Biden Administration Pressed To Revamp CMS Demos, Make Admin Changes To Medicare In 2021

Inside Health Policy

January 6, 2021 3:03 pm

Lobbyists and stakeholders are urging the incoming Biden administration to tackle health care changes through an administrative lens, coming as the courts face pressure to watch how the new administration acts on key policies before moving on cases involving regulations like the public charge rule. Health care advocates also enter 2021 with ambitious legislative agendas, the outcome of which could hinge on Georgia’s special Senate elections. Yet, the immediate health care focus in 2021 will be on COVID-19.

In addition to crafting its own national COVID-19 response strategy, the new administration will need to decide how to address a slew of coronavirus regulatory waivers put in place by the Trump administration.

The outgoing Trump administration also spent its last few months instituting new demonstration projects, regulations and advisory opinions that the incoming administration — and Biden’s HHS secretary pick Xavier Becerra — will have to factor into their plans.

Senate Finance ranking Democrat Ron Wyden (OR) and committee member Tom Carper (D-DE) are pressing Finance Chair Charles Grassley (R-IA) to quickly begin the confirmation process for Becerra the Treasury nominee so they are in a position to tackle the pandemic and the economy on day one of the new administration.

COVID-19. The federal government will wait until late January, after the new administration takes office, to begin a national campaign to combat skepticism of the COVID-19 vaccine, HHS officials told reporters Tuesday (Dec. 29). Career officials said they would have preferred starting the campaign earlier, but public health officials face high levels of public distrust under the Trump administration.

Recent polls show that roughly half of the population is unsure whether to take a COVID-19 vaccine when it’s available to them. National Institutes of Allergy and Infectious Diseases Director Anthony Fauci recently said as many as 90% of Americans need to get vaccinated for the country to achieve herd immunity.

Meanwhile, FDA wants developers of at-home and over-the-counter COVID-19 tests to ensure their testing platforms are set up to report users’ results to public health officials, but one cybersecurity consultant warns that allowing software to share user information raises the potential for cybersecurity and data integrity issues.

Innovation center and value-based care. The Trump HHS is saddling the incoming administration with a series of new Medicare demos, and stakeholders are watching to see whether the Biden team will embrace them. For example, in early December CMS released the third part of the innovation center’s direct contracting demonstration, known as the Geographic Direct Contracting Model, or Geo, but the full-risk demo, which will require participants to take on risk for beneficiaries in an entire geographic region, isn’t slated to get started until 2022, well into President-elect Joe Biden’s term.

CMS Administrator Seema Verma has said this shouldn’t be a problem, but stakeholders are split on whether the Biden administration should continue it. America’s Physician Groups supports the demo, while the Center for Medicare Advocacy and the National Association of Accountable Care Organizations want the Biden administration to put it on hold.

Meanwhile, the American Society for Radiation Oncology wants to work with HHS on changes to the mandatory radiation oncology demonstration once the Biden administration takes office in January. Congress in its 2020 year-end law delayed the start date of the highly criticized CMS radiation oncology model demonstration until Jan. 1, 2022, six months beyond what CMS proposed in a final rule earlier in December but in line with what stakeholders had requested.

The Health Care Transformation Task Force is urging the Biden administration to publicly support value-based pay and the innovation center overall, after Verma recently said the entire center needs a course correction as few models have seen success.

“At the core of CMS’s current analysis appears to be a flawed approach to VBP model evaluations, and we believe a better way to evaluate models is needed. The HCTTF is actively gathering perspectives on better ways to modernize evaluations of VBP models from experts and will share with CMS any resulting recommendations in early 2021,” the task force says in a Dec. 18 letter to incoming administration.

The group also says CMS’ view “appears to be premised on the conclusion that net savings to the Medicare program is the sole measure of success. We disagree here too.”

The group calls for CMS, in the first 100 days of the new administration, to begin a national dialogue about the innovation center’s operations, models, evaluations and lessons learned. There are circumstances where the net savings for a model might not be positive, but the CMS chief actuary could find that an expanded, permanent model would achieve savings — especially if a national model moved from voluntary to mandatory participation as part of an expansion, the group says.

Medicare administrative changes. Aside from work by the innovation center, the Center for Medicare Advocacy says there are numerous changes that the incoming administration could tackle to improve Medicare. These include long-standing requests by the group for CMS to improve the Medicare appeals system, increase access to durable medical equipment for those dually eligible for Medicare and Medicaid, enforce the Jimmo v. Sebelius court decision and hold more meetings with advocates.

The advocates also want the incoming administration to withdraw the Trump administration’s proposed SUNSET rule that they worry could lead to the expiration of critical Medicare and other regulations. The rule, proposed by HHS the morning after the election, calls for the department to review its rules every 10 years to determine whether they’re still necessary or too burdensome.

The advocates also make the case that the incoming administration can — and should — change how beneficiaries’ time in a hospital under outpatient observation factors into whether Medicare covers a nursing home stay. They also say Medicare can, and again should, make sure it covers medically necessary dental care.

The center also says the Biden administration should rescind the so-called public charge rule, arguing the rule creates “almost insurmountable barriers to entry into the United States for older immigrants.”

The courts. Democratic states and consumer advocates are asking the Supreme Court not to take up a lower court ruling that paused the Trump administration’s controversial public charge policy that denies green cards for immigrants who could benefit from public programs including Medicaid, arguing in briefs filed Dec. 9 that the high court should sidestep the case because the incoming Biden administration is likely to overturn the public charge policy.

In other court news, the U.S. Court of Appeals for the District of Columbia Circuit on Dec. 29 ruled that HHS could move forward with its controversial hospital price transparency rule on Jan. 1, agreeing with a lower court just days before the rule was set to go into effect.

Becerra, meanwhile, has been a vocal opponent of the Trump administration’s efforts to dismantle the Affordable Care Act. He led the Democratic states fighting the lawsuit, California v. Texas. The Supreme Court is expected to announce the fate of the ACA early in Biden’s term, and the lawsuit could take center stage the first year of Biden’s presidency.

Becerra has also waged lawsuits against Republicans on multiple other health care policies — from abortion rights to the Trump administration’s public charge rule to drug company kickbacks.

340B. Becerra could also step into lawsuits — and an ongoing controversy — around 340B discounts at contract pharmacies, and he has said that HHS should make sure those discounts are available.

Following three lawsuits that ask the courts to force the Health Resources and Services Administration to stop Eli Lilly, Novartis, Astra Zeneca, Sanofi, United Therapeutics and Novo Nordisk from limiting 340B drug discounts through various contract pharmacies and claims sharing policies, the HHS Office of General Counsel said Dec. 30 that drug manufacturers are required to provide 340B discounts to providers in the program via contract pharmacies.

An advisory opinion from the counsel’s office says the method by which 340B providers dispense drugs doesn’t affect the drug makers’ obligation to provide discounts. However, HHS also notes the advisory opinion is not a final agency action and doesn’t have the force of law — though it says the opinion lays out the general counsel’s interpretation of the statute and thus manufacturers’ obligations.

“We are enormously pleased that the Department of Health & Human Services has issued this opinion. The important work of repairing the damage done to these hospitals must begin as quickly as possible. We stand ready to work with the department to identify overcharges and facilitate refunds,” said 340B Health President and CEO Maureen Testoni in a statement.

Surprise Billing. The surprise billing battle may be over in the halls of Congress, but provider groups, hospitals and insurers are just beginning their battle at HHS, as the agency gears up to begin its rulemaking process now that the president has signed the year-end legislative package.

The No Surprises Act, which is tucked into Congress’ 2020 year-end spending law, says that by July 2021 the HHS secretary, along with the secretaries of Labor and Treasury, need to establish details surrounding the arbitration and payments process. The surprise billing ban is set to go into place Jan. 1, 2022.

The National Coalition on Healthcare, is urging the Biden administration to immediately work to lower health care costs by quickly implementing the surprise billing legislation, as well as extending financial assistance to struggling providers and working with Congress to incentivize states to expand Medicaid.