New IRS rulemaking impacts FCA settlement payment deductibility

Effective January 14, 2021, the Internal Revenue Service (“IRS”) implemented a final rule (the “Final Rule”) concerning the tax deductibility of settlement payments made to the government.  This rulemaking followed a legislative update to the Internal Revenue Code of 1986 (“IRC”), which was implemented as part of the 2017 federal tax overhaul and specifically included a prohibition against deducting certain settlement payments.  Relative to the IRS proposed regulations released in May 2020 (the “Proposed Rule”), and as further detailed below, aspects of the Final Rule favor taxpayers, relaxing certain restrictions contemplated under the Proposed Rule.  Those making payments in connection with litigation or governmental investigations, including False Claims Act (“FCA”) investigations by the Department of Justice (“DOJ”), should consider the Final Rule’s impact on their approach to documenting a settlement or related payment.

Background

The Tax Cuts and Jobs Act of 2017 (“TCJA”) modified the rules governing the deductibility of certain government settlement-related expenses under IRC Section 162(f).  As amended, Section 162(f) prohibits deductibility for “any amount paid . . . to, or at the direction of, a government or governmental entity in relation to: (1) the violation of any law or (2) the investigation or inquiry by such government or entity into the potential violation of any law.”

The TCJA-amended Section 162(f) includes a related exception, however, allowing tax deductions for “amounts constituting restitution or paid to come into compliance with law.” To qualify for this exception, an order or settlement agreement must identify as restitution, remediation, or amounts paid or incurred to come into compliance with a law (see “identification requirement” described below), and the taxpayer must establish that the amounts were paid or incurred as restitution or to come into compliance with a law (see “establishment requirement” described below).  If the applicable governmental entity agrees to include exception language associated with this exception under an order or settlement agreement, that governmental entity must also contemporaneously file an IRS form required under the TCJA-created IRC Section 6050X.

On May 13, 2020, the IRS published a notice of proposed rulemaking detailing guidance under the Section 162(f) deduction disallowance rules and associated Section 6050X reporting requirements.  The Final Rule followed on January 14, 2021, lending additional regulatory clarity and loosening certain restrictive provisions that were proposed in May 2020, as further described below.  The Final Rule confirms that the TCJA amended Section 162(f) does not apply to any order or settlement agreement issued or entered into before December 22, 2017.

Deduction Prohibition

The Final Rule’s deduction prohibition remains largely unchanged from the Proposed Rule, confirming that a taxpayer may not take a deduction for amounts: (1) paid or incurred by suit, agreement, or otherwise; (2) to, or at the direction of, a government or governmental entity; and (3) in relation to the violation, or investigation or inquiry by such government or governmental entity into the potential violation, of any civil or criminal law.  The Final Regulations rejected commenter requests to exclude certain administrative proceedings from the definition of “suit, agreement, or otherwise,” confirming that this language is intended to apply both to formal legal proceedings and other, less formal proceedings.  Specifically, the final regulations confirm that the Section 162(f) deduction disallowance rule applies to the following, without limitation:

  • settlement agreements;
  • non-prosecution agreements;
  • deferred prosecution agreements;
  • judicial proceedings;
  • administrative adjudications;
  • decisions issued by officials, committees, commissions, or boards of a government or governmental entity; and
  • any legal actions or hearings in which a liability for the taxpayer is determined or pursuant to which the taxpayer assumes liability.

Exception Clarification and Guidance

As confirmed under the Final Rule, the Section 162(f) exception to the disallowance prohibition requires applicable amounts to be identified in the order or agreement as paid or incurred for restitution or remediation, or to come into compliance with a law.  Key components of this exception, particularly to the extent they deviate from the Proposed Rule, are detailed below:

Identification Requirement

The Final Rule clarified Section 162(f)’s “identification requirement,” which mandates that a qualifying, tax deductible payment must be specifically identified in its applicable order or agreement as restitution, remediation, or amount paid to come into compliance with law.  The IRS clarified that it is the order or agreement, and not the taxpayer, that must meet this identification requirement.

According to the Final Rule, this identification requirement will be met even if the order or agreement uses a different form of the key terminology mentioned above (i.e., “restitution, remediation, or amount paid to come into compliance with law”), including alternative language such as ‘‘remediate’’ or ‘‘comply with a law.’’  Similarly, even if those key terms are not used in any form, an order or agreement will meet the identification requirement if “the nature and purpose of the payment, as described in the order or agreement, are clearly and unambiguously to restore the injured party or property or to correct the non-compliance.”

The Final Rule also acknowledges that the precise payment amount relating to “restitution, remediation, or coming into compliance with the law” may be unknown on the date of the settlement agreement or order, particularly in instances where only a lump sum payment is specified or if a payment is divided among multiple taxpayers.  The Final Rule clarifies how a taxpayer may meet the identification requirement in these circumstances and also confirms that the identification requirement may be met even if the order or agreement does not provide an estimated payment amount.  Particularly in the latter circumstance, the agreement or order must contain language specifically stating that the forthcoming amount, once established, will be paid or incurred in accordance with the Section 162(f) exception requirements.

Establishment Requirement

The TCJA-amended IRC Section 162(f) also requires that a taxpayer establish, with appropriate records and documentation, that a tax deductible amount was actually paid or incurred for the nature and purpose identified above.  The final regulations clarify that this “establishment requirement” is met if the documentary evidence submitted by the taxpayer proves: (1) that the taxpayer was legally obligated to pay the amount identified in the order or agreement as restitution, remediation, or to come into compliance with a law, (2) the amount actually paid, and (3) the date on which the amount was paid.  The Final Rule expanded upon the Proposed Rule’s non-exhaustive list of documents that can be used to fulfill this establishment requirement, including the following:

  • receipts;
  • the violated or potentially violated legal or regulatory provision;
  • government documents relating to the investigation or inquiry;
  • judgment;
  • decree;
  • documents describing how the payable amount was determined; and
  • correspondence between the taxpayer and government.

According to the Final Rule, in the case of a lump sum payment or multiple damage award that includes a combination of restitution, remediation, and coming into compliance with the law, the taxpayer must establish the exact amount paid or incurred for each purpose to meet the establishment requirement.  Similarly, if an order or agreement involves multiple taxpayers, each taxpayer must establish the amount it paid or incurred as restitution, remediation, or to come into compliance with the law, each as required under Section 162(f).

Disgorgement and Forfeiture

Under the Proposed Rule, the Section 162(f) deduction exception did not apply to payments for “forfeiture or disgorgement” (the latter being an equitable remedy involving the return of ill-gotten gains), meaning that any amount paid or incurred as forfeiture or disgorgement would have been unequivocally disallowed.  The IRS changed its course in the Final Rule, however, implementing a circumstantial, fact-based test to determine deductibility for forfeiture and disgorgement payments, looking to whether each of the following is true: (1) the amount is otherwise deductible under IRC, (2) the identification rule is met, (3) the establishment rule is met, and (4) the amount is not disbursed to the general account of the governmental entity for general enforcement purposes.

Qui Tam Cases

The Final Rule clarifies that the deduction disallowance rule does not apply to any amount paid in connection with an order or agreement for a suit in which no governmental entity is a party.  Citing a commenter concern regarding qui tam cases brought by private citizens on behalf of a governmental entity, the Final Rule confirms the absence of any “single rule” that determines the treatment of such cases.  The final regulations do note, however, that the governmental entity is the real party in interest in qui tam cases, and Section 162(f) likely applies to any amount paid, including any share ultimately paid by the governmental entity to the relator, whether or not the governmental entity intervenes in the suit.  Therefore, any amount paid or incurred to a governmental entity as a result of the suit will likely be disallowed unless a Section 162(f) exception applies.

Government Reporting under Section 6050X.

The Final Rule also interprets IRC Section 6050X, which provides appropriate officials of government entities the operational, administrative, and definitional rules for complying with the statutory information reporting requirements for suits or agreements to which that section applies.  In general, under the final regulations, if the aggregate amount a payor is required to pay pursuant to an order or agreement for a violation, investigation, or inquiry to which Section 6050X applies equals or exceeds the $50,000 regulatory threshold amount, the appropriate official of a governmental entity that is a party to the order or agreement must file an information return with the IRS regarding certain amounts paid or incurred pursuant to the order or agreement, the payor’s taxpayer identification number, and other IRS required information.

Practical Impact. 

Taxpayers making governmental related settlement payments, including those in connection DOJ FCA investigations, should consult the Final Rule and determine how it might impact their approach to documenting potentially deductible payments and maintaining associated records.  Specifically, a taxpayer should ensure that its settlement agreement specifically identifies amounts that are paid as “restitution or remediation, or to come into compliance with law,” and thereafter, taxpayers should maintain sufficient records and documentation to be able to establish that the amounts were paid for that identified, qualifying purpose.

FDA and USDA battle over regulating genetically engineered animals

A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing comment period, which ends on February 26, 2021. The proposed rule strips FDA’s jurisdiction over food-bearing GE livestock and places it within USDA’s purview, thereby granting USDA jurisdiction over pre-market review and post-market safety monitoring of such products. This significant change would create a less burdensome pathway for the regulatory approval of certain GE livestock, which are currently regulated by FDA as a new animal drug. While the Trump Administration endorsed the proposal before leaving office, the Biden Administration has yet to indicate whether it supports or disapproves of the measure. 

Genetically engineered (“GE”) food is a signature dish on the regulatory menu as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) battle for jurisdiction to regulate GE animals for human consumption. The turf war was sparked on December 28, 2020, when the USDA published a proposed rule seeking comment for sixty (60) days regarding transitioning jurisdiction for safety assessments of certain GE agricultural animals away from FDA and into USDA’s purview. Shortly thereafter, the Trump Administration signed an interdepartmental memorandum of understanding, moving the conventionally FDA authority over food-bearing GE livestock to USDA. The proposed change has not gone without contest, as now-former FDA Commissioner Stephen Hahn indicated he had no plans to sign off on the jurisdictional transfer based in part on public health concerns. It is also unclear whether the current head of the USDA supports the measure. Given the comment period for the proposal ends February 26, 2021, the Biden Administration will have the final say on whether the jurisdictional transfer takes place.

Historically, the two agencies have shared jurisdiction over food, with FDA regulating animal biotechnology and USDA overseeing GE crops for protecting agriculture from pests and diseases. Under the new proposal, USDA will be in charge of end-to-end regulation over GE livestock, from pre-market review though post-market safety monitoring, which would change significantly the current regulatory landscape. USDA would receive broad authority over GE animals including cattle, sheep, goats, swine, horses, chickens, and others, while FDA would retain authority over GE animals developed for nonagricultural purposes, such as medical or pharmaceutical use. Currently, FDA regulates most GE animals under the Federal Food, Drug, and Cosmetic Act (“FCA”), pursuant to which FDA has considered each specific genomic alternation to be a “new animal drug” that is subject to FDA’s new animal drug approval requirement. Understandably, FDA’s approval process for GE animals takes a holistic approach that sometimes lasts for years. FDA, however, has approved only two GE animals for human consumption in its history, while USDA has made it possible for hundreds of GE crops to be widely adopted throughout the country. Industry stakeholders have expressed frustrations that the current system is too cumbersome and competitively disadvantageous, as numerous nations have developed gene editing capabilities, which include capabilities to engineer more disease resistant animals designed for human consumption.

It will be interesting to see how the Biden Administration responds. It would not be surprising to see the current administration walk back an attempt to usher in a less rigorous regulatory framework and opt to maintain FDA’s jurisdiction to oversee the health and safety of GE animals used for human consumption. As some commentators have proposed, another alternative to consider is treating GE foods as a new food additive. No longer classifying GE foods as drugs would subject these products to the less restrictive regulatory requirements applicable to food additives. This approach would allow FDA to retain jurisdiction, while simultaneously creating an easier pathway for GE animals to obtain pre-market approval. Food for thought.

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic (or just looking to learn more), below is a brief primer on so-called “midnight regulations.”

What exactly is a “midnight regulation”?

The term “midnight regulation” refers to a last-minute rulemaking generated by an outgoing administration’s executive agencies during the “lame duck” period between Election Day in November and Inauguration Day on January 20th of the following year—also known as the “midnight” period. Historically, since the midnight period of the outgoing Carter administration in 1981, the United States has experienced significantly increased regulatory output during the final quarter of an outgoing President’s term (relative to the final quarter in other years) regardless of political party.

What is the reason for the surge in rulemaking after “midnight”?

Although there are likely multiple factors that contribute to the phenomenon, most scholars agree that the late-term surge in rulemaking primarily derives from increased pressure as a result of the upcoming presidential transition. That is, political appointees seek to take advantage of their last chance to advance the outgoing administration’s regulatory agenda before the incoming administration alters priorities, while non-political agency staff seek to hurry and complete work to avoid any delays brought about by the incoming administration. Additionally, the rulemaking process can routinely take up to four years to complete.

What is unique about rulemaking during the midnight period relative to other times?

Depending on the status of an outgoing administration’s midnight regulation (i.e., proposed but not yet final, final but not yet in effect, or final and in effect) on Inauguration Day, the incoming administration may have the authority to freeze, rescind, and/or amend the rulemaking. Notably, the speed with which a midnight regulation can emerge from the procedural pipeline is contingent on several statutory requirements.

What are the relevant statutory requirements that govern the rulemaking process?

With respect to midnight regulations, two statutes governing the rulemaking process stand out. First, under the Administrative Procedure Act (APA), executive agencies are typically required to publish a notice of proposed rulemaking in the Federal Register, solicit comments from the public, publish a final rulemaking in the Federal Register, and provide for at least a 30-day waiting period before the regulation goes into effect.

Second, under the Congressional Review Act (CRA), executive agencies are typically required to submit a report on the final rulemaking to both houses of Congress and the Government Accountability Office (GAO) before the rulemaking can take effect. Additionally, with respect to “major” regulations (e.g., those that have a $100+ million annual effect on the economy), the CRA provides for at least a 60-day waiting period from the later of (i) the date both Houses of Congress receive the report on the final rulemaking or (ii) the date of publication in the Federal Register.

What is the significance of Inauguration Day?

Following the inauguration of the newly elected President, the incoming administration customarily issues a memorandum that instructs all executive agencies to freeze various regulatory activity, including all final rules that have not yet taken effect. This year was no exception: on January 20, 2021, the new White House Chief of Staff Robert Klain issued a memorandum with the subject line “Regulatory Freeze Pending Review” to all executive agencies.

What midnight regulations will survive the presidential transition?

For those midnight regulations that have been published as final in the Federal Register and already taken effect (in compliance with the APA and CRA), the incoming administration cannot freeze, withdraw, or postpone the rulemakings. Any attempt to repeal and/or amend this type of midnight regulation would likely require another, separate round of rulemaking.

For those midnight regulations that have been published as final in the Federal Register but not yet taken effect (or whose stated effective date was not in compliance with the APA or CRA), the incoming administration could postpone the effective dates of the rulemakings (typically up to 60 days) and review them for any questions of fact, law, and policy they may raise, which could subject the rulemakings’ effective dates to additional delay.

For those midnight regulations that have been proposed but are not yet published as final in the Federal Register, the incoming administration could halt and withdraw them entirely.

What is an example of a midnight regulation that Reed Smith attorneys are monitoring and tracking?

Here is a prime example of why the above information may be important to know. Say you are a health care company that would like to engage in a value-based arrangement protected by the recently-promulgated rulemakings modernizing the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute (AKS), which rulemakings were published in the Federal Register on December 2, 2020. Given that December 2, 2020, is squarely in the midnight period of the outgoing Trump administration, you would like to know whether these value-based rulemakings will persist during the Biden administration.

The untrained eye may look at the value-based regulations’ stated effective dates (i.e., January 19, 2021), determine that the rulemakings went into effect before Inauguration Day, and move forward with a value-based arrangement. However, the trained eye—one that has reviewed this primer—will note that the value-based regulations, which are “major” regulations, have effective dates that are not in compliance with the CRA’s mandatory 60-day waiting period. In fact, in December 2020, GAO formally determined that the January 19, 2021 effective dates in both of the value-based regulations violated the CRA. That finding possibly provided the incoming Biden administration, if so inclined, the ability to assert that the original effective dates in the value-based regulations were unlawful and to stay implementation of those rulemakings at least temporarily.

To date, we have not seen the Biden administration take any such action—in fact, using the CRA, the Stark Law amendments took effect on January 31, 2021, or 60 days after December 2, 2020—but we will continue to watch closely for any updates. Using the CRA, the AKS amendments are scheduled to take effect on February 14, 2021, or 60 days after December 16, 2020 (i.e., the date that the House of Representatives received the report on the AKS final rulemaking).

What if I have additional questions?

Should you have any questions related to the incoming Biden administration’s treatment of the Trump administration’s midnight regulations, including those related to modernizing the Stark Law and the AKS, please do not hesitate to reach out to the health care attorneys at Reed Smith.

President Biden implements policies to expand access to health care and coverage

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic.  In addition to this Executive Order, the White House also announced President Biden’s Presidential Memorandum on Protecting Women’s Health at Home and Abroad (the “Presidential Memorandum”).

The Executive Order acknowledges that, in the year since the U.S. Department of Health and Human Services (“HHS”) declared COVID-19 a public health emergency, the pandemic has continued to spread and has had a disproportionate impact on Black, Latino, and Indigenous communities.  Citing over 30 million Americans without health insurance and an overwhelmed health care system, the Executive Order directs the following actions:

Special Enrollment Period:  The Executive Order directs the Secretary of HHS to consider establishing a “Special Enrollment Period” to provide an opportunity for under-insured and uninsured Americans to obtain coverage through the Federally Facilitated Marketplace’s healthcare.gov webpage.  A Fact Sheet issued by the White House states that the Special Enrollment Period is expected to take place from February 15, 2021 through May 15, 2021.

Immediate Review of Agency Actions:  The Executive Order directs the Secretary of the Treasury, the Secretary of Labor, the Secretary of HHS, and the heads of other executive departments and agencies relevant to Medicaid and the Affordable Care Act (collectively, “heads of agencies”) to review all existing regulations, orders, guidance, polices, and other agency actions (collectively, “agency actions”) to determine whether such agency actions are inconsistent with the policies set forth in the Executive Order.  Namely, the heads of agencies are to review:

  • Policies undermining protections for pre-existing conditions, including complications related to COVID-19;
  • Policies that may reduce coverage under or undermine the Affordable Care Act or Medicaid;
  • Polices that may undermine the Health Insurance Marketplace or other insurance markets;
  • Polices that impose “unnecessary barriers” to access coverage through Medicaid or under the Affordable Care Act; and
  • Policies that reduce the affordability of or financial assistance for insurance coverage, including for dependents.

To the extent practicable and appropriate, the Executive Order directs the heads of agencies to suspend, rescind, or revise agency actions identified as inconsistent with the policies outlined in the Executive Order and, as applicable, publish for notice and comment any proposed rules necessary to accomplish the same.  The Executive Order further directs the heads of agencies to consider any additional agency actions that may be necessary to more fully implement the policies set forth in the Executive Order.

Revocation of Certain Presidential Actions and Review of Associated Agency Actions:  The Executive Order revokes two executive orders issued by the previous administration:

  • Executive Order 13765: Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal, issued January 20, 2017; and
  • Executive Order 13813: Promoting Healthcare Choice and Competition Across the United States, issued October 12, 2017.

Additionally, the Executive Order directs the heads of agencies to identify agency actions related to the revoked orders and consider whether to suspend, revoke, or rescind such agency actions.

Presidential Memorandum on Protecting Women’s Health at Home and Abroad

Finally, the White House announced President Biden’s Presidential Memorandum aimed at expanding and protecting access to comprehensive reproductive health care.  This Presidential Memorandum rescinds the “global gag rule,” also referred to as the Mexico City Policy, which barred international non-profits that provide abortion counseling or referrals from receiving funding from the United States.  This Presidential Memorandum is consistent with prior memoranda issued by President Clinton and President Obama during their administrations.  In an effort to further strengthen protections for reproductive health care access, the Presidential Memorandum directs HHS to consider whether to rescind the family planning program regulations under Title X.

Department of Justice files statement of interest addressing the preemptive effect of the PREP Act

On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes such claims removable from state court. However, it remains to be seen whether the views expressed in the statement of interest, which was filed in Bolton v. Gallatin Center for Rehabilitation & Healing, LLC, Civil Action No. 3:20-cv-00683 (M.D. Tenn.), will continue to be the official position of DOJ following the recent change in presidential administration. Notably, the position advanced by DOJ’s statement of interest is consistent with guidance recently issued by the outgoing General Counsel of the Department of Health and Human Services, which concluded that the PREP Act is a “complete preemption” statute.

The PREP Act is a critical component of the concerted federal effort to promote the “[r]apid distribution and administration of medical countermeasures” in response to a public health emergency,” and vests the Secretary of Health and Human Services with the authority to determine the existence or credible future risk of a public health emergency, and to issue a declaration recommending administration of specified countermeasures. 42 U.S.C. § 300hh-1(b)(2). See also id. § 247d-6d(b). In light of the fact that successful distribution and administration of these countermeasures depends upon the cooperation of private-sector partners and state and local officials, Congress provided broad immunity to “covered persons” for claims relating to the administration to, or use by, an individual of countermeasures that aid in that response. See id. §§ 247d-6d(i)(2), 247d-6d(a).

Consistent with these principles, DOJ’s recent statement of interest notes that PREP Act immunity is sweeping, and that all damages actions for conduct relating to covered persons’ administration of countermeasures specified in a PREP Act declaration are preempted. DOJ contends that the PREP Act constitutes a complete-preemption statute with respect to the administration or use of covered countermeasures by covered persons under a declaration by the Secretary, relying on the immunity and exclusive alternative remedy provisions in support of this position.

First, the immunity provision provides for immunity “under Federal and State law with respect to all claims for loss caused by, arising out of, or resulting from the administration” of countermeasures specified by the Secretary. Id. § 247d-6d(a)(1). Second, the “sole exception” to the immunity grant is “an exclusive Federal cause of action” for claims of willful misconduct resulting in death or serious physical injury. Id. §247d-6d(a)(1). DOJ’s statement of interest contends that, together, these provisions show that Congress determined that state-court tort actions are not an appropriate means, in this emergency, to deter tortious conduct, except as provided in the “exclusive” federal cause of action created by the statute itself. See 42 U.S.C. § 247d-6d(d)(1).

In further support of its position, DOJ’s statement of interest relies on existing case law for the proposition that a reference in a statute to an “exclusive” remedy or cause of action is demonstrative of Congress’s intent for a completely preemptive reading of the statute.

Based on the foregoing, the statement of interest argues that the PREP Act provisions supersede state tort laws and create a federal remedy for certain claims of loss related to covered countermeasures that is exclusive, even when premised entirely on state law.

Congress’s approval of Competitive Health Insurance Reform Act (CHIRA) could mean significant antitrust changes for health insurers

The U.S. Senate recently voted unanimously to approve the Competitive Health Insurance Reform Act (Act), which the House of Representatives had already passed earlier in the fall. Currently, health insurers have federal antitrust immunity under the McCarran-Ferguson Act for state-regulated activity that constitutes the business of insurance. Should President Trump opt to sign CHIRA into law, however, that immunity would be largely repealed, although CHIRA does preserve some protections for health insurers.

For a deeper discussion on the potential impact of CHIRA, please read our full post on Reed Smith’s Antitrust and Competition Report blog.

Congress passes legislation impacting the Provider Relief Fund

In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133.  The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act.  The President is expected to sign the legislation shortly.  Of note, in the course of appropriating billions of additional dollars to combat COVID-19, division H, title II of the legislation alters certain requirements of the Provider Relief Fund (“PRF”) affecting health care providers and suppliers.

First, the legislation provides that if the recipient of PRF funds is a subsidiary of a parent organization, that parent organization may allocate all or any portion of such payment among any of its subsidiaries that are eligible for PRF funds. This includes any payments made by the Department of Health and Human Services (“HHS”) under so-called “Targeted Distributions,” which represents a change from the position taken in guidance issued by HHS.  The legislation expressly provides that the responsibility for reporting the reallocated payments remains with the original recipient of the funds.

Second, the legislation gives recipients of PRF funds greater flexibility in how they calculate lost revenue by referencing a since-superseded version of guidance issued by HHS in June 2020.

If enacted into law as expected, the above legislative changes could soon have a significant impact because the first reporting deadline for recipients of PRF funds is February 15, 2021. Should you have any questions related to this new legislation and how it may impact your organization, please do not hesitate to reach out to the health care attorneys at Reed Smith.

HHS proposes important changes to key aspects of HIPAA Privacy Rule

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes to key standards, definitions, and patient rights under the HIPAA Privacy Rule, which are geared toward promoting care coordination and value-based care, and empowering patients with greater access to their health information.

As we recently flagged, even amidst the chaos of a global pandemic, multiple HHS agencies, including the Office of the National Coordinator for Health Information Technology (ONC), the Centers for Medicare & Medicaid Services (CMS), and most recently, CMS and OIG, have focused their attention in 2020 on facilitating and enforcing patients’ rights to access their health information, encouraging interoperability among health information technology (IT) systems, prohibiting information blocking by key health industry stakeholders such as health care providers and health IT developers, and promoting value-based care.  OCR’s NPRM is no different.

Most notably, the NPRM –

  • Shortens response time for patient health record requests from 30 days to 15 days (with a 15 day extension under limited circumstances).
  • Reduces identity verification burdens on patients (or their personal representatives) exercising a right under the Privacy Rule.
  • Amends the definition of health care operations to permit disclosure of patient information for care coordination and case management activities, whether population-based or focused on particular individuals.
  • Clarifies the minimum necessary standard with respect to care coordination and case management activities.
  • Removes antiquated elements of Notice of Privacy Practices (NPP) requirements.
  • Amends the permissible fee structure for responding to patient health record requests and requires covered entities to post estimated fees on their website for access and for disclosures with a patient’s authorization.
  • Clarifies and facilitates family and caregiver involvement in the care of individuals experiencing emergencies or health crises.

If finalized, these proposals will require HIPAA-regulated entities to update their policies and procedures that impact daily business operations, train workforce members on updated processes, revise their Notice of Privacy Practices, renegotiate business associate agreements (BAAs) to comply with the new requirements, and coordinate compliance with the conglomerate of overlapping privacy, interoperability, information blocking, patient access, and value-based regulatory frameworks – each of which is actively transforming  the way in which the health care industry shares patient information.

Further Reed Smith analysis on the NPRM is forthcoming, particularly with respect to the implications of the proposed changes on the value-based rulemakings and the new interoperability, information blocking, and patient access rules.

In the meantime, please let us know if you have questions.

Open for business in 2021

With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons safe.  In an effort to resolve this seemingly open question, just this week, the National Institutes of Health (“NIH”) unveiled an innovative online mechanism that may give businesses the tools they need to choose a COVID-19 testing strategy for the year ahead.  This mechanism, developed by a branch of the NIH called the National Institute of Biomedical Imaging and Bioengineering (“NIBIB”), will act as a COVID-19 Testing Impact Calculator (the “Calculator”) and will show how different approaches to testing and other mitigation efforts (e.g., mask use, social distancing, and contact tracing) may curb the spread of COVID-19 within a particular organization.

The Calculator is the first online tool in the U.S. that will provide businesses with purportedly clear guidance on risk-reducing behaviors in an effort to help them re-open and stay open. And a special perk—the Calculator is free.

  • Where was the Calculator developed?

The Consortia for Improving Medicine with Innovation and Technology at Massachusetts General Hospital and researchers at the Massachusetts Institute of Technology created the Calculator to model the costs and benefits of COVID-19 testing strategies for individual businesses.

  • What can users expect?

Users of the Calculator will enter a few specifics about their business, such as which safety and prevention methods are already in place (e.g., whether mask wearing and social distancing are required, and whether contact tracing is or will be utilized).  Users can even adjust details such as whether mask-less meetings or dining will be allowed, or how big group settings are expected to be.

The Calculator then models four different COVID-19 testing methods, which include onsite and lab-based methods, and calculates the number of people that should be tested each day.  It will provide the estimated cost of each testing option and will outline the tradeoffs in the speed and accuracy of each kind of available test.  Each user will get a customized scenario for surveillance testing.

  • How to get started?

The Calculator is available now at https://whentotest.org/.

We hope tools like the Calculator will assist businesses in remaining resilient in the face of challenges posed by COVID-19.  As research institutes and regulators continue to adapt to these unprecedented times, we recommend that businesses continue to stay apprised of new technology and new guidance related to COVID-19.  Should you have any questions related to testing during COVID-19 or any of the issues raised in this article, please do not hesitate to reach out to the health care attorneys at Reed Smith.

Long-Awaited issuance of Section 340B ADR final rule

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B discounted product). The ACA directed the Secretary to issue such regulations within 180 days of the ACA’s enactment.

The Secretary had long failed to issue such regulations, leading to recent and ongoing Administrative Procedure Act (APA) litigation by covered entities challenging the Secretary’s failure to do so in connection with the ongoing controversy between covered entities and certain manufacturers over covered entities’ use of contract pharmacies.

On December 10, 2020, the Secretary released a pre-publication version of his ADR final rule, which will be published in the Federal Register on December 14 and go into effect on January 13, 2021—one week before President-Elect Biden’s inauguration. Among other things, the ADR final rule:

  • Establishes a new six-member “340B Administrative Dispute Resolution Board” comprised of officials drawn from within HHS, which will sit in three-member “Administrative Dispute Resolution Panels”;
  • Provides for the initiation of claims by covered entities or manufacturers against each other seeking “monetary damages” and/or equitable relief (e.g., injunctions), which are forms of relief that may exceed the authority provided by the underlying statute;
  • Draws from certain aspects of the Federal Rules of Civil Procedure, particularly those rules involving pleadings and summary judgment;
  • Establishes that decisions of the ADR Panel are precedential and constitute final agency action subject to judicial review; and
  • Establishes a three-year limitations period for covered claims.

Because the ADR final rule will go into effect before the upcoming inauguration, the Biden Administration will likely have to engage in additional notice-and-comment rulemaking if it wants to alter the final rule’s contents. Issuance of the ADR final rule will also likely moot ongoing APA claims challenging the Secretary’s failure to issue regulations. However, that litigation also includes other claims for declaratory and injunctive relief more specifically associated with the ongoing contract-pharmacy controversy.

In any event, the existence of a formal ADR process will likely lead to covered entities initiating claims in the 340B ADR Board against certain manufacturers arising from the contract-pharmacy controversy as well as other overcharge matters.

Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading marketing related to COVID-19 seems to be even more brazen this fall. Last month—on the heels of the first FDA-authorized COVID-19 at home testing kit and FDA’s announcement of its December 10, 2020 FDA Advisory Committee meeting concerning a COVID-19 vaccine candidate—the FDA and FTC began honing in on unapproved products and advertising offering not just virus protection or mitigation, but virus prevention and cures.

To date, the FDA and FTC have issued 135 COVID-19-related warning letters for unapproved drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a), and for drugs misbranded in violation of section 502 of the FD&C Act, 21 U.S.C. § 352. These warning letters flagged products ranging from salt therapy solutions promising to “strengthen the lungs to fight against the novel Coronavirus” and essential oils that are “clinically proven to possess antiviral properties,” to an “umbilical cord derived cellular product” advertised during a Facebook chat as a “preventative treatment[] that can help boost the immune system and fortify lungs against viruses.”

Discussing the marked rise in mislabeling and fraudulent virus-related products, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, reminded marketers in a June 17, 2020 press release that “[p]roviding regulatory flexibility during this public health emergency never meant we would allow fraud.”

Perhaps as a result of “pandemic fatigue” triggering consumer demand for quick fixes or motivated by the booming COVID-19 mitigation product market, potentially fraudulent and deceptive virus-related marketing targeting prevention and treatment is even more prevalent this fall.  Just last month, the FTC sent letters warning 20 more marketers nationwide to stop making unsubstantiated claims that their products and therapies—ranging from copper water bottles to personal training, bead bracelets, and water filtration systems—can prevent or treat COVID-19. In September 2020, FDA’s Bad Ad Program issued a warning letter citing a pharmaceutical company for touting its budesonide generic asthma drug as a treatment for symptoms of COVID-19.  Other recent FDA enforcement actions combatted a new wave of at-home COVID-19 devices, including antibody testing kits and rapid results virus testing kits.

Despite the booming market and consumer demand, manufacturers and advertising agencies must remain vigilant and disciplined when incorporating COVID-19 into marketing campaigns.  There are ways to do this without triggering FDA or FTC action.

Takeaway:  Marketers should beware of heightened scrutiny over health care advertising related to COVID-19. Currently, there is no approved vaccine for COVID-19, so claims related to virus protection and mitigation (e.g., flagged claims include that a product is “effective against all types of pathogens, including a wide variety of viruses,” “anti-coronavirus and antimicrobial activity,” and “helps lower[] everything that is virus and inflammation”) must be carefully crafted in a way that achieves commercial goals while mitigating risk of a regulatory enforcement action.  Lastly, no platform or marketing medium is exempt from regulatory scrutiny, as several recent COVID-19 warning letters cited claims made via email accounts and on social media.

Final Rules Modernizing Stark Law and Anti-Kickback Statute Released

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute.

As we wrote when the proposed rules were released last autumn (see client alerts here and here), the rules reflect HHS’s attempt to create exceptions and safe harbors that refine the Stark Law’s strict-liability-based civil penalties and the Anti-Kickback Statute’s criminal penalties. The goal is to prevent certain non-abusive and beneficial arrangements from finding themselves subject to enforcement activities. As HHS itself notes, the final rules are the result of its effort to address health care industry concerns that these laws, as well as the Civil Monetary Penalty (CMP) Law, function as barriers to the delivery of value-based care that would improve quality of care, health outcomes, and efficiency.

The final rules number over 1,600 pages in current form and incorporate and address over 650 comments industry stakeholders submitted in response to the proposed rules. For our overview and analysis of the final rules, please read our client alert.

CMS finalizes rule to ensure no-cost COVID-19 vaccine

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine.

The IFR governs any vaccine that is licensed by FDA under a Biologics License Application (BLA), or, significantly, receives an Emergency Use Authorization (EUA) from the Agency. While the CARES Act obligates Medicare to cover the costs of a vaccine formally approved through the BLA process, the Act does not explicitly provide for coverage of a vaccine that is alternatively authorized by FDA under an EUA. In implementing this IFR, however, CMS reasoned that an EUA is tantamount to a BLA based partly on the rigors of the process, as well as Congress’ intent to extend no-cost, rapid access to a vaccine – particularly with respect to seniors, a large population considered at high-risk to the effects of COVID-19 and which makes up the vast majority of Medicare beneficiaries.

Under the IFR, providers would be prohibited from charging for the administration of a vaccine as a condition for receiving it free from the federal government. In addition to eliminating cost, the wide-ranging IFR’s overarching goal is to remove administrative barriers and reduce potential delays to patient access to a vaccine. As such, the IFR also endeavors to create flexibilities:

  • For states maintaining Medicaid enrollment during the COVID‑19 public health emergency; and
  • In the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 public health emergency.

Significantly, the IFR also provides:

  • Enhanced Medicare payments for new COVID-19 treatments;
  • Price transparency for COVID-19 tests; and
  • An extension of Performance Year 5 for the Comprehensive Care for Joint Replacement model.

Medicare Beneficiaries

 The IFR utilizes Section 3713 of the CARES Act in order to add FDA-authorized or approved vaccines to the list of preventative vaccines covered under Medicare Part B. In addition to covering the costs of administration, the IFR also eliminates any copayment/coinsurance or deductible.

The IFR extends the same coverage of costs to Medicare Advantage (MA) participants by paying directly for the administration of a vaccine to beneficiaries enrolled in MA plans. MA plans will directly cover the costs of administration for providers who administer the vaccine to MA beneficiaries during calendar years 2020 and 2021. Similar to traditional Medicare enrollees, any copayment/coinsurance and deductibles will be waived for MA beneficiaries.

As part of the IFR, CMS announced Medicare payment rates for single-dose and multi-dose immunizations, which can be adjusted in light of practical geographic considerations related to cost. Additionally, CMS intends to announce coding instructions through program memoranda as expediently as possible once FDA authorizes or approves a vaccine.

 Medicaid Beneficiaries and the Uninsured

 The IFR generally requires state Medicaid programs to provide vaccine administration at no cost to most beneficiaries. The IFR does so by invoking the Families First Coronavirus Response Act (FFCRA), Section 6008 of which ties a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage for the duration of the COVID-19 public health emergency. That increase in funding is conditional on states covering the costs of a vaccine and its administration for Medicaid enrollees without cost sharing during the duration of the public health emergency, with additional flexibility after its expiration. While the IFR supports this general principle it is not absolute and we thus encourage stakeholders in Medicaid and CHIP programs to consult the IFR directly to ensure compliance.

As for the uninsured, under the IFR providers will be able to seek reimbursement for administration of a vaccine through the FFCRA Relief Fund and the Provider Relief Fund, as managed by the Health Resources and Services Administration. While the lion’s share of the $175 billion appropriated to the Provider Relief Fun via the CARES Act and Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) has already been spent, the FFCRA Relief Fund is intended to make available an additional $2 billion through a combination of FFCRA and PPPHCEA funds.

What’s Next

The IFR became effective on November 2, 2020, even though it will not be published in the Federal Register until November 6, 2020. CMS will accept comments on the IFR if they are submitted on or before 5:00 PM EST on January 4, 2021.

HHS further delays compliance for Interoperability and Information Blocking Rule

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an advanced copy of an interim final rule with comment period (the “Interim Final Rule”) extending the compliance dates and timeframes necessary to comply with the Final Rule. In doing so, ONC sought to provide additional flexibility for health care providers and developers of certified health IT in particular, given the sustained and unprecedented strain on the health care system due to the COVID-19 pandemic.

This is the second compliance extension since the ONC announced the Final Rule in March, also due to the pandemic.  Now, in addition to extending the compliance dates relating to information blocking, the 2015 Edition Cures Update certification criteria, and the Conditions and Maintenance of Certification requirements, ONC’s Interim Final Rule offers some technical corrections and clarifications of certain points in the Final Rule.  To the relief of many regulated actors, for instance, ONC clarifies that the information blocking provisions do not explicitly require regulated actors to purchase or update certified health IT.  Instead, regulated actors must leverage their existing health IT, certified or not, in a manner that does not interfere with appropriate requests to access, exchange, or use electronic health information.  By contrast, the 2015 Edition Cures Update certification criteria do establish new functional requirements intended to facilitate interoperability and deadlines for when such functionalities must be present for a health IT product to maintain its certification.

ONC considered several factors in determining the appropriate extension length for each requirement, establishing shorter extensions for requirements that do not require the implementation of new technology, such as the information blocking provisions.  Other requirements, such as the 2015 Edition Cures Update certification criteria, do require technological updates and, accordingly, received longer extensions.

We have outlined certain key changes to the ONC Final Rule compliance timeline below.

Information Blocking

  • General Prohibition – Information Blocking: April 5, 2021
  • Condition of Certification – Information Blocking: April 5, 2021
  • Assurances Condition of Certification – Information Blocking: April 5, 2021

Application Program Interfaces (APIs)

  • Condition of Certification – Existing API Technology: April 5, 2021
  • New Standard API Certification Criterion: December 31, 2022
  • Condition of Certification – New Standardized API: December 31, 2022

EHI Export

  • Assurances Condition of Certification – Existing Data Export Certification Criterion: April 5, 2021
  • New EHI Export Certification Criterion: December 31, 2023
  • Assurances Condition of Certification – New EHI Export Certification Criterion: December 31, 2023

For questions regarding the rules or this post, please contact Nancy Bonifant Halstead, Vicki Tankle, and Lauren Bentlage, or any Reed Smith attorney with whom you work.

New Executive Order seeks to address COVID-19 impact on mental health

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic.

The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic has had on mental and behavioral health conditions due to “stress from prolonged lockdown orders, lost employment, and social isolation,” and emphasizes the importance of coordinating action across federal, state, local, and Tribal partners to effectively address these concerns. The Executive Order points to survey data issued by the Centers for Disease Control and Prevention, which indicates that during the last week of June 2020, 40.9 percent of Americans reported struggling with mental health or substance abuse issues, with 10.7 percent reporting seriously considering suicide. Accordingly, the Executive Order states that “[i]t is the policy of the United States to prevent suicides, drug-related deaths, and poor behavioral-health outcomes, particularly those that are induced or made worse by prolonged State and local COVID-19 shutdown orders.”

To address these concerns, the Executive Order focuses on the following strategies to be taken at a national level, among others:

  • Increased crisis intervention services;
  • Increased availability of and access to continuing care following an initial crisis;
  • Increased mentorship programs and support groups;
  • Increased availability of telehealth and online mental health and substance use tools and services; and
  • Public and private resources to address mental health, including factors that contribute to prolonged unemployment and social isolation.

Additionally, the Executive Order establishes a Coronavirus Mental Health Working Group (the “Working Group”) tasked with formulating an “all-of-government” collaborative response to address the mental health impacts of COVID-19. The Working Group will be co-chaired by the Secretary of Health and Human Services, Alex Azar, and the Acting Director of the Domestic Policy Council, Brooke Rollins, and will be further comprised of representatives from various federal agencies, including the Department of Justice, the Department of Housing and Urban Development, and the Office of National Drug Control Policy.

The Working Group is directed to consider the mental-and behavioral-health conditions of certain vulnerable populations who have been disproportionately impacted by the pandemic and evaluate existing protocols and evidence-based programs to identify potential strategies for improving support for these populations. Based on this review, the Working Group is further tasked with developing and submitting a plan to facilitate coordination between public and private stakeholders to improve service offerings and better assist individuals in crisis. The Working Group’s plan must be submitted to the President by November 19, 2020. Secretary Azar released a statement in support of the Executive Order, noting that it was a “welcome opportunity to increase efforts to address the mental health effects of the pandemic,” which has compounded mental health and behavioral health conditions by “adding new stresses and disrupting access to treatment.”

Finally, the Executive Order further directs the heads of agencies, in consultation with the Director of the Office of Management and Budget, to examine existing grant programs that fund mental health, medical, or related services and encourage grantees to consider adopting policies that have been shown to improve mental health and reduce suicide risk, with an emphasis on “safe in-person” services. As part of this initiative, the agencies are also encouraged to award contracts and grants to community organizations and other local entities to enhance mental health and suicide prevention services, including outreach, education, and case management services for vulnerable populations.

Patient access to health information at the forefront of government initiatives and scrutiny

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient). Continue Reading

CMS releases roadmap for states to accelerate adoption of value-based care

On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance value-based care (VBC) across their health care systems, with an emphasis on Medicaid populations, and how to share pathways for adoption­ of such approaches.  Within the 33-page letter, CMS highlights the merits of VBC; provides an assessment of key lessons learned from early state and federal experiences in implementing VBC reforms, as well as a comprehensive toolkit of available federal authorities for states to adopt for innovative payment-reform efforts within their Medicaid programs; and stresses the importance of multi-payer alignment in VBC to drive care transformation.  Notably, however, the guidance does not address prevalent concerns among providers and industry about what types of VBC arrangements could run afoul of federal and state fraud and abuse laws and/or which entities can participate in such arrangements.

Merits of Value-Based Care Arrangements

Under VBC arrangements, providers are rewarded—based on specific evidence of performance on negotiated quality measures—for helping patients improve their health, reduce the effects and incidence of chronic disease, and live healthier lives.  That is, VBC arrangements can hold providers accountable by tethering reimbursement to their ability to improve quality of care in a cost-effective manner or lower costs while maintaining standards of care, rather than the volume of care they provide.  Moreover, according to the guidance, VBC can be a part of the solution to reducing health disparities in the health care system and handling unexpected challenges, including those brought about by the COVID-19 pandemic.

Value-Based Payment as Key Driver

CMS points to value-based payment as the key driver of VBC.  Accordingly, the guidance highlights and explains critical elements of value-based payment design and operations, including:

  • Level and scope of financial risk;
  • Benchmarking; and
  • Payment operations.

Additionally, the guidance discusses in depth several key considerations for states pursuing value-based payment, including:

  • Multi-payer participation;
  • Assessment of delivery system readiness;
  • Robust health information exchange and technology;
  • Stakeholder engagements;
  • Quality measure selection; and

Availability of Alternative Payment and Delivery Models

To further facilitate the advancement of value-based payment methodologies in state Medicaid programs, the guidance outlines the key features and applicable Medicaid authorities for various payment and service delivery models, with examples of each, including:

  • Payment models built on fee-for-service architecture;
  • Payments for “episodes of care”; and
  • Payment models involving total cost of care accountability.

The guidance notes that these payment models are not mutually exclusive, and ultimately encourages states to consider the adoption of one or more of them—or, if need be, pursue other delivery system reforms via section 1115(a) waiver authority—depending on their individual program circumstances and reform goals.

Lack of Detail Surrounding What Types of Value-Based Care Arrangements are Impermissible and/or Which Entities Can Participate in Such Arrangements

Significantly, despite the strong push by CMS for state movement towards VBC, the guidance does not provide any discussion or detail about what types of VBC arrangements could run afoul of federal and state fraud and abuse laws and/or which entities can participate in such arrangements.  Without clear (or at least better) guideposts for providers and industry, active participation in VBC arrangements will continue to be stifled by ongoing concerns about the potential risk of liability.

Overall, the guidance represents a step in the right direction towards VBC at the state level.  According to CMS, although many states have made progress, there remain growth opportunities for more states to improve health outcomes and efficiency across payers through adoption of value-based payment models.  Should you have any questions related to VBC and navigating federal and state fraud and abuse laws, please do not hesitate to reach out to the health care attorneys at Reed Smith.

FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important because by integrating patients’ voices throughout the total product lifecycle, concepts important to patients can be considered in the evaluation and surveillance of medical devices.

Goals of the Draft Guidance 

FDA recognizes there are many ways PRO instruments can be used during clinical studies.  As such, FDA issued the draft guidance with the following objectives:

  • Describing principles that may be considered when using PRO instruments in the evaluation of medical devices;
  • Providing recommendations about the importance of ensuring the PRO instruments are fit-for-purpose; and
  • Outlining best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach.

Principles to be considered for PRO Instruments

FDA outlines the following principles that should be considered when using PRO instruments in the evaluation of the medical device:

  • Establish and define the concept of interest (COI) the PRO instrument is intended to capture;
  • Clearly identify the role of the PRO in the clinical study protocol and statistical analysis plan;
  • Provide evidence showing that the PRO instrument reliably assesses the concept of interest; and
  • Effectively and appropriately communicate the PRO-related results in the labeling to inform healthcare provider and patient decision making.

PRO Fit-For-Purpose Criteria

As it relates to the fit-for-purpose criteria, FDA outlines three overarching principles to determine if a PRO instrument is fit for its purpose:

  1. Is the concept being measured by the PRO instrument meaningful to patients and would a change in the concept of interest be meaningful to patients?
  2. What role will the PRO instrument serve in the clinical study protocol and statistical analysis plan?
  3. Does the evidence support its use in measuring the concept of interest as specified in the clinical study protocol and statistical analysis plan?

While these points seem straightforward and clear, they are important ones that should be considered when evaluating the PRO instrument will meet FDA’s expectations. Of note, the draft guidance does not provide what level of evidence is required for a PRO to be fit-for-purpose.

PRO Instrument Best Practices

Finally, the draft guidance provides other best practices for PRO development, which include measuring concepts important to patients, ensuring PRO instruments are understandable to patients, and being clear about the role of PRO instrument in the Clinical Study Protocol and Statistical Analysis Plan.

Overall, the draft guidance provides insight into FDA’s current thinking for use of PRO instruments in medical device clinical studies and should be analyzed by sponsors considering PRO instruments. Interested stakeholders can submit comments on this draft guidance for FDA’s consideration until October 30, 2020 to docket FDA-2020-D-1564 available at https://beta.regulations.gov/docket/FDA-2020-D-1564.

[1] FDA Draft Guidance, “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation” (August 2020) (available at: https://www.fda.gov/media/141565/download).

CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage of breakthrough medical devices widely available, and clarify the application of coverage standards.  In response, on September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (85 FR 54,327) that would establish an expedited Medicare coverage pathway for innovative medical devices, and codify, with some modification, the long-standing Program Integrity Manual standards to be used in making “reasonable and necessary” determinations under Section 1862(a)(1)(A) of the Social Security Act.

  1. MCIT Pathway

The proposed rule sets up the Medicare Coverage of Innovative Technology (MCIT) pathway, under which breakthrough devices, which are designated as part of the Food and Drug Administration’s (FDA) Breakthrough Devices Program, would be covered under Medicare from the moment the device receives FDA market authorization, either through receipt of FDA Premarket Approval, 510(k) clearance or the granting of a De Novo classification request. Under the MCIT proposal, an item or service that receives a breakthrough device designation from the FDA would be considered “reasonable and necessary” under section 1862(a)(1)(A) of the Act because breakthrough devices are innovative, serve unmet needs and have already met the FDA’s “unique breakthrough devices criteria.”

This coverage would continue for up to 4 years, allowing the manufacturer time to submit a National Coverage Determination (NCD) request.  Currently, Medicare coverage pathways include (among other things) local coverage determinations (LCDs) or case-by-case decisions of whether a device will be covered while CMS is processing the NCD, which can take 9-12 months.  The delay for NCDs and local coverage of immediately available coverage pathways under the LCDs result in inconsistent results nationwide. In contrast, the MCIT proposal would allow for immediate national Medicare coverage of any FDA-market authorized breakthrough device, subject to meeting the criteria under the program.  CMS proposes to work closely with the FDA through the regulatory process for these devices to ensure immediate Medicare coverage upon market authorization. The MCIT pathway would be voluntary, requiring device manufacturers to affirmatively opt in.  CMS proposes regulations codifying the MCIT pathway at 42 C.F.R. Part 405, Subpart F.

The FDA’s Breakthrough Device Program is targeted at streamlining approval of devices “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Also, these devices must be either 1) a breakthrough technology; 2) a device for which there is no approved or cleared alternatives; 3) a device that offers significant advantages over existing approved or cleared alternatives; or 4) a device whose availability is in the best interest of patients.

  1. Defining “Reasonable and Necessary”

EO 13890 also directs the Secretary to “clarify the application of coverage standards.”  Accordingly, the proposed rule would codify the long-standing Program Integrity Manual definition of “reasonable and necessary” for items and services that are furnished under Medicare Parts A and B.  CMS has the authority to determine if a particular medical product or service is “reasonable and necessary” under § 1862(a)(1)(A) of the Social Security Act. To date, there have been no formal regulations on this term, yet the Medicare Program Integrity Manual does provide instructions for Medicare contractors in this regard.

We propose that an item or service would be considered ‘‘reasonable and necessary’’ if it is—(1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is—

  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • One that meets, but does not exceed, the patient’s medical need; and
  • At least as beneficial as an existing and available medically appropriate alternative.

We also propose that an item or service would be ‘‘appropriate for Medicare patients’’ under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.[1]

The comment period is open now and runs until November 2, 2020. Comments can be submitted electronically through http://www.regulations.gov  or by mail. Specifically, CMS is requesting comments on whether it should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study. Additionally, CMS wishes commenters to provide feedback on whether the MCIT should also include diagnostics, drugs and/or biologics that utilize breakthrough approaches as they are not currently included in the MCIT pathway. A fact sheet on the proposed rule can also be found on CMS’s website at  https://www.cms.gov/newsroom/fact-sheets/proposed-medicare-coverage-innovative-technology-cms-3372-p.

 

[1] 85 FR 54,328 (emphasis added).  Codification of this proposal would revise 42 C.F.R. §  405.201.

CMS unveils additional COVID-19 LTC facility testing and reporting rules during public health emergency

On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control COVID-19 transmission during the continuing public health emergency (“PHE”).

New LTC Resident and Staff COVID-19 Testing Requirements

The IFC’s key LTC regulatory revision involves the amendment of existing infection control requirements to require COVID-19 testing for all facility residents and staff.  Applicable facilities must also electronically report COVID-19 information, including suspected and confirmed resident and staff infections, in a standardized format specified by the HHS Secretary.  Below are additional details regarding the IFC’s new testing requirements:

  • Individuals Subject to Testing. The new COVID-19 testing requirements apply to all residents and staff that physically work on-site at an applicable LTC factility.  “Staff,” for the purposes of the IFC, includes “any individuals employed by the facility, any individuals that have arrangements to provide services for the facility, and any individuals volunteering at the facility.”  CMS indicated that the new testing mandate may implicate individuals providing services for a facility “under arrangement,” including, for example, a hospice with an agreement to provide care for LTC facility residents.
  • Testing Parameters.  LTC facilities must conduct the newly required testing in accordance with forthcoming Secretary-implemented parameters, which may include testing frequency, result response timing, identification of symptoms, and asymptomatic testing guidelines.  CMS is also requiring all resident and staff COVID-19 testing to be conducted in a manner consistent with current professional standards of practice.  The IFC provides little guidance regarding what constitutes “professional standards of practice,” other than to confirm that the applicable standards are those that exist at the time the care or service is delivered.  CMS is soliciting comments regarding any other appropriate testing parameters that the Secretary should consider for implementation.
  • Testing Documentation and Policies.  CMS is also requiring that the completion and results of each resident and staff COVID-19 test be appropriately documented in staff personnel records, resident medical records, or other individual files, as applicable.  LTC facilities must also maintain appropriate policies and procedures, including those addressing instances where residents and staff refuse or are unable to be tested, access to and acquisition of testing supplies, and emergency staffing strategies.
  • Transmission Prevention.  CMS expects that LTC facilities will take action to prevent transmission when a resident or staff member presents with COVID-19 symptoms or a positive test result.  Specifically, CMS transmission prevention recommendations include restricting facility access for an affected staff member until the applicable individual is deemed safe to return to work, or, in the case of facility residents, the implementation of “cohorting” procedures, which involve the confinement of residents who are known or suspected to have COVID-19 to a specified area of the facility and not sharing staff beyond those residents’ “cohort.”

New CMPs for LTC Data Reporting Violations

The IFC also strengthens CMS’s ability to enforce recently imposed LTC facility reporting requirements, which were established on May 8, 2020, in an effort to support ongoing COVID-19 surveillance.  Specifically, these recently implemented reporting regulations require nursing homes to report COVID-19 and infection control data to the CDC National Healthcare Safety Network (“NHSN”) at least weekly.  The IFC’s enhanced enforcement mechanisms center on the imposition of civil monetary penalties (“CMPs”) for each week that a facility fails to electronically report required COVID-19 data through the NHSN system.

As set forth under the IFC, LTC facilities must pay a $1,000 CMP for the first instance of reporting noncompliance, a figure that will increase by $500 for each subsequent weekly reporting failure.  For example, an LTC that fails to meet the data reporting requirements will receive a $1,000 CMP for the first week of reporting violations, $1,500 for the second week, and $2,000 for the third week.  This weekly $500 penalty escalation process will continue until the penalty amount reaches a $6,500 cap after 12 weeks of noncompliance.  Subsequent violations occurring beyond that 12-week period will continue to be assessed at $6,500 per week.  If a facility is unable to meet reporting requirements and/or experiences financial hardship, that facility may dispute the findings under an independent informal dispute resolution process set forth under 42 C.F.R. Part 488.431, and the facility may submit a financial hardship request to CMS.  The foregoing CMP enforcement policies will continue in effect for up to one year beyond the end of the PHE.

The IFC’s changes become effective as of the rule’s anticipated September 2, 2020, Federal Register publication, and unless otherwise noted, the changes will remain in effect only for the duration of the PHE.  Any comments must be received within 60 days of the September 2 Federal Register publication to be considered.

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