HealthCare Roundtable e-News – April 21, 2021

Nominees for CMS Administrator, Deputy HHS Secretary, Questioned on Telehealth, Medicare Waivers in Confirmation Hearing

Last Thursday, the Senate Finance Committee held its first confirmation hearing for Biden’s picks to lead CMS and deputy HHS secretary. In the session, Chiquita Brooks-LaSure, Biden’s nominee for CMS administrator, and Andrea Palm, nominee for deputy secretary, answer questions relating to the administration’s recent revocation of Medicaid work requirement waivers and its proposals to lower the Medicare age threshold and increase funding for home and community-based services.

Brooks-LaSure had not spoken about her stance on telehealth waivers and reimbursements prior to the hearing, but promised lawmakers she will work with them and within CMS to continue COVID-19 flexibilities on policy proposals. When questioned by Sen. Maria Cantwell (D-Wash.) on topics from telehealth reimbursement to broadband investment, Brooks-LaSure emphasized the agency would need to ensure program integrity when setting pay.

“Reimbursement, I would say, is something I, if confirmed, would be happy to talk to you and think through,” Brooks-LaSure told Cantwell. “There’s certainly, you know, safeguards that we need to make sure to—from a program integrity perspective—make sure that we know that services are being delivered.” (InsideHealthPolicy)

Palm was questioned throughout the hearing on various topics, including nursing homes and provider relief funds. Sen. Steve Daines (R-Mont.) asked Palm about her stance on who should be prioritized when distributing the remaining provider relief funds. The senator, among a bipartisan group of 23 other lawmakers, asked HHS in a letter last week—prior to the hearing—to prioritize senior living operators when allocating the estimated $23 billion left in the provider relief fund. Palm replied that all frontline workers “have borne the brunt of this pandemic. When I was in Wisconsin, we added additional dollars to what the feds were providing to help ease the workload and the burden that they were facing.” (InsideHealthPolicy)

PhRMA Legislative Agenda Opens Doors for Ending Drug Patent Gaming

According to an announcement from the Pharmaceutical Research and Manufacturers of America regarding their upcoming legislation agenda, it appears that brand-name drug manufacturers will be open to discussing policy to end some patent-gaming industry practices.

Among the more common industry gaming practices includes “product hopping,” a process by which brand drug makers look to move patients off a drug that is nearing the end of its monopolistic life over to a reformulation of the drug that has longer exclusivity. Product hopping was called out specifically in the agenda, referencing The Affordable Prescriptions for Patients Act by Sens. John Cornyn (R-TX) and Richard Blumenthal (D-Conn.), that would end that industry practice by codifying Federal Trade Commission definitions of “product hopping” and “patent thickets” to give the commission clear authority to bring antitrust suits against companies that use those tactics. The Public Sector Roundtable has long advocated to end patent gaming. (InsideHealthPolicy)

The practice of “patent thicketing” involves overlapping intellectual property rights for brand drugs that companies must hack their way through in order to actually commercialize new technology or generic drug. While “patent thickets” were not called out specifically in the agenda, the organization stated that it “supports addressing patent settlements at the federal level to ensure generic, biosimilar and innovator companies can resolve patent litigation and allow generic and biosimilar medicines to enter the market prior to the expiration of innovators’ patents without applying new policies retroactively to previous agreements or restricting companies’ ability to enter into pro-competitive agreements in the future.” (InsideHealthPolicy)

PhRMA’s legislative proposals are a part of a campaign that is expected to clash with House Democrats’ plan to let Medicare negotiate drug prices and extend those prices to the commercial market. Democratic leaders, including House Speaker Nancy Pelosi (D-Calif.), are expecting the savings from drug pricing reforms to help fund President Joe Biden’s infrastructure package.

White House May Consider New Public Health Option Or Credit Expansion In Effort to Close Medicaid Gap

According to health policy experts, the Biden administration may look to create a targeted federal program similar to a public option or give access to free health plans on the marketplace in an effort to close the Medicaid gap. Millions of Americans would be eligible to apply though health experts warn that the policy must be carefully crafted to not incentivize expansion states to drop coverage.

President Biden’s American Rescue Plan included a 5-percentage point increase in federal Medicaid matching funds in order to potentially convince hold out states that have not yet expanded Medicaid to do so. So far none have acted, and the refusal to expand Medicaid has left coverage out of reach for millions of Americans who earn less than the 100% of the poverty threshold for receiving the ACA tax credits, but whose incomes are still too high for their state’s traditional Medicaid program. Some experts have said the administration may also seek to propose expanding the ACA’s premium tax credits to essentially offer expansion-eligible people a free plan in the marketplace where the infrastructure already exists. (InsideHealthPolicy)

Other experts have concluded that a public option is not the only way for the federal government to close the Medicaid gap. Sara Rosenbaum, a professor of health law and policy at George Washington University, thinks a free option for expansion-eligible people on the marketplace through the COVID-19 public health emergency is the best way to close the gap. Rosenbaum concluded that the move could give states a bridge period to undertake expansion, though commented on the fact that interestingly enough, lawmakers could have included it in the American Rescue Plan and didn’t. (InsideHealthPolicy)

Biden Administration to Invest $1.7 Billion to Fight COVID-19 Variants

The Biden administration announced last week that it would donate up to $1.7 billion from the American Rescue plan to help the CDC and local governments monitor new coronavirus variants appearing across the country. The investment includes an expansion of genomic sequencing, establishing new centers of excellence, and creating a national infrastructure for sharing and analyzing genomic data.

In February, U.S. laboratories were only sequencing in the arena of 8,000 COVID-19 variants per week, but sequencing has increased substantially over the last month, according to the White House. Due to an increase in investments—around $200 million funded so far—labs are currently sequencing about 29,000 samples per week. Additional investments will further expand laboratories’ abilities to monitor and defeat the variant strains of COVID-19.

“With this critical and substantial investment, CDC will fund the equipment, supplies, training staff and electronic infrastructure, partnerships, and innovation needed to build a robust national genomic sequencing effort,” CDC chief Rochelle Walensky announced at a press briefing on Friday (Apr.16). Six Centers of Excellence in Genomic Epidemiology will be set up with an additional $400 million from the budget, and $300 million will support development of a National Bioinformatics Infrastructure. (InsideHealthPolicy)

Becerra Promises to Solicit Feedback from Stakeholders on Surprise Billing Legislation

House appropriators questioned HHS Secretary Xavier Becerra last week on surprise billing, raising concerns that the secretary might avoid soliciting feedback on the legislation, titled the No Surprises Act. Rep. Andy Harris (R-MD) urged the agency not to issue an interim final rule on the subject without lawmakers being given the opportunity to share their input. In her own confirmation hearing last week, Chiquita Brooks-Lasure, President Joe Biden’s nominee for CMS Administrator, told Senate Finance Committee lawmakers that she would work hard to get a rule out as soon as possible.

Currently, the No Surprises Act bars providers from billing patients more than the in-network charges for emergency treatment done at an out-of-network hospital, or for services performed at an in-network facility by a physician who is out of network. The legislation will require the provider to bill the insurer, and each party has 30 days to negotiate a payment. If an agreement still cannot be reached, either party could move to independent dispute resolution, with the arbitrations set to be “baseball style”. (InsideHealthPolicy)

“I’d like to know if you could commit that you will give ample opportunities for stakeholders to participate in the rulemaking process by assuring that there will be a proposed rule with a 60-day comment period on this,” asked Harris on the subject of the final interim rule approach, to which the secretary replied saying that before HHS takes any action, it will get feedback and make sure the department’s actions are based on the science and the law. (InsideHealthPolicy)