As part of the confirmation process to become Health and Human Services (HHS) Secretary, Kansas Governor Kathleen Sebelius was questioned on the issues surrounding of conflicts of interest and transparency.
The questions were around the areas of:
· Disclosure of Payments to Physicians (Physician Payment Sunshine Act)
· Continuing Medical Education
· Conflicts with Physician Owned Hospitals
· Conflicts in Clinical Trials
· Conflicts in HHS Contracting/Contractors
Physician Payment Sunshine Act
Senator Grassley touched on the monies spent by pharmaceutical and medical device companies to practicing physicians each year in the form of consulting agreements, funding for research or a night out on the town.
He even cited the “mountains of evidence” that exist to suggest these relationships can have an affect on physician practice – on what drugs a doctor prescribes, or what device a surgeon implants.
Furthermore, he acknowledged that other than a few states, people have no way of knowing what financial relationships might be affecting their doctor; physicians have no way of knowing what relationships might be affecting journal authors or opinion leaders; and Universities have no way of knowing if medical faculty members are adhering to disclosure rules required by NHI regulations.
As a result, he mentioned and briefly explained how his present legislation, the Sunshine Payment Act, will address these issues. (Perhaps the longest question asked of the Governor)
Governor Sebelius outlined her views on the bill, by offering her promise to ensure that all HHS departments and agencies take conflicts of interest seriously, and that the public interest is always put first.
However, she wanted to explain the importance of wanting scientists to have interests, to share information and collaborate, including with the private sector, to challenge each other‘s ideas and advocate for their own ideas.
It is important to distinguish between interest and conflicts. We want our scientists to have interests. We want them to share information and collaborate, including with the private sector, to challenge each other‘s ideas and advocate for their own ideas. We do not want, nor is it in the nation‘s interest, to create a world where university and government scientists are completely isolated from industry scientists.
She discredited thoughts of an America where university and government scientists are completely isolated from industry scientists.
Thus, she called for case-by-case review of any situation that is not completely straightforward to ensure that HHS manage those conflicts that arise from legitimate interests, and the agency prohibit interests that do not further the scientific mission of NIH and its grantee institutions.
The HHS Secretary designate also gave her support for the principle of transparency in the relationship between practicing physicians and drug and device companies, offering to hear from physicians, states and industry about their perspective on these efforts before deciding whether federal legislation is appropriate at this time.
Continuing Medical Education
With regards to Continuing Medical Education (CME) practices and policies regarding industry influence, Governor Sebelius stated that she supports the current system regulated by the ACCME.
The Accreditation Council for Continuing Medical Education (ACCME) has the primary responsibility for identifying, developing, and promoting the standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities.
The ACCME fulfills its mission through a voluntary self-regulated system for accrediting CME providers and a peer-review process responsive to changes in medical education and the health care delivery system.
NIH does not grant CMEs directly, but does fund conferences that may have sessions that are accredited for CMEs by other organizations in line with ACCME guidelines. These grantees must abide by the NIH rules governing management of conflicts of interest.
The ACCME approves the educational content and reviews the potential for real or perceived conflicts of interest for granted CMEs.
Clinical Trials
The question was asked how the nominee would ensure that clinical trials are free of commercial bias, and whether she would support transparency initiatives to help illuminate potential conflicts of interest in the medical and scientific communities.
Consequently, the Governor of Kansas noted that “Maintaining objectivity in the conduct and reporting of clinical trials, including those supported by NIH, is critical to protecting the health and safety of the public”. Moreover, she recognized that effective oversight and management of the extramural community‘s financial conflicts of interest necessitates a commitment from institutions and their investigators to complete disclosure, appropriate review, and robust management of identified conflicts. In addition, she declared that if confirmed as Secretary, she would ensure that NIH and the other relevant health agencies enhance move forward quickly with the issuance of the pending Advance Notice of Proposed Rule Making (ANPRM which was issued May 8 and Due July 7, 2009) to seek broad public input on the current policy on conflict of interest.
She advocated for promoting enhanced transparency in the disclosure of financial interest investigators, particularly when these interests may present apparent conflicts of interest. The nominee also gave her support towards efforts to enhance consistency and perhaps broaden these and other disclosures to enhance transparency in these matters.
Physician Owned Hospitals
In response, Governor Sebelius noted that she was familiar with this issue and mentioned that under current federal law, referrals to entities in which the referring physician (or an immediate family member) has a financial interest are prohibited for many types of services, including hospital services, by the physician self-referral statute, which is enforced by HHS.
She further stated that if confirmed as Secretary, she would ensure that program integrity protections of Medicare, including effective oversight of the physician self-referral law, continue to be a high priority for HHS. Lastly, she touched on the President‘s budget for including additional measures to curb specialty hospitals.
Contractors
Senator Grassley talked about conflicts of interest in outside contractors hired by HHS. In reply, the Kansas Governor noted how recently enacted legislation has directed OMB‘s Office of Federal Procurement Policy (OFPP) to develop and implement conflict of interest acquisition guidance for all federal agencies. She once again advocated for full public disclosure of all such relationships, and a case-by-case review of any situation that is not completely straightforward to manage conflicts that arise from legitimate interests, and prohibit interests that do not further the mission of HHS. The nominee ended her statements with this issue by also noting that she would enforce new guidelines that require government contractors to establish and maintain specific internal controls to detect and prevent improper conduct in connection with government contracts or subcontracts.
Summary
Since the “Daschle Disaster,” the Secretary of HHS cabinet in the Obama Administration has taken a back seat.
With health care reform already having started in the 111th Congress way before Sebelius was named, and with numerous hearings and executive meetings occurring before she could get her foot in the door her impact is uncertain.
Her statements around physician industry collaboration seem very reasonable in a time when the rhetoric is red hot against working together. Perhaps she can assist in bringing the debate back to reality. Rural states like Kansas depend on collaboration, to ensure their patients receive quality care. Perhaps the rest of Washington will listen to her reasoned approach.