On June 15, 2021, the Medicare Payment Advisory Commission (MedPAC) released one of their two annual Reports to Congress.[1],[2] The report includes recommendations to revise Medicare Advantage (MA) benchmark policy, streamline the portfolio of alternative payment models (APMs), replace the existing skilled nursing facility value-based purchasing program, revise indirect medical education (IME) payments, and improve [...] Read More
The Biden administration, via the Health Resources and Services Administration (HRSA) and the Department of Health and Human Services (HHS), released a proposed rule which seeks to rescind a previous final rule related to 340B discounts for insulin and injectable epinephrine that was adopted in the final months of the Trump administration. Comments on the [...] Read More
On June 15, 2021, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) released one of their two annual Reports to Congress.[1],[2] The June report addresses high-cost specialty drugs in the Medicaid program; access to mental health services for Medicaid and Children’s Health Insurance Program (CHIP) enrollees; the use of EHR [...] Read More
On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) released a final rule containing policies for Medicare Advantage (MA) and Medicare Part D plans in contract year 2022. The rule finalizes policies initially proposed in February 2020. Some policies in that February proposed rule were finalized in previous rulemaking while the remainder [...] Read More
In late December 2020, the Trump Administration released a final rule designed to promote the use of value-based purchasing (VBP) arrangements between drug manufacturers and payers, including Medicaid. The final rule, released by the Centers for Medicare & Medicaid Services (CMS), also contains policies related to line extensions and copay accumulators. The incoming Biden Administration [...] Read More
The Food and Drug Administration (FDA) has issued a final rule to allow for the importation of certain prescription drugs from Canada. In conjunction with the final rule, the FDA also released guidance for manufacturers that lays out a pathway for manufacturers to import their own drugs. The rule has not yet been published in [...] Read More
On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule, Implementation of Executive Order 13937, “Executive Order on Access to Affordable Life-saving Medication.” This Executive Order (EO) directed HHS to take action to ensure that future grants under the Public Health Service Act are conditioned upon a Federally Qualified Health [...] Read More
CMS has released a proposed rule that would update program policies for Medicare Advantage and Medicare Part D beginning in 2021, if finalized. CMS has also released the draft Call Letter for 2021; however, this year’s Call Letter is limited to standard benefit parameters, risk-sharing, and other technical details and does not feature any additional [...] Read More
The Food and Drug Administration (FDA) has released their long-awaited proposed rule on prescription drug importation. President Trump has mentioned his plan at events in recent months, citing the plan as part of the administration’s efforts to lower prescription drug costs. The proposed rule outlines requirements for so-called Section 804 Importation Programs (SIPs), named after [...] Read More
Earlier this week, the Centers for Medicare and Medicaid Services (CMS) released a memo to Part D plan sponsors with some additional information about submission of calendar year (CY) 2020 Part D plan bids. The bid submission deadline is June 3, 2019 and many stakeholders had been asking whether the recent rebate proposal would be [...] Read More