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CMS Releases Long-Awaited Sunshine Act Final Rule

Global Life Sciences: US-Healthcare Update

After a long period of delay, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) at last released its final rule (the “Final Rule”) implementing the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act) (the “Act”) on February 1, 2013. Due to the Agency’s delay, CMS will not require applicable manufacturers to report payments occurring prior to August 1, 2013, and the first manufacturer reports made pursuant to the Act will be due to CMS by March 31, 2014.

In response to numerous comments, CMS implemented significant modifications to several of its original proposals in an attempt to streamline tracking and reporting obligations for manufacturers. For example, CMS finalized several provisions to simplify the reporting of research payments, including eliminating the proposed requirement that applicable manufacturers report research payments as direct or indirect and implementing a process by which research-related payments will be reported and published separately from other payments and transfers of value made to covered recipients. In addition, CMS has made modifications related to reporting indirect payments provided through a third party, reporting the value of food and beverages provided in group settings, delayed publication, dispute resolution, and attestation, among others.

Additional detail regarding the provisions of the Final Rule is available here.

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Meenakshi Datta 

Donielle McCutcheon 

Catherine Starks 

Healthcare Practice 

Our Healthcare Practice represents participants in all facets of the healthcare industry, including pharmaceutical, biotech and device companies, DME suppliers, hospitals, skilled nursing facilities, physician-owned companies, professional associations and research institutions. Our lawyers combine a strong background in the complexities of healthcare financing and delivery, including coding, reimbursement, and coverage issues, privacy and security, trade regulation, and competition. We have extensive experience representing clients on enforcement and regulatory matters before federal and state enforcement agencies.

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Paul E. Kalb, M.D.

Richard Raskin

Sidley Global Life Sciences Practice 

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology.

Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and leaders in various life sciences fields.

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Scott Bass

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