Sunshine spawns fresh questions for med ed Marc IskowitzFebruary 19, 2013

Many people in CME are breathing a sigh of relief that the Sunshine Act isn't a bad thing for them, but whether it's the white knight that comes to their rescue remains to be seen, say providers. The transparency rules, set to lay bare financial ties between physicians and pharma, spare some forms of medical education but not others, and they also spawn fresh questions.

The Centers for Medicare & Medicaid Services, part of HHS, issued its long-delayed final rule for collecting data on industry payments to physicians earlier this month. The regulations exempt reporting payments to an accredited provider of CME under a physician speaker's name, granted that certain criteria are met.

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United States: Here Comes The Sun: Final Rules Implementing The Federal Sunshine Law 21 February 2013 Article by Ropes & Gray LLP's Health Care Practice

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal Register on February 8, 2013.)

The Federal Sunshine Law requires manufacturers of drugs, biologics, devices and medical supplies covered under Medicare, Medicaid and the Children's Health Insurance Program to report payments and other transfers of value made to physicians and teaching hospitals to CMS for subsequent public disclosure. Collection of information was to begin January 1, 2011, but CMS had delayed collection pending promulgation of the final rule. The final rule requires collection of information beginning August 1, 2013 with information collected for 2013 to be reported to CMS on March 31, 2014.

CMS, in the final rule, responds to feedback from stakeholders as well as the HHS Office of Inspector General and implements regulations that depart from the proposed rule in significant ways. These departures reflect a better understanding of interactions between manufacturers and covered recipients and the agency's intent to ensure that the transparency created by the law discourages inappropriate relationships without harming beneficial relationships. CMS further seeks to allow reporting flexibility while providing the detail, clarity and standardized processes necessary to ensure accurate information.

Our detailed summary analysis of the final rule and CMS commentary is available here.

Key provisions in the final rule and clarifying commentary include:

• Limiting application of the law to manufacturers that have a physical presence or conduct activities in the United States (which includes selling a product in the United States);
• Finalizing the proposal to restrict application of the law to manufacturers of prescribed drugs and biologics (effectively excluding manufacturers of over-the-counter drugs) and to manufacturers of medical devices for which premarket approval by or premarket notification to the U.S. Food and Drug Administration is required (effectively excluding manufacturers of many Class I devices and some Class II devices);
• Clarifying that an entity under common ownership or control with a manufacturer (with common ownership requiring a minimum 5% ownership interest) is also a manufacturer only if the entity provides assistance or support that is "necessary or integral" to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered product.

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United States: CMS Releases Sunshine Act Final Rule, Finally 19 February 2013 Article by Wesley D. Anderson

After over a year of delays, on February 8, 2013 the Centers for Medicare and Medicaid Services (CMS) published its regulations (Final Rule) implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests statute, a key facet of the Affordable Care Act known more commonly as the Sunshine Act. The Final Rule was first issued on February 1, 2013 after the release of the Proposed Rule in December 2011 and the myriad industry comments that followed.

The Final Rule maintains the Proposed Rule's significant and far-reaching financial disclosure obligations for drug manufacturers, their affiliates, physicians (including dentists, podiatrists, optometrists and chiropractors) and certain teaching hospitals. The Sunshine Act generally requires manufacturers and their affiliates (applicable manufacturers) of drugs and other products covered under federal health programs (covered products) to report payments or other transfers of value to physicians and teaching hospitals (covered recipients). It further requires manufacturers and group purchasing organizations to disclose certain ownership and investment interests.

Regulators hope the Sunshine Act will increase transparency and deter financial relationships between drug manufacturers and providers that drive up the cost of health care. Affected providers and entities must begin collecting relevant data on August 1, 2013 and must report the data back to CMS no later than March 31, 2014. Some of the Final Rule's most significant changes include:

Applicable Manufacturers

The Sunshine Act defines an "applicable manufacturer" as an entity that operates in the United States and falls within one of two categories:

CMS Announces Final Regulations Interpreting the Physician Payment Sunshine Act--

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS)
published the final regulations interpreting the physician payment “sunshine”
provisions of the Patient Protection and Affordable Care Act (the Act).1

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FDA Blog: CMS Belatedly Issues Sunshine Rule; HP&M Promptly Issues Summary

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