Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s intent to advance health care equity and racial justice in the United States by minimizing the influence of the social determinants of health. The Executive Order mobilized 90 federal agencies and 50 independent agencies to evaluate and implement action plans to reduce systemic barriers to access.[1] On April 14, 2022, the U.S. Department of Health and Human Services (HHS), published the HHS Equity Action Plan (Action Plan).
Continue Reading The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger insurers. Last week the Fifth Circuit issued an opinion in one of those cases, affirming the lower court’s rulings in favor of the United States Department of Health and Human Services (HHS) and its administration of the risk-adjustment program. See Vista Health Plan, Inc. v. United States Dep’t of Health & Hum. Servs., No. 20-50963, 2022 WL 807554, at *1 (5th Cir. Mar. 17, 2022).
Continue Reading Fifth Circuit Upholds ACA Risk Adjustment Program

On March 2, 2022, the Department of Health and Human Services (“HHS”) Office of the Inspector General (the “OIG”) issued a new advisory opinion (“AO 22-04”) related to a program through which the Requestor would provide certain individuals access to digital contingency management (“CM”) and related tools to treat substance use disorders (“Program”).  The OIG advised that it would not impose administrative sanctions under the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty Law (“CMPL”).
Continue Reading HHS OIG Signs Off on Substance Use Recovery Incentive Program

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021 (CAA) received a welcome reprieve via guidance published August 20. The Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments) announced that they would exercise enforcement discretion and defer enforcement of requirements that plans and issuers publish machine-readable files for in-network rates and out-of-network allowed amounts and billed charges until July 1, 2022 instead of January 1, 2022. The Departments also explained that they would reconsider whether the TiC Final Rule’s requirement to publish negotiated rates and historical net prices for covered prescription drugs in a machine-readable file remains appropriate given the subsequent enactment of the provisions in the Division BB, Title II—Transparency of the Consolidated Appropriations Act, 2021, which requires plans and issuers to report similar prescription drug pricing information to the Departments by December 27, 2021.

Continue Reading Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies.

Continue Reading 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation

On February 26, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued Frequently Asked Questions (FAQs) on the implementation of the Families First Coronavirus Response Act (“FFCRA”), the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), and other health coverage issuesrelated to COVID-19.

Continue Reading New Guidance on Health Plans’ COVID-19 Coverage Obligations

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially those in the healthcare space.  But while President Biden may have success in reversing much of his predecessor’s last minute regulatory activity, he is likely to face at least some headwinds as it relates to one of those midnight rules – the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (the “Final Rule”) – that was published in the Federal Register on January 14, 2021 and became effective on January 12, 2021.
Continue Reading Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of Guidance Documents in Civil Enforcement Actions

This week, Rep. Mike Thompson (CA-05), founder and co-chair of the Congressional Telehealth Caucus reintroduced the Protecting Access to Post-Covid-19 Telehealth Act of 2020 (the “Act”) with support from Co-Chairs Rep. Peter Welch (VT-AL), Rep. Bill Johnson (OH-06), and Rep. David Schweikert (AZ-06) and caucus member Rep. Doris Matsui (CA-06).  The Act was originally introduced in the House of Representatives on July 16, 2020. The focus of the Act is to do away with certain restrictions on providing telehealth services, and to permanently expand coverage for telehealth services both during and beyond the COVID-19 Pandemic. Among other things, the Act:
Continue Reading Re-Introducing the Protecting Access to Post-Covid-19 Telehealth Act

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets