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Sunshine Act update

CMS urged to delay data collection under ACA

Washington—Rep. Nydia Velazquez, D-N.Y., urged the Centers for Medicare & Medicaid Services July 18 to delay 'transfer of value' data collection from physicians and teaching hospitals, including dentists, scheduled to begin Aug. 1 under the Affordable Care Act.

The ACA "Sunshine Act" final rule requires manufacturers and distributors of drugs, devices, biological or medical supplies covered under Medicare, Medicaid and the Children's Health Insurance Program to report financial transactions and transfers of value to covered recipients and to begin collecting data Aug. 1 for reporting these transfers of value. This information will be reported to the CMS by March 31, 2014, for release on a public website by Sept. 30, 2014.

Dentists should be aware of possible manufacturer or distributor inquiries toward the required reporting of Sunshine Act transfers of value, including certain payments, entertainment costs, gifts, meals and travel costs. See also the ADA News March 4 'transfer of value' report. Rep. Velazquez, ranking member of the House Small Business Committee, expressed "serious concerns" with the Feb. 1 final rule as amended and "the short timetable" for compliance.

In a letter drafted with Association assistance, Rep. Velazquez told the Obama administration that "CMS should be assisting professional associations to ensure physicians, manufacturers and distributors are provided ample time to understand the impact of the amended rules on their members. This extension will ensure the affected parties are provided accurate guidance so they can comply with the law.

"Proper implementation is a challenge because the professional community consists of many small businesses that need to be duly informed prior to any implementation of the requirements. With solo practitioners making up nearly 70 percent of all dental practices, many lack the time and resources to dedicate towards researching the new rules. The burden of compliance, from implementing proper recordkeeping to correct reporting, will harm the 92 percent of small manufacturers in the dental industry because uncertainty remains in the final rules."

In many respects the regulations are "vague and provide insufficient guidance for professionals, manufacturers and distributors," Rep. Velazquez said in the letter to CMS, which is charged with issuing the lion's share of the regulations necessary to implement the Affordable Care Act.

"Given the lack of clarity and the possible adverse impact on patient interests, I respectfully urge CMS not to implement the final rule until adequate time has been allowed for the agency to address these specific issues, provide much needed clarification and for all affected parties to receive the education necessary to ensure proper implementation," Rep. Velazquez wrote. "I look forward to working with you as CMS implements the Sunshine Act."