Department of Health & Human Services

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. Overall, the healthcare provisions of the IRA reflect the Administration’s goal of expanding the accessibility of healthcare to individuals by reducing costs to beneficiaries and capping charges by drug manufacturers. Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation.

Continue Reading Healthcare Reforms Under the IRA: Expanding Access to Care

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule[1] that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).

Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.

Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

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

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

On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. As first announced by President Biden on December 2, 2021, the Biden Administration explained that health plans and health insurance issuers (meaning the commercial insurance market) would be required to reimburse individuals who purchase OTC COVID-19 tests during the public health emergency. The Administration directed the Tri-Agencies to issue guidance by January 15, 2022 detailing how to effectuate this expanded coverage of COVID-19 diagnostic testing. Yesterday, the Tri-Agencies published FAQ 51 which requires health plans and health insurance issuers to cover no less than 8 tests per 30-day period per individual beneficiary beginning January 15, 2022.

Continue Reading Tri-Agencies Release Guidance on Coverage of OTC COVID-19 Tests

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

On March 4th, the U.S. District Court for the District of Maryland struck down four provisions of the Trump Administration’s Notice of Benefit and Payment Parameters for 2019, 83 Fed. Reg. 16930 (April 17, 2018) (the “Rule”), which governs many aspects of Affordable Care Act (“ACA”) insurance markets beginning in the 2019 plan year.  The decision in City of Columbus, et al. v. Norris Cochran comes two and a half years after the cities of Columbus, Baltimore, Cincinnati, Chicago, and Philadelphia, as well as two individuals who rely on health insurance offered on ACA exchanges, filed suit alleging that the actions of the U.S. Department of Health and Human Services (“HHS”) drove up premiums, made enrollment more difficult, and caused more people to go without affordable, high-quality health insurance.
Continue Reading Federal Court Decides ACA “Sabotage” Case

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government agencies, and the public, social, and health services sectors.
Continue Reading Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf.  Individuals who are blind or have low vision may require assistive devices and specialized software to access the Internet.  These devices often include software that enables them to magnify the content of a web page, reads the content to them, or enables them to use a braille reader to read a website.  Some individuals with disabilities cannot use a mouse and can only navigate with a keyboard, touchscreen, or voice recognition software.  For persons with hearing impairments, the visual aspects of a website are accessible, but audio on a website may not be.
Continue Reading New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have Accessible Websites