E-Prescribing Initiative Expected to Encourage Use of Electronic Health Records
On Monday, July 21, US Department of Health and Human Services (HHS) Secretary Michael Leavitt provided comments on the electronic prescribing incentive program that is part of a new Medicare law going into effect January of 2009. The legislation will provide doctors with a 2% bonus in 2009 and 2010 in their Medicare payments if they utilize e-prescriptions. From 2011 to 2012, those adopting e-prescriptions will receive a 1% bonus, and in 2013, a 0.5% bonus will be given. The Centers for Medicare and Medicaid Services (CMS) estimates the cost of implementing such an electronic system to be around $3,000 with additional monthly expenses of $80-$400. This incentive program has garnered positive reviews as a method of lowering cost barriers for smaller practices looking to switch to an electronic prescribing system. Secretary Leavitt believes that such a transition could save taxpayers up to $156 million over five years and reduce the 1.5 million injuries annually resulting from drug-related mistakes.
Dingell, Barton Health IT Bill Approved By Energy and Commerce Committee
On Wednesday, July 23, the House Energy and Commerce Committee approved a revised version of HR 6357, the PRO(TECH)T Act, authored by Representatives John Dingell and Joe Barton. The legislation now requires the initiation of a study into the way health information technology can be used in the care of the elderly and the creation of an informed-consent model outlining the uses of patient data. It also allows graduate professional schools to use grant money to develop pilot projects on clinical education programs using health IT. The main area of contention surrounding health information technology legislation remains privacy, although all sides continue to work towards a compromise.
Ways and Means Health Subcommittee Plans to Submit Alternative Health IT Bill
During a Thursday, July 24 hearing, the House Ways and Means Health Subcommittee discussed the possibility of submitting their own version of the health information technology bill (HR 6357) approved on July 23 by the House Energy and Commerce Committee. The Ways and Means Health Subcommittee has criticized the existing bill for having privacy protections that are too restrictive and for having no punishments for doctors who choose not to switch to an electronic health records system. Health Subcommittee Chair Pete Stark also argued that the $560 million allocated for the transition to an electronic system will be insufficient, and ranking member Dave Camp wants to see tax incentives for health care providers who utilize health information technology. Representatives Stark and Camp are both expected to submit alternative bills over the next week.
NEJM Article Argues for Extension of GINA's Principles To All Health Information
A perspective piece in the July 24 edition of the New England Journal of Medicine (NEJM) addresses the implications of the Genetic Information Nondiscrimination Act (GINA). The article, written by University of California-Los Angeles School of Law Professor Russell Korobkin and Brigham and Women's Hospital medical resident Rahul Rajkumar, argues that GINA's protection of genetic information should be extended to all health information. Both authors feel that all predispositions and unchangeable characteristics ought not play a role in insurance coverage and pricing because they are factors outside the patient's control.
Genetic Testing and Personalized Medicine Bill Introduced in the House
On Tuesday, July 15, Rep. Patrick Kennedy (D-RI) introduced H.R. 6498, the Genomics and Personalized Medicine Act of 2008. As a modified House version of the Obama-Burr Genomics Bill (S. 976), H.R. 6498 recognizes the promise of genetic research and genetic testing to facilitate national health care reform. Specific points of the legislation call for a public registry of all laboratory-developed genetic tests, expansion of genomics research and professional training grants, the establishment of a Genomics and Personalized Medicine Interagency Working Group within the Department of Health and Human Services, and comparative review of laboratory requirements under both CLIA and the FDA. Furthermore, the CDC is required to expand genomic public awareness efforts and regulate direct-to-consumer markets for quality. The bill also adds a tax credit amendment for research and development related to companion diagnostic tests.
H.R. 6498 has been referred to the House Committee on Energy and Commerce and the Committee on Ways and Means.
Bill to Raise Lifetime Insurance Cap Introduced in House
On Thursday, July 17, Congresswoman Anna Eshoo (D-CA) introduced H.R. 6528, the Health Insurance Coverage Protection Act, which aims to raise the minimum lifetime cap for private health insurance to $10 million. Currently, many private health insurance plans place lifetime caps on benefits, forcing out of pocket pay or government aid once the limit is reached. The 2007 Kaiser Family Foundation Survey of Employer Health Benefits reported the typical cap on these employer sponsored health plans is set at $2-$3 million. H.R. 6528 stipulates the minimum lifetime cap for a group plan at $5 million for the first two years, and $10 million in years three and four. It also requires annual adjustment to these numbers based on the updated consumer price index. The bill protects patients and families struggling with medical treatments often as a result of disability or chronic illness.
On Wednesday, July 15, the FDA issued a final rule to exempt certain phase 1 drug products from compliance with current good manufacturing practice (CGMP) regulations. This action is intended to promote drug development by creating more appropriate regulations for the earliest stage of investigational drug products. A phase 1 clinical trial is the first introduction of an investigational new drug product in humans to establish the basic safety of the drug. Once a drug product is available in the phase 2 or phase 3 study, it is subject to full CGMP compliance.
The FDA still retains oversight of these drugs at any stage under general CGMP authority and review of investigational new drug (IND) applications. With this authority, the FDA can place hold on any study if an IND has inadequate manufacturing, processing or standards of identity. The rule will take effect September 15 and will apply to small-molecule drugs and biologics including vaccines, gene therapy products, blood products, in vivo diagnostics, and allergenic products.
Senate Committee Holds Hearing to Discuss Nationwide Health IT
On Thursday, July 18, the Senate Finance Committee hosted a hearing to discuss strategies for nationwide electronic health records adoption. Congressional Budget Director Peter Orszag testified that physician subsidies should be targeted at physicians already engaged in electronic health record change. He also announced that the Congressional Budget Office plans to release two reports in December regarding electronic health records and their effect on the health care future.
Kaiser Permanente CEO George Halvorson testified to Kaiser's success with health care facilities that have already implemented health IT. Although cost issues are still seen as a challenge to implementation, this dialogue between government, business, and health care executives should accelerate and optimize the nationwide adoption.
In April the House of Representatives passed H.R. 5819, the Small Business Innovation Research/ Small Business Technology Transfer (SBIR/STTR) Reauthorization Act. Included in the Act are amendments targeting rare disease research as a topic deserving"special attention". The Senate Small Business Committee is currently drafting their version of the House bill, the Small Business Innovation Research (SBIR) Reauthorization Bill. The genetics community is looking for the same rare disease recognition in this Senate legislation.
The Cystic Fibrosis Foundation has written a letter to Chairman Kerry and Ranking Member Snowe advocating the funding for productive rare disease research via the inclusion of language emphasizing the importance of rare disease research in the Senate version.
To join the effort and to sign on to the letter of support, please contact Jason Ranville, at jranville@cff.org or call 1-800-FIGHT-CFF.
July 15
Genetics Day on the Hill 2008 A Success!
On Thursday, July 10, the largest group of Genetics Day participants in three years came together on behalf of the genetics community to visit Congressional offices. Together, we worked for the transformation of health through genetics. We thanked the champions of the Genetic Information Nondiscrimination Act and educated staff members. Genetics Day participants discussed the implications of GINA and laid the groundwork for addressing concerns in genetic testing oversight and health information technology, among other topics. We look forward to following up with each of the visited offices, building upon previous relationships, and forging new partnerships. Thank you to all who participated in this empowering event and contributed to its incredible success!
Representative Joe Barton (R-TX) stated on Thursday, July 10 that House Energy and Commerce Committee leaders plan to bring the Dingell-Barton health information technology (IT) bill, otherwise known as the PRO(TECH)T Act, to a vote by August. The bill places a significant emphasis on privacy in order to address the confidentiality concerns that have derailed previous health IT legislation.
In the Senate, Democratic and Republican aides have suggested that Senator Edward Kennedy's (D-MA) Wired for Health Care Quality Act may move forward soon. This health IT legislation faced criticism from Senator Tom Coburn (R-OK) and other Republicans concerning its $137 million authorization level. Senator Olympia Snowe (R-ME) also stated that she would like to see provisions requiring authorities to be notified in case of breaches to patient data and fines for those who mishandle the information. Kennedy's office indicated that both these issues must be addressed before the bill can progress.
Genetics Day on the Hill Offers Chance to Impact Policy
On July 10, Genetic Alliance will host the third annual Genetics Day on the Hill, where individuals from all areas of genetics come together to bring about change in the policies affecting every one of us. We will take our cause to key policymakers on Capitol Hill and educate them about policy issues of concern to our community. This year, we will celebrate the passage of the Genetic Information Nondiscrimination Act (GINA) by thanking our GINA champions and looking to the future for genetics and health. We will address concerns in genetic testing oversight and health information technology, among other topics. Washington policymakers have the ability to make decisions that impact laws throughout the nation, but we will exercise our role to influence those outcomes!
Learn more about Genetics Day on the Hill, and to register for the event.
Sixteenth SACGHS Meeting to Discuss Marketing to Consumers
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) will convene for a two-day meeting July 7-8 at the Hubert H. Humphrey Building, Room 800 of the Department of Health and Human Services. Open to the public and viewable via the web, the meeting will address issues related to the marketing of personalized genomic information and services directly to consumers. The Committee will also examine a proposed plan to solve specific concerns with the genetics education and training of health professionals.
Learn more about the meeting or how to submit comments.
July 8 Teleconference Q&A for Genetic Alliance July Events
On Tuesday, July 8, 12:00 PM EST, Genetic Alliance will host a teleconference for all participants in our July 2008 events, including Genetics Day on the Hill, In the Family Film Screening, 2008 Annual Conference, and the GINA Victory Celebration Dinner. Participants will have the opportunity to ask questions, discuss previous experiences, and share in the excitement for the upcoming events.
