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Trump’s Health Priorities Set Aside, Maybe for Good, by Pandemic

April 27, 2020, 9:27 AM

Some of President Donald Trump’s top health-care priorities before the coronavirus pandemic, including HIV prevention and paying for patient outcomes rather than individual procedures, have been swept away by the virus response and may end up permanently sidelined, former administration officials and some leaders of the policy efforts said.

Many key leaders at the Department of Health and Human Services pushing forward the policies have had to back away to lead the Covid-19 response, and the Office of Management and Budget has limited resources to review and approve rules not related to the pandemic. HHS officials in particular are going to have to pick and choose which policies to prioritize before the end of Trump’s term.

The timeline of the pandemic is uncertain and could last until the presidential election in November, creating the possibility that none of these policies are finished if Democratic candidate Joe Biden wins.

“Covid-19 has supplanted everyone’s priority because it’s a life-or-death situation,” said Carl Schmid, co-chair of the Presidential Advisory Council on HIV/AIDS.

The list of major policies—many of which are bipartisan—that still require action from the administration is long. It includes efforts to lower prescription drug prices and regulations to encourage that more dialysis be done at home.

People

HHS leaders including Assistant Secretary for Health Brett Giroir, Centers for Medicare & Medicaid Services Administrator Seema Verma, CMS Innovation Center Director Brad Smith, and Centers for Disease Control and Prevention Director Robert Redfield have been redeployed to work on Covid-19 testing, flexibility in Medicare policies, and increasing the supply of personal protective equipment.

One initiative Trump repeatedly asks his health officials about, especially Giroir, aims to lower new HIV infections in the U.S. by more than 90% by 2030. The initiative relies on increased testing, connecting those diagnosed with HIV to care more quickly, and prescribing prevention drugs to more people at risk for HIV.

Schmid’s own co-chair, Washington state Secretary of Health John Wiesman, had to miss the last HIV council meeting in early February because of the outbreak. Deborah Birx, now the White House Coronavirus Response Coordinator, spoke at the last council meeting and was planning to help members connect with global workers at the International AIDS Conference, Schmid said.

Many CDC staff members who work on HIV have been detailed to work on Covid-19, Schmid said, as have state and local health departments that were prepared to gear up their HIV efforts. “People are being diverted at the ground level,” he added.

The CDC extended the deadline for health departments to apply for HIV grants until May 1. However, “If we get all this funding, who is going to do all the implementation work?” Schmid asked.

Schmid said the pandemic is “definitely going to impact the trajectory” of the HIV initiative, though administration officials are still telling the HIV community the initiative is a priority.

Reviewing Regulations

The Office of Management and Budget’s capacity to review regulations is a “very legitimate concern,” said Abe Sutton, former White House Domestic Policy Council health policy adviser. Its staff, like others, has limited bandwidth and has been deployed to work on Covid-19 matters, he said.

Time constraints make it unlikely there will be any major changes in Medicare payment rules, said Kelly Cleary, former HHS deputy general counsel and Centers for Medicare & Medicaid Services chief legal officer. Those rules have to be finished by a certain time so Medicare rates are in place for the next year, and the OMB may not have time to review those policy riders, she added.

Others that create new work or impose new costs for providers likely won’t be the first to come out, like rules that mandate changes in provider payments for certain specialties or regulations to make the prices patients pay transparent, Cleary said.

The HHS Tuesday pushed back the implementation of two rules that would require increased health data-sharing. The rules are big and technical and were finalized right at the start of the pandemic, Cleary said.

The Center for Medicare & Medicaid Innovation probably won’t finalize any mandatory demonstration projects during the pandemic, Cleary said. It had sent a final rule to the OMB March 10—prior to the national emergency declaration—that would require nephrologists, transplant providers, and dialysis facilities to receive a set payment for handling Medicare patients with end-stage renal disease.

The CMMI also has to decide if it wants to move forward with voluntary demonstration projects when physicians may not be willing to participate right now, Cleary said.

They can’t properly test a model without participants, and getting people on board was one of the reasons Smith was brought into the administration. The CMS has already delayed the start date from May 1 to the fall for one model that would allow Medicare to pay for emergency transportation services to a location other than a hospital, according to an email sent to providers.

Drug Pricing

Trump has consistently focused on the causes of drug price increases and railed against drugmakers and other countries for, in his words, taking advantage of the willingness by the U.S. to pay high prices. Now, the administration needs those companies to develop new therapeutics and vaccines for Covid-19, meaning it may be less politically popular to champion policy changes the industry opposes.

The administration’s proposal that would tie Medicare reimbursements to foreign countries’ drug prices, known as the international pricing index, has been criticized as something that would impede innovation, so there may not be interest in moving forward with it during this crisis, Cleary said.

“The administration is really looking to the life sciences industry to innovate, develop products that will help us combat this pandemic and future pandemics,” Cleary said.

New White House Chief of Staff Mark Meadows could be a wild card in the drug pricing debate. Meadows has shown more willingness to work with Democrats on lowering drug prices than his predecessor, Mick Mulvaney, and he had a close relationship with former House Oversight Chairman Elijah Cummings (D-Md.), who died in October.

Drug pricing action likely won’t happen until just prior to the presidential election as a campaign announcement or during the lame duck session of Congress, said Chris Meekins, former HHS deputy assistant secretary for preparedness and response who is now a health-care policy research analyst at Raymond James.

Congress has a self-imposed Nov. 30 deadline to pass drug-pricing legislation. Lawmakers intend to pair drug-pricing legislation with an extension of popular federal health programs like community health centers, which have now been extended until the end of November.

Deregulation Push

The rules most likely to keep momentum or even gain it are ones that became newly relevant because of the coronavirus pandemic, that OMB has already reviewed and could therefore progress to final regulations quickly, or which are consistent with the administration’s broader deregulation push. The HHS has been ranked as the top cabinet agency in terms of deregulatory actions for the past two years, according to the OMB.

Regulations to encourage more home dialysis became more important now that it isn’t safe for people who are immunocompromised to congregate at dialysis centers, which wasn’t contemplated when the executive order covering them was being drafted, said Sutton, the former White House Domestic Policy Council adviser, who was also an HHS adviser for value-based reform. The order was issued in July.

Rules “that are viewed positively by the health-care industry” will likely go to the front of the line for consideration when the pandemic eases, Cleary said. Those would include regulations that modify standards under the physician self-referral and anti-kickback laws, she said. Cleary was one of the architects of the physician self-referral law changes and left the CMS in April.

Those two rules are seen as deregulatory, she said. The ones pertaining to the anti-fraud law may be delayed, but Cleary said she “would be surprised if they were shelved.

“A lot of blood, sweat and tears have gone into those rules, and industry is really counting on HHS to follow through,” said Cleary, a partner at Akin Gump Strauss Hauer and Feld.

To contact the reporter on this story: Shira Stein in Washington at sstein@bloomberglaw.com

To contact the editors responsible for this story: Bernie Kohn at bkohn@bloomberglaw.com; Fawn Johnson at fjohnson@bloomberglaw.com

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