This week, a draft Supreme Court opinion on abortion rights was leaked. Chief Justice John Roberts confirmed the authenticity of the draft and said that he has directed the Supreme Court Marshal to investigate the leak. The draft shows that the Supreme Court plans to overturn Roe v. Wade, a case that protects women’s rights to abortion. If overturned, approximately two dozen states are expected to place extreme restrictions on abortions or ban them entirely. Additionally, thirteen states have “trigger laws” that would almost immediately outlaw the procedure if Roe v. Wade were overturned. Senate Majority Leader Chuck Schumer (D-NY) announced that lawmakers will vote next Wednesday on legislation that would codify Roe v. Wade. However, that vote is expected to fail. Senators Susan Collins (R-ME) and Lisa Murkowski (R-AK) also have introduced separate legislation to codify Roe. Collins indicated that she would vote against Schumer’s bill because it does not include an exemption that would allow Catholic hospitals to refuse to perform abortions.

On Tuesday, several groups that represent health providers and insurers sent a letter to Congress, asking that the temporary expanded tax credits made available through the American Rescue Plan be made permanent. They warned that if Congress allows the expanded tax credits to expire as scheduled on December 31, 2022, that “the lowest income enrollees could see their premiums increase from less than $1 per month to $26 per month (2,500%) while the highest income enrollees could see their premiums increase from $425 to $577 (36%).” The full letter can be found here.

On Wednesday, leaders of the House Energy and Commerce Committee released a legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements. The package reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). The bipartisan legislation aims to improve the FDA’s review process for the safety and efficacy of medical products, strengthen the Accelerated Approval program, ensure that clinical trials are diverse, and reduce the cost of drugs by making it easier for generic competitors to enter the market. The legislative text can be found here and the section-by-section summary can be found here.

On Thursday, the Senate Commerce Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing on the prescription drug market. The hearing delved into pharmacy benefit managers (PBMs) and their impact on drug costs and consumer choice. Subcommittee Chairman Richard Blumenthal (D-CT) said, “PBMs are part of a broken drugs supply chain that leads to increasing profits for drug companies, increasing profits for PBMs, and increasing drug costs for patients.” Additionally, Senator Marsha Blackburn (R-TN) advocated for a bipartisan bill she introduced, the Pharmacy Benefit Manager Accountability Study Act (S. 298), which would require GAO to submit a report to HHS and Congress on PBMs and their role in the pharmaceutical supply chain.

Late last week, the Centers for Medicare and Medicaid Services (CMS) issued its CY 2023 Medicare Advantage and Part D Final Rule. This final rule makes revisions to the MA and Part D regulations related to marketing and communications and to the criteria used to review applications for new or expanded MA and Part D plans. Additional measures included in the final rule can be found here. 

This week, a draft Supreme Court opinion on abortion rights was leaked. Chief Justice John Roberts confirmed the authenticity of the draft and said that he has directed the Supreme Court Marshal to investigate the leak. The draft shows that the Supreme Court plans to overturn Roe v. Wade, a case that protects women’s rights to abortion. If overturned, approximately two dozen states are expected to place extreme restrictions on abortions or ban them entirely. Additionally, thirteen states have “trigger laws” that would almost immediately outlaw the procedure if Roe v. Wade were overturned. Senate Majority Leader Chuck Schumer (D-NY) announced that lawmakers will vote next Wednesday on legislation that would codify Roe v. Wade. However, that vote is expected to fail. Senators Susan Collins (R-ME) and Lisa Murkowski (R-AK) also have introduced separate legislation to codify Roe. Collins indicated that she would vote against Schumer’s bill because it does not include an exemption that would allow Catholic hospitals to refuse to perform abortions.

On Wednesday, leaders of the House Energy and Commerce Committee released a legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements. The package reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). The bipartisan legislation aims to improve the FDA’s review process for the safety and efficacy of medical products, strengthen the Accelerated Approval program, ensure that clinical trials are diverse, and reduce the cost of drugs by making it easier for generic competitors to enter the market. The legislative text can be found here and the section-by-section summary can be found here.

On Tuesday, several groups that represent health providers and insurers sent a letter to Congress, asking that the temporary expanded tax credits made available through the American Rescue Plan be made permanent. The groups wrote that, “More than 14.5 million Americans accessed these expanded tax credits by enrolling in marketplace coverage during the 2022 open enrollment period. Of those enrollees, 3 million were new consumers and 3.2 million chose plans with a monthly premium of $10 or less.” They warned that if Congress allows the expanded tax credits to expire as scheduled on December 31, 2022, that “the lowest income enrollees could see their premiums increase from less than $1 per month to $26 per month (2,500%) while the highest income enrollees could see their premiums increase from $425 to $577 (36%).” The full letter can be found here.

On Thursday, the Senate Commerce Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing on the prescription drug market. The hearing delved into pharmacy benefit managers (PBMs) and their impact on drug costs and consumer choice. Subcommittee Chairman Richard Blumenthal (D-CT) said, “PBMs are part of a broken drugs supply chain that leads to increasing profits for drug companies, increasing profits for PBMs, and increasing drug costs for patients.” Additionally, Senator Marsha Blackburn (R-TN) advocated for a bipartisan bill she introduced, the Pharmacy Benefit Manager Accountability Study Act (S. 298), which would require GAO to submit a report to HHS and Congress on PBMs and their role in the pharmaceutical supply chain. A witness at the hearing, Robin Feldman, a Professor at UC Hastings College of Law, discussed how PBMs and drug companies claim that rebate details are trade secrets, and said that when “heavily concentrated industries tightly control the flow of information, the end result is rarely in the interest of consumers.”

Late last week, the Centers for Medicare and Medicaid Services (CMS) issued its CY 2023 Medicare Advantage and Part D Final Rule. This final rule makes revisions to the MA and Part D regulations related to marketing and communications and to the criteria used to review applications for new or expanded MA and Part D plans. The rule also revises quality ratings for the plans, as well as medical loss ratio reporting. It also includes provisions that change how MA organizations calculate the maximum out-of-pocket (MOOP) limit for Parts A and B services. Additional measures included in the final rule can be found here. 

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House Committee on Appropriations - Hearing

Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Hearing: FY 2023 Budget Request for the National Institutes of Health

Wednesday, May 11 at 10:00 AM ET

House Committee on Appropriations - Hearing

Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Hearing: Healthy Aging: Maximizing the Independence, Well-being, and Health of Older Adults

Thursday, May 12 at 10:00 AM ET