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Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is not dispositive with respect to whether such arrangement implicates the Federal Anti-Kickback Statute (AKS).  Specifically, OIG…

On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of Treasury, Labor, and Health and Human Services (the “Departments”) over a challenge to…

In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the United States Department of Health and Human Services’ (“HHS-OIG”) permissive exclusion authority under 42 U.S.C. § 1320a-7(b)(7) (“Permissive Exclusion Authority”).[1]  Inclusion of a conditional exclusion release is atypical, as HHS-OIG’s historical practice has been to provide an outright release of its Permissive Exclusion Authority in exchange for a CIA or IA.  It appears, based on an IA executed last month and the other recent CIAs and IAs, that a trend may be emerging.

Specifically, in December 2022, HHS-OIG entered into an IA with a Georgia-based physician, Aarti D. Pandya, M.D., and his practice, Aarti D. Pandya, M.D. P.C. (collectively, “Dr. Pandya”).  In atypical fashion, however, HHS-OIG required the IA to be for five years (as opposed to three years) and held Dr. Pandya to a conditional exclusion release contingent upon Dr. Pandya’s satisfactory completion of the IA (as opposed to outright providing a release of its Permissive Exclusion Authority).  This IA signals to the industry that HHS-OIG is not bound by precedent and that, perhaps, a belt and suspenders approach to resolving conduct allegedly violating the False Claims Act (“FCA”) may be emerging as HHS-OIG’s new norm.

We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment amount to be used in arbitrations by certified IDR entities (viz. the regulation-established independent dispute resolution (“IDR”) process) between plans and providers, and that the United States District Court for the Eastern District of Texas (“Texas District Court”) vacated portions of the NSA regulations relating to the QPA for purposes of the IDR process.  The Federal government recently responded to the Texas District Court—by removing such portions of the NSA regulations.

The Centers for Medicare & Medicaid Services (“CMS”) recently published the proposed 2023 Physician Fee Schedule (“PFS”), which contains several important changes affecting Accountable Care Organizations (“ACOs”) that participate in the Medicare Shared Savings Program (“MSSP”), including a new Advanced Incentive Program. See Proposed 2023 PFS, 82 Fed. Reg. 45,860 (July 29, 2022).

ACOs enable health care providers to provide coordinated patient care to Medicare beneficiaries, and to share in the savings resulting from improved care. According to CMS, as of January 1, 2022, over 11 million Medicare beneficiaries receive care from 483 ACOs across the country. Id. at 46,093.

The proposed changes are intended to advance “growth, alignment, and equity,” and to “increase the percentage of people with Medicare in accountable care arrangements.” Id. at 46,093-94. Of note, and as described in a publication preceding the PFS, CMS proposed the changes to increase (i)  the number of beneficiaries assigned to MSSP ACOs; (ii) the number of higher spending populations in the program, since the change to regionally-adjusted benchmarks; and (iii) the representation of Black (or African American), Hispanic, Asian/Pacific Islander, and American Indian/Alaska Native beneficiaries assigned to MSSP ACOs, as compared to Non-Hispanic Whites.

On February 24, 2022, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), announced the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, which will begin January 1, 2023, and replace the Global and Professional Direct Contracting (GPDC) Model.  The Request for Applications (RFA) has been posted on CMS’s website, and applications are due by April 22, 2022.  While the application is not binding, the failure to apply will foreclose any opportunity to participate.

This article discusses the termination of the GPDC Model, the establishment of the ACO REACH Model, and the differences between them.

We previously noted that the No Surprises Act (NSA) regulation’s establishment of the presumption that the qualifying payment amount (QPA)—generally, the median payment by the plan to providers in the region—is the appropriate payment amount in arbitrations between plans and providers under the NSA did not appear to comport with…

On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (“Final Rule”) that advances the shift from paying for Medicare home health services based on volume to a system that pays based on value. In addition to other matters, the Final Rule expands the…

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