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This Week in Washington: Treasury Finalizes “Family-Glitch” Fix
Congress
House
Administration
- Biden Signs Executive Order to Direct HHS to Lower Drug Prices
- Treasury Department Finalized Family Glitch Rule
- CMS Announces Future Rule on Device Coverage
- Centers for Medicare and Medicaid Services Seeks Input on Provider Directories
- FDA Announces Shortage of Adderall
- FDA Seeks Public Feedback and Public Workshop in November on Distributed and Point-of-Care Drug Manufacturing
Proposed Rules
Final Rules
- Homeland Security Issues Final Rule Reversing Trump “Public Charge” Rule
- Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
Congress
House
Progressive Caucus Members Announce Bill to Rename Medicare Advantage
Two members of the House Progressive Caucus announced they will introduce legislation that would change the name of Medicare Advantage (MA) in order to make clear that MA plans are offered by private insurers. They believe that seniors may be misled into enrolling into MA plans.
The bill is sponsored by Rep. Mark Pocan (D-WI), a former chair of the caucus, and Rep. Ro Khanna (D-CA). In addition to changing the name of the program, the legislation would impose financial penalties on private insurers using the term “Medicare” in plan names.
The bill comes as the issue of how best to strengthen Medicare is already shaping up to be a midterm election issue. The administration has been promoting the Medicare drug-price controls included in the recently enacted Inflation Reduction Act as a major effort to strengthen the program, while Republican lawmakers blast the IRA provisions as anti-competitive.
A majority of Medicare beneficiaries are projected to be enrolled in Medicare Advantage by next year.
Senate
The Senate is in recess and will return Nov. 14.
Administration
Biden Signs Executive Order to Direct HHS to Lower Drug Prices
On Oct. 14, President Biden signed an executive order to direct the Department of Health and Human Services to lower drug prices through administrative actions. The EO serves to put drug manufacturers on notice that it will address issues that may be created if manufacturers sue over the price controls in the Inflation Reduction Act.
Treasury Department Finalized Family Glitch Rule
On Oct. 11, the U.S. Department of the Treasury finalized a rule that fixes what is known as the “family glitch” rule, which targets an issue that inadvertently raises insurance costs for certain families. The rule goes into effect next month.
The Kaiser Family Foundation estimates that 5.1 million people could benefit from this rule, largely women and children. The rule will assist low-income families for whom employer-sponsored insurance meets certain cost thresholds.
An employee would qualify for such assistance if they must spend more than 9.5 percent of their household income on premiums. However, a glitch in the regulation meant that the threshold only affects the individual’s health plan and not the premium for dependents. While the individual and family can meet the 9.5 percent threshold, they would get premium assistance for only the individual’s healthcare costs.
To review the rule: https://public-inspection.federalregister.gov/2022-22184.pdf
CMS Announces Future Rule on Device Coverage
On Oct. 12, the Centers for Medicare and Medicaid Services announced that it will release a rule in the coming months to establish an expedited Medicare coverage system for new devices. The system would be voluntary and build off coverage with evidence development. As part of the new pathway, CMS would conduct early evidence reviews prior to certain new devices’ obtaining FDA market authorization. CMS will continue to meet with stakeholders and others including the FDA.
Centers for Medicare and Medicaid Services Seeks Input on Provider Directories
On Oct. 5, CMS released a Request for Information (RFI) concerning the concept of creating a directory with information on healthcare providers and services or a “National Directory of Healthcare Providers and Services” (NDH).
CMS is seeking comment on whether consolidating data could help improve access to care and patient choice by making it easier for patients to identify, compare and locate providers who meet their specific needs. CMS is seeking comment on how a CMS-led directory could reduce directory maintenance burden on providers and payers by creating a centralized system.
The RFI is open for a 60-day public comment period ending Dec. 6, 2022. To read the RFI:
FDA Announces Shortage of Adderall
On Oct. 13, the Food and Drug Administration (FDA) announced a national shortage of the immediate-release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall or Adderall IR. This announcement comes amidst concerns that the drug is over prescribed.
The Drug Enforcement Administration recently launched an investigation into a major telehealth provider’s prescribing patterns, after which the provider ended all prescriptions of controlled substances, and key pharmacy chains including Walgreens, Walmart and CVS blocked or delayed ADHD drug prescriptions from telehealth providers.
Adderall is approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. The FDA said alternatives will be available for patients, including the extended-release version of Adderall.
FDA Seeks Public Feedback and Public Workshop in November on Distributed and Point-of-Care Drug Manufacturing
On Oct. 14, the Food and Drug Administration (FDA) announced that the FDA in being proactive wants to evaluate its existing risk-based regulatory framework as it applies to distributed manufacturing and point-of-care drug manufacturing technologies, even though there are currently no FDA-approved drugs manufactured through these technologies.
The FDA has identified certain areas of consideration and is asking for public feedback on some key issues identified in a discussion paper. https://www.fda.gov/drugs/distributed-manufacturing-and-point-care-manufacturing-drugs-discussion-paper
- How often might a DM unit move to a new location and what might an applicant report to the agency when doing so?
- What locations are envisioned for POC unit operation?
- How might a centralized quality system (i.e., at a “parent location”) ensure each manufacturing unit complies with regulatory requirements and quality standards?
- What type of business relationships are envisioned between companies developing POC manufacturing platforms and healthcare facilities?
Interested stakeholders can provide input at a public workshop on Nov. 14-16 and to the public docket under docket number FDA-2022-N-2316.
Proposed Rules
FDA Releases Proposed Rule to Standardize the National Drug Code Format
On July 25, the Food and Drug Administration (FDA) issued a proposed rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The proposed rule would amend the National Drug Code (NDC) to require one standardized format for all NDCs.
Public comments will be accepted until Nov. 22, 2022.
Final Rules
Homeland Security Issues Final Rule Reversing Trump “Public Charge” Rule
On Sept. 8 the administration issued final rules making it clear that the Department of Homeland Security will not refuse entry to non-citizens seeking admission to the U.S. or a green card due to their likelihood to receive Medicaid/CHIP or other health benefits except for long-term institutionalized care. The rule reverses the Trump administration’s public charge rules issued in 2019.
https://public-inspection.federalregister.gov/2022-18867.pdf
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.