- Top News
- Administrative Action
- Regulatory Action
- Congressional Action
- Commercial Market
HHS OIG to Study Impact of Part B Payment Policies on Biosimilars Uptake
The HHS Inspector General plans to study the effect of Medicare Part B reimbursement policies on the uptake of biosimilars. Lawmakers in both parties have introduced legislation to change Part B reimbursement of biosimilars, but those bills haven’t gained much traction, and a study by the IG might boost those policy changes. The IG will study use and cost trends of biosimilars and the brand biologics they reference. It also will determine how much Medicare and beneficiaries would have saved in 2021 if reimbursement policies had favored biosimilars.
In 2020, legislation was introduced in both the House and Senate to make Medicare test a policy of sharing with doctors some of the savings from prescribing biosimilars over their brand counterparts. Current law already attempts to encourage doctors to use cheaper biosimilars by paying them 6% of the price of brand biologics that biosimilars reference. But makers of biosimilars say the current reimbursement system still favors brands over biosimilars because the base payment for biosimilars is less than for brands. The base payment is supposed to match what doctors pay for products, but the base pay is the “average” sales price, so doctor practices that buy brand biologics in high volume get discounts, and they profit from the difference between the average sales price and the discounted price they pay.
Senate Finance Eyes Hearing on Drug Pricing Policy As Democrats Revisit Reconciliation
The Senate Finance Committee is considering holding a hearing on drug pricing legislation, but it remains to be seen whether Democrats might change the Medicare price negotiation deal they struck in November to get more money out of pharma. The hearing itself is not a sign that Democrats plan to change the drug pricing deal.
On March 1st, 2022, President Joe Biden delivered the first State of the Union address of his presidency where he outlined his administration’s priorities to curtail the conflict in Ukraine, to continue to fight the COIVD-19 pandemic, and to further grow the U.S. economy. The president highlighted a number of key health care priorities that his administration will focus on passing through Congress this year, including prescription drug prices, nursing home safety and quality, mental health, Veteran care, cancer research, and the COVID-19 pandemic. Healthsperien’s comprehensive summary outlining each of the policy priorities can be found here.
The Government Accountability Office (GAO) published a brief on the science, challenges, and policies related to long COVID, which is defined by the CDC as the occurrence of new, returning, or ongoing health problems 4 or more weeks after an initial COVID-19 infection. The brief notes that long COVID has potentially affected up to 23 million individuals, pushing an estimated 1 million people out of work. The brief further points out that the causes of long COVID are not fully understood, complicating diagnosis and treatment options.
CMS announced that beginning in Performance Year (PY) 2023, the Global and Professional Direct Contracting (GPDC) model will be redesigned and renamed to the ACO Realizing Equity, Access, and Community Health (REACH) Model. CMS notes that the redesign is in response to stakeholder feedback, participant experience, and the Biden-Harris Administration’s priorities, including a commitment to advancing health equity. The GPDC Model will continue until December 31, 2022, before transitioning to the ACO REACH Model on January 1, 2023, and continue through PY 2026. CMS released a Request for Applications for provider-led organizations interested in joining the ACO REACH Model. Current participants in the GPDC Model must agree to meet all the ACO REACH Model requirements by January 1, 2023, to participate. A comprehensive summary of the ACO REACH RFA can be found here.
Senators Ed Markey (D-MA) and Tammy Duckworth (D-IL) joined Senator Tim Kaine (D-VA) in introducing the Comprehensive Access to Resources and Education (CARE) for Long COVID Act. The legislation aims to improve research on long COVID symptoms and provide resources to those suffering from them. Some reviews estimate that more than half of COVID survivors experience lingering symptoms from the illness, including neurological, cardiovascular, respiratory, and mental health issues well after their primary symptoms reside. The legislation is endorsed by a wide range of health care organizations and joins several other previously introduced bills that aim to provide similar resources and investments in research capacity.
CMS recently updated enrollment information for Medicaid & CHIP, Medicare, and the Marketplace, with a total of approximately 151 million people covered through these programs. Currently, there are 78 million individuals enrolled in Medicaid and 7 million children enrolled in CHIP, for a total of almost 85 million individuals covered. Within Medicare, 36 million people are enrolled in Fee-For-Service plans and 28 million people are enrolled in Medicare Advantage plans. Of this data over 11.8 million individuals are dually eligible for Medicare and Medicaid and are counted in the enrollment for both programs. State-based and federal marketplaces have about 15 million applicants (see 2019-2021 Marketplace enrollment data here).
CMS announced that they have reopened the Merit-based Incentive Payment System Extreme and Uncontrollable Circumstances (MIPS EUC) application for the 2021 performance period for groups, virtual groups, and Alternative Payment Model (APM) entities (citing COVID-19 as the trigging event) through March 31, 2022. Previously, CMS applied the automatic EUC to all individual MIPS eligible clinicians for the 2021 performance period. If applications are approved, eligible clinicians will receive a neutral payment adjustment for the 2023 MIPS payment year.
CMS published guidance, a PHE Unwinding Toolkit, Eligibility and Enrollment Planning Tool, and a slide deck that outlines how states may address the large volume of pending Medicaid and CHIP eligibility and enrollment actions that will need to be addressed when they restore routine operations. This includes redeterminations, mitigating churn for eligible beneficiaries, and smoothly transitioning individuals between coverage programs. In the guidance, CMS reiterates that states will need to develop and document a comprehensive plan to restore routine operations, as previously discussed in the December 2020 guidance, as well as several items that had been included in prior guidance, including states needing to develop and document a comprehensive plan to restore routine operations.