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This newsletter outlines key federal regulatory developments and highlights PAI’s advocacy on matters that impact physicians and patients, including updates on upcoming Merit-based Incentive Payment System (MIPS) dates and deadlines, preliminary 2019 QPP performance results, proposed and final rules by HHS and CMS, and more.

As the COVID-19 Public Health Emergency (PHE) continues, PAI’s advocacy efforts have focused on securing adequate financial supports and regulatory flexibilities to allow physicians to continue to safely care for their patients and remain financially viable. Please visit PAI’s COVID-19 Resources page and the Healthsperien COVID-19 Resource Updates page for up-to-date information. 

Upcoming Important MIPS Dates and Deadlines

On November 2, CMS released the following important upcoming MIPS dates and deadlines for physicians:

CMS Releases Summary and Infographic of Preliminary 2019 QPP Performance Results

On October 27, CMS released a summary and infographic on the preliminary 2019 Quality Payment Program (QPP) performance results. CMS has not yet released a full, detailed report of the performance results. Below we share CMS’ key findings, as well as our additional insights.



Various researchers have noted issues with MIPS, especially related to scoring physicians with high socially at-risk populations and category skipping, resulting in lower reimbursements or even negative adjustments for physicians and other qualified providers.

PAI has previously weighed in on the issue, advocating to simplify the program and reduce the physician burden. PAI is committed to ensuring physicians are afforded opportunities to successfully participate in the QPP, and to continue providing and be rewarded for their high-quality patient care.

HHS Proposed Rule: Securing Updated and Necessary Statutory Evaluations

On November 4, HHS released a proposed rule requiring the Department to assess its regulations every 10 years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of certain significant regulations. If a regulation is subject to the RFA, the Department must review the regulation every 10 years to determine whether the regulation is still needed and providing the appropriate impacts. Regulations will expire if the Department does not assess and (if required) review them in a timely manner. Certain regulations are exempt, including regulations that are jointly issued with other agencies, regulations that legally cannot be rescinded, and regulations issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters. Regulations that affect other agencies will be reviewed in conjunction with those agencies. This proposed rule may pose an issue for physicians if drastic changes are made to physician-related regulations that would require substantial retraining for physicians.
 
HHS requests comments on all aspects of this notice of proposed rulemaking, including its likely costs and benefits. General comments on the proposed rule are due by December 4, 2020. Comments pertaining to the application of the proposed rule on the ‘federal old age, survivors, and disability insurance’ section of the Social Security Act are due by January 4, 2021. To read the proposed rule and submit comments, please click the following link.

HHS Announces Extended Compliance Dates for Information Blocking and Health IT Certification Requirements

On October 29, the HHS Office of the National Coordinator for Health IT (ONC) released an interim final rule that extends the compliance dates and timeframe for meeting certain requirements from the 21st Century Cures Act regarding information blocking and Conditions of Certification (CoC) and Maintenance of Certification (MoC) requirements. The Cures Act mandates certain new health information technology (HIT) certification requirements meant to improve patient access to health information on mobile devices. In April, ONC provided three months of relief from the initial timelines for health IT stakeholders to comply with the Cures Act Final Rule. Following further requests for flexibility, the new interim final rule allows stakeholders additional time to respond to threats posed by COVID-19 and establishes new dates for compliance with the statute. Compliance with information blocking and CoC/MoC provisions has been pushed back to April 5, 2021, while the timelines for other provisions have been extended until December 31, 2022. PAI has previously expressed support in requiring developers to satisfy CoC and MoC conditions. While we understand the reasoning behind the extension, we want to ensure that without too much delay, compliance will be enforced for health IT stakeholders. The interim final rule can be accessed here.

CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

On October 28, CMS released Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency Final Rule with Comment Period (IFC) and fact sheet. This rule codifies vaccine coverage and payment requirements for Medicare Part B, commercial plans, Medicaid, CHIP, and the Basic Health Program per the CARES Act and Families First Coronavirus Response Act (FFCRA). The IFC also outlines regulatory flexibilities for state Medicaid Programs, and enhanced Medicare payments for new COVID-19 treatments, among other provisions.
 
Notably, CMS discusses a reinterpretation of the Medicaid maintenance of eligibility requirements included in Section 6008 of the FFCRA that would allow states to make programmatic changes to benefits, cost sharing, and to transition individual beneficiaries between eligibility groups with differing benefit packages while still maintaining the expanded Federal Medical Assistance Percentages (FMAP) allowed under FFCRA. CMS calls this reinterpretation of the FFCRA language the “enrollment interpretation” because it may allow states to “make cost-saving decisions that could reduce beneficiaries’ coverage below what they had access to as of or after March 18, 2020,” and potentially allow states to transition beneficiaries to a benefit package below minimum essential coverage.
 
However, CMS ultimately chose to adopt a blended approach of its current interpretation and the new “enrollment interpretation,” which requires states to ensure that Medicaid beneficiaries who were validly enrolled for benefits as of or after March 18, 2020 with access to minimum essential coverage retain access to minimum essential coverage, and that beneficiaries with access to testing services and treatment for COVID-19 maintain access to those services. Comments are due by January 4, 2021 and can be submitted here.

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