still meet the criteria of being medically necessary to prevent ‘risk for serious adverse medical consequences or death, as determined by the patient’s physician,’ regardless of the office, facility, local, regional, or state availability of PPE and hospital capacity.[18]

In order to assist providers with determining whether a surgery or procedure can be performed, the Board has drafted a number of questions for the provider to consider:

Question #1: Does this prohibition apply to me or my practice location?

“The prohibition applies to ALL licensed healthcare providers and their delegates. It also applies to all licensed healthcare facilities. If you are a licensed healthcare professional or delegate, or performing the medical act in a licensed healthcare facility, proceed to #2.

Question #2:  Is the medical act a surgery or procedure?

  • Yes, proceed to #3.

  • No, I am performing other medical acts, such as a history, physical exam, non-invasive diagnostics, or ordering/performing lab tests. If your answer is no, you may proceed with the medical act.

Question #3:  If the medical act is a surgery or procedure, then you must ask the following questions:

  • Is this immediately medically necessary to correct a serious medical condition or to preserve the life of a patient?

  • Would this patient, without immediate performance of the surgery or procedure, be at risk for serious adverse medical consequences or death? If you answer yes to either of the above questions, you can proceed with the medical act. You should document the medical necessity and serious risk in the patient’s medical record. In determining how to answer the above questions, please review the above discussion of urgent vs. non-urgent and elective surgery or procedure.

Also note that performance of the following medical acts would generally not be considered immediately medically necessary/pose a serious risk:

Routine dermatological procedures;

  • Routine ophthalmological procedures;
  • Routine dental procedures;
  • Nonemergent orthopedic surgeries;
  • Cosmetic and plastic surgeries;
  • Nonsurgical cosmetic procedures; and
  • Abortion not medically necessary to preserve the life or health of the mother.

If a physician determines that an elective surgery is necessary and that the surgery would not violate Executive Order GA-09 or Board rules, the Board advised: “Documentation is key. It is very important that the medical record clearly reflects why the elective surgery or procedure was urgent and necessary to prevent serious adverse medical consequences or death. This documentation could include information on the patient’s medical history, prescriptions, lab results, imaging, or other relevant factors used to help make the determination of the urgent necessity of the elective surgery or procedure.” Therefore, if a surgery or procedure must be performed, it is very important that the physician clearly document why the procedure or surgery was necessary at this time.

The Board has also stated in its guidance that the performance of a non-urgent elective procedure may be determined by the Board to be a continuing threat to public welfare. If the Board received a complaint of this nature, it “may result in a temporary suspension or restriction hearing with or without notice depending on the circumstances. Any Board action to restrict or suspend a licensee’s license, even if temporary, will trigger a mandatory report to the National Practitioner Data Bank (NPDB).”[19]

 III.  Conclusion:

If a surgery or procedure is elective and it is possible to postpone the procedure, the procedure should be postponed. However, where a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician, it may be performed. While the rules state that if the procedure were performed in accordance with the commonly accepted standard of clinical practice, the [non-urgent elective surgery or procedure] would not deplete the hospital capacity or the personal protective equipment needed to cope with the COVID-19 disaster, then the physician may perform the procedure. However, the Board has clearly stated that due to the pandemic, all surgeries must meet the criteria of being medically necessary to prevent “risk for serious adverse medical consequences or death, as determined by the patient’s physician.”

If a practice in Texas is going to perform any surgeries or procedures while these rules are in effect, the decision to perform the surgery or procedure must be made on a case by case basis. The physician will need to make a determination that the specific patient would be at risk for a serious adverse medical consequences or death without performance of the procedure. These findings would need to be clearly documented in the patient’s record along with any support for the findings. A Texas physician who performs any procedure during this disaster should be prepared to defend the procedure in front of the Board if necessary.

Physicians should be aware though that the Board has significant authority to enforce the recently passed emergency legislation. Physicians are required under the newly enacted laws to immediately report “any physician scheduling to perform, preparing to perform, performing, or who has performed a non-urgent elective surgery or procedure.”[20] If a physician was reported for having performed a non-urgent elective surgery or procedure, it could result in a temporary suspension hearing with or without notice depending on the circumstances. Any Board action to restrict or suspend a licensee’s license, even if temporary, would trigger a mandatory report to the NPDB. Therefore, if a physician believed that any of the surgeries or procedures performed by another physician were non-urgent, that physician would be required to immediately report the performing physician. The performing physician could then have to defend the action before the Board at a temporary suspension hearing. As the Board can temporarily suspend a practitioner without notice, the provider may not have an opportunity to defend the procedures until after the suspension has been put in effect. In addition, the suspension would be reported to the NPDB which would then send out a notice to all payors the provider is credentialed with. Therefore, all providers should be aware that the performance of any procedure or surgery at this time comes at a risk and therefore, only truly necessary procedures or surgeries should be completed.

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.

Call Meaghan McCormick for help with an 1155 waiver.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] 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] An article that discusses the updates made by Medicare for telemedicine can be accessed here.

[4] The Board’s press release regarding these changes can be accessed here.

[5] The Board’s responses to the FAQs regarding telemedicine during Texas disaster declaration for COVID-19 pandemic can be accessed here.

[6] 22 TAC § 174.5(e)(2)(A) can be accessed here.

[7] The Board’s Press Release regarding the waiver for chronic pain patients can be accessed here.

[8] The full text of the order can be accessed here.

[9] It should be noted that some providers have filed suit against Texas regarding Attorney General Paxton’s declaration.

[10] Press release from Texas Attorney General Ken Paxton can be accessed here.

[11] CDC guidance for healthcare facilities can be accessed here.

[12] CMS’ guidance and tier list can be accessed here.

[13] The Board’s press release regarding the emergency rules passed to enforce Executive Order GA-09 can be accessed here.

[14] The amended 22 TAC § 187.57(c) can be accessed here.

[15] The amended 22 TAC § 178.4(d) can be accessed here.

[16] The Board’s responses to the FAQs regarding non-urgent, elective surgeries and procedures during Texas disaster declaration for COVID-19 pandemic can be accessed here.

[17]  Id.

[18] Id.

[19] Id.

[20] The amended 22 TAC § 178.4(d) can be accessed here.

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

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(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.

covid-19 public health emergencyJennifer 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

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DOJ is aggressively prosecuting instances of COVID-19 fraud and related wrongdoing.(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:

Federal Statutory Authority 
15 U.S.C. § 1 — Trusts, etc. in Restraint of Trade Illegal; Penalty
15 U.S.C. § 2 – Monopolizing Trade a Felony; Penalty
15 U.S.C. § 14 – Sale etc., on Agreement not to Use Goods of Competitor
15 U.S.C. § 1263 Prohibited Acts (Introduction of Misbranded or Banned Hazardous Substances into Interstate Commerce)
15 U.S.C. § 2068 – Prohibited Acts (Sale, Manufacture, Distribution or Import of a Consumer Product or other Product that is not in Conformity with Consumer-Product-Safety Regulations)
18 U.S.C. § 175Prohibitions with Respect to Biological Weapons
18 U.S.C. § 875 — Interstate Communications
18 U.S.C. § 876 – Mailing Threatening Communications
18 U.S.C. § 1030Fraud and Related Activity in Connection with Computers
18 U.S.C. § 1038 — False Information and Hoaxes
18 U.S.C. § 1040 — Fraud in Connection with Major Disasters and Emergencies
18 U.S.C. § 1341 – Frauds and Swindles (Mail Fraud)
18 U.S.C. § 1343 – Fraud by Wire, Radio or Television (Wire Fraud)
18 U.S.C. § 1347 — Healthcare Fraud
18 U.S.C. § 1349 — Conspiracy to Commit Fraud
18 U.S.C. §§ 1028-1028A — Fraud and Related Activity in Connection with Identification Documents, Authentication Features, and Information (Identification Fraud and Aggravated Identity Theft)
18 U.S.C. § 2320 –Trafficking in Counterfeit Goods
18 U.S.C. § 2332a — Use of Weapons of Mass Destruction
21 U.S.C. § 333 — Violation of the Food, Drug, and Cosmetic Act

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. LilesRobert 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.

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