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Tony Miles is a partner who focuses his practice on health care law with an emphasis on health care regulation and technology. He provides corporate, transactional and regulatory advice to a broad range of clients and entities whose products and services include multi-specialty physician practices, specialty and retail pharmacies, diagnostic radiology, disease management, electronic patient communication, e-prescribing and database support for clinical trials.

Tony helps health industry clients conceive, negotiate and implement strategic affiliations to expand their service offerings through collaboration, alternative care delivery structures and innovative benefits program structures in compliance with federal health program rules such as Medicare Part D, anti-kickback and self-referral ("Stark") prohibitions and other fraud and abuse provisions. Tony also helps clients protect and manage sensitive individual health information in compliance with HIPAA, FDA electronic recordkeeping requirements, security breach notification requirements and other federal and state privacy and security requirements. He also advises clients with legal and regulatory requirements concerning the distribution and marketing of FDA-regulated drugs, biologics and devices.

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As a result of a new rule published on February 1, 2023, at 88 Fed. Reg. 6643, Medicare Advantage (MA) organizations soon will be facing enhanced exposure from Risk Adjustment Data Validation (RADV) audits. Under the new rule, effective for audits of payment years 2018 and after, Centers for Medicare & Medicaid Services (CMS) will use extrapolation to calculate MA organizations’ repayment obligations based on RADV audit findings. While CMS did not adopt any specific extrapolation methodology and plans to use methodologies appropriate to the specific audit, it will be focused on contracts identified as being high-risk for improper payments using statistical modeling, data analytics, or both. CMS does commit to disclosing the extrapolation methodology used in connection with any particular audit so that MA organizations will know how their repayment obligation was calculated. Notwithstanding its prior proposal to do so (, CMS did not adopt a Fee-For-Service Adjuster in RADV Audits.  Relying on a recent D.C. Circuit decision, CMS takes the position that the obligation to report and return overpayments is not subject to the “actuarial equivalence” provision of the statute (42 U.S.C. § 1395w-23(a)(1)(C)) that applies to the risk adjustment payment methodology. UnitedHealthcare Ins. Co. v. Becerra, 16 F.4th 867, 885-86 (D.C. Cir. 2021), cert denied, 142 S. Ct. 2851 (2022).Continue Reading CMS Issues Final Rule Authorizing Extrapolation as Part of RADV Audits

On April 10, 2020, HHS announced the distribution of the first tranche of $30 Billion from the Provider Relief Funds authorized and appropriated under the CARES Act and deposited within HHS’s Public Health and Social Services Emergency Fund.  The funds released in this tranche are different from the previously announced Accelerated and Advanced Payment Program