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.


HELP Drug Pricing, PBM Markup Rescheduled

The Senate Health, Education, Labor, and Pensions (HELP) Committee markup of four drug pricing related bills was postponed last week after a disagreement between panel Democrats and Republicans about the process by which the legislation was brought forth for consideration. Republicans argued that several amendments filed by Democrats contained policies that committee leadership agreed to set aside during their initial bipartisan negotiations on the package of bills, some of which had been awaiting scores from the Congressional Budget Office and technical assistance from federal agencies. HELP Committee members also questioned why the markup was taking place prior to a related hearing scheduled for May 10 in which the nation’s largest insulin manufacturers and pharmacy benefit managers have agreed to testify. The markup has been rescheduled for Thursday, May 11.

Appropriations Markups to Begin Mid-May

Senate Appropriations Chair Patty Murray (D-Wash.) announced plans for her panel to begin marking up fiscal year (FY) 2024 spending legislation on May 18th. Negotiations between Murray and Ranking Member Susan Collins (R-Maine) on top-line spending levels are still ongoing. House Appropriations Committee leadership recently announced its own FY 2024 appropriations markup schedule as well: the first subcommittee markups will be held May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

E&C Republicans Probe Viral Manipulation Research, CDC Reorganization

Top Republicans on the House Energy and Commerce Committee are asking the Government Accountability Office to evaluate the benefits and risks of predictive field research programs for viruses. The letter comes as a part of the panel’s investigation into the origins of COVID-19. The letter was signed by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.). The lawmakers have also asked acting director of the National Institutes of Health (NIH) Lawrence Tabak to supply details about all internal and external NIH research projects involving virus manipulation.

Rodgers, Guthrie, and Griffith also sent a letter to the Centers for Disease Control and Prevention (CDC) requesting information related to its Moving Forward Initiative which has resulted in the agency undertaking a large-scale reorganization. The letter criticizes the CDC for conducting the initiative “largely in secret,” providing just a 10-day notice and comment period and only convening a single related public meeting. The agency used the findings of the Moving Forward Initiative to justify its request to Congress for additional authority to mandate data reporting from state, local, territorial, and tribal public health agencies. “The CDC must provide the Committee with more than a cursory, summarized overview of the findings of the Moving Forward Initiative before the Committee can even begin to consider the agency’s request for additional authority,” the lawmakers state.

Wyden, Matsui, McHenry Urge Bakers to Comply with Spirit of Sesame Labeling Law

Sen. Ron Wyden (D-Ore.), Rep. Doris Matsui (D-Calif.), and Rep. Patrick McHenry (R-N.C.) have sent a letter to the American Bakers Association urging its members to stop unnecessarily adding sesame to baked goods in order to protect consumers with a sesame allergy. “The dangerous practice of adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry,” the letter states. The lawmakers argue that “instead of acting to protect consumers, manufacturers are adding trace amounts of sesame to their baking products since the passage of the FASTER Act. It appears that this is being done to avoid the costs associated with the processes and systems controls necessary to ensure safe baking practices.” The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which became law in April 2021, requires manufacturers to ensure that products containing sesame are appropriately labeled.

Finance Committee Explores Prevalence of Mental Health Ghost Networks

The Senate Finance Committee released a ‘secret shopper’ report last week which found that most Medicare Advantage plan mental health provider directories contain misleading or false contact information. In a study of directories across 12 different plans in six states, Finance majority staff found that more than 80% of mental health care providers listed as in- network were in fact not available to the plan’s enrollees. The report recommends increased oversight and audits of health plan directories, and suggests fining plans that do not have accurate directories. The committee released the report prior to a hearing on the prevalence of these so-called ghost networks on Wednesday, May 10.

Sen. Ben Cardin Will Not Seek Reelection

Sen. Ben Cardin (D-Md.), 79, announced last week that he will not seek re-election in 2024. Cardin was first elected to the Senate in 2006 following 17 years representing Maryland’s Third Congressional District in the House of Representatives. He currently serves as Chair of the Small Business and Entrepreneurship Committee and is a senior member of the Senate Foreign Relations, Finance, and Environment and Public Works committees. Rep. David Trone (D- Md.) and Montgomery County Council member Will Jawando (D) have announced that they will run for Cardin’s Senate seat, and Prince George’s County Executive Angela Alsobrooks (D) is also considering a bid in the 2024 election.

WHO Declares End of COVID-19 Global Health Emergency; U.S. PHE to End May 11

At the recommendation of the World Health Organization’s (WHO) COVID-19 Emergency Committee, WHO Director-General Tedros Adhanom Ghebreyesus has declared an end to COVID-19 as a Public Health Emergency of International Concern. WHO officials were careful to emphasize that while the emergency phase of the coronavirus pandemic is over, COVID-19 remains a global public health threat. “COVID has changed our world and it has changed us,” Tedros said. “If we all go back to how things were before COVID-19, we will have failed to learn our lessons and we will have failed future generations.”

As previously announced, the Biden administration will officially terminate the U.S. COVID-19 public health emergency (PHE) on May 11. The end of the PHE declaration will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will continue to be able to access vaccines and treatments at no out-of-pocket cost through 2024. Vaccines will remain free in Medicare, Medicaid, and the Children’s Health Insurance Program, but beneficiaries of these programs could face increased cost sharing for COVID-19 tests and treatments. Certain other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extended certain telehealth policies and hospital at home waivers through 2024.

Experts have warned that there is an approximately 20% chance of an outbreak rivaling the intensity of the omicron variant occurring in the next two years. It was reported last week that scientists shared their analysis of the possibility of the virus mutating in such a way that evades vaccines and treatments with the Biden administration as it was working to wind down the PHE. The White House declined to comment about the experts’ analysis.

Walensky to Leave Post of CDC Director

Rochelle Walensky will leave her position as Director of the Centers for Disease Control and Prevention (CDC), a post she has held since the start of the Biden administration. During her time as director Walensky acknowledged the CDC’s shortcomings in response to the COVID-19 pandemic and launched an effort to reorganize and modernize the agency. Walensky plans to step down on June 30 but did not provide a reason behind her decision to resign.

Tanden Tapped as Next Head of the Domestic Policy Council

According to recent reports, President Joe Biden will soon name Neera Tanden as the next Director of the Domestic Policy Council. Tanden will replace Susan Rice, who has announced her plans to leave the administration later this month. Tanden currently serves as White House staff secretary and senior adviser. She was previously nominated to lead the Office of Management and Budget but withdrew from consideration after bipartisan objections to her use of Twitter to criticize political opponents. Biden aide Stef Feldman will replace Tanden as staff secretary.

DEA Temporarily Extends COVID-19 Telehealth Prescribing Flexibilities

The Drug Enforcement Administration (DEA) announced last week that it will continue to permit providers to prescribe controlled substances via telehealth as the agency works to finalize its related proposed regulations in response to the end of the COVID-19 public health emergency (PHE). The rules proposed in February would have allowed doctors to prescribe only an initial 30-day supply of certain DEA-regulated drugs through telehealth. For other drugs – including Adderall – patients would be required to complete an in-person visit with a provider before receiving a prescription. The DEA stated that it received a record number of comments in response to the proposed rules. It did not specify how long the temporary extension of the COVID-19 era flexibilities will last.

In related news, a bipartisan group of senators sent a letter to the DEA calling on the agency to address gaps in patient access to the opioid use disorder drug buprenorphine. “We are concerned that the DEA has failed to develop and provide sufficiently clear guidance for pharmacists, wholesalers, distributors, and patients for accessing buprenorphine,” the lawmakers said in a letter to the agency. The letter was signed by Sens. Maggie Hassan (D-N.H.), Martin Heinrich (D-N.M.), Thom Tillis (R-N.C.), Elizabeth Warren (D-Mass.) and Sheldon Whitehouse (D-R.I.).

New Survey Examines Impact of Pandemic on Nursing Shortages

Anew survey from AMN Healthcare reveals that nearly one-third of nurses nationwide will leave the profession because of the COVID-19 pandemic. The percentage of nurses saying they were satisfied with their choice of career dropped to 71% in 2023, after holding steady at 80% to 85% for the prior decade. The survey of 182,000 nurses also found a decline in the percentage of nurses who are satisfied with the quality of care they provide from 75% to 64%.

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