This week in Washington: Congress gets organized for next Congress; House passes health care bills; COVID-19 vaccine is the talk of the town.
House Passes 10 Health Care Bills
On Nov. 17, the House passed 10 health care-related bills that include legislation to support new research into health disparities, improvements to food and drug labeling, and a new $10 million grant program for trauma centers that intervene in cyclical violence. The legislation also provides $1.5 billion annually in grants to states and tribal organizations to support substance use disorder (SUD) treatment and prevention, as well as new tools and authorities to prevent the illegal distribution of controlled substances. All of the bills were passed by voice vote and now must be considered by the Senate.
The House passed the following bills:
- H.R. 4499, the NIMHD Research Endowment Revitalization Act of 2020, authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence.
- H.R. 5668, the Making Objective Drug Evidence Revisions for New Labeling Act of 2020 or the MODERN Labeling Act of 2020, allows the Food and Drug Administration (FDA) to require modifications of outdated labeling for certain generic drugs to ensure labels have complete and accurate information. The bill would require FDA to report any actions taken under this new authority to update labeling for covered drugs, including the number of drugs, description of the changes and the rationale, as well as any FDA recommendations to modify the program.
- H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, closes a loophole in the Orphan Drug Act by requiring drug manufacturers seeking orphan drug designations under the rarely used cost recovery pathway to demonstrate the absence of any reasonable expectation of the costs they incur in developing and making those drugs available in the U.S. for such disease or condition. The legislation requires FDA and the manufacturer to take into account the sales of all of the manufacturer’s drugs developed under the same orphan drug designation.
- H.R. 2466, the State Opioid Response Grant Authorization Act of 2020, authorizes the Substance Abuse and Mental Health Services Administration (SAMHSA) State Opioid Response Grants program to align with the grant authority provided through the 21st Century Cures Act. The bill also authorizes support for state actions to address stimulant use.
- H.R. 2281, the Easy Medication Access and Treatment for Opioid Addiction Act or the Easy MAT for Opioid Addiction Act, would require the Drug Enforcement Administration (DEA) to allow a practitioner to dispense up to a three-day supply of medication-assisted treatment. This practice is intended to relieve potential acute withdrawal symptoms while the individual awaits longer-term treatment.
- H.R. 2117, the Food Allergy Safety, Treatment, Education, and Research Act of 2020 or the FASTER Act of 2020, would require the Centers for Disease Control and Prevention (CDC) to expand the collection of information related to the prevalence of food allergies for specific allergens and to include that information in reports to Congress. The bill would also amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen and allow FDA, through regulation, to add other food ingredients as major allergens based on the prevalence and severity of allergic reactions to the food ingredient. Additionally, the bill would require FDA to include patient experience data on treatments for patients with food allergies in its reports on patient experience data.
- H.R. 5855, the Bipartisan Solution to Cyclical Violence Act of 2020, would create a grant program at the Department of Health and Human Services (HHS) to support trauma centers with violence intervention and violence prevention programs. Program support would be provided to conduct research to reduce the incidence of re-injury and re-incarceration caused by intentional violent trauma.
- H.R. 3878, the Block, Report, And Suspend Suspicious Shipments Act of 2020, creates additional requirements for drug manufacturers and distributors who discover a suspicious order for controlled substances. In addition to reporting a suspicious order of controlled substances to DEA, a manufacturer or distributor must also exercise due diligence, decline to fill the order or series of orders, notify DEA of each suspicious order or series of orders and the indicators that led to the belief that filling such orders would be a violation. These requirements would become effective one year following enactment.
- H.R. 4806, the Debarment Enforcement of Bad Actor Registrants Act of 2020 or the DEBAR Act of 2020, would amend the Controlled Substances Act to allow the Attorney General to prohibit any registrant from manufacturing, distributing or dispensing a controlled substance or a list I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations.
- H.R. 4812, the Ensuring Compliance Against Drug Diversion Act of 2019, terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify DEA. Registrants must receive written consent from DEA in order to assign or transfer a registration. Registrants are also required to return certain documentation if a registrant’s work is discontinued.
Wyden Presses UnitedHealth for Details on Mental Health Coverage Shortfalls
On Nov. 19, Senate Finance Committee Ranking Member Ron Wyden (D-OR) sent a letter to health insurance company UnitedHealth requesting it disclose details about its behavioral health business, which has been subject to ongoing class action litigation for improperly denying coverage for mental health and substance use disorder (SUD) care. Sen. Wyden requested more information on factors that are driving revenue and profit growth for UnitedHealth in its behavioral health business. The letter also asks for more information about allegations that UnitedHealth directed at least one customer to Medicaid rather than covering the care itself, and whether such practices are widespread at the company. Additionally, the letter seeks details about subsidiaries, affiliates and contractors that UnitedHealth may use to administer behavioral health care coverage for third-party health plans. Find the letter here.
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.