The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the guidance documents issued by the Centers for Medicare and Medicaid Services (“CMS”) detailing the proposed implementation of the Medicare Part B and Medicare Part D Prescription Drug Inflation Rebate Programs.
On February 15, 2023, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require nursing homes enrolled in Medicare and Medicaid to disclose new information about their ownership and management structures. If finalized, the rule would require nursing homes to disclose any ties to private equity companies or real estate investment trusts (REITs) (defined below), as well as the names and information of individuals and entities that provide certain administrative, management or consulting services.
On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”) and Medicare Part D (“Part D”) Prescription Drug Inflation Rebate Programs (each, a “Rebate Program” and, collectively, the “Rebate Programs”). The Rebate Programs are administered as part of the prescription drug affordability provisions of the Inflation Reduction Act (the “IRA”), which is aimed at “lower[ing] out-of-pocket drug costs for people with Medicare and improv[ing] the sustainability of the Medicare program for current and future generations.”[1] The IRA represents the most sweeping healthcare legislation passed by Congress since the Affordable Care Act.[2] Please refer to our previous blog post on the IRA.
On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”). CMS promotes the Final Rule as improving program integrity and payment accuracy as well as transparency and certainty. One thing that is certain, CMS can expect further challenges to its RADV audit methodology.
Continue Reading CMS Issues Long-Awaited Medicare Advantage RADV Final Rule
Just in time for the holidays, the Centers for Medicare and Medicaid Services (“CMS”) issued the Contract Year 2024 Proposed Rule for Medicare Advantage organizations (“MAOs”) and Part D sponsors (the “Proposed Rule”). The Proposed Rule includes changes on an array of topics including: Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, behavioral health services, identification of overpayments, requirements for valid contract applications, and formulary changes.
On Monday, we discussed that the Centers for Medicare and Medicaid Services (“CMS”) has heightened oversight of Medicare Advantage (“MA”) organizations’ and Part D sponsors’ marketing practices. We also noted that the United States Senate Committee on Finance (the “Committee”) sent letters to 15 state insurance commissioners and state health insurance assistance programs, requesting data and information on MA marketing complaints in August 2022. Yesterday, the Committee, chaired by Ron Wyden, released a report entitled Deceptive Marketing Practices Flourish in Medicare Advantage (“the Report”).
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 June 29, 2022, the Centers for Medicare and Medicaid Services (CMS) announced it issued significant changes to surveyor guidance for Long Term Care (LTC) facility health, quality and safety standards.[1]
Continue Reading CMS Adopts Major Changes to LTC Facility Surveyor Guidance
On January 5, 2022, we discussed the Notice of Benefit and Payment Parameters for 2023 proposed rule released by the Centers for Medicare & Medicaid Services (CMS). On April 28, 2022, CMS issued the NBPP 2023 Final Rule. CMS published a Fact Sheet and other resources on April 28, 2022. The rule will take effect on January 1, 2023, but the optional early bird application deadline is May 18, 2022 and the final deadline for issuers to submit changes to their QHP Application is August 17, 2022.
Continue Reading 2023 Payment Rule’s Nondiscrimination Provisions and Anticipation of New Section 1557 Rules
On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). CMS promotes the Final Rule as advancing “CMS’ strategic vision of expanding access to affordable health care and improving health equity in Medicare Advantage (MA) and Part D through lower out-of-pocket prescription drug costs and improved consumer protections.” With a few exceptions, the Final Rule is a wholesale codification of the proposed rule. Except as noted below, the requirements of the Final Rule are effective January 1, 2024.
Continue Reading CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors
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