Sunshine Act May Not Be So Bright: Why Hospitals, Physicians Are Concerned

A recent poll of 50,000 specialists and primary care physicians found that 56 percent are concerned about the pending Physician Payments Sunshine Act. Hospitals are taking note too, uncertain how CMS will implement the Sunshine Act, which requires pharmaceutical, medical device and other supply manufacturers to report payments made to physicians and teaching hospitals. CMS is tasked with making the information public and transparent online and has issued a draft of how it will carry out the Sunshine Act.

Legislators asked CMS to implement the Sunshine Act this summer, but the federal agency has delayed necessary data collection until January 2013 in order to give organizations time to prepare for data submission and to sufficiently address the input received when CMS drafted its ruling.

Michaeline Daboul, President and CEO of Portsmouth, N.H.-based company MMIS, which provides compliance software for the healthcare industry, answers questions on the effect the Sunshine Act will have on hospitals and physicians.

Question: What about the Sunshine Act concerns people in the healthcare industry?

Michaeline Daboul: While the vast majority of stakeholders within the healthcare system embrace the concept of additional transparency, the major concern is over the forthcoming details and requirements set forth in CMS' draft rules.

From a broad prospective, all stakeholders — hospitals, physicians, group purchasing organizations and the medical and pharmaceutical industry — are concerned that information available in the public domain could unfairly distort the positive nature of the collaborative relationships that physicians maintain with the industry.

CMS is required to provide context and background information, posted on a public website, in order to educate consumers about the relationships that exist between physicians and the industry. Significant improvements to enhanced patient care — new drugs and new medical devices to diagnose and treat diseases — have occurred because of these close, ethical relationships; a physician’s financial relationship with the industry does not mean the physician's judgment is compromised or that the relationship with the manufacturer or drug maker is unethical.

Other areas of concern include: correct identification of a physician, reporting of a physician's specialty as listed in the NPI database (which could inadvertently create issues for off-label marketing), the manner in which research payments are reported and listing food and beverage dispersal to physicians who may not have participated in a meal.

Q: Why are hospitals concerned about the Act?

MD: The primary issue hospitals face involves the reporting of indirect payments for independent continuing medical education. Specifically, the question is: Does the industry have to report payments to teaching hospitals, in support of independent continuing medical education, over which the industry has no control?

Additional hospital concerns involve research related payments to institutions reported as such and not attributed to the physician investigator. Other areas of interest include the timely review and resolution of disputes, the accuracy of payments made to physicians and the reputation of the hospital, which may be adversely impacted should negative information about an affiliated physician or department chair be published.

Q: Why are physicians concerned about the Act?

MD: Physicians are concerned that the relationships they currently maintain with the medical device and pharmaceutical industry are being construed as suspect. Just because a physician receives a transfer of value from an industry member does not mean the physician is ethically compromised. The vast majority of transactions involve fair market value payments in exchange for consulting, speaking, and research. Like other professionals, physicians earn compensation for these services.

Physicians are also concerned about the accuracy of the data. The last thing that a physician wants is erroneous data published on a publicly searchable database.  This information is important to watchdog groups, and no physician wants to be the poster child on a list called "Doctors for Dollars."

Q: What are some ways the Sunshine Act might change relationships in healthcare delivery?

I don't anticipate any direct change to healthcare delivery based on new transparency requirements but there may be unintended negative consequences. For example, a continuing trend where physician's practices ban food and visits from pharmaceutical sales representatives. According to a recent study published in the Journal of Clinical Hypertension, limiting physician access to pharmaceutical sales reps can have the effect of reducing responses to negative and positive information about a drug. At a basic level, a pharmaceutical rep is an information provider for physicians; limiting interactions between reps and physicians might eliminate a valuable source of information for medical leaders.

Additionally, the Sunshine Act may change the relationship between the physician and patient. Assuming that patients review the public data prior to visiting their physician, the patient may be better informed about treatment decisions.

Q: How can hospitals and physician groups navigate the Sunshine Act?

MMIS is working with many organizations, medical societies, hospital groups, physician groups and medical device and pharmaceutical companies to provide much needed education to the physician community. Unfortunately, as our recent survey suggests, there is a lack of knowledge on the part of many physicians regarding what the new transparency laws require of them. MMIS is leading an education initiative by talking to all healthcare transparency stakeholders, encouraging them to take a proactive approach and demand an opportunity to review data before it's submitted to CMS.  That review process is consistent with the stated intent of the legislation's sponsors, Sens. Herb Kohl (D-Wis.) and Charles Grassley (R-Iowa).

Q: What's the ideal outcome of CMS' final rule for implementing the Sunshine Act?

Considering the effects of the law on each of the healthcare stakeholders is paramount to successful implementation. In its final ruling, CMS must successfully define a reporting structure that is unambiguous for the industry. It must represent, to consumers, the nature of the interactions between physicians and the medical device and pharmaceutical industry. It is also important for consumers to recognize the existence of relationships between their physician and the industry in a positive light, as most of these relationships are ethical. In fact, many of the relationships physicians maintain have a very positive effect on patient care.

Q: What good might come out of the Act?

At the very least, the Sunshine Act will provide further transparency on the relationships that physicians maintain with the medical device and pharmaceutical industry and will hold all parties accountable for healthcare decision-making based on the needs of the patient.  

More Articles on the Sunshine Act:

CMS Delays Data Collection for Physician Sunshine Act
Senators Ask CMS to Start Sunshine Act Data Collection by June
Survey: 56% of Physicians Concerned About Sunshine Act

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