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OIG And DOJ Issue Important New Compliance Guidance

Recently, the Office of Inspector General of the United States Department of Health and Human Services (OIG) and the Criminal Division of the Fraud Section at the United States Department of Justice (DOJ) have issued guidance on measuring the effectiveness of corporate compliance programs.  In February, DOJ placed on its website a document entitled “Evaluation of Corporate Compliance Programs.”  That document lists 119 sample questions that DOJ’s Fraud Section has in the past found relevant in its evaluation of the effectiveness of corporate compliance programs for the purpose of deciding whether to prosecute cases, and in recommending sentences for criminal violations.  These questions are separated into eleven (11) topic areas: analysis and remediation of underlying conduct, senior and middle management, autonomy and resources, policies and procedures, risk assessment, training and communication, confidential reporting and investigation, incentives and disciplinary measures, continuous improvement, periodic testing and review, third party management, and mergers and acquisitions.  While not specifically addressing health care organizations, per se, the guidance is highly relevant to organizations and practices since they are questions that Federal prosecutors will be asking when evaluating compliance programs in any criminal investigation.  The guidance can be reviewed in its entirety at https://www.justice.gov/criminal-fraud/page/file/937501/download.

Even more recently, on March 27 of this year, OIG published a parallel and more inclusive document focused specifically on the health care industry, “Measuring Compliance Program Utilization – A Resource Guide.” The Guide, which is 52 pages in length, sets out a checklist of questions broken down into seven standards based on the standard seven elements of an effective compliance programs, and further broken down into various subcategories under each element.  The guidance is the product of a round table on January 2017 that brought together a group of compliance professionals and staff from OIG “to discuss ways to measure the effectiveness of compliance programs.”  While the guidance is clear that it is not a “one size fits all,” it provides a number of ideas of “what to measure” and “how to measure” these programs, and should be mandatory reading for all compliance officers in organizations, whether a small physician’s office or a large hospital system or health care organization.  The guidance can be accessed at https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf.

Liles Parker attorneys, and frankly any knowledgeable attorney who specializes in health care, have for many years advised clients that is essential to establish a compliance program that is implemented effectively.  Among other things, an effective compliance program establishes the culture of compliance for an organization in following the law, that should demonstrate an ethos from the top down through every employee and professional.  It also provides management with the opportunity to detect and correct problems and potential issues before they either emerge or become widespread. Many, if not most, whistleblower lawsuits are the result of employees feeling that their concerns, when reported internally, were not investigated.

Moreover, Congress has mandated compliance plans for skilled nursing facilities and the revised requirements of participation require them for both nursing and skilled nursing facilities so that the effectiveness of these programs will become part of the survey process.  And, if an investigation arises, the conversation with enforcement agencies is dramatically different when an organization can demonstrate that it has an effective program as opposed to no program, or one that sits on a shelf.

One of the criteria that OIG has had for determining whether a compliance program is effective is whether the organization measures the effectiveness of its program, itself.  At a minimum, every organization should do this once per year.

Finally, in September 2015, DOJ issued a memorandum entitled “The Individual Accountability for Corporate Wrongdoing.”  Among other things, the memorandum, referred to as the Yates Memo,” instructs prosecutors and investigators to hold highly placed individuals within an organization accountable for the organization’s misconduct.  Prior to the issuance of the Yates memo, those of us involved as defense counsel in investigations were frequently able to obtain releases for individual members of an organization in settlements of civil and administrative investigations.  Since the issuance of the Memo, releases of individuals now occur on only the rarest of occasions.

For all of these reasons, it is imperative that every health care provider establish an effective compliance program and that it periodically measure the effectiveness of that program.  These guidances provide important and helpful information in how to accomplish that result.

Michael CookLiles Parker attorneys have extensive experience in developing compliance programs, providing compliance guidance, and working with clients in investigations.  Clients having questions related to these issues should contact Michael Cook at (202) 298-8750, mcook@lilesparker.com

 

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Home Health Final Rule Creates New Exclusion Screening Obligation

March 29, 2017 by  
Filed under Featured, Health Law Articles

(March 29, 2017):  The Centers for Medicare and Medicaid Services (CMS) has recently published a new Final Rule that makes changes to the Conditions of Participation for home health agencies.  Under the Final Rule, providers are required to ensure that individuals and entities providing services under arrangement are not excluded, terminated, or debarred from any Federal health care program.  Simply put, these new requirements are an affirmative obligation to screen both the Federal and State exclusion lists.

While CMS does not provide detailed guidance on how a home health agency is supposed to meet this new requirement, it does make it clear that the responsibility of properly screening contracted entities remains with the home health agency.  Additionally, it makes no mention of how a provider could screen for a Medicaid exclusion.  This lack of clarity on how to effectively meet this Condition of Participation could be problematic since CMS may now hold an HHA liable for failing to catch a Medicaid exclusion.  Home health agencies are cautioned to ensure that they are properly screening for State exclusions in addition to Federal exclusions to avoid having their participation terminated. What should your home health agency do?  As a start, we recommend that you review the detailed discussion on this new requirement written by Paul Weidenfeld, Esq. and Catalina Jandorf at Exclusion Screening.

Do you have questions regarding your screening obligations?  Give us a call.  Liles Parker attorneys represent home health agencies around the country in connection with ZPIC audits, OIG investigations, exclusion issues, False Claims Act cases and transactional matters.  Please call Robert W. Liles for a free consultation.  He can be reached at:  1 (800) 475-1906.

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Are you Ready for the Next Round of CMS Re-Validation?

Recovery AuditCMS announced recently that it will be initiating its next round of revalidation requests to all Medicare enrolled providers and suppliers.

Current law and regulations require providers and suppliers to revalidate their enrollment with Medicare every five years (every three years for DME suppliers). There are a few changes being made to try and give providers a bit more flexibility this time around.  Below are some key highlights for the next cycle of revalidation beginning this year:

  • CMS will maintain a master list of providers/suppliers due for revalidation along with the due date for their applications here: https://data.cms.gov/revalidation. CMS has advised that all providers/suppliers should check this list to see when their application is due. If a due date is more than six months away, the list will show “TBD” for a provider/supplier due date. DO NOT SUBMIT A REVALIDATION APPLICATION IS NO DUE DATE APPEARS. IT WILL BE RETURNED.
  • The website will also provide a list of all reassignments for those suppliers that maintain reassignments.
  • Providers and suppliers don’t have to wait for a letter from their Medicare Administrative Contractor (“MAC”) to submit a revalidation application. If you are within six month of your due date shown on the above website, you are encouraged to submit your application.
  • MACs will still send an email or letter to providers/suppliers 2-3 months prior to their due date asking them to revalidate. Emails will include the title “URGENT: Medicare Provider Enrollment Revalidation Request.” If emails are returned as undeliverable, a paper letter will be sent. All letters will be sent to at least two of a providers/suppliers reported addresses (e.g. a correspondence and special payments or primary practice location address.
  • Revalidation notices sent to individual practitioners who have reassigned their billing rights to a group or groups will include a list of all reassignments on file with CMS. Special procedures will be available for groups with more than 200 members.
  • An upcoming revalidation does not relieve providers/suppliers from submitting updates to their enrollment record in the timeframes required by relevant regulations. Submit all changes of information timely, even if a revalidation is due within the next six months.

In addition to outlining the process for the next round of revalidation, CMS has provided tips for ensuring your revalidation is complete.

  • Providers and suppliers are required to revalidate their entire Medicare enrollment record, including all practice locations where they see patients and all groups to which they reassign benefits.
  • All of a provider’s or supplier’s NPIs and PTANs must be revalidated when revalidation is requested.
  • Either PECOS or the paper CMS-855 applications may be used for revalidation.
  • If a provider or supplier is deactivated for failing to submit a revalidation application on time or failing to respond to a request for additional information on a pending application, they may reactivate their enrollment by submitting a new, full application. The provider/supplier, once the application is processed and approved, will maintain their original PTAN, but the reactivation date will be whatever date the new, full application was submitted. Retroactive billing privileges back to the date of deactivation will not be granted and the provider/supplier will have gap period where they may not receive payment for services provided to Medicare beneficiaries.
  • CMS has reminded certain providers and suppliers that a fee is due with their revalidation application. All “institutional providers” that submit an application via PECOS or a paper Medicare enrollment application using the CMS-855A, CMS-855B (except physician and non-physician practitioner organizations), or CMS-855S forms are required to pay the application fee. For Calendar Year 2017, the fee is $560. It can be paid via this website: https://pecos.cms.hhs.gov/pecos/feePaymentWelcome.do#headingLv1 Be sure to print proof of payment with your revalidation application to avoid delays in processing.

CMS also noted that all providers and suppliers that have not billed Medicare for 12 consecutive months will have their billing privileges deactivated. To reactivate their provider number, a complete, new application must be submitted. Once approved, the provider/suppliers will retain its original PTAN.  The effective date of reactivation will not be retroactive to the date of deactivation.

We encourage all providers and suppliers to check CMS’ list of revalidations due in the upcoming six months. The list is updated every sixty days. If you choose to use PECOS to complete your revalidation, be sure to print a copy of your submission BEFORE you click the submit button. You need to retain a copy of what you submit indefinitely in order to substantiate what you input via PECOS. We have seen far too many providers and suppliers think they properly completed a revalidation application via PECOS only to be revoked later on because some data point was missing from a submission or was submitted under the incorrect enrollment file or field. Also:

  • If you are a physician who is the sole shareholder of your practice, you do NOT need to complete a CMS-855B in most instances. However, it is very important to properly identify your practice locations under both your individual and your entity’s enrollment in PECOS when you revalidate those enrollments. Don’t make the mistake of thinking that listing practice locations under just your individual enrollment will make them automatically appear under your entity (or vice versa).
  • Physicians and non-physician practitioners that reassign payments to groups must identify all groups to which they reassign on their revalidation. Failure to list a group may result in a reassignment being deactivated. You do not need to submit new CMS-855Rs with your revalidation.
  • If you check the list of revalidations that are due and you can’t locate your record after searching by name or NPI…CALL YOUR MAC. The list contains all active Medicare program providers and suppliers, including DME suppliers. If you do not appear on the list, you need to find out why.

CMS has published an article discussing the revalidation process in more detail here: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE1605.pdf  In addition, you may visit this CMS website for additional information: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Revalidations.html

Liles Parker PLLC attorneys are experienced in helping providers and suppliers with the Medicare enrollment and revalidation process. Please contact us if you have questions or need assistance.

Jennifer Papapanagiotou, Esq is a health law attorney with the firm, Liles Parker, Attorneys & Counselors at Law.  Liles Parker has offices in Washington DC, Houston TX, McAllen TX and Baton Rouge LA.  Our attorneys represent dentists, orthodontists and other health care professionals around the country in connection with Medicare provider enrollment and revocation matters.  Need assistance?  For a free consultation, please call: 1 (800) 475-1906.

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Upcoming Webinar — CJR/Bundled Payment Impact on Post-Acute Providers–Navigating Alternative Payment Systems (Intermediate)

January 31, 2017 by  
Filed under Firm News, Health Law Articles

Michael Cook, Partner and Co-chair of the Health Care Group at Liles Parker and Fred Bentley, Vice President, Center for Payment and Delivery System Reform, Avalere Health, will be presenting a webinar for the American Health Lawyers Association, on CJR/Bundled Payment Impact on Post-Acute Providers–Navigating Alternative Payment Systems (Intermediate).  The webinar will be presented from 2 – 3:30 Eastern on February 8.

Click here for more information and to register.

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HHS Issues Final Rule to Address Record High Medicare Appeals Backlog

gavel(January 20, 2017): The Medicare appeals backlog has reached its all-time worst. If you’re a healthcare provider or supplier waiting for a hearing before an Administrative Law Judge (ALJ) at the Office of Medicare Hearings and Appeals (OMHA) – the third level of the Medicare appeals process – you’ve likely been waiting years to have your case heard or, at least, you’re expecting such a wait. This wait time has persisted despite that ALJs are statutorily required to issue a decision within 90 days of receipt of a hearing request. The reasons for the backlog depend on who you ask: the American Hospital Association (AHA) and others have contended that the Recovery Audit Program is the “primary culprit in creating and sustaining” the backlog because Recovery Audit Contractors (RACs) “receive a cut of any improper payments they recover […] and can challenge claims going back as far as three years”; the U.S. Department of Health and Human Services (HHS) agrees that the Recovery Audit Program has contributed to the backlog, but believes there are other reasons as well, like an increase in Medicare beneficiaries and a growing practice among some providers to appeal virtually every claim denial through ALJ review (coupled with only modest increases in funding for the agency, thereby limiting their ability to address the growing number of appeals and backlog). In any event, the statistics are astounding:

  • The number of ALJ appeals filed grew 936%, from 41,733 to 432,534, between fiscal years (FY) 2010 and 2014.
  • By the end of FY2014, 767,422 appeals were pending at ALJ.
  • ALJ decisions are issued well after the 90-day statutory deadline: in FY2014, it took OMHA an average of 415 days to process an ALJ appeal; in FY2015, it took OMHA an average of 662 days to process an ALJ appeal; and in FY2016, it took OMHA an average of 877 days to process an ALJ appeal.

The backlog has been a significant source of frustration for healthcare providers and suppliers (and their representatives) stuck in the lingering appeals process – and not just because it takes so long to achieve a final judgment by the Secretary. The delay often has significant financial consequences because Medicare can statutorily recover the alleged overpayment shortly after a second level (reconsideration) appeal decision issues, despite that the appeals process is not over and despite that the first two levels of appeal are littered with problems (e.g., we see chronic misapplication of Medicare coverage and payment rules by appeals contractors at the first two levels of appeal).

Thanks to the efforts of AHA and other plaintiffs who sought relief in court, we may see the backlog resolve over the next few years. On 12/05/2016, the United States District Court for the District of Columbia ordered that the HHS Secretary reduce the backlog according to the following timeline:

  • 30% reduction from the current backlog of cases pending at the ALJ level by 12/31/2017;
  • 60% reduction by 12/31/2018;
  • 90% reduction by 12/31/2019; and
  • 100% reduction by 12/31/2020.

In an effort to meet these mandated backlog reduction timelines, HHS issued a final rule on 01/17/2017 titled “Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures”. The final rule includes an assortment of initiatives to reduce the backlog which become effective 03/17/2017, including:

  • Giving select Medicare Appeals Council decisions precedential effect. The final rule provides that designated “Medicare Appeals Council decisions […] have precedential effect and are binding on all CMS components, on all HHS components that adjudicate matters under the jurisdiction of CMS, and on the Social Security Administration to the extent that components of the Social Security Administration adjudicate matters under the jurisdiction of CMS.” This is significant because, currently, even if the Medicare Appeals Council interprets a Medicare authority or provision in a specific way in a decision, that interpretation only applies to the case at hand (even though the decision represents the final decision of the Secretary). In other words, an Appellant can’t contend that the interpretation of a Medicare authority or provision in a previous Medicare Appeals Council matter is binding in their case as well, even if the facts and issues are very similar. HHS hopes the precedential nature of Medicare Appeals Council decisions as of 03/17/2017 will create consistency in the appeals process. It’s possible, though, that the discretion given to the Departmental Appeals Board (DAB) Chair to decide which cases have precedential effect may impact how effective this change will ultimately be.
  • Expanding the pool of adjudicators at OMHA to include attorney adjudicators. An attorney adjudicator is a licensed attorney employed by OMHA with knowledge of Medicare coverage and payment laws and guidance, and authorized to take the actions on requests for ALJ hearing and requests for reviews of QIC dismissals. HHS estimates that the expansion of the pool of adjudicators at OMHA could redirect approximately 24,500 appeals per year to attorney adjudicators who would be able to process these appeals at a lower cost than would be required if only ALJs were used to address the same workload.
  • Creating process efficiencies. These include, for example, allowing ALJs to vacate their own dismissals rather than requiring Appellants to appeal a dismissal to the Medicare Appeals Council and using telephone hearings for certain Appellants.

For more information on these and numerous other initiatives, please refer to the Federal Register. The hope is that the finalization of this rule and the Secretary’s accountability to the District Court – the Court retained jurisdiction of the case to review the quarterly status reports the Secretary is required to prepare and to rule on any challenges to unmet deadlines – will achieve the intended result: complete elimination of the backlog by 2020.

The Centers for Medicare and Medicaid Services (CMS) has taken steps in the past to improve the appeals process, and these steps have not always achieved the intended result. For example, with regard to appeals stemming from a post-payment review, CMS directed redetermination (first level) and reconsideration (second level) appeals contractors – effective August 2015 – to restrict their review on appeal to (in most cases) only the issues alleged by the reviewing contractor (i.e., the contractor that requested the records and issued the initial audit results). The purpose was to avoid a moving ball – where one Medicare contractor alleges one issue and the Appellant addresses it, but then another contractor alleges another issue, requiring the Appellant to then address a different issue with regard to the same claim. However, we have seen the redetermination and reconsideration appeals contractors repeatedly disregard this CMS directive and continue to try and add new denial reasons to the administrative record. We have also seen the initial auditing contractors increasingly allege more than one denial reason, throwing everything but the kitchen sink at providers and suppliers. It seems that Medicare is hoping for at least one denial reason to persist through the appeals process.

Judicial oversight is the difference this time around and could be the key to reducing the backlog. We’ll be monitoring HHS’s progress closely and hoping for expeditious relief for our current and future clients, and healthcare providers and suppliers everywhere.

Sources:

AHA v. Burwell, 2016 U.S. Dist. LEXIS 126840 (D.D.C. Sept. 19, 2016).

AHA v. Burwell, 2016 U.S. Dist. LEXIS 167291, 2016 WL 7076983 (D.D.C. Dec. 5, 2016).

Federal Register, Volume 82, Number 10, Pages 4974-5140, “Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures” (01/17/2017). Available at https://www.federalregister.gov/documents/2017/01/17/2016-32058/medicare-program-changes-to-the-medicare-claims-and-entitlement-medicare-advantage-organization.

HHS, “FACT SHEET: HHS Issues Final Rule to Improve the Medicare Appeals Process”.

HHS, OMHA, “Average Processing Time By Fiscal Year” (11/18/2016). Available at https://www.hhs.gov/about/agencies/omha/about/current-workload/average-processing-time-by-fiscal-year/index.html#.

IMG_1897Lorraine Ater, JD is a health law attorney with the firm Liles Parker.  She is also a Certified Medical Compliance Officer (CMCO) and a Certified Medical Reimbursement Specialist (CMRS).  Lorraine represents healthcare providers and suppliers around the country in connection with Medicare audits and appeals.  Liles Parker is a boutique health law firm with offices in Washington, DC; across the State of Texas; and in Baton Rouge, LA.  Need assistance?  For a free consultation, please call: (202) 298-8750.

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Home Health Audits: Pre-Claim Demonstration Project Update – Part 1.

(January 9, 2017):  As the Centers for Medicare and Medicaid Services (CMS) has announced, the alleged error rate associated with home health claims has risen from 17.3 % in FY 2013 to 51.38% in FY 2014 and 58.95% in FY 2015.  In light of these increases, CMS has taken steps to address the home health claims error rate.  Section 402(a)(1)(J) of the Social Security Amendments of 1967 authorizes the Secretary for the Department of Health and Human Services (HHS) to develop demonstration projects that:

“[D]evelop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act.”

Consistent with this authority, on February 5, 2016, the Centers for Medicare and Medicaid Services (CMS) published notice in the Federal Register that it intended to collect information that would be used by the agency to serve as a:

“[B]aseline estimate of probable fraud in payments for home health care     services in the fee-for-service Medicare program.”  42 U.S.C. 1395b-1(a)(1)(J).

On June 8, 2016, CMS announced in the Federal Register (81 Fed. Reg. 37598) that five states would be part of the new Pre-Claim Review Demonstration. These states included:  Illinois, Florida, Texas Michigan and Massachusetts.  While the program was implemented in Illinois on August 3, 2016, the rest of the implementation schedule was delayed due to a variety of implementation-related problems.

CMS has recently announced that the Pre-Claim Demonstration Project will be resumed and that it will be implemented in Florida on April 1, 2017.  While no implementation dates have been announced yet for Texas and the remaining test states, Texas home health providers could conceivably be facing this program as early as May 1, 2017.

In addition to providing an overview of the home health Pre-Claim Demonstration Project, this article examines the primary reasons for claims denial identified so far by Illinois home health agencies. In this first article, we are focusing on the denial reasons associated with errors identified with face-to-face and plans of care / certification / recertification documentation.

I. What are Medicare’s Home Health Benefit Requirements?

To qualify for the Medicare Home Health benefit, under 1814(a)(2)(C) and 1835(a)(2)(A) of the Social Security Act, a Medicare beneficiary must meet the following requirements:

  • Be confined to the home at the time of services;
  • Medicare considers the person homebound if:

1) There exist a normal inability to leave the home, and

2) Leaving home requires a considerable and taxing effort.

  • Additionally, one of the following must also be true:

1) Because of illness or injury, the person needs the aid of supportive devices such as crutches, canes, wheelchairs, and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence; or

2) The person has a condition such that leaving his or her home is medically contraindicated.

  • Under the care of a physician;
  • Receiving services under a plan of care established and periodically reviewed by a physician;
  • Be in need of skilled services;
  • Have a face-to-face encounter with an allowed provider type as mandated by the Affordable Care Act. This encounter must:

1) Occur no more than 90 days prior to the home health start of care date or within 30 days of the start of the home health care; and be related to the primary reason the patient requires home health services and was performed by a physician or non-physician practitioner.

II. Primary Reasons for the Denial of Home Health Claims Identified:

Based on the claims submitted by home health agencies in Illinois thus far, the following reasons for denial have been cited by Palmetto when reviewing agencies’ home health claims:

Denial Reason Code
Face-to-Face Errors


HH01A
The physician certification was invalid since the required face-to-face encounter document was missing (actual clinical note for the face-to face encounter visit for admissions on or after 1/1/15, or the narrative for admissions on or after 4/1/11and before 1/1/15) Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5.1.1 and 30.5.1.2.


HH01B
The physician certification was invalid since the required face-to-face encounter document was untimely and/or the certifying physician did not document the date of the encounter. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5.1.1.2


HH01A
The physician certification was invalid since the face-to-face encounter was not performed by an approved practitioner. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5.1.1.1


HH01D
The physician certification was invalid since the required face-to-face encounter was not related to the primary reason for home health services. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5.1.2


Denial Reason Code
Plan of Care / Certification / Recertification


HH02A
The Plan of Care was missing. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.2.


HH02B
The content of the Plan of Care submitted was insufficient. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.2.1.


HH02C
The Plan of Care submitted was not signed. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.2.3


HH02I
The Plan of Care submitted was not signed timely by a qualified physician. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.2.4.
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HH02D
Missing physician certification/recertification. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5


HH02E
The physician certification/recertification submitted does not support skilled need. Documentation in the certifying physician’s medical records and/or the acute/post- acute care facility’s medical records (if the patient was directly admitted to home health) shall be used as the basis for certification of home health eligibility. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5 and 42CFR 424.22 (a) and (c).


HH02F
The physician certification / recertification submitted does not support homebound status. Documentation in the certifying physician’s medical records and/or the acute /post-acute care facility’s medical records (if the patient was directly admitted to home health) shall be used as the basis for certification of home health eligibility. Refer to CMS IOM Publication 100- 02, Chapter 7, Section 30.5 and 42CFR 424.22 (a) and (c).


HH02G
The physician recertification estimate of how much longer skilled services are required is missing. Refer to CMS IOM Publication 100-02, Chapter 7, Section 30.5.2.


HH02H
The home health agency generated record contained relevant clinical information addressing the “confined to the home” (homebound) eligibility requirement, which was corroborated by the certifying physician or the acute/post-acute facility documentation, but was NOT signed and dated by the certifying physician. Please have the certifying physician sign and date the relevant HHA-generated information and resubmit. Refer to CMS IOM Publication 100-08, Chapter 6, Section 6.2.3.


HH02J
The home health agency generated record contained relevant clinical information addressing the “need for skilled services” eligibility requirement, which was corroborated by the certifying physician or the acute/post-acute facility documentation, but was NOT signed and dated by the certifying physician. Please have the certifying physician sign and date the relevant HHA-generated information and resubmit. Refer to CMS IOM Publication 100-08, Chapter 6, Section 6.2.3.

III. Lessons to be Learned:

Home health agencies in Florida, Texas, Michigan and Massachusetts should carefully review the denial reasons outlined above and conduct internal audits of your home health claims documentation to determine whether your agency’s documentation is complete.  The experiences of home health agencies in Illinois can be invaluable to your efforts to better ensure the full compliance of your agency with applicable statutory and regulatory requirements.  In future installments of this article, we will examine other reasons for denial seen by Illinois home health agencies.

robert_w_lilesRobert W. Liles, M.B.A., M.S., J.D., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law. Liles Parker is a boutique health law firm, with offices in Washington DC, Houston TX, San Antonio TX, McAllen TX and Baton Rouge LA. Robert represents home health agencies around the country in connection with Medicare audits and compliance matters. Our firm also represents health care providers in connection with federal and state regulatory reviews and investigations. For a free consultation, call Robert at: 1 (800) 475-1900.

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Medicaid Dental Audits are Examining Dentist Eligibility to Provide Treatment

Doc Prescription(January 9, 2017):  A recent report of the New York State agency that administers the Medicaid program by the Department of Health and Human Services, Office of Inspector General (OIG) further highlights the importance of ensuring that dentists providing services to Medicaid beneficiaries are properly licensed, enrolled as a Medicaid provider and not excluded from program participation.  This article examines the steps that must be taken by all dental practices providing services to Medicaid beneficiaries in order to ensure that their providers meet these basic eligibility requirements.

 

I. Has Your Dental Practice Implemented a Compliance Program?

As an initial step, every dental practice participating in the Medicaid program must develop and implement an effective Compliance Program. Among its many provisions, the Affordable Care Act requires that a “provider of medical or other items or services or supplier within a particular industry sector or category” shall establish a compliance program as a condition of enrollment in Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP).  An effective Compliance Program can greatly assist a dental practice in its efforts to ensure that each of its dentists are eligible to provide and bill for services administered to Medicaid beneficiaries.

II. Are Your Dentists Properly Licensed?

As a first step to determining eligibility, you must ensure that the individuals providing dental services in your practice are properly licensed by the state.  All states require that dentists be properly licensed in order to engage in the practice of dentistry.  For example, anyone seeking to practice a profession in the State of New York must comply with a strict requirements set out in Title VIII of the New York State Education Law.  Under this law, Article 133 – Dentistry and Dental Hygiene, defines the practice of dentistry in §6601.  As the applicable section provides:

  • 6601. Definition of practice of dentistry.

The practice of the profession of dentistry is defined as diagnosing, treating, operating, or prescribing for any disease, pain, in jury, deformity, or physical condition of the oral and maxillofacial area related to restoring and maintaining dental health. The practice of dentistry includes the prescribing and fabrication of dental prostheses and appliances. The practice of dentistry may include performing physical evaluations in conjunction with the provision of dental treatment.

While the definition of the practice of dentistry has been purposely written in broad, general terms, the law clearly reflects that only an individual properly licensed to practice dentistry can engage in the profession or use the title of “dentist.”  As set out this section:

  • 6602. Practice of dentistry and use of title “dentist”

Only a person licensed or otherwise authorized to practice under this article shall practice dentistry or use the title “dentist.”

Should an unlicensed individual engage in the practice of dentistry, they may be guilty of a Class E Felony §6612 of the New York State Education Law.  Moreover, if a licensed dentist aids of abets three or more unlicensed persons in the practice of the profession, that person may be guilty of a Class E. Felony.

As part of your ongoing compliance efforts, you should periodically verify that each of your professionals are properly licensed by the state to practice dentistry and that there are no limitations on their license.  It is also important to monitor the status of any licenses maintained by members of your staff in other states.

III. Is a Dentist Properly Enrolled as a Medicaid Provider?

All states have established strict requirements that must be met if a dentist desires to enroll as a Medicaid provider. For example, the New York Medicaid Enrollment Form expressly states that:

You will be at financial risk if you render services to Medicaid beneficiaries before successfully completing the enrollment process. Payment will not be made for any claims submitted for services, care, or supplies furnished before the enrollment date authorized by the Department of Health.

Unfortunately, when audits of paid Medicaid dental claims are conducted, this is a common risk area that has been identified around the country.  Dental practices bringing on new staff may mistakenly think that it is permissible to bill for dental services provided by a non-credentialed dentist (whose enrollment application with Medicaid is pending) under the number of a credentialed dentist.  In most states, such a practice is improper and could subject a practice to fines, penalties and other sanctions.  The enrollment process is there to help protect the integrity of the Medicaid program.  If an applicant has previously been terminated, denied enrollment, suspended or otherwise sanctioned by Medicaid, a state may determination that it is not in the interests of the program to allow the applicant to participant in the program.  Similarly, an applicant may have been convicted of a health care related crime or may have adverse licensure actions pending in another state. For these reasons (and others), the enrollment process is an essential tool used by the state to filter out applicants that may represent a significant risk to the Medicaid program or its beneficiaries.

IV. Have You Screened Your Dentists and Staff Through Available Databases?

Among its many duties, OIG has been delegated the authority to “exclude” individuals and entities from participating in federal health benefits programs. Depending on the nature of the offense, the decision to exclude an individual or entity may be either mandatory or permissive.  There are currently 38 state databases and 2 federal databases that must be checked every 30 days to ensure that the members of your staff have not been added to the one or more exclusion list. Should you fail to properly screen and inadvertently employ an excluded dentist or other staff member, you may face overpayments, civil monetary penalties and / or other sanctions. Essentially, Medicaid will not pay for any claim if an excluded individual or entity contributed to the basket of services provided to the patient — either directly or indirectly.   Exclusion screening is a fundamental component of an effective Compliance Plan.  There are a number of companies that can provide these screening services for a low monthly cost. Two of our attorneys established a company, Exclusion Screening, LLC to conduct these screening services. For information on their services, you can call:  1 (800) 294-0952.

V. Lessons Learned.

As a participating provider in the Medicaid program, you are obligated to comply with a wide variety of statutory and regulatory provisions.  Confirming the eligibility of each of your professional staff members to provide services to Medicaid beneficiaries is merely one of these requirements. The development, implementation of an effective Compliance Program can greatly reduce your overall level of regulatory risk.

robert_w_lilesRobert W. Liles, M.B.A., M.S., J.D., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law. Liles Parker is a boutique health law firm, with offices in Washington DC, Houston TX, San Antonio TX, McAllen TX and Baton Rouge LA. Robert represents home health agencies around the country in connection with Medicare audits and compliance matters. Our firm also represents health care providers in connection with federal and state regulatory reviews and investigations. For a free consultation, call Robert at: 1 (800) 475-1900.

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Responding to Audits of Home Health Agencies by the Office of Inspector General of Home Health Agency Services

November 23, 2016 by  
Filed under Featured, Health Law Articles

AuditThe Office of Audit Services, Office of Inspector General (“OAS”), is in the process of conducting audits of large home health agencies.  These audits are being conducted, in part, because the Centers for Medicare and Medicaid Services (“CMS”) had determined through the Comprehensive Error Rate Testing Program (“CERT”) that for 2014, there was greater than a 50% error rate nationally in Medicare claims for home health services.  Additionally, it is our belief that because the advent of alternative payment methodologies is likely to diminish the relevance of the current process for medical necessity audits in the future, home health agencies are likely to experience a spike in audits of Medicare claims in the near future.

Irrespective of the motivation behind the audits, the first two audit reports resulted in findings of large error rates with extraordinary recommended refunds of more than $15 million for one agency and more than $8 million for the other.  These results were generated by the application of a statistical extrapolation and a recommendation that the results be applied with an attendant request for refunds, not only for the three-year look-back period, but also for earlier years as a result of the “60 day” repayment rule.  See Medicare Compliance Review of Excellent Home Care Services, LLC, Report No. A-02-14-01005 (OAS, July 2016); Medicare Compliance Review of Home Health VNA for 2011 and 2012, Report No. A-01-13-00518 (August 2016).

As a result, we are aware of several companies that are now undergoing similar types of audits by OAS.  The review of these claims has been subcontracted to Maximus, a Qualified Independent Contractor (“QIC”) with experience in reviewing medical necessity audit determinations.

In the past for claim audits by MACs or ZPICs, clients would frequently submit the medical records without preparing any claim summaries, and instead prepare those summaries for purposes of the appeals process after the initial findings.

Because of the extraordinary refunds that have been recommended by the OAS reports cited, above, coupled with the significant delay in obtaining ALJ hearings after refunds are required, providers that receive notices of these audits may wish to take a more proactive approach to defend the legitimacy of the claims under review, including retaining and working with legal counsel at the beginning stage of this process.

Specifically, providers undergoing these audits of which we are aware have been asked to submit the medical records for 100 claims.  For each of these claims, providers should bates label the pages of the claim.  Additionally, they should organize the records so that it is easy to track the various components of the adverse findings of the earlier audit reports, such as face-to-face, nursing, therapy, etc.  Finally, they may wish to consider submitting detailed claim summaries that identify how each of the claims meets the various criteria for coverage and payment, that cite to specific pages of the medical record and that are submitted at the time that the client initially submits the medical record.  Additionally, to the extent that the initial review discloses gaps or ambiguities that can be appropriately and legitimately supplemented or explained, agencies may wish to accomplish that process up front, rather than risking the potential of adverse findings that might not otherwise accurately reflect the claims.  By responding proactively, providers may be able to minimize the likelihood of recommended denials based upon misunderstandings by the reviewers.

Given the magnitude of the findings and recommendations for refunds in the two audit reports published to date, we strongly recommend that providers who are notified that they are to undergo these audits contact legal counsel familiar with responding to audits at the initial stage, rather than waiting for the initial recommendations or draft audit report. Knowledgeable legal counsel familiar with the audit process and the types of individuals conducting the audit, can  work effectively with the clinical team to present the records to the audit team in a manner that provides an accurate picture of the claim at the beginning stage, and by doing so, potentially minimize or avoid improper adverse findings prior to the issuance of the audit report .

 

Michael CookBy Michael H. Cook.  Michael is the co-chair of Liles Parker’s health care group and has more than 35 years of experience representing providers in regulatory matters, including matters of this nature. Before entering private practice, Michael also represented the Federal regulators of the Medicare and Medicaid programs, is a member of the Board of Medical Assistance Services in Virginia, and has advised the campaigns of a number of candidates for state and federal office.  Any entity experiencing an audit of this nature or having questions can contact Michael at (202) 298-8750 or mcook@lilesparker.com.

 

 

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It’s Time for CMS and Congress to Review Outdated Medicare and Medicaid Provisions

November 23, 2016 by  
Filed under Firm News, Health Law Articles, Medicaid

Michael Cook, co-chair of the Health Care Group, has an article published in the October issue of the American Health Lawyers Association Journal of Health Law & Life Sciences entitled “It’s Time for CMS and Congress to Review Outdated Medicare and Medicaid Provisions.”  The article discusses the fact that given the dramatic changes in payment and delivery system reform, there are a number of outdated, and in some instances counter-productive, rules that no longer make any sense and that should be reviewed by CMS and Congress.  The article cites three examples – the three day hospital stay requirement for Medicare SNF coverage, the limitations for coverage of care in Institutions for Mental Diseases and psychiatric hospitals under Medicaid, and for certain circumstances in alternative payment systems, the homebound requirement for Medicare home health coverage, but there likely are many more that will need examination in the coming years.  Ashley Hudson, an associate of the Firm, assisted in the research for the article.

The article can be reviewed at http://www.healthlawyersjournal.com/healthlawyers/october_2016/?pg=24&pm=2&u1=friend.

Michael CookMichael has more than 40 years’ experience representing clients on health care issues in government and in private practice, serves on the Board of Medical Assistances Services that oversees Virginia’s Medicaid program, and also has advised a number of campaigns of candidates for state and national political offices.  Michael and Ashley can be reached at 202-298-8750.

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Home Health Pre-Claim Review Demonstration Project Update!

Multiple Patient Record(September 20, 2016): On August 3, 2016, the Centers for Medicare and Medicaid Services (CMS) implemented its “Pre-Claim Review Demonstration” project in Illinois.  This demonstration project effectively requires that Illinois home health agencies submit home health claims for review by the Medicare Administrative Contractor (MAC) or face possible penalties (and be forced to have the claim evaluated through the pre-payment process).  As part of the pre-demonstration project, home health agencies are required to submit a complete set of medical records which show that the claim at issue is associated with medically necessary services, meets applicable documentation requirements, qualifies for Medicare coverage and has been coded and billed correctly.  As the demonstration project has been rolled out in Illinois, many home health agencies have experienced problems with the “affirmation” process.  It has been reported that the MAC has allegedly “missed” documentation that has been submitted and that very few of the claims reviewed have been affirmed by the reviewing contractor.  While CMS has not address these specific points, it has acknowledged that additional refinements in the program are required before expansion can continue. Earlier today, CMS announced that the home health pre-claim review demonstration project is temporarily being placed on hold to allow for additional provider education efforts to be conducted.  These provider educational efforts are expected to focus on the main reasons that pre-claim requests have been “non-affirmed” and the documentation that is required to support a home health claim.  Additional information regarding the home health pre-claim demonstration review project is set out below.

I. Background

Section 402(a)(1)(J) of the Social Security Amendments of 1967[1] authorizes the Secretary for the U.S. Department of Health and Human Services (HHS) to develop demonstration projects that:

“develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act.”[2]

The home health pre-claim review demonstration project was initiated by CMS due to the increase over the last three fiscal years of improper payment rates for home health claims. On June 8, 2016, CMS announced in the Federal Register[3] that five states would be involved in this new project to collect information to compile a “baseline estimate of probable fraud in payments for home health care services in the fee-for-service [FFS] Medicare program.” These five states include Illinois, Florida, Michigan, Massachusetts, and Texas. Furthermore, the goal of the project was to assess the use of pre-claim reviews as a means of reducing Medicare FFS expenditures for home health services by reducing improper payments while maintaining or improving the quality of care experienced by the beneficiary.”[4]

II. Pre-Claim Review Demonstration Process

Under the pre-claim review demonstration process requires home health agencies are strongly encouraged to request a preliminary confirmation of coverage by submitting home health claims and associated clinical documentation, for review after services have begun but before the final claim for services is submitted for payment. The home health pre-claim review process is designed to better help ensure that applicable medical necessity, documentation, coverage, coding and billing rules are met before a claim is submitted to Medicare for payment.

The pre-claim review process does not create new clinical home health documentation requirements. Rather, home health agencies are only required to submit the same information they currently maintain for payment. As mentioned, they will do so earlier in the process, which will help assure that all relevant coverage and clinical documentation requirements are met before the claim is submitted for payment. CMS contends that the pre-claim review process will not delay care to Medicare beneficiaries and will not alter the Medicare home health benefit.

Home health agencies in one of the five demonstration states have been advised that if they do not submit their claims through the pre-claim review process, those claims will be flagged for prepayment review and will essentially treated like an ADR.  Moreover, after the first three months of the program, even if found to qualify for coverage and payment, CMS intends to reduce payment by 25% on each claim that is not submitted through the pre-claim demonstration review process.

III. Conclusion

The decision by CMS to postpone the implementation of the pre-claim review demonstration in Florida was influenced, in large part, by the advocacy of supportive political and home health industry groups.  The postponement of the pre-claim review demonstration project is a major victory for health care providers in Florida, Michigan, Massachusetts, and Texas. Unfortunately, However, the implementation of the demonstration project is inevitable so providers should continue to prepare for the impact it will have on their health care practice. The exact start dates for Florida, Michigan, Massachusetts, and Texas have yet to be announced, but the dates will be provided on CMS’ website at least 30 days in advance to the implementation. Providers can expect a staggered start beginning with Florida, which provides additional time for preparation.

robert_w_lilesRobert W. Liles, M.B.A., M.S., J.D., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law. Liles Parker is a boutique health law firm, with offices in Washington DC, Houston TX, San Antonio TX, McAllen TX and Baton Rouge LA. Robert represents home health agencies around the country in connection with Medicare audits and compliance matters. Our firm also represents health care providers in connection with federal and state regulatory reviews and investigations. For a free consultation, call Robert at: 1 (800) 475-1900.

 

 

[1] 42 U.S.C. 1395b-1(a)(1)(J).

[2] Id.

[3] 81 Fed. Reg. 37598.

[4] “Pre-Claim Review Demonstration for Home Health Services in Illinois,” available at http://www.palmettogba.com/Palmetto/Providers.Nsf/files/Workshop_Home_Health_PCR_Workshop_Series.pdf/$File/Workshop_Home_Health_PCR_Workshop_Series.pdf

[5] See the Palmetto GBA website for helpful resources, available at http://www.palmettogba.com/palmetto/providers.nsf/docsCat/Providers~JM%20Home%20Health%20and%20Hospice~Home%20Health%20Pre-Claim%20Review.

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