Medical Device Daily Washington Editor
As debate commences on the Senate healthcare reform bill, the media are replete with coverage of how much power both the House and Senate bills would confer upon the Secretary of Health and Human Services. However, the Obama administration has yet to offer a nomination for the post of administrator at the Centers for Medicare & Medicaid Services, an interesting omission in the current political environment, and the influence HHS would have over reforms suggests fewer opportunities for Congress to micromanage Medicare.
The idea that Congress micromanages Medicare is hardly a new one, and the charge resurfaced earlier this year during a session held by the healthcare policy journal Health Affairs. In one of the sessions, Mai Pham, MD, of the Center for Studying Health System Change (Washington), made the case that Medicare payment reforms "are extremely vulnerable to political micromanagement" (Medical Device Daily, Sept. 14, 2009). The prospect of handing over substantial policymaking power to HHS does not set well in some quarters, as was seen in Tuesday's hearing in the House Energy and Commerce Committee (MDD, Dec. 3, 2009), with GOP members of the health subcommittee charging that the House bill would insert government between patients and doctors.
Opinions on how the Senate bill – and the House bill for that matter – might play out in the real world vary. Devon Herrick, a health economist with the National Center for Policy Analysis (NCPA; Dallas) said he is of the view that the Senate bill would indeed focus far more power in the Secretary of HHS. He told Medical Device Daily, "I do think that the Senate bill ... would empower HHS and the government over a lot of areas of healthcare and would create a bigger bureaucracy than we already have." He said one obvious effect is that it would boost the percentage of healthcare paid by taxes to far beyond the current 45% set point. "It would climb much higher" under the Senate legislation, he said.
As to whether the legislation would transfer authority from the Centers for Medicare & Medicaid Services, Herrick said, "I don't think HHS will take powers away from CMS," but will likely delegate them. Most of the authorities charged to HHS in the bill "will have to be delegated to a whole army of bureaucrats" at CMS, he said.
Regarding Republican claims that HHS or CMS would have to follow the recommendations of a body such as the U.S. Preventive Services Task Force, which were heard in Wednesday's hearing in the House, Herrick observed, "you look at the task force. They're job is to make recommendations, and CMS has the authority to decide which they follow and which they choose not to follow." On the other hand, concerns about costs and the emphasis on comparative effectiveness research tend to stimulate "the fear ... that we would empower bureaucrats to decide what we do and don't get."
Herrick also said that public support for reform seems to be slipping substantially, which is based in part on the promise "a year ago that if you like what you have, you can keep it," a promise that does not have the same credibility now. He said most Americans are saying, "I don't want to give up my right to have a high-deductible plan," which allows enrollees to keep unspent monies.
On the question of whether the Senate bill is likely to get Congress out of the business of micromanaging Medicare, Herrick remarked, "the current bill has a much weaker independent Medicare commission than was proposed in July," so congressional intervention is not ruled out in the Senate bill. He acknowledged that "certain people believe it needs to be moved away from the political arena to get anything done," but nonetheless made the claim that many inhabitants of Capitol Hill, including House Speaker Nancy Pelosi (D-California), "do not want to give up congressional control of Medicare."
NIH approves new stem cell lines
The National Institutes of Health has approved a series of 13 lines of human embryonic stem cells (ESCs) for research under the new policy by the Obama administration in a Dec. 2 announcement.
NIH director Francis Collins, MD, said in the statement that the 13 lines "were derived from embryos that were donated under ethically sound informed consent processes." Collins also said that additional lines "are under review now," and NIH "anticipate[s] continuing to expand this list of responsibly derived lines eligible for NIH funding."
The administration of President George W. Bush had imposed a moratorium on the use of federal funds to back research on ESCs beyond 60 lines that were already in play at the time of the decision. Critics charged that only 20 or so of those lines were viable for research, but supporters of the decision argued that many ethical issues had yet to be worked out.
Whether ESCs will be ready for commercial prime time in the next half decade or so is another question. Biotech firm Geron (Menlo Park, California) achieved a milestone earlier this year in that it became the first firm to acquire an FDA stamp of approval for a clinical trial for embryonic stem cells in humans (MDD, Jan. 26, 2009). The Geron application covers a study of ESCs in spinal cord repair in 10 patients.
On the other hand, some investors are content to stay on the sidelines of the ESC field pending more confirmatory results. This view is held Lou Bock of Scale Venture Partners (Foster City, California), who is quoted as saying at Portfolio.com that his firm would "like to see something in the clinical stage" because of the view that drug development "is inherently risky."
Mark McCarty, 703-268-5690