The Association of Clinical Researchers and Educators (ACRE), recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
ACRE, founded in 2009, is a non-profit organization of medical professionals who recognize that physician-industry collaborations and relationships benefit patients and advance science. ACRE provides a forum for physicians and industry partners to further such collaborations, and to advocate on behalf of better patient care. ACRE is lead by a steering committee of physicians from major medical institutions.
ACRE members include active practitioners of diverse medical specialties and subspecialties, medical society leaders and distinguished educators and researchers at academic centers and others in industry, who are engaged in promoting excellence in medical service, education, and innovation with substantive records of accomplishment in these endeavors.
Comments on Sunshine
ACRE requested that CMS consider the manifest benefits Americans have received from physician-industry collaboration and the threats the proposed regulations pose for these relationships. They urged CMS more vividly to envision the important and necessary collaboration that physician, academia and industry must have in order to produce new life saving medicines and the chilling effects of this Act on collaboration.
ACRE asked that CMS reevaluate the proposed regulations, particularly in light of the significant disproportion between their manifest costs and their uncertain, remote and speculative benefits.
They noted how the “Regulatory compliance will consume resources that would be better directed to enhancing the value of care physicians provide to patients through development of better medicines and devices.” It is ACRE’s view “that these regulations will impose undue regulatory burdens on medical products companies, discourage research, severely discourage scientific progress, and deny patients of benefit from the innovations that would be slowed down or eliminated as a result of the increased scrutiny and focus on administration over reaseach.”
ACRE noted that, “The intimidating and burdensome consequences of implementing the Sunshine Act will be detrimental to the speed of the process and in many instances may curtail it entirely. Furthermore, the evidence that there is harm in these collaborations is nil to nonexistent, while the benefits are large and easily demonstrable.”
They explained how, “Very few people and especially patients come even close to having the experience or training to comprehend the minute and complex information that will accumulate under the Sunshine regulations.”
Accordingly, ACRE’s concern “is that companies and physicians will spend countless hours ensuring the accuracy of information that has not been shown to have any benefit to patients. Literally billions will be spend to Sunshine compliance that will never be utilized by patients. The likelihood is just like the computer software, the vast majority of American’s will simply ignore the information even if presented at their point of care as no one really cares.”
The maintained that, “the most destructive aspect of Sunshine is its flawed premise that every payment presents a conflict of interest. The fact is that payment information can serve either good or bad purposes.”
The “good” outcome “sunshine” advocates claim is that “transparency” will rein in medical care costs based on the absolutely unproven and arguably false premise that industry payments to physicians drive overprescribing of unnecessary and overly expensive brand products. ACRE noted how products constitute less than 10% of health care spending and practitioners prescribe generics over 75% of the time.” In addition, third party payers routinely limit payment and reimbursement to those medical products which have demonstrated both safety and efficacy in the diseases for which they are prescribed. More importantly, “innovative medical products, acquired through paid collaborations between physicians and industry, help prolong life and improve life quality, considerations as or more important than costs.”
ACRE also recognized how “Payment data of the kind that will be published under the Sunshine Act has already been published for several years under various corporate integrity agreements that manufacturers have negotiated with the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS). However, ACRE said it was “not aware of any study showing that patients have benefited in any way, nor have savings in health care costs been achieved.”
For example, they noted how payment data have been published in Massachusetts for two years now however, “There has been no research or evidence indicating that patients have benefited from the publication of such payments or the State has reduced its medical costs or improved health outcomes.” More to the point – there have been negative effects of these regulations as relates to innovation and physician education – see Wolf DW.
ACRE maintained that, “How these data are to be taken in the context of analyzing scientific research is unknown and merely will serve the interests of fascinated individuals (certainly not patients or researchers). Without context, these data cannot be interpreted; intentionality, influence, alleged corruption and causality cannot be defined by the data alone.”
ACRE also expressed its concern, “that the tremendous burden of additional work that manufacturers, physicians, and teaching hospitals will have to do, and the amount of money and time they will have to allocate to compliance is an immense diversion of already limited and diminishing resources better spent on innovation and education. Money spent on implementing Sunshine regulations will not improve patient or clinical outcomes or reduce health care system costs, and will unnecessarily divert resources away from more productive activities.”
They noted further how “the publication of such payments without any context will discourage physicians from productive collaborations with industry. This will only further accelerate clinical research leaving the U.S.”
ACRE also provided specific comments, echoing many of the same concerns that other organizations have expressed, with regard to exempting third parties and accredited CME providers from reporting; providing adequate context on the public website; etc.
Ultimately, ACRE noted that, “The academic and scientific return on investment for sunshine is negative. The evidence of risk or harm is nil but the bureaucratic consequences of implementation will lead to diversion of increasingly limited resources for these new reporting requirements.” They concluded by noting that, “Americans need jobs today, and current clinicians and researchers need to maintain the relationships they have with industry to ensure that new scientific advances and technological breakthroughs continue.”