by Ellen Riker & Johanna Gray, Artemis Policy Group, Hemophilia Alliance Advocacy Consultants

• Proposed Rule on Affordable Care Act Provisions Published

Positive developments in lawsuit about copay accumulator adjustors – There have been two positive developments in the lawsuit challenging the HHS rule that allows copay accumulator adjustors. First, the judge in the case ruled against the HHS assertion that they would not have to enforce the 2020 NBPP (that only allows copay accumulator adjustors to be imposed when it is a brand name drug with a generic alternative) as they were planning rulemaking on the issue. The judge said no – that the 2020 NBPP policy was in force. The second update is that the federal government withdrew its appeal of the decision.

These two developments combined are very promising and suggest that today, copay accumulator adjustor programs are NOT allowed for any hemophilia or other bleeding disorders treatments. We are working on toolkits for both patients and providers to help them push back on any payers or PBMs implementing accumulator adjustor programs with more power due to the lawsuit.

We are continuing to ask HHS to release guidance to clarify how it will enforce this policy. We are also still pushing for the HELP Copays Act to be enacted by Congress to make clear in the law that both copay accumulators and maximizers aren’t allowed.

Please stay tuned for more information about how HTCs can best advocate for their patients in light of these developments.

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• Congress puts off funding bills until March

Late last year, Congress extended the continuing resolution funding federal departments and agencies into January 2024. Still unable to find consensus on spending levels, a further extension of current funding levels until early March was passed and signed by President Biden. While March 8 is the expiration of the continuing resolution, April 30 is a more important deadline for Congress to resolve their differences and pass a 2024 appropriations bill, if not across-the-board cuts would be triggered as mandated under last year’s debt ceiling compromise.

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• CMS publishes prior authorization final rule

On January 17, 2024, the Centers for Medicare and Medicaid Services (CMS) released a final rule aimed at improving the electronic exchange of health information and prior authorization (PA) processes for medical items and services. The original proposed rule was released on December 6, 2022. Most of the provisions of the rule become effective January 1, 2027.

The prior authorization provisions of the rule apply to the following payers:

• Medicare Advantage (MA) organizations
• Medicaid and the Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs
• Medicaid and CHIP managed care plans
• Issuers of Qualified Health Plans (QHPs) offered on the Federally Facilitated Exchanges (FFEs)

With this rule CMS is addressing both technological and operational requirements related to its prior authorization process. The rule requires impacted payers to support an electronic PA process that is embedded within physicians’ electronic health records (EHR)—bringing much-needed automation and efficiency to the current time-consuming, manual workflow. In addition, CMS is shortening PA processing timeframes and significantly enhancing transparency around PA, including requirements for specific denial reasons and public reporting of program metrics. CMS is also requiring that payers provide physicians and patients more PA-related information.

The provisions in this final rule do not include standards or policies for any drugs, including covered outpatient drugs under Medicaid, and Medicare Part B or Part D drugs. The rule does apply to medical items and services, including supplies, including those dispensed at a pharmacy and DME, that are considered medical benefits and are not prescription drugs.

A more detailed summary of the rule can be found here.