Anthony Miles

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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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CMS Issues Final Rule Authorizing Extrapolation as Part of RADV Audits

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 … Continue Reading

HHS Distributes $30 Billion from CARES Act Public Health Emergency Funds

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 … Continue Reading