Perspectives on Health Care and Life Sciences advisory by Bob Atlas, President of EBG Advisors, Inc. 

Following is an excerpt:

The U.S. Senate and House of Representatives have both passed their tax reform bills and will now confer toward creating a unified bill that both chambers can support, and that President Trump will sign. The two bills differ in some key respects, but their implications for health care are already rather clear. Some aspects of the legislation explicitly touch health care, while other effects would be indirect. Overall, it appears that most of the changes would adversely affect many health care industry participants, especially those in the nonprofit sector that would not gain from the reduction in the corporate tax rate that is the central feature of the legislation. …

Read the full post here or download a PDF of this piece.

On March 15, 2017, the United States District Court for the Western District of Pennsylvania issued an opinion that sheds insight on how courts view the “writing” requirement of various exceptions under the federal physician self-referral law (or “Stark Law”). The ruling involved the FCA qui tam case, United States ex rel. Emanuele v. Medicor Assocs., No. 1:10-cv-245, 2017 U.S. Dist. LEXIS 36593 (W.D. Pa. Mar. 15, 2017), involving a cardiology practice (Medicor Associates, Inc.) and the Hamot Medical Center. The Court’s detailed discussion of the Stark Law in its summary judgment opinion provides guidance as to what may or may not constitute a “collection of documents” for purposes of satisfying a Stark Law exception.

This opinion is of particular note because it marks the first time that a physician arrangement has been analyzed since the Stark Law was most recently amended in November 2015, at which time the Centers for Medicare and Medicaid Services (“CMS”) clarified and codified its longstanding interpretation of when the writing requirement is satisfied under various exceptions.

Arrangements Established by a “Collection of Documents”

Both the “professional services arrangement” and “fair market value” exceptions were potentially applicable, and require that the arrangement be “in writing” and signed. However, two of the medical directorships were not reduced to a formal written agreement. The Defendants identified the following collection of documents as evidence that the writing requirement was satisfied:

  • Emails regarding a general initiative between Hamot and Medicor for cardiac services, but without any specific information regarding directorship positions, duties or compensation.
  • Letter correspondence between Hamot and Medicor discussing the potential establishment of a director position for the women’s cardiac program.
  • Internal summary that identified a Medicor physician as the director of the women’s cardiac program.
  • Unsigned draft Agreement for Medical Supervision and Direction of the Women’s Cardiac Services Program.
  • A one page letter appointing a Medicor physician as the CV Chair and identifying a three-year term that expired June 30, 2008.

The Court said that although “these kinds of documents may generally be considered in determining whether the writing requirement is satisfied, it is essential that the documents outline, at an absolute minimum, identifiable services, a timeframe, and a rate of compensation.” (emphasis added). In addition, the Court noted that CMS requires that at least one of the documents in the collection be signed by each party. After confirming that these “critical” terms were missing from the documents described above, the Court concluded that no reasonable jury could find that either arrangement was set forth in writing in order to satisfy Stark’s fair market value exception or personal service arrangement exception.

Expired Arrangements

Other directorships were initially memorialized in signed, formal written contracts, but they all terminated pursuant to their terms on December 31, 2006 and were not formally extended or renewed in writing on or prior to their termination. Thereafter, Medicor continued to provide services and Hamot continued to make payments under the agreements. The parties eventually executed a series of “addendums” to extend the term of each arrangement, although these addenda had a prior effective date. During the timeframe between when the agreements expired and when the addenda were executed, invoices were continuously submitted and paid.

Plaintiff argued that the failure to execute timely written extensions in advance of renewals resulted in a failure of all six arrangements to meet the “writing” requirement under a relevant Stark Law exception. The Court disagreed, explaining that there is no requirement that the “writing” be a single formal agreement and CMS has provided guidance as to the type of collection of documents that could be considered when determining if the writing requirement is met at the time of the physician referral. In this case, the Defendants specifically relied upon the invoices from Medicor to Hamot and the checks that were sent in payment thereof.

In deciding that a reasonable jury could find that there was a sufficient collection of documents, the Court denied Plaintiff/Relator’s motion for summary judgment with respect to these six ‘expiring” directorships, and the case will proceed to trial on these claims.

Hospitals should carefully consider this opinion when auditing Stark Law compliance of their physician arrangements. A more detailed article analyzing this case will be published in the July edition of Compliance Today.

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that the Section 1557 regulations force them to provide gender transition services and abortion services against their religious beliefs and medical judgment in violation of the Religious Freedom Restoration Act (“RFRA”).

By way of background, the Section 1557 regulations prohibit discrimination on the basis of gender identify, which regulations define to mean “an internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual’s sex assigned at birth.”[i] The regulations prohibit a categorical insurance coverage exclusion or limitation for all health services related to gender transition and requires providers to provide transition-related procedures if the provider performs an analogous service in a different context. The plaintiffs also alleged that because they perform certain procedures for miscarriages, the Section 1557 regulations will require them to perform such procedures for abortions to avoid discriminating on the basis of termination of pregnancy.

The court held that the Section 1557 regulations failed to incorporate the exceptions for religious institutions and abortions services that Congress provided in Title IX. The court also found that Title IX, which is incorporated by Section 1557 statute, only prohibits discrimination on the basis of biological sex. The court further noted that “the government’s own health insurance programs, Medicare and Medicaid, do not mandate coverage for transition surgeries; the military’s health insurance program, TRICARE, specifically excludes coverage for transition surgeries. . .”[ii]

Specifically, the court concluded that “the regulation violates the Administrative Procedure Act (“APA”) by contradicting existing law and exceeding statutory authority, and the regulation likely violates the [RFRA] as applied to Private Plaintiffs.” The court also agreed that the plaintiffs would likely suffer irreparable harm without the injunction as “one of the State Plaintiffs is already undergoing investigation by the HHS’s OCR, and entities similarly situated to Private Plaintiffs have already been sued under the Rule since it took partial effect on May 18, 2016″ (emphasis added). Conversely, the court found that HHS will not suffer any harm by delaying implementation of this portion of the Section 1557 regulations. It should be noted that this is a ruling granting a preliminary injunction and a final ruling on the merits of a permanent injunction is still to come.

While an HHS appeal of this order would normally be expected, the impending change of Administration—including new leadership at HHS and an expected early Congressional push to repeal and replace the Affordable Care Act—makes it very uncertain whether an appeal will be filed, or ruled upon, prior to any possible changes in the regulatory scheme or underlying statute.

Health care entities should take note, however, that the remaining provisions of the Section 1557 regulations, including those that prohibit discrimination on the basis of disability, race, color, age, national origin, or sex (other than gender identity), are not impacted by the nationwide injunction and HHS can still enforce such provisions. Indeed, HHS has issued a broadcast email specifically stating that:

“[OCR] will continue to enforce the law—including its important protections against discrimination on the basis of race, color, national origin, age, or disability and its provisions aimed at enhancing language assistance for people with limited English proficiency, as well as other sex discrimination provisions—to the full extent consistent with the Court’s order.”

Health care entities should closely monitor this area of law for further developments and ensure that their operations are compliant with the remaining provisions of the Section 1557 regulations.

Further information regarding Section 1557 and its accompanying regulations can be found in EBG Client Alerts and Webinars.

[i] 45 C.F.R. § 92.4

[ii] The court cited Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2780 (2014). The Supreme Court will consider whether Title IX covers gender identity in Gloucester Cty. School Bd. V. G.G., Sup. Ct. No. 16-273, during the current term.

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”).  Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often referred to as “surprise bills”).  As a result, calls for improved network adequacy and transparency mounted.  A September 2014 HHS Office of Inspector General (OIG) report was critical of variation in state oversight of the Medicaid managed care market.  An August 2015 Government Accountability Office (GAO) report called for greater CMS network oversight in the Medicare Advantage market.  In response, a series of proposed rules and other changes have accumulated –

Medicare Advantage (MA) – In April 2015, CMS announced in a Call Letter that it will impose more stringent network adequacy requirements in the application process for MA plans.  To address surprise provider terminations, CMS will require 90 days notice of any significant mid-year changes.  Additionally, plans must establish and maintain a process to keep provider directories current in real-time.  CMS intends to monitor compliance and is considering a CY2017 requirement for standardized electronic submission for inclusion in a nationwide provider database.  CMS has also expressed its intent to review network adequacy as part of its regular program audits, as a pilot in 2016 and as a standard feature in 2017.

Medicaid Managed Care – In May 2015, CMS released the first proposed rule to make comprehensive changes to its Medicaid managed care rules in 12 years, including new quantitative network adequacy standards.  Once finalized, states would be required to establish time and distance standards for specific provider types, including primary care (adult and pediatric), OB/GYN, behavioral health, specialists (adult and pediatric), hospital, pharmacy, pediatric dental, and any “additional provider types when it promotes the objectives of the Medicaid program for the provider type to be subject to such time and distance standards.”[1]  Interestingly, CMS suggested in its proposed rule that states look to MA and state commercial standards as models.

Federal Exchanges – In December 2015, CMS, through its Center for Consumer Information and Insurance Oversight (CCIIO), released a proposed rule that featured more prescriptive network adequacy standards for Qualified Health Plans (QHPs) offered on the federal Exchange.  Where CCIIO is satisfied that a state uses “an acceptable quantifiable metric,” it will defer to their review of QHPs.  In other states, a default federal standard would apply.  Starting in 2017, CMS expects to take a similar approach as to MA and apply time and distance standards, with an emphasis on high-utilization specialties.  While CMS says it will not “prohibit certification of plans with narrow networks or otherwise impede innovation in plan design,”[2] it intends to set a floor with the federal Exchange default standards and it seeks greater network transparency.  Toward that end, ratings on QHP network coverage may be a future feature of HealthCare.gov.

State Regulated Group and Individual Markets – In November 2015, the National Association of Insurance Commissioners (NAIC) released a long-awaited network adequacy model act with more detailed requirements than federal and many state standards.  While the act would not impose quantitative standards such as provider number and type requirements, it does include reimbursement parity provisions for emergency and out-of-network facility-based providers.

Looking Ahead

With legislative sessions underway in all but four states this year, there are several important developments to watch for in 2016.  Some states will adopt the NAIC model act, in whole or in part, or use the act as a baseline from which to tailor its own standards.  Other states will decline to adopt it, leaving existing standards intact that range from minimal to highly detailed and prescriptive.  With increasing pressure from CMS across markets, some states may seek to aggressively increase the specificity of their network adequacy standards, adding number and type requirements or legislating that their insurance commissioners do so through an administrative process.  Some states may consider aligning standards across markets to ensure regulatory uniformity.  While there is nothing in the model act that suggests states increase oversight and enforcement activities, CMS is clearly increasing its own oversight and is pushing states to set a floor for state level access standards.  Changes to the landscape will come better into focus as CMS releases its final rules for all of the above proposed changes.

 

[1] 80 Fed. Reg. at 31145.

[2] 80 Fed. Reg. at 75550.

On September 28, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule.  The RFI was originally open for a 30-comment period.  However, CMS has announced that it is extending the comment period for an additional 15 days.  Comments to the RFI are now due to CMS on November 17, 2015.

The RFI included an extensive list of questions related to the implementation of the Merit-Based Incentive Program System (“MIPS”), as well as adoption and physician participation in Alternative Payment Models (“APMs”) and Physician-Focused Payment Models (“PFPMs”).  More details on the questions that CMS has raised and the areas where CMS is seeking input in the RFI are discussed in the Epstein Becker Green Client Alert, “New Opportunity to Comment on Key Components of Medicare Physician Payment Reform: CMS Issues 30-Day Request for Information on MIPS and APMs.”

Importantly, in the CMS announcement extending the public comment period released on October 15, 2015, CMS identified sections and questions in the RFI that are of higher priority to the agency.  For example, CMS has ranked questions about how physicians should be identified to determine eligibility, participation, and performance under the MIPS performance categories, and what measures and reporting mechanisms should be used for each of the four MIPS performance categories (quality, resource use, clinical practice improvement activities, and meaningful use of certified electronic health record technology), above questions about public reporting requirements, use of measures from other payment systems, and the weighting of performance categories and the determination of performance scores and thresholds.  Similarly, for questions related to the adoption of APMs, CMS has prioritized questions about how to define the amount of services furnished through an eligible APM entity, how to determine the Medicare and other payer payment thresholds used to identify qualifying and partial qualifying APM participants, and how to compare state Medicaid medical home models to medical home models expanded under Section 1115A(c) of the Social Security Act.  Given the short period of time to provide comments to CMS, stakeholders should consider the priority rankings that CMS has assigned to the various topics that it is seeking input on.

All stakeholders, not just physicians, should consider how the fundamental shift in Medicare physician payments, from traditional fee-for-service to value-based models, will impact them.  It is important to engage with CMS now by submitting comments to the RFI, in order to shape how these new payment mechanisms are implemented in the years to come.  For additional information about the physician payment reforms implemented in MACRA, or if you are interested in submitting comments to CMS, please contact Lesley Yeung or the Epstein Becker Green attorney who regularly handles your legal matters.

On March 31, 2015, the Supreme Court of the United States decided Armstrong v. Exceptional Child Center, Inc. The Court handed down a hodgepodge of opinions but, in the end, five Justices concurred in the judgment that the Constitution’s Supremacy Clause does not confer a private right of action, and that Medicaid providers, therefore, cannot sue for an injunction requiring compliance with the reimbursement laws.  This ruling will adversely affect at least those health care companies that have contemplated suing on the basis that the reimbursement they are getting is less than what the law entitles them to. 

 

By Clifford E. Barnes and Marshall E. Jackson, Jr.

Recent enforcements in home health fraud have highlighted the need for home health companies of every state to engage the State Medicaid payment agency in pro-active affirmative discussion to work together to identify issues related to fraud and abuse.  Such discussions will provide home health companies further insight regarding compliance with federal and state fraud and abuse laws. That being said, recent enforcement actions have shown that home health companies may be liable under fraud and abuse laws, despite efforts to comply with such laws.  

On September 9th Lewis J. Levine a chiropractor practicing in Washington, DC pleaded guilty to signing fake prescription for services to be provided by DC Medicaid in exchange for cash.  According to the plea agreement, Dr. Levine prepared prescriptions and approved and recertified plans of care for Medicaid beneficiaries brought to him by Personal Care Aids who worked for several home care agencies.  Dr. Levine was paid by beneficiaries and personal care aids $75 to $150 for each home health service he prescribed.  The home care agency was unaware of the payments to the Dr. Levine.  Under District of Columbia law, only physicians and advanced practice registered nurses can order home health services for Medicaid.  As a chiropractor, Dr. Levine was neither a physician or advanced practice registered nurse and cannot practice medicine.  In addition, Dr. Levine was not enrolled as a provider in DC Medicaid.  Nevertheless for more than 2 years Dr. Levine and company were able to execute a scheme against home health companies and the DC Medicaid Agency.  Even though Dr. Levine was not legally or medically qualified and could not determine whether the services prescribed were medically necessary, Dr. Levine signed intakes and plans of care.

For the home health companies whose services are denied and who did not participate in the scheme, it does not matter for the State Medicaid Agency that such companies were totally unaware of the scheme and could not reasonably know of such scheme.  For these non-participating companies, it is incumbent to not only remain diligent in efforts to comply with fraud and abuse laws, but to also develop a dialogue with the State Medicaid Agency to find ways in which they can work together to detect fraud and ensure that providers referring for home health services are legally and medically qualified to determine if such services are necessary. 

Is your home health agency involved in proactive discussions with your Medicaid policy office?

By Constance Wilkinson, Alan Arville, and David Gibbons

The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a Report [1] on February 5th based on in-depth interviews with a sample of thirty 340B Covered Entities – half were disproportionate share hospitals (“DSH”) and half were community health centers (“CH”) – and eight contract pharmacy administrators to gain a better understanding of how contract pharmacy arrangements operate under the 340B Drug Discount Program, codified as Section 340B of the Public Health Service Act (“340B Program”).

By way of background, the 340B Program, created in 1992 and administered by the Health Resources and Services Administration (“HRSA”), requires drug manufacturers to give discounts to entities covered under the law – known as “Covered Entities” – in order to have their drugs covered by Medicaid. The manufacturer must agree to sell each of its outpatient prescription drugs to Covered Entities enrolled in the 340B Program “at or below a ceiling price” that is derived from the same Average Manufacturer Price and Unit Rebate Amount calculated under the Medicaid Drug Rebate Program.[2] Covered Entities are subject to certain compliance requirements, including preventing duplicate discounts (i.e., preventing Medicaid rebate claims for prescriptions that were filled with drug purchased at the 340B price by reporting how they bill Medicaid on the Medicaid Exclusion File) and preventing diversion of 340B drugs (i.e., ensuring that only eligible patients receive 340B drug in accordance with the 340B program definition of a patient). According to HRSA’s subregulatory guidance, a Covered Entity may enter into agreements with one or more specified pharmacies to dispense drugs purchased at 340B discounts to the Covered Entity’s eligible patients.[3]

The Report provides a useful overview of the contract pharmacy arrangement “replenishment” model in use today and notes that the use of contract pharmacies by Covered Entities as well as the number of contract pharmacy arrangements has increased dramatically over the past several years. The Report focuses on the statutory prohibitions of diversion and duplicate discounts and also on access to discounted prices for 340B eligible uninsured patients. Notably, the Report does not discuss the applicability of the Federal Anti-Kickback Statute to 340B contract pharmacy arrangements. While limited in its scope, the Report raises some significant issues that HRSA will need to consider as it develops comprehensive regulations anticipated to be released later this year.

First, the OIG found that Covered Entities are taking inconsistent approaches to interpreting HRSA’s definition of an “eligible patient” under the 340B Program.[4] The OIG found that Covered Entities differ with respect to how they classify prescriptions as 340B-eligible, with regard to when the determination is performed (before or after the prescription is written), the time limits applied to when a prescription can be 340B-eligible relative to a physician visit, and the data used to determine eligibility. For example, eligible patients must receive health care services from providers that are either employed by or under a contractual or other arrangement with the Covered Entity such that the Covered Entity is responsible for the health care services delivered to eligible patients. In practice however, these providers sometimes provide services in their private offices, which creates some ambiguity as to whether such services, including prescribing of drugs otherwise covered by the 340B Program, meet the eligibility requirements. When the OIG examined how contract pharmacies operate in scenarios such as this, they found that Covered Entities categorized 340B eligibility differently and used different means to make such categorizations, resulting in inconsistencies among Covered Entities in similar circumstances regarding the utilization of 340B drug.

Second, Covered Entities encounter difficulties in identifying 340B eligible prescriptions for patients enrolled in Medicaid managed care plans. To comply with the statutory prohibition against duplicate discounts (noted above), Covered Entities choose whether or not they will dispense 340B drugs to Medicaid beneficiaries; if they do dispense 340B drugs to Medicaid beneficiaries, Covered Entities must provide HRSA with their pharmacy Medicaid Provider number, which is then entered in the HRSA Medicaid Exclusion File. The HRSA Medicaid Exclusion File is provided to state Medicaid agencies and manufacturers to ensure that a Medicaid rebate is not sought from a manufacturer for drugs already sold at the 340B discount. The difficulty in complying with this provision for Medicaid managed care patients arises from a lack of information available from state Medicaid agencies and managed care plans using the same routing numbers for their Medicaid managed care patients as for privately insured patients.

Third, the Report noted that eight of the thirty Covered Entities included in the study do not offer the 340B discounted drug price to their uninsured patients who are dispensed prescriptions through a contract pharmacy. Most of the 340B contract pharmacy administrators serving these entities revealed that the determination of eligibility is made after the drug is dispensed. Therefore, the contract pharmacy charges the uninsured patient the full cost of the prescription at the time it is dispensed. Among the eighteen Covered Entities interviewed that do offer 340B discounts to uninsured patients, it is common for the Covered Entity to address the underlying issue by providing their 340B eligible uninsured patients with a 340B discount card that, when presented to the pharmacy, notifies the pharmacy to charge the discounted rate.

The Report does not provide any recommendations in response to the inconsistencies in contract pharmacy arrangement operations identified by the OIG, but notes that comments or questions concerning the Report can be submitted by April 5. The OIG states that recommendations could be forthcoming in a future report as the agency continues to review contract pharmacy arrangements.

An accompanying podcast is available at available at https://oig.hhs.gov/newsroom/podcasts/reports.asp#pharmacy.

 


ENDNOTES

[1] HHS OIG, Memorandum Report: Contract Pharmacy Arrangements in the 340B Program (Feb. 5, 2014), https://oig.hhs.gov/oei/reports/oei-05-13-00431.asp.

[2] Section 340B(a)(1) of the Public Health Service Act. 42 U.S.C. § 256b(a)(1) (2011), http://www.hrsa.gov/opa/programrequirements/phsactsection340b.pdf.

[3] HRSA, Notice Regarding 340B Drug Pricing Program—Contract Pharmacy Services, 75 Fed. Reg. 10272 (Mar. 5, 2010).

[4] HRSA, Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility, 61 Fed. Reg., 55156, 55157-55158 (Oct. 24, 1996).

by Lynn Shapiro Snyder and Shawn M. Gilman

Speculation abounds with respect to the decision that states will make on the issue of whether to expand Medicaid coverage under the Affordable Care Act, now that the Supreme Court of the United States has made the option to abstain a meaningful one. This health reform alert highlights some key factors that may influence a state’s decision on whether to implement such an expansion.

Read the full alert here

Danielle Steele, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green’s Washington, DC, office, contributed significantly to the preparation of this alert.

This health reform alert is a revised version of an article published in the Aug. 22, 2012, issue of the Health Insurance Report, a publication of Bloomberg BNA, and is being reprinted here with permission.

by Pamela D. Tyner, Amy Lerman, and Lesley R. Yeung

The Recovery Audit Contractor (“RAC”) program is a national program aimed at identifying Medicare program overpayments and underpayments through a review of individual Medicare claims by contractors paid on a contingency fee basis. Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service payments under Medicare Parts A and B to include Medicare Part C (Medicare Advantage) and Part D (Prescription Drug Benefit) as well as state Medicaid programs. As Medicaid RAC programs get underway in the states, and private insurers offering coverage under Medicare Part C and D prepare for new, yet still undefined, RAC efforts, it is more important than ever for providers to make sure that their processes for documentation, billing, and coding are accurate and comprehensive.

Read the full alert here