This Week’s Dose

Congress returned to session this week following the Memorial Day holiday.  The House passed largely along party lines a package of gun control measures advanced by the Judiciary Committee on June 2, while in the Senate bipartisan negotiations continued on a more narrow response to gun violence that they hope can attain the 60 votes needed to surpass a filibuster.  The House also advanced its Food and Drug Administration (FDA) user fee reauthorization package, while the Senate Health, Education, Labor and Pension (HELP) Committee plans to look at its package early next week.

Congress

FDA User Fee Bill Advances in House, Delayed in Senate. On June 8, the House approved H.R. 7667, the Food and Drug Amendments of 2022, by a wide margin of 392-28. 176 Republicans joined all present Democrats in voting in favor of the bill, which had been approved by the House Energy and Commerce Committee 55-0 on May 18.

Across the Capitol, the Senate HELP Committee was scheduled to take up its FDA user fee package—S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act—on June 8, but the markup session was delayed until June 14, as committee leaders grapple with potential amendments that may test the bipartisanship and cooperative nature that these user fee reauthorizations—and many other HELP Committee priorities—traditionally enjoy.  It is also important to note that the Senate and House bills differ—the Senate includes provisions impacting the regulation of cosmetics and dietary supplements as well as lab-based tests (the VALID Act), that are not in the House-passed legislation. 

Both chambers are working to complete action on the FDA user fee authorizations in short order. The FDA’s user fee programs provide the agency with funding needed to conduct a number of activities, including product reviews, facilitation of product development, facility inspections, and product monitoring.  The user fee authorizations are due to expire on September 30, though the FDA will begin to experience disruptions—including the sending of layoff notices—should the reauthorizations not be complete by August, so there is genuine urgency to enact this legislation.

With House action complete, all eyes are now on the Senate, as confidence wanes on whether Congress can complete action on this “must-pass” package during the June work period.

House Appropriations Committee Sets Schedule for Spending Bills.  On June 8, House Appropriations Chair Rosa DeLauro (D-CT) announced the committee’s schedule for FY 2023 spending bills. Subcommittee reviews are set to begin June 15, followed by full committee markups of each of the 12 annual appropriations bills.  The committee is expected to conclude its FY 2023 review by June 30, teeing up potential floor votes in July.

Of note to healthcare stakeholders, the Agriculture Subcommittee (which includes the FDA) is scheduled for June 15, with the full committee scheduled for June 23.  The Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) Subcommittee markup is scheduled for June 23, with the full committee markup scheduled for June 30.

Administration

CMS Begins Issuing Price Transparency Fines.  This week, the Centers for Medicare & Medicaid Services (CMS) began issuing the first fines for violations of the hospital price transparency rules that took effect in January 2021, requiring hospitals to publicly display standard charge information for a number of services.

Two hospitals in one system in Georgia received letters from CMS on June 7, which listed the violations, cited previous warning letters, and set forth the fines, which total more than $1 million for the two hospitals.  The letters can be found here and here.

According to recent reports, CMS has issued 352 warning letters to hospitals, and 157 hospitals are not yet in compliance. This week’s issuance of fines to the two Georgia hospitals indicates that additional compliance efforts could be forthcoming.

CMS Extends Deadline for Home- and Community-Based Services Enhancements.  On June 3, CMS sent a letter to State Medicaid Directors, informing states that they now have one additional year to use funding made available by the American Rescue Plan (ARP) to enhance, expand, and strengthen home- and community-based services (HCBS) for people with Medicaid who need long-term services and supports.

The ARP provided states with a temporary 10% increase to the federal medical assistance percentage (FMAP) for certain Medicaid expenditures for HCBS, and states originally had a three-year period—from April 1, 2021 through March 31, 2024—to use the funds on efforts to enhance, expand, or strengthen HCBS in Medicaid. The June 3 notification means that states now have until March 31, 2025 to use this increased funding.

According to a CMS press release, the extended timeframe will help to facilitate high-quality, cost-effective, person-centered services for people with Medicaid, and will allow beneficiaries to remain in the service setting of their choice. CMS will continue to monitor states during this extended time period, with respect to progress and compliance.

Funding for HCBS was a key component of the House-passed Build Back Better Act, which included new investments of $150 billion into these services.  It is not yet known if negotiations on a slimmed-down reconciliation package will be productive or if any funding for HCBS services will be included if it is.  

Quick Hits

• The Federal Trade Commission (FTC) announced the launch of a pharmacy benefit manager (PBM) inquiry, to scrutinize the impact of certain PBMs on the access and affordability of prescription drugs. The FTC inquiry will require the six largest PBMs—CVS Caremark, Express Scripts, Inc., OptumRx, Inc., Humana Inc., Prime Therapeutics LLC, and MedImpact Healthcare Systems, Inc.—to provide information and records regarding their business practices.

• On June 9, the Senate voted 49-43 to confirm Sam Bagenstos as HHS General Counsel.

• CMS released an agency-wide Strategic Plan white paper and Agency Accomplishments fact sheet, highlighting accomplishments and impacts over the past year.

• House Energy and Commerce Chairman Pallone (D-NJ) and Senate Finance Chairman Wyden (D-OR) wrote to CMS urging enforcement of Medicaid’s guarantee that beneficiaries may see the health care providers of their choice.

• The Health Resources and Services Administration (HRSA) announced nearly $15 million in funding for rural communities to address psychostimulant misuse and related overdose deaths. This HRSA announcement brings total funding for the Rural Communities Opioid Response Program initiative—aimed at reducing the morbidity and mortality of substance and opioid use in high-risk rural communities—to more than $400 million.

Health Policy Breakroom Podcast

The House passed the User Fee Acts (UFA) legislation last night (Wednesday) by a vote of 392-28. Now, it is headed to the Senate, where the HELP Committee is scheduled to consider its UFA proposal next Tuesday. Debbie Curtis, Amy Kelbick and Rodney Whitlock discuss this must-pass legislation.