On The Hill

Progress on CR, Additional Relief Talks

Late Tuesday evening (Sep. 22), the House passed a stopgap funding bill to keep the government running through Dec. 11, 2020. The Senate plans to hold a final vote on a funding bill next Tuesday (Sep. 29), putting it right up against the Wednesday deadline to prevent a shutdown.

House Speaker Nancy Pelosi (D-CA) indicated Thursday (Sep. 24) Democrats will draft a new COVID-19 relief bill and bring it to a vote before Oct. 2, 2020. House Ways and Means Committee Chairman Richard Neal (D-MA) estimated the new package will be in the range of $2.2 – $2.4 trillion.

The new legislation comes as Treasury Secretary Steven Mnuchin and Pelosi have agreed to restart talks about a second stimulus bill.

 

RBG Passing Tees Up Supreme Court Battle

On Friday (Sep. 18), Supreme Court Justice Ruth Bader Ginsburg passed away due to complications from pancreatic cancer. She was 87 years old. Ginsburg was nominated to the bench in 1993, and went on to be known as a champion of gender equality, civil liberties, and pay equity.

Her death sets up a battle over the future of the Supreme Court. President Trump plans to announce a nominee to fill Ginsburg’s seat on Saturday (Sep. 26). Senate Majority Leader Mitch McConnell (R-KY) announced he will hold a vote for the nominee, and appears to have the votes needed for a confirmation to go through. Senators Lisa Murkowski (R-AK) and Susan Collins (R-ME) are the only GOP senators to oppose immediately filling Ginsburg’s seat.

Many Democrats, including Senate Minority Leader Chuck Schumer (D-NY) have called on Republicans to hold off confirming a nominee to the bench until after the election, following the precedent set by the GOP in 2016 when McConnell chose not to hold a vote on President Barack Obama’s nomination of Merrick Garland.

The Supreme Court will hear arguments on a case to decide the constitutionality of the ACA on Nov. 10.

 

Trump Unveils ‘America First’ Healthcare Plan

On Thursday (Sep. 24), President Trump released his ‘America First Health Plan.’ The plan, outlined in an Executive Order (EO), promises protected coverage for patients with pre-existing conditions, a ban on surprise medical billing should Congress fail to pass legislation on the matter before the year’s end, lower drug prices for patients, and more choice for patients.

Additionally, the ‘America First’ plan highlights previous administrative actions to meet these goals, including: repealing the Affordable Care Act (ACA) individual mandate; expanding the availability of Association Health Plans, Health Reimbursement Arrangements, and short-term, limited duration plans (STLDPs); reducing premium costs in Medicare; and the drug pricing EOs released earlier this year to allow certain drug importation from Canada and tie prices to those in other countries.

Notably, the plan outlines Trump’s intent to assist seniors with medical expenses by sending out $200 drug discount cards to 33 million Medicare beneficiaries. The discount cards will cost the government at least $6.6 billion and will be sent through the Medicare 402 demonstration program, which tests innovations that could save money and improve quality of care.^[1] 

“The President’s plan delivers better care, more choice, and lower costs for all Americans,” said HHS Secretary Alex Azar.^[2] 

“Because of the President’s leadership, Americans will enjoy lower drug costs, lower insurance premiums, real access to prices of healthcare services and to their medical records, new protections from surprise bills, and the ability to work with their doctor to determine what treatments make sense for them,” Azar added.

Senate Finance Committee Ranking Member Ron Wyden (D-OR) slammed the discount cards for being a campaign “gimmick,” and claimed the president is resorting to this plan to cover up his failure to lower drug prices. The move has also been criticized by Public Citizen, a watchdog and consumer advocacy group, for being an “attempt to bribe seniors for their votes.” ^[3] 

On a Friday (Sep. 25) informational industry call, HHS officials noted that specifics on the discount cards, including whether the $200 will count towards senior’s total out-of-pocket, and the authority of the proposal’s funding through the 402 demonstration program, will be coming out in the coming weeks.

To view the White House Fact Sheet, click here.

To view the Executive Order, click here.

 

FDA Finalizes Drug Importation Rule

On Thursday (Sep. 24), the FDA released its final rule and guidance on the implementation of the July EO to allow states to import certain prescription drugs from Canada when importation poses no public health risk and achieves a significant reduction of costs to American consumers.

“Today’s action is an important part of FDA’s priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” FDA Commissioner Stephen M. Hahn, M.D said in a press release.

“The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines,” he continued.

States, territories, Indian tribes, and certain pharmacists and wholesalers can now begin submitting importation program proposals to the FDA for review and authorization.

HHS is unable to estimate the cost savings of the rule due to a lack of information on the specifics of states’ individual proposals.^[4] 

U.S. drug manufacturers and pharmacists oppose the plan. U.S. manufacturers have cited safety issues that may arise due to a lack of supply chain and labeling oversight, and pharmacists doubt the proposal would lower costs significantly as high cost drugs, like insulin, are excluded under the rule. Additionally, pharmacists claim the costs of relabeling and retesting drugs that are included would outweigh savings.

Canadian pharmacists also oppose the proposal due to concerns that populous states, should they opt to participate, could enhance Canada’s drug shortages by importing already limited drug stores.

Six states – Colorado, Vermont, Florida, Maine, New York, and New Mexico – have already begun work on their Canadian drug importation plans.

To view the final rule, click here.

To view the FDA announcement, click here.

To view FDA guidance on the rule, click here.

 

CDC to Release $200m for Vaccine Distribution

On Wednesday (Sep. 23), HHS announced CDC will be releasing $200 million, appropriated by the CARES Act, to jurisdictions to assist with vaccine distribution preparedness. Funding amounts will be determined through a population-based formula and will be distributed to the 64 jurisdictions through the existing Immunizations and Vaccines for Children cooperative agreement.

To view the HHS announcement, click here.

 

Canadian Trade Chief Comments on Supply Chain EO

Canada’s Minister for Economic and Trade Policy Nadia Bourély said on Wednesday (Sep. 23) that President Trump’s EO to boost U.S. production of drugs and medical supplies could harm cross-border supply chains that have helped both the U.S. and Canada fight the COVID-19 pandemic.

“These policies also put at risk U.S. and Canadian jobs, distort investment and result in higher prices for businesses and consumers,” Bourély said. “To facilitate our pandemic responses and ensure mutually beneficial economic growth, Canada is of the view that — as it relates to the U.S. and Canada — we should minimize the impact of any local content requirements on North American value chains,” she added.

The September EO directs federal agencies to post domestic production by limiting competition for federal contracts as much as possible “to only those essential medicines, medical countermeasures and critical inputs that are produced in the United States.”

An earlier International Trade Commission study found that Canada was a top-five supplier of more than one-third of the 203 medical items and goods needed to fight the COVID-19 pandemic.^[5] 

 

Senate HELP Reviews Federal COVID-19 Response

On Wednesday (Sep. 23), the Senate Committee on Health, Education, Labor and Pensions heard testimony from NIAID Director Anthony Fauci, CDC Director Robert Redfield, HHS Assistant Secretary for Health Brett Giroir, and FDA Commissioner Stephen Hahn on the federal government’s response to COVID-19.

To view an executive summary of the hearing, click here.

 

E&C Panel Hears Testimony on ACA

On Wednesday (Sep. 23), the House Energy and Commerce Subcommittee on Health held a hearing on the Affordable Care Act.

To view an executive summary of the hearing, click here.

 

References

^[1] Luthi, Susannah & Roubein, Rachel, “UPDATED: Trump makes fresh health care push, saying he’ll protect sick Americans,” Politico Pro, 24 Sep. 2020. https://link.edgepilot.com/s/a7efdcbd/cqEjS1nzwEm1_n9-r6J-5Q?u=https://subscriber.politicopro.com/article/2020/09/trump-makes-fresh-health-care-push-saying-hell-protect-sick-americans-1999818

^[2] U.S. Department of Health and Human Services, Press Release “HHS Takes Action as Part of President Trump’s Healthcare Plan,” 24 Sep. 2020. https://link.edgepilot.com/s/1e28b4a6/M97OsdTfcUawYgemjpNbCg?u=https://www.hhs.gov/about/news/2020/09/24/hhs-takes-action-as-part-of-president-trumps-healthcare-plan.html

^[3] Roubein, Rachel & Luthi, Susannah, “Trump says he’s sending seniors $200 drug coupons,” Politico Pro, 24 Sep. 2020. https://link.edgepilot.com/s/bbfb8101/9Va4Pg4qFU2TPaLI96ocyQ?u=https://subscriber.politicopro.com/article/2020/09/trump-says-hes-sending-seniors-200-drug-coupons-3984172

^[4] Brennan, Zachary, “Trump offers limited drug import plan with unknown savings,” Politico Pro, 24 Sep. 2020. https://link.edgepilot.com/s/afcf7a9d/dpRQefxBLkOXeawwQzbJuQ?u=https://subscriber.politicopro.com/article/2020/09/trump-offers-limited-drug-import-plan-with-unknown-savings-3984171

^[5] Palmer, Doug. “Canada seeks to reprieve from Trump’s medical supply executive order.” Politico Pro, 23 Sep. 2020. https://link.edgepilot.com/s/c122a3ce/nB_zAsMb40OCG2F2o-Z8Eg?u=https://subscriber.politicopro.com/article/2020/09/canada-seeks-reprieve-from-trumps-medical-supply-executive-order-1999334