This newsletter outlines key federal regulatory developments and highlights PAI’s advocacy on matters that impact physicians and patients, including:

1. PAI Files Amicus Briefs Supporting Texas Medical Association’s (TMA) and American Medical Association (AMA) and American Hospital Association’s (AHA) Lawsuits Challenging Implementation of the Dispute Resolution Provisions of the No Surprises Act
2. The Centers for Medicare & Medicaid Services (CMS) Introduces the Patient-Physician Dispute Resolution Process
3. CMS Releases Consent Documents and Model Disclosure Notice under the No Surprises Act
4. President Biden Signs Medicare Physician Relief Legislation into Law
5. CMS and Occupational Safety and Health Administration (OSHA) Update Vaccine Mandates
6. CMS Seeks Recommendations on Specialty Measure Sets for 2023 Merit-based Incentive Payment System (MIPS)
7. CMS Terminates Seriously Ill Population Component of Primary Care First

PAI Files Amicus Briefs Supporting TMA and AMA/AHA Lawsuits Challenging Implementation of the Dispute Resolution Provisions of the No Surprises Act

PAI coordinated a broad coalition of physician organizations to file amicus briefs supporting two lawsuits that challenge federal regulators’ interim final rule (“IFR”) implementing the independent dispute resolution (IDR) provisions of the No Surprises Act.  

On December 17, 2021, PAI and thirteen state medical associations (including every PAI-affiliated state medical association, Kentucky Medical Association, Massachusetts Medical Association, Oregon Medical Association and Washington State Medical Society) filed an amicus curiae brief in support of TMA’s lawsuit challenging only the dispute resolution provisions in the IFR, leaving the consumer protection provisions in place. The lawsuit alleges that regulators failed to follow clear direction from Congress on how IDR entities should resolve surprise medical billing disputes between physicians and insurers under the law by considering several enumerated factors. By sharp contrast, the IFR relies almost solely on the insurer-determined “qualified payment amount,” which relates to the in-network median rate. PAI’s amicus brief emphasizes Congress’s decision to reject this type of rate-setting approach and to instead establish a balanced dispute resolution process in order to protect against unfair insurer behavior that will negatively impact patients’ to access care. The PAI brief supports TMA’s Dec. 13, 2021, motion for summary judgement, filed in the U.S. District Court for the Eastern District of Texas, as part of a lawsuit TMA filed on Oct. 28, 2021. If the motion is successful, the court would decide the case in favor of TMA without a trial.

On January 7, 2022, PAI and a coalition of seven national medical specialties and 16 state medical associations filed an amicus brief supporting similar litigation filed by the AMA and AHA in U.S. Federal District Court in the District of Columbia. This coalition of organizations collectively represent 620,000 U.S. physicians, residents and medical students, signaling a broad consensus of concern among physicians over the impact that this aspect of the IFR will have on patient care should it go into effect.

CMS Introduces the Patient-Physician Dispute Resolution Process

On December 22, 2021, CMS released guidance on the Patient-Physician Dispute Resolution Process (PPDR) that went into effect January 1, 2022. The No Surprises Act stipulates that physicians are required to give an uninsured (or self-pay) individual, or their authorized representative, a good faith estimate of the expected charges of an item or service once it is scheduled, or upon request. These good faith estimates must include a list of items and services expected to be provided as part of the initial reason for the visit, as well as any other items or services provided in conjunction within this period of care.

Should an uninsured (or self-pay) individual receive a bill at least $400 more than the expected charges of a good faith estimate, they can choose to initiate the PPDR process, engaging a third-party entity certified by the Department of Health and Human Services to arbitrate their dispute. This company will decide how much the uninsured (or self-pay) individual will pay to the physician or facility. The options are: the amount on the good faith estimate, the billed amount, or another amount in between the estimated amount and billed amount. To utilize this dispute process, there is a $25 administrative fee that the individual must pay at the start of the process.

PAI will monitor the impact of and continue to advocate for physicians as the No Surprises Act is implemented. Policies must ensure more rigorous network adequacy oversight, use of independent data to drive payment and the independent dispute resolution process, transparent and accurate plan information for patients, and accurate physician directories. 

CMS Releases Consent Documents and Model Disclosure Notice under the No Surprises Act 

On November 26, CMS released standard notice and consent documents (starting on page 3) as well as a model disclosure notice (starting on page 7) regarding balanced billing that is intended to be used by physicians and other healthcare providers beginning January 1, 2022. Summaries of the documents are provided below:

President Biden Signs Medicare Physician Relief Legislation into Law 

On December 10, 2021, President Biden signed the Medicare physician relief legislation, Protecting Medicare and American Farmers from Sequester Cuts Act, into law to avert the 9.75% payment cuts in 2022. All proposed provisions in the legislation were passed and are summarized below (policies highlighted in the light blue boxes have gone or will go into effect in 2022 and policies highlighted in the dark blue boxes have been deferred to 2023):

It is estimated that by the end of CY 2022, there will be a phased in 2.75% cut to physician payments – 0.75% cut on Part B services beginning January 1, 2022, 1% sequester cut from April 1^st to June 30^th, and an additional 1% sequester cut from July 1^st to December 31^st.

PAI is appreciative that Congress took swift action to address the significant payment cuts affecting physicians in 2022. However, these changes do not address the ongoing structural issues with sequestration, the Pay-As-You-GO (PAYGO) scorecard, and the Medicare Physician Fee Schedule (MPFS). Physicians must be able to prioritize providing care for their patients and not worry about impending cuts to reimbursement each year, especially as many continue to serve on the front lines of the pandemic.

CMS and OSHA Update Vaccine Mandates

On December 28, 2021, and January 4, 2022, CMS and OSHA, respectively, issued new guidelines concerning their vaccine mandates. CMS’ IFR issued on November 4, 2021, requires employees working in Medicare- or Medicaid-funded facilities be fully vaccinated against COVID-19 or be subject to testing by January 4, 2022. However, after two lawsuits, the agency initially noted it would not enforce the mandate while cases were ongoing. CMS then reversed course, requiring workers in states not affected by the lawsuits to receive their first shots by January 27 – when CMS will begin surveying for compliance – and their second by February 28. On January 13, the Supreme Court confirmed that the CMS rule can go into effect nationwide. They noted CMS has the authority to mandate as a condition of participation in the Medicare or Medicaid program that physicians be vaccinated or follow the prescribed testing requirements.

OSHA’s emergency temporary standard (ETS), also issued on November 4, 2021, requires employers with at least 100 employees to require their workers to be fully vaccinated by January 4 or be subject to weekly COVID-19 testing. The OSHA rule was not being enforced due to ongoing litigation but OSHA announced after the 6th Circuit reinstated the ETS, that they will issue citations for noncompliance with any requirements of the ETS after January 10 and will issue citations for noncompliance with the standard’s testing requirements after February 9. However, on January 13, the Supreme Court blocked the implementation of the OSHA ETS citing that the Agency had exceeded its authority to enforce such a mandate. As a result of this decision, OSHA will not be able to implement nor enforce the ETS.   

Key updates from each guidance are provided below:

CMS Seeks Recommendations on Specialty Measure Sets for 2023 MIPS 

On January 3, CMS announced they are accepting stakeholders’ recommendations regarding potential new specialty measure sets and/or revisions to existing specialty measure sets for the 2023 performance year of MIPS. All recommendations submitted will be considered and assessed for possible inclusion in rulemaking for the 2023 performance year of the Quality Payment Program. Submissions of recommendations should be sent to the Practice Improvement and Measures Management Support Quality Measures Support mailbox at PIMMSQualityMeasuresSupport@gdit.com by close of business on February 14.

CMS Terminates Seriously Ill Population Component of Primary Care First

On November 30, 2021, CMS announced they would not be moving forward with the Seriously Ill Population (SIP) Component of the Primary Care First (PCF) Model due to challenges with operationalization. The SIP component of PCF was designed to have advanced primary care practices, including physicians whose clinicians are enrolled in Medicare and who typically provide hospice or palliative care services, coordinate care for high need, seriously ill beneficiaries. CMS proposed a method for identifying and attributing eligible beneficiaries to participants, but after careful review determined that it is unlikely to result in sufficient beneficiary uptake to allow for model evaluation. CMS noted that as part of the Innovation Center's strategy refresh, they are exploring additional ways to serve seriously ill beneficiaries, whether through existing models or new model opportunities.