Health Policy Report (8/17)

Capitol Hill Update

House Speaker Nancy Pelosi (D-CA) is poised to call Members back to Washington for votes amid growing concerns about the state of the U.S. Postal Service (USPS). Lawmakers will likely come back later in the week to vote on House Oversight and Reform Committee Chairwoman Carolyn Maloney’s Delivering for America Act, which prohibits the Postal Service from implementing any changes to operations or level of service it had in place on January 1, 2020. The vote comes following a series of USPS letters to 46 states and the District of Columbia warning that it could not guarantee all ballots cast by mail will arrive to elections officials in time to be counted, raising the possibility that the pace of its delivery could disenfranchise voters. While the measure is likely to pass the lower chamber, it faces a cloudy future in the GOP-controlled Senate as President Donald Trump has publicly opposed additional funding for the USPS.

In the upper chamber, Senators have officially adjourned for their August district work period after remaining in a holding pattern last week in anticipation of a deal on COVID-19 relief legislation. With talks at a standstill after President Trump issued a series of executive orders on pandemic-related priorities last weekend, the Senate will resume legislative business on Tuesday, Sept. 8. Meanwhile, House Majority Leader Steny Hoyer (D-MD) is expected to issue an updated schedule for this week that could, in addition to Chairwoman Maloney’s postal bill, include additional pandemic-related legislation. Lawmakers in both chambers will receive at least 24 hours’ notice of any scheduled votes.

Kamala Harris Hews Close to Biden on Drug Pricing, Insurance Reform

Democratic Presidential Nominee Joe Biden announced his Vice-Presidential pick last Tuesday: Sen. Kamala Harris (D-CA), a relative moderate within the Democratic caucus who is expected to support the ticket’s positions on drug pricing and health insurance reform. Even though former Vice President Biden’s and Harris’ plans to implement a public option and base drug prices in the United States off prices overseas would dramatically reshape the American health care system, the proposals stop short of those backed by the more progressive wing of the Democratic party.

On drug pricing, when Sen. Harris was a candidate for the Democratic nomination, she vowed to tie prices in the United States to prices abroad. Similar to Vice President Biden, her proposal directed the Department of Health and Human Services (HHS) to set prices for drugs when prices are cheaper in comparable, economically-developed countries or when U.S. prices increase faster than inflation. The reference countries would include Canada, Britain, France, Germany, Japan and Australia. In turn, drug companies would have to pay back all profits when they sell a drug above the fair price and those refunds would be paid to insurers, so that insurers then pass that money to their customers. Sen. Harris also supports allowing Medicare to directly negotiate drug prices, something that is also part of Biden’s drug pricing platform. President Trump does not support this policy.

With respect to health insurance, Sen. Harris was criticized for her indecisiveness on whether she wants to completely eliminate private health insurance, but she eventually settled on a 10-year Medicare for All transition plan that closely resembles Vice President Biden’s. For his part, Vice President Biden’s plan relies on a federal public option that would function alongside private insurance and would be available to all, including those who want to switch from employer-sponsored coverage. He also wants to lower the Medicare eligibility age to 60.

For additional details on Sen. Harris’ record on health care in the Senate and her presidential campaign, click here to view TRP’s recent slide deck.

FDA Creates COVID-19 Vaccine Advisory Committee

FDA Commissioner Stephen Hahn and biologics center director Peter Marks announced they are convening a vaccine advisory committee to review COVID-19 vaccines and decide on emergency use authorization or licensure. The impact of the logistical planning around the committee is unclear, but it is a time-consuming endeavor. FDA leaders, lawmakers, and stakeholders have been pushing for this public review panel, as public anxiety over a possible vaccine is becoming more apparent. FDA clinical deputy director for vaccines, Doran Fink, has expressed concern that this review process’ timeframe of eight to twelve months wastes precious time.

However, the White House and drug companies expect a much faster review process by the committee. Pfizer CEO, Albert Bourla, is confident that FDA review of their company’s vaccine will go quickly. “From my perspective, by October… there is a highly likelihood that we will know if it works, and we will have enough product to start distribution,” Bourla said, “We will go for regulatory approvals in October.” President Trump forecasted that a vaccine could be ready by November 3.

CMS Hints at Audio-Only Telehealth Coverage

CMS Administrator Seema Verma said last week that the agency plans to release a new regulation addressing audio-only telehealth coverage for physician supervision. “One of the things I’m really excited about with telehealth is around supervision through telehealth. We’re not doing it for everything, in terms of residents and all that, but I think it has a real opportunity especially in rural areas,” she said. “You’ll see more of that in rules and some of the stuff that is upcoming.”

The proposed rule would be especially useful in rural areas. CMS Innovation Director, Brad Smith, recently hosted a round table with rural health providers at which stakeholders and rural healthcare providers voiced concerns about broadband capacity, making audio-only calls a necessity. While the proposed rule does not include codes for Medicare audio-only visits, the comment period is expected to increase traction for this medium.

White House Announces Deal with Moderna for 100 Million Doses of Potential Vaccine

On Tuesday, the White House said that it entered an agreement with Moderna, Inc. to acquire 100 million doses of a promising COVID-19 vaccine as part of Operation Warp Speed. This mRNA-1273 vaccine is in the final stage of testing and is on track for completion by September. Its deal with the U.S. is contingent on specific timing benchmarks, and the dosage cost comes to about $30.50 per person for a two-dose regimen. The cost breakdown means that the government is paying about $15 per dose, and it will be given to patients for free.

The U.S. is reportedly pursuing similar purchase agreements with Johnson & Johnson, AstraZeneca, Pfizer, BioNTech, Sanofi, and GlaxoSmithKline. Other countries, including Japan, the U.K., and Canada are forging similar deals. President Trump’s recent White House press briefing highlighted progress on a vaccine, where he said that there is “tremendous promise” in every vaccine that the U.S. chooses to acquire.

Trump Administration Steps in Amongst Fear of COVID ‘Death Panels’

Some hospitals are reaching a grave impasse in deciding how to allocate resources for COVID patients. Disability rights groups are targeting certain states that are allowing doctors to “cut off treatment for some of the sickest patients in hot zones and revive the specter of so-called death panels.” Guidelines in Texas and Arizona allow doctors to base treatment off of survival odds and if the patient is predicted to live another five years. A specific case in Austin, Texas involved a quadriplegic patient who was moved to hospice care after contracting the virus. The case garnered national attention in addition to 11 complaints lodged with HHS’ Office of Civil Rights since May.

While some states defend their decisions, disability rights advocates are forging ahead, demanding guidance that would discourage withholding services based on a doctor’s beliefs about a patient’s quality of life or longevity. They also want individuals with disabilities to be treated with necessary accommodations and follow-up care, pursuant to the Americans with Disabilities Act. The American Medical Association and American College of Physicians rejected measures that discriminate against groups that are “not ethically defensible.” The White House point person on the issue, Roger Severino, said that “it sends a message on who we are as a nation, it’s a reflection of our national character — how we treat the vulnerable.” He added that the lack of clear guidance in some states “puts an unfair burden on medical professionals and opens the door to discrimination.”