Part D Contracting in the Six Protected Classes

The six protected classes represented one of the most talked about provisions in the Medicare Part D program. A year after the Part D kickoff, the classes are still around, but there could be some tweaks going forward.

One of the most talked about and lobbied-for provisions of the Medicare Part D prescription drug benefit was the creation by the Centers for Medicare and Medicaid Services of six "protected" classes. Under the program, plan sponsors must cover "all or substantially all" drugs in six categories: antipsychotics, antidepressants, antiretrovirals, immunosuppressants, anticonvulsants and antineoplastics.

The designation was an undeniable boon for drug manufacturers. For example, if you were Eli Lilly & Co. (Zyprexa)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

340B Reform Advocates Hail CBO Report, But ‘Scoreable’ Savings Still In Doubt

 

The 340B program increases federal health care costs by encouraging the use of costlier medications, the Congressional Budget Office said. But the agency also did not provide a specific estimate of the impact.

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

Stakeholders Warn Medicare Payment Proposals For Cell, Gene Therapy Could Hamper Access

 
• By 

CMS proposals would reduce Medicare payments for cell and gene therapy manufacturing and preparation, which will further disincentivize outpatient or community-based treatment, advocates and sponsors said.

Canada, Britain And Australia Push For Greater International Regulatory Alignment

 

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

More from Pink Sheet

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.