Two weeks ago, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA), the original authors of the Physician Payments Sunshine Act (PPSA), called on the Centers for Medicare and Medicaid Services (CMS) to adopt rules to implement these transparency provisions in the Affordable Care Act (ACA) by June. CMS is currently considering more than 300 sets of public comments submitted in February on the agency’s proposed regulations. Hundreds of groups across all sectors in the health care system submitted recommendations, and now CMS is charged with issuing the final rules and setting a date for industry to begin tracking their payments to doctors and teaching hospitals. The statute requires that manufacturers of drugs, devices, biologics, or medical supplies, or their subsidiaries that sell product s in the United States, report to CMS most payments made to physicians and teaching hospitals, and that this information be disclosed on a public website by CMS.
Like the Senators, we campaigned for these important transparency provisions because we want to shed light on the full range of financial interactions between manufacturers of drug or device products, and the doctors or teaching hospitals. These interactions can undermine good prescribing, patient trust in doctors and affordable care. While we agree that some financial relationships between industry and doctors may not be problematic, or may even be appropriate, transparency will allow the public and policymakers to determine if they are or are not, once we can see all the facts.
The process for implementation of this important law has been complex process. Detailed regulations or “rules” must be promulgated, and CMS’s Office for Program Integrity was charged with writing these regulations by October 1, 2011, so that manufacturers could begin collecting data January 1, 2012. Unfortunately the October 1 deadline was missed, but CMS did issue a 22 page draft rule on December 16, 2011. CMS provided a thorough 94 page description of the rule, and asked stakeholders to comment on as many as 90 issues raised in the draft rules. Seventeen different stakeholder sectors responded with more than 300 sets of comments. Now we await the CMS decisions on the shape of the final rule, so that manufacturers can begin collecting the data.
The array of comments submitted showed consensus in some areas and sharp disagreement in others. To better understand what CMS is now wrestling with, our colleagues at The Pew Charitable Trusts analyzed all the submissions and summarized them by sector, along several important dimensions. Here are some of the results.
Clearly define “Nature of Payment” Categories There was near universal consensus among all sectors that the “nature” of reported payments be clearly described under the 14 categories listed in the statute (e.g. gifts, consulting fees, education, research etc.). This point was made by consumer and beneficiary advocates; drug and device manufacturers; physician societies; universities and teaching hospitals; states and medical boards; healthcare providers; health IT companies; MedPac (the independent Congressional agency concerned with Medicare); and ACRE (Association of Clinical Researchers and Educators).
However, we opposed the CMS proposal to simply allow industry to use “dictionary definitions” for these terms because dictionary definitions are vague, overlapping, or contradictory, which would cause inconsistency and confusion in the reported information. Community Catalyst, Pew, and 14 other consumer groups and beneficiary advocates all recommended that they be clearly defined by CMS rules so that they would be non-overlapping and clear to the public. Along with Pew, we even proposed a set of detailed definitions for consideration by CMS.
Ensuring that the public website is user-friendly CMS is required to disclose industry payments on a public, searchable website, where the information is easily aggregated and downloadable. Most consumer advocates urged CMS to make the website as consumer-friendly and easy to understand and navigate as possible. And some advocates urged CMS to ensure the data is usable for states and researchers. Health IT groups, the National Business Group on Health and the Association of Health Care Journalists also supported these concepts. Several sectors urged CMS to seek input from the public in the design of the website and to add information that would allow the public to better understand the reporting categories and their significance.
MedPac, the federal agency charged with helping to keep Medicare sustainable, urged CMS to assess if the annual aggregate amount of payments subject to delayed disclosure could be disclosed, in order “to help policymakers assess whether rules for delayed publication should be adjusted” to a shorter period. Under the statute, delayed public disclosure of up to four years is allowed for certain research payments, to protect the proprietary interests of industry. Both MedPac and Community Catalyst were also concerned that delayed disclosure could be overly broad, especially if applied to investigations on new uses of products. Delayed disclosure in this area could hide inappropriate payments to prescribers that facilitate unapproved “off- label” uses of drugs.
The big controversy: third party payments and Continuing Medical Education One of the major areas of disagreement in the comments submitted concerns industry reporting of payments to doctors through third parties, especially CME related payments. Not surprising, since the statute and the CMS rules plug an important potential transparency loophole, by requiring reporting of most payments to doctors through third parties. We’ll address that controversy in an upcoming Postscript.
–Marcia Hams, Director of Prescription Access and Quality –Wells Wilkinson, Director, Prescription Access Litigation Project