As we noted last week, the Centers for Medicare and Medicaid (CMS) held a Conference Call entitled, “Special Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.”
During the conference call, a number of issues and questions were discussed regarding Section 6002 of the Affordable Care Act (ACA)—commonly known as the Physician Payment Sunshine Act—which requires the public reporting of payments or other value transfers made to physicians and teaching hospitals by manufacturers and group purchasing organizations of drugs, devices, biologicals, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program.
Before addressing the questions and comments, the moderator noted that CMS will soon begin a draft notice of proposed rulemaking on Section 6002, which is expected to be published later this year. She also noted that stakeholders should submit comments on the questions discussed during this conference call by April 7.
Comments can be emailed directly to physiciansunshine@cms.hhs.gov. Additionally, a recording of the call will be accessible until March 28 at 1-800-642-1687, meeting code: 51513536.
An audio recording and transcript of the call will be posted to the Special Open Door Forum website and will be accessible for downloading beginning on or around April 21, 2011.
A number of organizations and individuals participated in the conference call, including representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, Biotechnology Industry Organization (BIO), and the Association of Clinical Research Organizations. The moderator went through each of the questions and then participants offered comments.
Question 1: Other forms of payment or transfer of value
In response to this question, the overwhelming majority of comments indicated that CMS should not expand Section 6002 to other forms of payments or transfers of value.
Many comments firmly asserted that CMS must first clarify the statutes and rules applying to the current forms. Specifically, many participants noted that CMS is already going to be getting so much data from manufacturers on physician payments that it will be challenging enough to collect this information, organize it, and then make such information public. For example, one participant noted that in just a mid-sized pharmaceutical company, there could easily be more than 1 million transactions, with over 300,000 physicians. When you multiply that by all the companies in the U.S., this means a tremendously overwhelming amount of information and data to collect and analyze.
Accordingly, the unanimous sentiment was that CMS should get the proposed regulations done first, and not to expand to other forms. If, for whatever reason CMS decided to expand, one participant noted that it is crucial for CMS to indicate the intent of collecting this additional data, and to ensure that in their data collection process, CMS does not stifle innovation.
Question 2: Definitions of nature of payment or other transfers of value
Participants responding to this question were almost unanimous in asserting that CMS does not need to expand the definitions of natures of payment or transfers of value. It was noted that expanding the definition would provide no additive value than what Congress already proposed, and which is now public law. With respect to narrowing or broadening the scope of the definition, many participants emphasized the need to clarify the specifics of reporting.
Participants also expressed that Section 6002 already has enough categories for reporting and that there is no need for additional. On this issue, many noted the importance of CMS defining each category clearly, so that consumers, health care providers, and researchers can use the data correctly.
It was also noted again that currently, Section 6002 will give CMS so much information that CMS must first focus their proposed regulations on exactly what definitions will be used and the hierarchy of reporting that should be used. Specifically, many participants emphasized the potential for payment categories to overlap, and the need for CMS to ensure that reported payments do not fall into multiple categories or are counted twice.
Additionally, participants noted that the definitions were already specific enough, and in some instances too specific. For example, the requirement that payments for travel include destination was discussed and it was recommended that CMS tie travel in with the nature and purpose of the event in which travel was paid for, instead of a granular specification.
Question 3: Additional categories of information to report
One participant noted her experience in Massachusetts with payment reporting. She noted how payment for research grants often goes to an institution, and not a principal investigator. She recommended that the PI be included in the listed payment in addition to the teaching institution. This participant also noted that payments to other health care providers are reported in Massachusetts, and she recommended that categories be expanded under “teaching hospitals” to include nurse practitioners, physicians assistants, pharmacists, and other prescribers.
The majority of participants however emphasized that there is no need to add additional categories. Instead, many reiterated the need for CMS to ensure that payments are not double counted in categories, and the need for CMS to have clear and specific instructions spelled out about how payments are defined, such that they are only reported in one category.
Question 4: Ownership or investment interest
In response to this question, participants noted that under Section 82 of ACA, there is already a reporting requirement for physician owned hospitals. One participant noted that CMS should include a distribution model of physician owned hospitals. This participant also noted that CMS should review the legislative history that gave rise to these issues, and to review correspondence from the Office of the Inspector General (OIG) regarding physician owned companies.
Question 5: Average consumer information
Many participants emphasize the need for CMS and the Health and Human Services (HHS) Secretary to consult with health care stakeholders to assure that information provided to the public has an objective background, is directed at targeted to specific audiences, and that the information is clearly defined and explained. BIO recommended that CMS conduct focus group research and consult with experts to assure that the information presented is useful and not misleading.
BIO also recommended that CMS conduct such research here, and also establish a taskforce comprised of representatives from industry, the provider community and public advocacy groups to advise on the development of the required background information on industry-physician relationships to be posted on the website.
AdvaMed noted that reported information must emphasize how the interaction between industry and physician advances medical care, technology and treatment, in order to provide safe and effective medical care. They recommended that companies be allowed to provide additional contact information surrounding payments so that patients can better understand the payments.
ACRO noted that there are two kinds of payments: One from consumers for the agency to assess, evaluate the usefulness of information for consumers, and how it affects their decision-making in healthcare, research, participation, etc. The second kind is payment information that will affect the physicians and hospitals, which the information is reported on or from. ACRO noted that this kind of reporting is already having a negative impact on health care because doctors do not want to be principal investigators because their names will then be in a public database.
Other participants emphasized the need for physicians and hospitals to have the ability to correct errors in the publicly reported information. Under this comment, some noted the idea of letting doctors or hospitals check payments before they are made public because it is important that the public can rely on such payments being accurate.
Another participant recognized that not all payments or conflicts of interest are wrong. Instead, he noted that doctors and hospitals can have conflicts of interest, rather, it is what they do to manage them that is important.
Question 6: Reporting of data
Participants recommended that CMS consider the use of a spreadsheet, which is used in industry and is a common form accepted by states that already have reporting laws in place. Some recommended that CMS create a standardized template for manufacturers for providing and reporting data for consistency, given the large nature of information being reported and the potential for inconsistency.
Others noted that manufacturers should get a confirmation from CMS when the information is submitted. They also emphasized that CMS should provide a reasonable time to correct data, after submission, and a reasonable chance to correct data after it has been posted.
Discussion
One important question that was noted by BIO is the definition of “covered recipient.” Specifically, BIO asked CMS, if a manufacturer makes a payment to someone other than a covered recipient, and that entity makes a further payment to a physician or teaching hospital, is that subsequent payment reportable?
There is no possible compelling reason to expand what was passed by congress at this time. It will take a miracle for CMS to issue workable rules in the time frame and reasonable expect companies to comply (which no human would consider 3 months to implement reasonable).
Ultimately, this conference call clearly showed that CMS has a lot of important factors to take into consideration when putting together this proposed rule and regulations. The overwhelming nature of the reporting, the potential for error and abuse, and a number of other problems must be addressed by CMS. Consequently, it is still uncertain exactly what value this database would provide to consumer or patients, and how this will actually save Americans money and reduce costs.