POLICY BRIEFINGS

Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - MAY 17, 2021

Senate Advances Top Health Nominees


The Senate confirmed Andrea Palm to serve as deputy secretary of the U.S. Department of Health and Human Services (HHS) last week by a vote of 61-37. Palm most recently led the Wisconsin Department of Health Services and previously served as HHS chief of staff and senior counselor to the secretary during the Obama administration. In her new position as the number two official at the Department, Palm will be responsible for managing HHS’ daily operations and the development and approval of regulations issued by its agencies.

The Senate voted 51-48 to discharge the nomination of Chiquita Brooks-LaSure to serve as Administrator of the Centers for Medicare and Medicaid Services (CMS) last week. Republican senators Susan Collins (Maine) and Jerry Moran (Kan.) joined Democrats in backing the discharge petition. The Senate could hold a final vote on her confirmation this week. Brooks-LaSure is a former Obama administration health official who helped implement the Affordable Care Act (ACA) while serving as deputy director for policy at the Center for Consumer Information and Insurance Oversight (CCIIO). She also chaired President Joe Biden’s health transition team. Earlier in her career, she was a staffer for the House Ways and Means Committee where she helped to draft the ACA while working with HHS Secretary Xavier Becerra, who served on the panel during his time in Congress. A final vote on her confirmation could occur as early as this week. Her nomination has been slowed due to Republican opposition led by Sen. John Cornyn (R-Texas) in protest of the Biden administration’s recent decision to revoke a 1115 Medicaid waiver extension for the state of Texas; the waiver was approved in January by the Trump administration.


House Passes Slate of Mental Health Legislation


The House of Representatives passed 13 pieces of legislation aimed at improving the nation’s mental health care system. The measures include

  • The Family Support Services for Addiction Act (H.R. 433)
  • The Pursuing Equity in Mental Health Act (H.R. 1475)
  • The Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (H.R. 586)
  • The Mental Health Services for Students Act (H.R. 721)
  • The Bipartisan Solution to Cyclical Violence Act of 2021 (H.R. 126)
  • The Improving Mental Health Access from the Emergency Department Act (H.R. 1205)
  • The Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 1324) • The Helping Emergency Responders Overcome (HERO) Act (H.R. 1480)
  • The Campaign to Prevent Suicide Act (H.R. 2862)
  • The Suicide Prevention Lifeline Improvement Act (H.R. 2981)
  • The Suicide Prevention Act (H.R. 2955)
  • The Block, Report, And Suspend Suspicious Shipments Act (H.R. 768) • The Behavioral Intervention Guidelines Act (H.R. 2877)

The Senate also passed the Improving Mental Health Access for Students Act (S. 1585) by voice vote last week.


Lawmakers Seek to Restore FDA LDT Oversight


The top Democrats on the House Energy and Commerce Committee have sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra calling on him to restore the ability of the Food and Drug Administration (FDA) to regulate COVID-19 laboratory developed tests (LDT). “Access to accurate diagnostic tests is a vital piece of our ongoing effort to stop the spread of COVID-19 and eventually ending the pandemic,” they said. “We therefore request that you immediately reverse the Trump administration’s shortsighted policy and restore FDA’s premarket review authority and oversight over COVID-19 laboratory-developed tests.” The letter was signed by Chairman Frank Pallone (D-N.J.), Health Subcommittee Chair Anna Eshoo (D-Calif.), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-Colo.).

Reps. DeGette and Larry Bucshon (R-Ind.) plan to reintroduce a revised version of the VALID Act in the coming weeks that would restore FDA premarket review requirements for LDTs. The Trump administration issued a policy last year which asserted that the FDA did not have the authority to require review of LDTs over the objection of top agency officials. The VALID Act would create a new category of medical products called in-vitro clinical tests which would fall under the authority of the FDA regardless of whether they are developed by a laboratory or device company, while exempting LDTs that are already developed and on the market. It is unclear what changes have been made to the bill since it was first introduced during the 116th Congress.


No Surprises Act Authors Comment on Congressional Intent


Sens. Bill Cassidy (R-La.) and Maggie Hassan (D-N.H.) and Reps. Larry Bucshon (R-Ind.) and Raul Ruiz (D-Calif.) have written to the Biden administration to clarify the congressional intent as the U.S. Department of Health and Human Services (HHS) works to implement the No Surprises Act. The bill, which was enacted last year, aims to end the practice of surprise medical billing. The law tasks HHS with establishing an independent dispute resolution (IDR) process by Jan. 1, 2022 to settle payment disputes between health care providers and insurance companies. The legislation says that arbitrators shall consider the qualifying payment amount (QPA) in addition to several other factors, including providers’ level of training, quality and patient outcomes, market share for providers and payers, patient acuity, teaching status, and prior contracted rates. While some stakeholders are arguing that Congress intended the QPA to be the primary consideration, the lawmakers assert that Congress intended equal weight to be given to all six factors outlined in the bill. “The law’s arbitration framework is designed to ensure that neither payors nor providers have a financial incentive to remain out of network as a tool to establish leverage for contract negotiations,” the lawmakers say. “To achieve this balance, we wrote this law with the intent that arbiters give each arbitration factor equal weight and consideration.” They ask the administration to “refrain from issuing guidance or taking other action that would give preference to one factor over the other as it works to promulgate rules for the No Surprises Act.”


Pelosi Faces Democratic Opposition to H.R. 3 Drug Pricing Bill


Agroup of 10 moderate Democrats in the House of Representatives have sent a letter to Speaker Nancy Pelosi (D-Calif.) stating their opposition to the party’s signature drug pricing legislation. Amongst other provisions, H.R. 3 would permit the Medicare program to negotiate the price of certain drugs. The letter urges leadership to instead advance drug pricing reforms that would “preserve our invaluable innovation ecosystem” such as capping Medicare beneficiaries’ out-of- pocket drug costs. Eight of the 10 signatories voted for the Lower Drug Costs Now Act during the 116th Congress, when it had no chance of becoming law under President Donald Trump and the Republican-controlled Senate. Some Democrats had hoped to move H.R. 3 along with the President’s infrastructure package that is expected to be passed along party lines later this year.



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