Oct. 31, 2011 — Having already missed the Oct. 1 deadline for issuing guidelines to implement the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act (PPACA), the Department of Health & Human Services (HHS) needs to begin the process of fully implementing this law, according to a group of industry and other organizations that wrote a letter to HHS Secretary Kathleen Sebelius urging HHS to move forward.
Although the Oct. 1 deadline passed without HHS providing any reason for the delay or a proposed new strategy for implementation, the deadline for industry to begin collecting data under the law has not changed. Industry is anxious for HHS to get the ball rolling to establish transparency in the financial relationships between pharmaceutical/medical device companies and health professionals and teaching hospitals under the Sunshine Act.
“Time has run out,” remarked Coalition Executive Director John Kamp. “The effective date of the Sunshine rules must be delayed to enable both government and industry to fully prepare for efficient, effective compliance. These rules are way too important to create an unrealistic, reckless compliance deadline,” he said.
Indeed, “an absence of established procedures could harm the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of those relationships,” the Oct. 25 letter states. Signatories to the letter are: the Advanced Medical Technology Association, the Biotechnology Industry Organization, Community Catalyst, Consumers Union, Medical Imaging & Technology Alliance, Pew Health Group, and the Pharmaceutical Research and Manufacturers of America.
Industry also wants to ensure that it has a chance to weigh in on the guidelines before they are final, pursuant to a requirement in the law to “engage stakeholders and allow public comment on any procedures established related to the submission and public reporting of information under Section 6002 of PPACA,” states the letter.
Although industry may have resisted financial transparency in the past, those days are over, Kamp said. “Now, industry needs to know the rules to ensure compliance as well as the context of the data, so that providers and patients understand the purpose and value of industry cooperation, collaboration and innovation,” he noted.
Many industry members have “already invested significant resources in preparing to comply with the Sunshine provision,” the Oct. 25 letter stated, noting that covered entities must begin collecting information required by the law in a matter of weeks – starting Jan. 1, 2012. “Delays in establishing procedures for the submission and public reporting of the required information [March 31, 2013] will make it increasingly challenging for manufacturers to know whether they are meeting their statutory obligation as they begin to collect data in 2012,” the letter states.
Congress had established a three-month window after the original Oct. 1 date to complete implementation of
the Sunshine Act. With industry’s deadline for compiling data only nine weeks away, Kamp stated that “good government and reasonable compliance expectations demand a new implementation schedule.”