Data Gathering for Sunshine Act Delayed

CMS Delays Data Gathering on Industry Payments to Physicians

May 11, 2012

May 11, 2012 — The federal government has once again postponed the implementation of regulatory requirements considered nettlesome by organized medicine.

Last week, the US Centers for Medicare and Medicaid Services (CMS) announced that pharmaceutical and medical device companies can wait until January 1, 2013, to begin collecting data on how much they pay or otherwise enrich physicians.

This requirement springs from the Physician Payments Sunshine Act, a piece of legislation incorporated into the Affordable Care Act. Its intent is to discourage relationships between industry and physicians that might compromise the latter's clinical judgment.

Companies are obliged to report to CMS any transfer of value of $10 or more, whether it is a consulting fee or a bag of bagels. They also must report whether physicians or their immediate family members hold an ownership stake beyond publicly traded securities.

The law required manufacturers to begin collecting this information about their financial relationships with physicians on January 1, 2012, and to report the 2012 data to CMS by March 31, 2013. In turn, CMS must post the data online in a searchable format by September 30, 2013.

The initial deadline for data collection had to be postponed because CMS took until December 2011 to issue proposed regulations on how to implement these sunshine requirements. At the time, CMS said data collection would begin after it issued a final version of the regulations sometime in 2012, and that it could possibly cover part of that year.

On May 3, CMS announced that drug and device makers would not have to go into data collection mode until January 2013. The agency said the delay would give affected organizations more time to prepare for data submission. In addition, CMS would have more time to address the voluminous feedback it received to the proposed sunshine regulations before it publishes final ones later this year.

Much of the feedback came from disgruntled medical societies. They asked CMS to guard physicians' reputations from inaccurate information about their relationships with drug and device makers that is posted online by allowing physicians to correct the information immediately. The proposed regulations lay out a slower timetable for corrections.

In addition, organized medicine recommended rewriting the reporting requirements to exclude payments made to physicians engaged in continuing medical education and to make sure that they are not credited with drug company meals they do not consume.

The 2 US senators who wrote the Sunshine Act said they were disappointed by CMS' decision to delay data collection until 2013. They have complained before about the agency's slowness in implementing the law.

"Consumers need to know more about the financial relationship between their doctors and drug companies sooner, rather than later," said Sen. Chuck Grassley (R-IA), who coauthored the legislation with Sen. Herb Kohl (D-WI).

Delays on ICD-10, Version 5010 Standards for Electronic Claims

The CMS decision to postpone the start date for companies to collect data on payments to physicians is the latest regulatory retreat by the government.

In April, the Department of Health and Human Services (HHS) announced that it would extend the deadline for physicians to begin using a new and expanded set of diagnostic codes called the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, or ICD-10, from October 1, 2013, to October 1, 2014. Organized medicine has decried the code set as overly complex and costly to implement. It wants HHS to come up with a simpler successor to the current diagnostic code set, called ICD-9.

In March, CMS also said it would push back the enforcement date for new standards designed to streamline electronic insurance claims from March 31 to June 30. The delay gives physicians, insurers, claims clearinghouses, and software vendors more time to switch their software over to the so-called Health Insurance Portability and Accountability Act Version 5010 standards, which will replace Version 4010. According to organized medicine, physicians who have tried to submit Medicare claims under the Version 5010 standards have had trouble getting paid.

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