‘Open Payments’: Has CMS gone too far?

Washington-I’ve been writing this column for Urology Times since the 1980s, and I’ve generally refrained from offering opinions or editorializing about legislation or regulatory developments affecting urologists. So I hope that longevity, at least, will allow me to stray from the path just a little this time.

“Open Payments,” also known as the Sunshine Act, is an Affordable Care Act program designed to inform the public about possible financial relationships or influences between drug and device manufacturers and health care providers.

As a consumer, that’s a good thing. Do I want my doctor giving me advice or recommending a drug or procedure because he has a sweetheart deal with a drug or device manufacturer? Of course not. But do I care if he gets a pen worth more than $10 from some drug company? Come on.

For docs, program starts March 31

As all too often is the case, the feds can’t just stop with implementing the law in a common sense way; they seem to take it to an extreme. Such is the case with this program, which is already requiring drug and device companies and group purchasing organizations (GPOs) to do some heavy-duty paperwork, and as of March 31, will begin to directly affect physicians.

“We view this program as a national resource for beneficiaries, consumers, and providers to know more about the relationships among physicians, teaching hospitals, and industry,” the Centers for Medicare & Medicaid Services said in an online fact sheet for physicians.

OK. Good.

Under the program, manufacturers and applicable GPOs are required to report to CMS:

• payments and other transfers of value of covered drugs, devices, biologics, or medical supplies to physicians and teaching hospitals

• payments and other transfers of value to physician owners/investors

• ownership or investments held by physicians or their immediate family in manufacturers and GPOs.

While CMS points out that physicians are not required to register with or send information to Open Payments, they have yet another administrative responsibility to deal with if they want to avoid getting slammed by inaccurate information reported to CMS and posted on a special website that will be available to consumers.

And so, CMS “encourages” physicians to:

• become familiar with the information that will be reported about them

• keep records of all payments and other transfers of value received from manufacturers or GPOs

• register with CMS and subscribe to its listserv to receive updates regarding the program

• look at the information manufacturers and GPOs submitted about them

• work with manufacturers and GPOs to make sure the information submitted is correct.

In other words, you need to be on the lookout that a company doesn’t report that it sent you on a fancy trip to Puerto Vallarta when no such thing ever happened.

What must manufacturers report? Consulting fees. Speaker fees or fees for serving as faculty. Honoraria, gifts, entertainment, food and beverages, travel and lodging, education, research, charitable contributions, royalties or licenses, compensation for serving as faculty or speaker for an unaccredited and non-certified education program, grants, space rental, or facility fees (teaching hospitals only).

The AUA has been working to help its members prepare for this, including providing detailed information on its website and establishing a special “tool kit.” In a Jan. 7 Health Policy Brief, the AUA points out that the first data-reporting requirement takes place on March 31 and will cover all data collected from August through December 2013.

In the report, the AUA also notes that, with this information being available to the consumer beginning Sept. 30, “Some practices are concerned that the data could unfairly distort the positive nature of the collaborative relationships that physicians maintain with the industry.”

Textbooks, reprints reportable

But there is one additional problem that the AUA and a number of other medical groups, in a joint letter, have identified and called to the attention of CMS. Since textbooks and article reprints will be considered reportable under Open Payments, there is a concern this could affect physician education and quality of patient care.

CMS has concluded that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of these articles are “not directly beneficial to patients, nor are they intended for patient use.”

“We believe this conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge,” the joint letter states.

Now, there is one bright spot: Small payments or transfers of value (less than $10) do not need to be reported, unless they total more than $100 in a year.

And even better, if you go to an event like the AUA annual meeting and get a note pad or some pens, never fear. That won’t be reported. However, if a manufacturer hands out an item valued at more than $10, beware; they must track and report who received it.

In my humble opinion, this falls into the category of, “Don’t they have anything better to do?”UT

Subscribe to Urology Times to get monthly news from the leading news source for urologists.