HealthCare Roundtable e-News – September 21, 2021

Save the Date

2021 Annual Conference

Monday, November 1 – Wednesday, November 3, 2021<

To protect the health and safety of our members and to maximize the opportunity for everyone to participate, this year’s conference will once again take place virtually. Our preliminary agenda, together with links to the conference registration form, can be found here.

Ways and Means Advances Child Tax Credit Extension, Expanded Medicare Coverage as Part of $3.5T Package

Last Wednesday (Sept. 15), the House Ways and Means Committee passed several provisions to President Joe Biden’s Build Back Better plan on a near party-line vote of 24-19. Among the passed provisions are extensions to the child tax credit and expansion of Medicare to include dental, vision and hearing benefits.

The Committee’s vote to pass the last section of provisions includes a proposal to make permanent the American Rescue Plan’s expanded premium tax credits to help middle-income people buy coverage on the health exchange. The section also includes funding for elder justice programs, bolstering long-term care staffing and improving data collection in nursing homes. (InsideHealthPolicy)

The expanded child tax credit, which was included in the American Rescue Plan signed by Biden in March, will carry over through 2025 and give families a monthly payment of at least $250 per child. Rep. Steven Horsford (D-Nev.), who supported the tax credit extension, claims the child tax credit has helped about 177,000 children in his district so far by helping to cover doctors’ visits and more ahead of the new school year.

The section will next head to the House Budget Committee, which will combine the various pieces of the spending package approved by House panels.

Energy & Commerce Passes Medicare Dental, Vision, Hearing Benefits while Three Dems Block Passage Of H.R. 3

The House Energy & Commerce Committee voted last week to pass the expansion of Medicare dental, vision and hearing benefits, despite opposition from Republicans and three Democrats. The proposed plan to allow Medicare to negotiate drug pricing stalled, however, after Reps. Scott Peters (D-Calif.), Kurt Schrader (D-Ore.) and Kathleen Rice (D-NY) voted against advancing a provision of the $3.5 trillion package that would give Medicare the power to negotiate for lower drug prices in Medicare Part B and apply those prices to commercial plans.

Republicans expressed concerns about the cost of adding benefits to Medicare when the Part A trust fund nears insolvency and duplicating benefits already available through most Medicare Advantage plans. Schrader also shared his concerns during the markup about adding additional benefits to Medicare when the Part A trust fund is predicted to become insolvent in 2026. However, the new benefits would be covered under Part B, a separately-funded element of Medicare. (InsideHealthPolicy)

Committee Chair Frank Pallone (NJ) pleaded with Peters, Schrader and Rice prior to the vote on drug price negotiation, asking the lawmakers to vote for the bill in exchange for a chance to negotiate changes to H.R. 3. The three votes against the bill meant the vote on the drug price reform package, which included caps on out-of-pocket costs for Part D beneficiaries, failed to pass due to a tie vote. (InsideHealthPolicy)

A spokesperson for Peters said that there are “unanswered questions” about what the overall size of the package will be and the policies that can fit within that framework.

“He is not opposed to providing those benefits to seniors but acknowledges that there will likely be difficult choices to come on what investments make the most difference to the most people,” said the spokesperson in a statement. Peters and Schrader had previously outlined their own legislation that creates a yearly out-of-pocket cap on drug costs for Medicare beneficiaries. The proposal includes a watered-down version of the bill allowing negotiation power for Medicare and also includes a $50 a month out-of-pocket cap for insulin. (InsideHealthPolicy)

Biden Administration Proposes Repeal of Trump-Era Medicare Breakthrough Device Coverage Rule

The Biden administration proposed last week to repeal a Trump-era Medicare breakthrough device coverage rule allowing MedTech companies to secure near-automatic coverage for a period of four years with an FDA breakthrough device designation. The call for repeal comes from CMS’ concerns that the rule poses preventable patient safety risks by forcing the agency to immediately cover devices going through the speedy FDA approval path.

CMS claims that the Trump administration’s rule does not function in beneficiaries’ best interest and has raised concerns about the availability of clinical evidence that a breakthrough device would be reasonable and necessary for Medicare patients that have a condition that a device is intended to treat or diagnose, as well as the benefits – or risks – to the Medicare population from breakthrough devices. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, stated in a blog post that the agency plans to explore alternatives to the rule after it has been repealed.

“We believe it is important to evaluate how a device works for Medicare patients. This includes a potential decision to cover a device under Medicare in the context of collecting additional evidence (e.g. by requiring clinical trials or outcome registries) before broadly covering the device in the Medicare program,” Fleisher adds. (InsideHealthPolicy)

Some critics of CMS’ repeal argue that it’s critical for patients to have immediate access to FDA-designated and -approved “breakthrough” technologies, particularly for Medicare patients suffering from debilitating illnesses and conditions that existing treatments and technologies are unable to address. In a statement, AdvaMed commented that it is disappointed in the administration’s decision and that the group will have the chance to make its case before the action is finalized.

FDA Panel Rejects Widespread Use of COVID-19 Booster Shots, Endorses Limiting Third Shots to Older Americans

Over the weekend, the Food and Drug Administration advisory panel rejected a proposed plan to offer Pfizer COVID-19 booster shots to the general population and instead endorsed the extra vaccine dose only for those who are 65 or older or run a high risk of severe disease. Panel members rejected the plan over concerns about lack of data regarding safety and the value of mass boosters.

The panel rejected the endorsement of proposing a third booster shot by a vote of 16-2; however, following the initial vote, panel members also voted 18-0 in favor of extra shots for people 65 and older and those at risk of serious disease. Those who voted also agreed that health workers and others who run a high risk of being exposed to the virus on the job should get boosters, too.

The Biden administration had previously announced an effort to launch a COVID-19 booster shot program this fall, which will be set back as a result of the panel’s decision. Despite the program’s rejection, the administration is framing the FDA’s decision as progress towards the ultimate goal of protecting Americans from the virus, with White House spokesman Kevin Munoz calling the announcement an “important step forward in providing better protection to Americans from COVID-19.”

Dr. Anthony Fauci defended the panel’s decision to reject widespread use of a third booster shot, saying that he would support a third dose when the data shows it’s effective. Fauci noted that the FDA’s main priority should continue to be gathering new information on boosters and convincing unvaccinated Americans to get their initial vaccinations.