Capitol Hill Update
Both chambers of Congress have adjourned for the President’s Day district work period after the Senate passed the short-term government funding bill last week. Appropriators will have until Friday, March 11 to complete their work on an omnibus spending package for fiscal year (FY) 2022. Reports out of Capitol Hill suggest that each appropriations subcommittee has received its specific topline allocation, but the full list of 302(b) funding numbers has not been made publicly available yet.
Meanwhile, Congress will begin the March legislative work session on Monday, February 28. Prior to adjourning, Senate Majority Leader Chuck Schumer (D-NY) offered a preview of the upper chamber’s schedule for the upcoming month. In addition to a potential appropriations deal, senators are likely to consider: (1) bipartisan postal service reform legislation; (2) a measure that seeks to codify Roe v. Wade abortion protections; and (3) a bill sponsored by Sen. Raphael Warnock (D-GA) that seeks to cap the price of insulin at $35.
Califf Confirmed as FDA Commissioner, Unveils Agency Priorities
In a 50-46 vote, the Senate confirmed Robert Califf to lead the Food and Drug Administration (FDA) following an arduous confirmation process riddled with concerns from lawmakers on both sides of the aisle. After nearly 14 months with no permanent commissioner, the agency now has a permanent leader, allowing for greater flexibility in enacting substantive policies and regulations. Former acting commissioner Dr. Janet Woodcock is set to become the FDA’s second-in-command, transitioning to the role of principal deputy commissioner as announced in a press release last week.
Upon his confirmation, Califf unveiled his priorities via Twitter thread on Thursday, citing the FDA’s continued involvement in COVID-19 pandemic response as a primary focus of the agency’s work going forward. Additionally, the newly-appointed commissioner pointed towards the following policy priorities: (1) the rapid development of new treatments and medical devices; (2) an enhanced response to the opioid and stimulant overuse; and (3) a better understanding of antimicrobial resistance.
CMS Announces RFI on Medicaid and CHIP Access and Coverage
On Thursday, the Centers for Medicare and Medicaid Services (CMS) issued a request for information (RFI) on access to care and coverage for individuals enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). The agency is seeking feedback on health care access, specifically calling for responses related to: (1) enrolling in and maintaining coverage; (2) accessing health care services and supports; and (3) analyzing adequate provider payment rates to bolster provider availability and quality.
With consideration of responses to the RFI, CMS plans to institute a multifaceted approach to bolster equitable access to health care for these individuals via the issuance of guidance and regulations. Specifically, the agency touched on improvements to fee-for-service, managed care, and alternative payment models as intended results of the RFI, adding that feedback will further inform efforts to ensure timely access to critical services, such as behavioral health care and home- and community-based services. The RFI is open for a 60-day public comment period set to close on April 18, 2022.
Congress Forges Ahead on Mental Health Package
Last week, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing to discuss mental health challenges in the U.S., specifically with regard to growing challenges faced by youth. This hearing was the fifth this year in a series intended to craft a broader legislative package aimed at addressing mental health in the U.S, coming on the heels of a number of recent hearings from the House Ways and Means Committee (TRP summary), Senate HELP Committee (TRP summary), and Senate Finance Committee (TRP summary; TRP summary) on the subject.
In these recent discussions, lawmakers have zeroed in on telehealth, access to coverage, provider reimbursement, and workforce shortages as areas in which mental health services could be improved. Across hearings, members expressed a desire to see this issue through in a bipartisan manner and voiced interest in incorporating community perspectives in this process, adding that parity is needed between the coverage and acceptance of mental health and physical health services.
FTC Votes Against Studying PBM Contractual and Reimbursement Practices
On February 17, 2022, the Federal Trade Commission (FTC) held an open Commission meeting to vote on whether to issue an order—under the Commission’s section 6(b) authority—to large pharmacy benefit managers (PBMs) to study the impact of “certain contractual provisions, reimbursement adjustments, and other practices affecting drug prices, including those practices that may disadvantage independent or specialty pharmacies.”
Rep. John Rose (R-TN), in his brief remarks, referenced the alleged anticompetitive contracting policies from PBMs that were raised by pharmacies during a community pharmacy advisory council meeting he recently held in his congressional district. He claimed that the three largest PBMs collectively control 77 percent of the market and, as a result, leverage their market power to increase costs for drugs while making it more difficult for independent and family-owned pharmacies to stay in business and serve their local communities. In his remarks, Rep. Rose referenced how the use of “take it or leave it” contracts by PBMs stifles competition.
Rep. Buddy Carter (R-GA) spoke on his familiarity of the issue under consideration as a registered pharmacist and policymaker while stressing his belief in the importance of the vote by the FTC on this issue. He spoke to the rise in profits of PBMs over recent years at the expense of small business owners and patients. In his remarks, Rep. Carter raised three topics that he hopes would be addressed: (1) the rise of direct and indirect renumeration (DIR) fees; (2) existing incentives to increase list prices so that PBMs could receive higher rebates from drug manufacturers to increase their profits; and (3) current practices of PBMs to direct beneficiaries to specialty pharmacies or mail-order pharmacies owned by PBMs.
Both Reps. Rose and Carter supported the FTC study under consideration by the Commission, however, after hearing from numerous public witnesses and a brief discussion amongst Commissioners, the motion to order such a study failed in a 2-2 vote.