Washington Watch for October 2021

The federal government will remain open following passage of a continuing resolution (CR) on September 30, the final day of the fiscal year (FY). The stopgap spending bill (H.R. 5305) funds the federal government at current levels through December 3. The measure also provides emergency funding for disaster relief and Afghan refugee resettlement and extends current restrictions on fentanyl analogues through January 28, 2022. The government’s authority to prosecute illegal possession of such substances was currently set to expire on October 22. The funding package passed both chambers with bipartisan support.

Impasse Remains on Debt Limit
The government funding measure does not address the debt ceiling, which must be raised or suspended in the coming weeks to avoid a U.S. default. Treasury Secretary Janet Yellen warned lawmakers in a letter last week that her department will exhaust its extraordinary measures if Congress has not acted on the debt limit by October 18, warning that a failure to act will result in a financial crisis and recession. Democrats had hoped to address both government funding and the debt ceiling in a single vehicle, but Republicans have vowed to vote against a clean debt limit suspension or increase while Democrats have ruled out using the latest reconciliation package.

Infrastructure and Reconciliation
Passage of the bipartisan infrastructure framework has stalled because of Democratic disagreements over the latest reconciliation package. The House of Representatives had planned to vote on the $550 billion infrastructure bill last week, but the vote has been postponed indefinitely because it lacked the necessary support for passage.

Progressive Democrats have pledged to oppose the infrastructure legislation until agreement has been reached on the details and passage of the Build Back Better reconciliation measure. Senators Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.) oppose the total size of the reconciliation bill as it currently stands at $3.5 trillion. Following discussions between President Joe Biden and the two moderate senators on Friday, the upper limit of the social spending plan is now expected to land between $1.5 trillion and $2.3 trillion. It remains unclear whether there is enough support for the inclusion of certain health care related measures, such as the current versions of Medicare and Medicaid expansion and drug pricing provisions.

Latest Surprise Billing Regulation Released
The Biden administration released regulations last week outlining how the No Surprises Act’s independent dispute resolution (IDR) process will work to resolve billing disputes between providers and insurers. The law, which applies to items and services provided under plans or coverage beginning on January 1, 2022 or later, aims to avoid patient receipt of surprise medical bills and provide a resolution process for disputes between plans and providers over payment. In the case of a billing dispute, patients can only be billed for the amount for which they would be responsible if the care had been delivered by a provider at a facility in their insurance network. This latest interim final rule details how dispute resolution process will work at the federal level for disputes that are not governed by state law or regulation.

As part of the federal IDR process, under the statute, arbitrators must consider rates paid for the same service in an area, the training and experience of the health care provider, the market share held by providers and payers, the complexity of a patient’s case, certain facility factors, and whether providers and payers have made good faith efforts to contract with each other. They are prohibited from considering usual and customary rates or payment rates by public programs (i.e., Medicare and Medicaid). The rules released last week create an IDR framework where the qualifying payment amount (QPA) – based on a health plan’s median contract rate for similar services in a geographic area – will be relied on as the primary benchmark upon which billing disputes are settled (when eligible for the federal IDR process). The Independent Dispute Resolution (IDR) entities that will conduct payment determinations will be certified on a rolling basis; applications are due by November 1. The rule also details requirements for providing cost estimates to uninsured individuals and for the external review process for individuals to dispute denied payment for some types of claims. The agency released two fact sheets on the rule, one on requirements related to surprise billing, and another on “what you need to know” about the administration’s actions to prevent surprise billing. The administration also released a fee guidance for the IDR process, specifying the allowable fees that certified IDR entities will be able to charge in 2022, as well as the administrative fee that parties to a dispute must pay to undergo the dispute process.

The administration is expected to continue to release regulations as necessary to implement the No Surprises Act. While House Energy and Commerce Chair Frank Pallone (D-N.J.) and Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) applauded the rule for establishing “a fair payment resolution process between providers and insurers while finally taking patients out of the middle,” others such as Rep. Brad Wenstrup (R-Ohio) argued that the rule is not in keeping with congressional intent. “This HHS Second Rule on surprise billing is a disaster for patient access. Congress was very clear that we did not intend to create a de facto benchmark for negotiations when creating the arbitration process…If unchanged, this rule will disincentivize insurance companies from keeping providers in their networks, limiting care for Americans, and threatening the health and safety of our nation,” Wenstrup stated.

A bipartisan group of 97 representatives previously sent a letter to the agencies stating, “To match Congressional intent, your implementation of the law should ensure an IDR process that captures the unique circumstances of each billing dispute and does not cause any single piece of information to be the default one considered.”

New GAO Report on MIPS Provider Experience, Performance
The Government Accountability Office (GAO) has released a new report on the experience and performance of providers under the Merit-Based Incentive Payment System (MIPS). The report found that from 2017-2019, over 90% of providers earned a small increase (less than 2%) to their Medicare payments. Providers questioned whether MIPS helps to meaningfully improve quality of care or patient outcomes. Some providers interviewed also raised concerns that the program’s design incentivizing reporting over quality improvement.

FDA, CDC Sign-off on Booster Shot Recommendations
The Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer- BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

• individuals 65 years of age and older;
• individuals 18 through 64 years of age at high risk of severe COVID-19; and
• individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Director for the Centers for Disease Control and Prevention (CDC) Rochelle Walensky broke with the recommendations of her agency’s advisory committee in her decision to endorse the Pfizer booster shot for people at risk of contracting COVID-19 because of on-the-job exposure. The CDC is recommending:

• people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
• people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

The CDC’s Advisory Committee on Immunization Practices (ACIP) had previously endorsed the Pfizer-BioNTech booster shot for people 65 and older, nursing home residents, and those with underlying medical conditions at risk of developing severe disease. Last week, ACIP’s interim recommendations rejected a booster campaign for health care workers and others who may be at increased risk of contracting their virus through their jobs or an institutional setting. In overruling the advisers, Walensky noted that the CDC’s recommendations for booster use will align with the FDA’s authorization. The booster shot rollout will likely rely on a system of self-attestation.

Lawmakers Urge CMS to Address Physician Fee Cuts
A group of more than 70 bipartisan members of the House of Representatives have sent a letter to the administration urging Director of the Center for Medicare Meena Seshamani to not finalize the clinical labor policy in the 2022 physician fee schedule (PFS) final rule. The letter, led by Representatives Bobby Rush (D-Ill.) and Gus Bilirakis (R-Fla.), warns that the cuts in the proposed rule disproportionately impact certain providers and may lead to practices closing or consolidating with larger health systems. “Year-over-year ‘budget-neutral’ cuts, being implemented during a pandemic, are causing significant disruption to the health care system and are being implemented without regard to patient outcomes, actual PFS provider resource needs, or any other rationale policy,” the lawmakers argue. They urge Seshamani to work with Congress on fundamental reform to the PFS this year to better address the scheduled cut to the conversion factor resulting from budget neutrality requirements.