RISE summarizes recent regulatory-related headlines.
Lawmakers push for more MA reforms to improve prior authorization, reinvest savings
Seventy lawmakers, led by Democratic Representatives Pramila Jayapal from Washington, Rosa DeLauro from Connecticut, and Jan Schakowsky from Illinois, are calling on the Centers for Medicare & Medicaid Services (CMS) to implement additional reforms to Medicare Advantage to improve health care for seniors and people with disabilities. In the letter, the lawmakers support CMS’ proposed rule that prohibits MA plans from imposing any additional burdensome criteria for prior authorization approvals and urge CMS to build on that action and continue to reform MA.
The letter calls on CMS to make the following improvements:
- Finalize and strongly enforce the proposed prohibition on MA plans denying prior authorization requests for coverage of a Medicare covered item or service based on criteria not found in traditional Medicare coverage policies and issue new guidance prohibiting the use of step therapy for Medicare Part B.
- Require MA plans to cover services from any medical provider that accepts Medicare’s approved rate. At a minimum, require MA networks to cover care at the top 50 cancer hospitals in the country.
- Stop overpayments by developing a more accurate risk-scoring model based on patient demographics and prohibiting the use of unscrupulous methods to increase care costs.
- Reinvest the $46.5 billion annual savings from MA overpayments into lowering Medicare premiums, eliminating deductibles, expanding benefits to include dental, vision, and hearing, or otherwise improving medical care for all Medicare beneficiaries.
CMS pushes to expand coverage for mobility devices to advance health equity for people with disabilities
CMS has proposed a National Coverage Determination (NCD) decision that would, for the first time, expand coverage for power seat elevation equipment on certain power wheelchairs to Medicare individuals. The proposed NCD is open for public comment for 30 days.
If finalized, power seat elevation equipment would be covered by Medicare for individuals with a Group 3 power wheelchair, which are designed to meet the needs of people with Medicare with severe disabilities, to improve their health as they transfer from the wheelchair to other surfaces. Transfers often strain shoulder and back muscles and constrain an individual’s daily mobility at home and other customary locations
“Millions of people with Medicare rely on medically necessary assistive devices to perform daily tasks that directly impact their quality of life. CMS remains committed to ensuring persons with disabilities are receiving available benefits that improve their health,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “Today’s proposal promotes a first of its kind benefit expansion providing people with Medicare additional tools to improve their lives.”
3 new Medicare models aim to lower drug costs
The Department of Health and Human Services (HHS) has selected three new models, which were tested by the CMS Innovation Center, to help lower the high cost of drugs. The models were selected in response to President Biden’s Executive Order, which complements the provisions in the Inflation Reduction Act of 2022 (IRA), and meet the selection criteria thresholds of affordability, accessibility, and feasibility of implementation. The models include:
- The Medicare $2 Drug List: Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients who pick plans that participate in the model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.
- The Cell and Gene Therapy Access Model: Cell and Gene Therapies are an emerging area of new drug development but can cost upwards of $1 million. Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies. As new therapies come to market, this will help Medicaid beneficiaries gain access to potentially life-changing, high-cost specialty drugs for illnesses like sickle cell disease and cancer.
- The Accelerating Clinical Evidence Model: Some drugs are approved before they have established evidence of improvement in a clinical endpoint, which is called accelerated approval. CMS would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration, to encourage timely confirmatory trial completion and improve access to post-market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.
“These selected models will test strategies to make it easier for Medicare patients to afford and access needed prescriptions at $2 or less, help expand access to cutting-edge cell and gene therapies for people with Medicaid, and help ensure drugs already on the market are safe and effective,” said CMS Deputy Administrator and Director of the CMS Innovation Center Liz Fowler, Ph.D., JD, in the announcement. “We look forward to working on these models and helping to lower drug costs for Americans with Medicare and Medicaid.”
HHS outlines initial guidance for Medicare Prescription Drug Inflation Rebate Program and seeks comment
HHS has outlined how the department will implement the new Medicare Prescription Drug Inflation Rebate Program, which will require drug companies to pay rebates to Medicare when their prescription drug prices increase faster than the rate of inflation for certain drugs dispensed to people with Medicare. Key dates for implementation:
- October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
- January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
- April 1, 2023: People with Traditional Medicare and Medicare Advantage may pay a lower coinsurance for certain Part B drugs with price increases higher than inflation.
- 2025: CMS intends to send the first invoices to drug companies for the rebates.
As part of the initial guidance, CMS is seeking comment from the public on the process to determine the number of drug units for rebatable drugs; reduction of rebate amounts for certain Part B and Part D rebatable drugs in shortage and in cases of severe supply chain disruptions; the process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates; and assuring accuracy of the inflation rebate payments.
“Public feedback is critical to successful implementation of the new drug law,” said Dr. Meena Seshamani, M.D., Ph.D., CMS deputy administrator and director of the Center for Medicare. “Technical expertise and feedback from a wide range of interested parties is crucial for our ability to strike the right balance in implementing the law, ensuring access to affordable and innovative therapies.” Comments received by March 11, 2023, will be considered for the revised guidance. CMS anticipates issuing revised guidance later in 2023 for the Medicare Prescription Drug Inflation Rebate Program.