The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed arrangements offering financial assistance to individuals who receive gene therapy treatments. These arrangements were specifically targeted to patients who may suffer from infertility as a result of the treatments’ required chemotherapy-based fully myeloablative conditioning (Conditioning).

While proposed arrangements for travel support (as discussed below and in a June 14, 2024 advisory opinion) appear to receive approval from OIG, other proposed financialsupports for infertility services have received unfavorable opinions primarily because of a lack of data available to OIG regarding whether the proposed assistance would improve the ability of patients to access the gene treatment therapies.

These unfavorable decisions effectively chill arrangements to provide additional financial support to individuals who are enrolled in federal and state health care programs and require gene therapy treatments, though OIG has indicated that it may issue favorable decisions in the future if it receives additional data.  

Continue Reading OIG Issues Opinions On Arrangements Involving Gene Therapy Treatments

In its recently released 2025 proposed Medicare Physician Fee Schedule (“MPFS”), the Centers for Medicare & Medicaid Services (“CMS”) proposed two important modifications to the Medicare 60-day overpayment refund rule—a new “identified overpayment” standard and codification of a 6-month timeframe to investigate and quantify an overpayment.

A product of the Affordable Care Act, the 60-day rule requires a person to report and return Part A and B overpayments within 60 days of identification. In 2016, CMS clarified that an overpayment is “identified” when a person, “through the exercise of reasonable diligence,” should have identified and quantified an overpayment. In the preamble to the 2016 rule, CMS established that “reasonable diligence” is demonstrated through a timely, good faith investigation, which is, at most, 6 months from the receipt of credible information of a potential overpayment.

Continue Reading CMS Revisits Medicare Overpayment Standards in 2025 Physician Fee Schedule

The Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have released a final rule establishing “disincentives” (i.e., penalties) for health care providers that participate in certain Medicare payment programs who have engaged in information blocking, as determined by the HHS Office of Inspector General (“OIG”).

The rule continues to signal the federal government’s commitment to encouraging permitted access to and exchange of electronic health information. The rule summarizes elements of the June 2023 OIG final rule, which established penalties for information blocking for certified health IT developers, health information networks, and health information exchanges. The rule also details the procedures that OIG will follow when investigating potential health care provider information blocking claims. There is a wide range of health care providers subject to the rule including, hospitals, physicians, nursing facilities, group practices, pharmacies, and certain eligible professionals participating in Medicare and Medicaid programs, among others, and disincentives are not limited to HIPAA-regulated entities or to healthcare providers who use ONC-certified health IT.

Continue Reading HHS Finalizes Rule on Health Care Provider Information Blocking Penalties

The fallout from last week’s Loper Bright/Relentless opinion by the U.S. Supreme Court that prospectively eliminated Chevron deference is still not fully clear, but Reed Smith has put together a Chevron Deference Resource Center where we will gather perspectives and events to help guide industry stakeholders through the new post-Chevron world.

The Resource Center will continue to build in the coming months, but right now it includes two major client alerts, one on the general impacts of the decision and one on the impacts of the decision on the complex regulatory regime overseen by the U.S. Food and Drug Administration (FDA). Additionally, there is an invitation to attend a webinar on the impacts of the decision which will be hosted next week by Reed Smith experts.

General impacts of the decision

To examine the ripple effects of the decision across regulated industries  Selina P. Coleman, David A. Bender and Matthew K. Loughran from the firm’s Life Sciences Health Industry Group, Jonathan T. Ammons from the Energy & Natural Resources Industry Group, Edward B. Schwartz of the Global Regulatory Enforcement Group, and Hadas A. Jacobi from the Financial Industry Group have penned a client alert detailing the expected challenges and opportunities facing industry stakeholders as a result of the decision.

Additionally, many of the same experts will be joined by Emily L. Hussey of the Life Sciences Health Industry Group, Kasey J. Curtis from the Appellate Group and Amanda E. Brown from the Labor & Employment Group in hosting a webinar on Wednesday, July 11 at 2:30 PM EDT. The focus of the webinar will be on expected impacts of the decision across multiple regulated industries.

FDA-specific impacts of the decision

Of particular interest is how the decision will impact the regulatory regime governed by the FDA. Within the firm’s Life Sciences Health Industry Group a group of experts who focus on FDA regulatory matters — Emily L. Hussey, Rebecca Jones McKnight, Rachael G. Pontikes, Cori Annapolen Goldberg, Sarah Thompson Schick, Sung W. Park, and Akosua Tuffuor — have written a client alert on the impacts of the decision on the FDA regulatory process. That process, which includes determinations of what types of products are even within the FDA’s jurisdiction and other statutory interpretations by the agency could be upended by the Court’s opinion.

Reed Smith will continue to track the fallout from the Loper Bright/Relentless opinion. If you have questions please check the Chevron Deference Resource Center and don’t hesitate to reach out to the lawyers at Reed Smith.

The Supreme Court’s decision last week in the companion cases of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce overturned the Court’s prior precedent in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., and, in the process, upended 40 years of administrative law practice by requiring a court that is reviewing a challenged administrative rule to rely on its own judgment in resolving ambiguities in the governing statute instead of relying on a reasonable agency interpretation of the statute.

The end of Chevron deference as it is known will mean different things for different industries, but one thing is clear: all regulated industries will have to grapple with this new administrative law landscape.

Reed Smith is hosting a webinar featuring members of the firm focused on many of the highly regulated industries, such as Health Care and Life Sciences, Energy, and Banking. Registration for the webinar is available here.

The webinar, scheduled for July 11 at 2:30 pm EDT will have a panel consisting of: Selina P. Coleman, Emily L. Hussey, and David A. Bender from the firm’s Life Sciences Health Industry Group,  Hadas A. Jacobi from the Financial Industry Group, Kasey J. Curtis from the Appellate Group, Jonathan T. Ammons from the Energy & Natural Resources Industry Group, and  Amanda E. Brown from the Labor & Employment Group.

Reed Smith has also prepared a number of client alerts that will focus on the impact that the Loper Bright decision will have on various regulated industries. As those are released, their authors will share them with you on this blog.

Reed Smith will continue to follow developments in the new administrative law world that will emerge after the end of Chevron deference. If you have any questions, please don’t hesitate to reach out to the lawyers at Reed Smith.

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates to whether two drug assistance programs would run afoul of the Federal anti-kickback statute (“AKS”).

In good news for the entity that requested the opinion, a United States corporate affiliate of a pharmaceutical manufacturer of the drug at issue (the “Requestor”), the OIG stated that it would not impose administrative sanctions for either program, despite the potential to generate prohibited remuneration under the AKS.  Although the advisory opinion is only applicable to the specific programs at issue and can be relied upon only by the Requestor, there are some potential considerations that could be applied more broadly to other arrangements.

Continue Reading OIG Issues Favorable Opinion on Drug Assistance Programs

This post was co-authored by Megan E. McWaters, a Reed Smith summer associate.

In a unanimous decision, the U.S. Supreme Court overturned a ruling by the U.S. Court of Appeals for the Fifth Circuit which had placed doubt on the continuing efforts by the U.S. Food and Drug Administration (FDA) to regulate the dispensing of mifepristone, one of the drugs used in a medication abortion.

The decision, written by Justice Kavanaugh, held that the doctors and associations who initially brought the challenge in the Northern District of Texas did not have sufficient standing to bring their claims before a federal court. The doctors involved in the suit do not prescribe or dispense mifepristone, and according to Justice Kavanaugh, nor would they be forced to provide even emergency abortion care to patients as a result of the FDA’s approval of the drug.

Continue Reading Supreme Court Decision Leaves FDA Approval of Mifepristone Untouched, But For How Long?

On June 17, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion, approving a plan to provide assistance with travel, lodging, meals, and other associated expenses for qualifying patients receiving a gene therapy product.

OIG determined that it would exercise its enforcement discretion by declining to impose administrative sanctions on gene therapy product manufacturer under the Federal Anti-kickback Statute (AKS), despite finding that the arrangement would generate prohibited remuneration if the requisite intent were present. Additionally, OIG found that the arrangement satisfies the “Promote Access to Care” Exception to the Beneficiary Inducements Civil Monetary Penalties law.

Continue Reading OIG Approves Travel and Lodging Assistance for Patients Receiving Gene Therapy

As Reed Smith has previously covered, an issue before the Supreme Court that could be decided this week could bring a seismic shift in the balance of power between agencies and courts, upend regulatory certainty, and open new opportunities for regulated industries, including health care. 

The Supreme Court’s pending decision in a pair of cases governing Commerce Department regulations warrants attention because it may bring new uncertainty to the operating environment, and could change how all regulated industries interact with agencies, lawmakers and courts, as outlined below:

  1. Currently, Chevron deference, a core principle of administrative law for forty years, has told courts that where a statute is ambiguous, the court should defer to the agency on any reasonable reading of that statute, even if the court disagrees with the reading.  
  1. The Supreme Court will soon issue an opinion in two cases—Relentless v. Dep’t of Commerce, and Loper Bright Enters. v. Raimondo—in which the petitioners have asked the Court to overrule Chevron deference. 
  1. The Supreme Court seems to be seriously considering whether to overturn or modify Chevron deference, although there were vigorous questions about the effects of doing so during oral arguments.   A decision is expected in the coming weeks.
  1. If judges, not agencies, will have the final say in what ambiguous statutes mean, that will carry potential implications and opportunities for health care and other highly-regulated industries, which include:

Potential Implications

  • May chill agencies from more expansive coverage and other interpretations.
  • May lead to challenges of longstanding agency decision-making upon which the industry may be relying (e.g., FDA approvals).
  • May allow state regulations to fill the gaps, which would create more of a patchwork approach for purposes of compliance across states.
  • Will favor the use of clear and specific statutory language, to the extent achievable through the efforts of Congress and collaboration across parties.

Potential Opportunities

  • More opportunities to challenge rules and regulations from agencies that burden regulated industries.
  • More benefit from working with lawmakers on clear and specific language in legislative drafting.
  • More opportunities to support for approaches that benefit regulated industries, whether by submitting comments to proposed rules or through amicus briefs in litigation, which help persuade a court in any post-Chevron landscape. 

We are closely watching this and after the Supreme Court’s decision, plan to offer a webinar on the implications for the healthcare industry.

Hospitals and large healthcare organizations have increasingly become prime targets for cybercriminals. In response, the Department of Health and Human Services (HHS) has established a new initiative within the National Institutes of Health (NIH) aimed at enhancing cybersecurity measures for hospitals.

This initiative, called “Universal Patching and Remediation for Autonomous Defense” (UPGRADE), was launched on May 20. UPGRADE’s mission is to develop a tailored and scalable suite of software tools that will enable hospital IT teams to effectively combat ransomware attacks and reduce the time needed to patch vulnerable healthcare products from months to just days or weeks.

Continue Reading HHS Pledges $50 million to Empower Hospitals in the Battle Against Cyberattacks

Colorado recently passed a law creating consumer protections for interactions with artificial intelligence systems. The law specifically identifies high-risk systems, including in those that impact health care. The law requires risk mitigation, documentation and robust governance.

Monique N. Bhargava has written an in-depth article on the law and what it means for AI regulation in the U.S. As AI systems pervade more of society, their regulation will continue to be an issue that states and eventually the federal government will have to tackle.

Reed Smith will continue to follow developments in the regulation of AI, if you have any questions about this Colorado law or other efforts to regulate AI systems, please reach out to Monique or to the lawyers of Reed Smith.

On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as FDA’s phaseout of its general enforcement discretion approach to laboratory developed tests (LDTs).   

The October 2023 proposed rule sought to phase out enforcement discretion for LDTs more broadly. However, FDA seems to have considered some of the concerns commenters raised about access to LDTs and the cost of compliance. The final rule retains varying degrees of enforcement discretion for specific types of LDTs.

Continue Reading FDA LDT Rule Begins Enforcement Discretion Phaseout, But Some Discretion Remains

The Centers for Medicare & Medicaid Services (CMS) has finally published the minimum staffing rule for Long Term Care facilities in the Federal Register, which starts the clock for compliance with some provisions of the rule.

But what does the rule actually do? And what do facilities have to do in order to come into compliance? We wrote a client alert that details most of the more difficult portions of the rule and some advice on how to comply with it. Included is a chart that provides guidance on the exemptions and waivers that are available.

Reed Smith will continue to track developments with regard to the regulation of long term care facilities. If you have any questions about compliance with this rule or about regulation of long term care facilities, please reach out to the authors or the health care lawyers at Reed Smith.

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 24-02, involving independent charity patient assistance programs (PAPs) associated with 12 specific diseases (the Disease Funds) operated by the Requestor. Each Disease Fund has a single donor–a pharmaceutical manufacturer that manufactures or markets a drug to treat the disease state associated with the fund.

Although the arrangement generates remuneration prohibited under the federal Anti-Kickback Statute (AKS) if the requisite intent were present, the OIG determined it would not impose sanctions on the Requestor. In exercising its enforcement discretion, the OIG acknowledged the public policy benefits of independent charity PAPs while highlighting the importance of a charity’s independence from pharmaceutical manufacturer influence. Additionally, the arrangement does not implicate the federal Beneficiary Inducements Civil Monetary Penalties (CMP) law.

The OIG set an effective period for the opinion that expires January 1, 2027 due to upcoming reductions in Medicare Part D cost sharing associated with the Inflation Reduction Act. The reduction in beneficiary out-of-pocket expenses could ease demand for PAP subsidies and alter the OIG’s assessment of the benefits and risks of the arrangement.

Continue Reading OIG Exercises Discretion in Independent Charity Patient Assistance Program

Elliott is a law clerk at the firm and his work is supervised by licensed attorneys. His admission to the New York bar is pending.

During a hearing before the Oversight Committee of the U.S. House of Representatives on April 11, Dr. Robert Califf, the commissioner of the U.S. Food and Drug Administration (FDA), requested congressional action to create a new pathway to regulate hemp-derived Cannabidiol (CBD) products, which the agency does not consider safe enough to be sold lawfully as a dietary supplement.

In a January 2023 statement by the prior Commissioner, Janet Woodcock the FDA declined to develop rules to allow CBD to be sold in dietary supplements or food, citing its belief that CBD does not fall under a particular regulatory scheme currently available to the agency.

Continue Reading The FDA’s Continued Search for a Legal Pathway for CBD Products

In a final rule published on April 26, the U.S. Department of Health and Human Services (“HHS”) amends the HIPAA Privacy Rule to bolster protections for individuals’ reproductive health information. This final rule comes almost exactly a year after HHS published its draft rule on the subject.

The rule is part of the Biden administration’s effort to address the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization. Dobbs’ reversal of Roe v. Wade resulted in a patchwork of state laws governing abortion, some of which require or permit health care providers to release personal information about reproductive health care to state authorities for patients who sought an abortion.

The rule is scheduled to take effect on June 25, 2024 and most provisions will be enforceable as of December 23, 2024. Below, we summarize in more detail some of the notable changes to the HIPAA Privacy Rule. 

Continue Reading HHS Modifies HIPAA Privacy Rule to Shield Reproductive Health Information from Third Party Access

Making good on its promises to enhance oversight of Medicare Advantage (MA) and Medicare Part D plans, the Centers for Medicare and Medicaid Services (CMS) has submitted for public inspection its Contract Year 2025 Final Rule. The final rule, published in the Federal Register on April 23 and taking effect on June 3, 2024, codifies existing MA and Part D sub-regulatory guidance, adds a number of new policies for Contract Year 2025 and implements provisions of the Bipartisan Budget Act of 2018 (BBA) and the Consolidated Appropriations Act, 2023 (CAA 2023).

The rule contains many substantive changes to current MA and Part D requirements. The most impactful sections of the rule include: (1) changes to the Part D formulary, including substitutions of biosimilar biological products; (2) modification of agent and broker compensation requirements for MA plans; (3) codification of consent requirements within the MA regulations for the sharing of personal beneficiary data between third party marketing organizations (TPMOs); (4) standardization of the MA Risk Adjustment Data Validation Appeals Process; (5) changes to the Part D medication therapy management program eligibility criteria; (6) changes to contracting standards and limitations on dual-eligible special needs plans; and (7) changes to the network adequacy standards within MA to add a new facility-specialty type called “Outpatient Behavioral Health”.

Also notable is what CMS does not address in the rule – CMS declined to establish what qualifies as an identification of an overpayment that needs to be returned to avoid False Claims Act violations. That potential standard has been in the works since the Contract Year 2023 rule, but stakeholders have to keep waiting as CMS notes that it may be the subject of a future rulemaking.

Continue Reading Are you listening, Medicare Advantage and Medicare Part D Plans? It’s CMS (Again)

Last week, on April 18, several federal agencies jointly launched a “one-stop shop” to facilitate reporting of allegedly anticompetitive behavior in the health care sector. While there has always been a complaint portal for the antitrust agencies, the Federal Trade Commission (FTC), the U.S. Department of Health and Human Services (HHS), and the Antitrust Division of the U.S. Department of Justice (DOJ) established the site, HealthyCompetition.gov, to allow the public to submit complaints about potentially unfair and anticompetitive health care practices.

There is no timeframe within which reports may be submitted, as the agencies look to solicit assistance from the public in their oversight of potential antitrust violations. There is also no limitation on who can submit such reports—employees, customers, vendors, competitors, etc.

Reports will undergo a preliminary review by staff at the FTC and DOJ. Complaints that raise sufficient concern under the antitrust laws will be selected for further investigation, which may lead to formal investigation or enforcement activity by one or more of the agencies.

The portal is intended to be used only for the submission of complaints about health care competition, and not complaints about other health care issues such as failure to pay claims or cover health care services, increases in individual insurers’ rates, billing disputes, general unhappiness with the health care system, or other non-health care competition issues.

The new portal is the latest salvo in the agencies’ intensifying scrutiny of consolidation in the health care industry as part of the Biden Administration’s focus on lowering health care costs across the board, and comes on the heels of the online workshop hosted by the agencies just last month to discuss the impact of private equity ownership in the health care sector.

We covered the details of that forum, during which the agencies denounced the purported “financialization” of health care markets, in a previous blog post and client alert. In conjunction with the workshop, the agencies also issued a request for information (RFI) seeking public comment on transactions in the health care sector involving private equity firms or similar entities. Responses to the RFI are due by May 6, 2024.

Reed Smith will continue to follow developments in FTC, HHS, and DOJ’s ongoing efforts to regulate competition in the health care sector. If you have any questions about this portal or about competition enforcement in health care or would like to submit a response to the RFI, please reach out to the authors of this post.

On March 9, 2024, in response to the cyberattack on UnitedHealth Group’s subsidiary, Change Healthcare/Optum, in late February 2024, the Centers for Medicare & Medicaid Services (“CMS”) made available Change Healthcare/Optum Payment Disruption (“CHOPD”) accelerated payments to Medicare Part A providers and advance payments to Medicare Part B suppliers experiencing claims disruptions as a result of the cyberattack.

CMS, through the Medicare Administrative Contractors (“MACs”), may grant CHOPD accelerated and advance payments in amounts representative of up to thirty days’ worth of Part A or Part B claims to eligible Medicare providers and suppliers, which is calculated by taking the total claims paid to the provider/supplier between August 1, 2023 through October 31, 2023 and dividing that number by three.

In this post, we will detail eligibility requirements and terms of the payments. We note that these are not loans or grants. They are advanced and accelerated payments and CMS will immediately begin to recoup the payments. For more details, CMS has issued a Fact Sheet and Frequently Asked Questions.

Continue Reading CMS Offers Change Healthcare/Optum Payment Disruption Payments to Medicare Providers and Suppliers

The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. We have put together this alert to summarize the provisions of the rule and what you need about how, if finalized, the rule could impact the drug industry.

With the rule, the FDA seeks to establish criteria for the list of drug products or categories of drug products that present demonstrable difficulties for compounding under certain sections of the federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions and therefore may not be compounded under either section 503A or section 503B, respectively.

Reed Smith will continue to follow developments on this and other issues facing compounding pharmacies and FDA regulation. If you have any questions, please reach out to the authors or to the health care lawyers at Reed Smith.