Comparative Effectiveness Bill Calls For Private Group To Plan Research

While getting little exposure in the new Medicare law, comparative effectiveness research is getting full attention in a bill introduced by Sen. Max Baucus, D-Mont., that offers a comprehensive roadmap toward conducting the research and disseminating findings.

The bill, the Comparative Effectiveness Research Act of 2008, S. 3408, marks an evolution in the approach to conducting this type of research has occurred since previous legislative attempts. Joining Senate Finance Committee Chairman Baucus as a co-sponsor of the bill is Budget Committee Chairman Kent Conrad, D-N.D. The bill was introduced July 31.

S. 3408 follows a June 2007 recommendation from the Medicare Payment Advisory Commission that "Congress should charge an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers, and public and private payers."

CERA calls for the establishment of a private, nonprofit corporation, the Health Care Comparative Effectiveness Research Institute, the purpose of which is to "improve health care delivered to individuals in the United States by advancing the quality and thoroughness of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated and managed clinically through research and evidence synthesis, and the dissemination of research findings with respect to the relative outcomes, effectiveness, and appropriateness of the medical treatments, services and items."

Research Criteria

The institute would develop priorities for research based on five criteria:

• Disease incidence, prevalence and burden in the U.S.;

• Evidence gaps in terms of clinical outcomes;

• Practice variations, including variations in delivery and outcomes by geography, treatment site, provider type and patient subgroup;

• The potential for new evidence concerning certain categories of heath care services or treatments to improve patient health and well-being, and the quality of care; and

• The effect or potential for an effect on health expenditures associated with a health condition or the use of a particular medical treatment, service or item.

Charging the institute with setting the research agenda represents a change in thinking from earlier legislation introduced by Baucus. In a Part D price negotiation bill, S. 3, he looked to HHS to set the agenda with the purpose of targeting Part D-covered drugs, but the bill stalled in the Senate in April 2007 (¹ 'The Pink Sheet,' April 23, 2007, In Brief).

According to the language of S. 3, HHS would have been directed to "develop a comprehensive prioritized list of comparative clinical effectiveness studies that are most critical to building the evidence needed to advance value-based purchasing of covered Part D drugs."

However, that bill did not offer any language regarding the conducting of studies. A Senate Finance Committee staffer said the thinking behind the language was that the HHS priorities list would be "the starting point for a permanent effort - what [S. 3408] creates. There was always an intention to do a full bill after S. 3."

HHS is not left out of the decision-making process in this new entity. CERA calls for the institute to be governed by a multi-stakeholder board of governors, including the HHS secretary, the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health, and 18 members representing the public and private sectors.

Baucus' latest proposal also deviates from another 2007 legislative proposal aimed at developing a comparative effectiveness research strategy found in the Children's Health and Medicare Protection Act, H.R. 3162.

The CHAMP Act placed AHRQ at the forefront with a Center for Comparative Effectiveness Research established within the agency, and calling upon the center to "conduct, support and synthesize research relevant to the comparative clinical effectiveness of the full spectrum of health care treatments, including pharmaceuticals, medical devices, medical and surgical procedures and other medical interventions."

The provisions also failed to become law as much of the CHAMP Act was gutted to allow for passage of the Children's Health Insurance Program extension (² (Also see "CTI Seeks ASP Payment For Zevalin; Medicare Cap Temporarily Lifted" - Pink Sheet, 7 Jan, 2008.), p. 33).

CERA directs the institute to contract primarily with government organizations to conduct the research (ranging from comparing existing data to conducting new clinical research), though opportunities for private research exist. The bill also directs the institute to examine the feasibility of conducting its own research.

No Policy Or Coverage Recommendations

Another area where the Baucus bill follows the MedPAC recommendations is that any research would not be disseminated in a way that recommends coverage or payment decisions or practice guidelines.

CERA outlines a specific set of guidelines regarding dissemination, noting that information "shall convey findings of research so that they are comprehensible and useful to patients and providers in making care decisions; shall discuss findings and other considerations specific to certain subpopulations, risk factors and comorbidities, as appropriate; shall include considerations such as limitations of research and what further research may be needed, as appropriate; and shall not include practice guidelines or policy recommendations; and shall not include any data the dissemination of which would violate the privacy of research participants or violate any confidentiality agreements made with respect to the use of the data."

It also does not offer any specific guidance on how the information can or cannot be used by CMS or other payers in regard to making its own coverage determination, another change from S. 3.

In the 2007 price negotiation act, the legislative language clearly stated the bill was "authorizing consideration of comparative clinical effectiveness studies in developing and reviewing formularies under the Medicare prescription drug program."

The CHAMP Act also suggested that the dissemination of data could play a greater role in coverage policies. H.R. 3162 stated that one of the duties of the center was to "make recommendations for a strategy to disseminate the findings of research conducted ... that enables clinicians to improve performance, consumers to make more informed health care decisions and payers to set medical policies that improve quality and value."

Public And Private Funding

One area where the Baucus bill seemingly draws from previous legislation is from the CHAMP Act in relation to the development of the Comparative Effectiveness Research Trust Fund, but funding levels under the program are vastly different.

CERA calls for government appropriations of $5 million in 2009, followed by $25 million in 2010 and $75 million in 2011. From 2012 through 2018, when all sources of funding sunset, the government would contribute $75 million each year in addition to an annual transfer of $1 per beneficiary from the Medicare Trust Fund and a $1 fee per covered life assessed annually on insured and self-insured health plans.

In a floor statement entered into the Congressional Record July 31, Baucus noted that the reason behind the funding sunset allows Congress to "review a report from the Comptroller General on the value of research to the public and private insurance sectors." He added that starting in 2013, funding levels are expected to be $300 million per year.

CHAMP set government appropriation levels at $90 million, $100 million and $110 million during the first three years, but was not as direct in setting levels for private participation. It only said that the private share should contribute its part beginning in the fourth year to bring the total trust fund amount of $375 million.

The funding mechanism for comparative effectiveness research has been a source of debate and has included issues related to how much money is needed and how the share should be divided.

For example, a bill introduced in May 2007 by Reps. Tom Allen, D-Maine, and Jo Ann Emerson, R-Mo., set contributions to a public-private trust at $100 million in the first year, $200 million in the second and $900 million annually for the next three years. Around that time, the Blue Cross Blue Shield Association estimated it would take $500 million to fund a comparative effectiveness research effort, and committed to providing a share of that total (³ (Also see "Comparative Effectiveness Funded By Public-Private Trust Proposed In House" - Pink Sheet, 14 May, 2007.), p. 25).

- Gregory Twachtman ([email protected])