Originally published Sept. 19.
By Turna Ray
The Personalized Medicine Coalition has put forth recommendations for the Genomics and Personalized Medicine Act that would streamline the bill from previous iterations and take bolder steps toward incentivizing the development of individualized medicines.
The bill has been proposed for several Congressional sessions but has seen little action on the legislative floor. Much of the content in the most recent version, the Genomics and Personalized Medicine Act of 2010, introduced by Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) last summer, was originally presented in a 2007 bill championed by then Senator Barack Obama and then again in 2008 by Kennedy. Those earlier versions were criticized as too broad, however.
Even though the 2010 version of the GPMA, introduced to the House Committee on Energy and Commerce, touched on some of the regulatory and reimbursement issues hindering personalized medicine development, stakeholders still felt that the legislative proposals were not prescriptive enough for the deeply entrenched, systemic challenges that drug and diagnostics developers must overcome to bring genomic medicines to market (PGx Reporter 6/2/2010).
The PMC, which keeps a close watch on legislation that might impact the field, previously told PGx Reporter that it found the Kennedy/Eshoo legislation "wanting" in its handling of the business, reimbursement, and regulatory barriers to personalized medicine. Earlier this year, the advocacy organization convened a workgroup, in which 100 of its 220 member organizations were represented, to discuss and refine some ideas for improving the GPMA. According to Amy Miller, PMC's public policy director, although there is no guarantee that the PMC's recommendations will show up in a new version of the bill, Eshoo is considering the proposals.
Eshoo is "looking to redraft GPMA in a way that will enjoy wide community support, so we only presented her with ideas that the entire community favors," Miller said, hopeful that many of the PMC's ideas will gain acceptance in a redrafting of the bill, which is slated to be introduced before the end of the current congressional session. "We retained legal counsel to help us put our ideas into a format that is most useful for legislators," she added.
In a document issued in August, the PMC recommends changes to the GPMA in several areas, such as creating an advisory committee to recommend policies to advance personalized medicines, improve patient access to such drugs, and review applications for drugs and tests. PMC's recommendations also call for aligning the regulatory framework for drugs and diagnostic tests so that Rx/Dx combination products are reviewed at the same time by the appropriate FDA divisions; changing Medicare coverage policies to ensure coverage of a companion diagnostic test when it is approved simultaneously with a drug, or when a drug's label recommends the use of a particular genetic test; and reforming the delivery system for personalized drugs, particularly for underserved populations.
In line with previous iterations of the GPMA, the PMC maintains the need for the creation of an Office of Personalized Medicine within the HHS to facilitate integrated reviews of Rx/Dx products. However, the advocacy organization would like the new version of the bill to include provisions to ensure timely reviews of companion tests. Noting that there are scenarios when a drug is on the market before a companion test is launched, the PMC recommends that the FDA be required by Congress to review the application for a "qualified companion diagnostic" that comes in the post-marketing setting of a drug within 180 days after the test's premarket approval submission.
The PMC also wants Congress to amend the Medicare statute to provide coverage of multi-gene tests when a person shows signs of a genetic condition or cancer or has a family history for such a condition. "This coverage would be extended without the need for a [national coverage determination] or [local coverage determination], and would also reimburse such services under the physician fee schedule or the clinical laboratory fee schedule, as appropriate," the PMC notes.
The American Medical Association is currently developing new current procedural terminology codes for molecular diagnostics and the Centers for Medicare & Medicaid Services is in the process of ironing out whether molecular diagnostics fall into the CLFS or the PFS. Designation of tests into either the PFS or CLFS could impact reimbursement rates for test developers, pathologists, and laboratory experts analyzing test results (PGx Reporter 7/20/2011).
Additionally, PMC members that worked on these recommendations also want Congress to craft mechanisms by which patients can challenge the exclusion of a personalized medicine product from insurers' formularies. The advocacy organization seeks to "amend the Medicare statute to require that a request for an exception that involves a personalized medicine drug/biologic be made on an expedited basis (i.e., 24 hours within receiving materials from the enrollee)."
Finally, the PMC recommends that the Center for Medicare and Medicaid Innovation develop pilot programs through which it could update the decision-support system for administering personalized medicines. Furthermore, the PMC suggests that through a federal grant program, the government facilitate access to personalized drugs and educate healthcare providers and patients in places with limited healthcare resources.
"Most of PMC’s suggestions are new concepts to move personalized medicine forward; however, some of our suggestions streamline ideas that were included in the last version of the GPMA," Miller told PGx Reporter via e-mail. "For example, the old version of the bill would have created many new government advisory committees. Our proposal … is to create one new committee that would be similar to the disbanded [Secretary's Advisory Committee on Genetics, Health, and Society] but better balanced to include industry voices, a cross-section of government agency representatives, as well as academics."
Compared to the older version of the GPMA, "our proposal is designed to be realistic about what will aid the development and adoption of personalized medicine," Miller noted.
Although personalized medicine is by and large not seen as a partisan issue, lawmakers have been reluctant to introduce bills on the topic in the post-healthcare-reform environment, fearing that any proposals related to healthcare may be torpedoed. If a new version of the GPMA is introduced in the current Congress, its chances of getting to a vote are uncertain.
According to Miller, the political climate for personalized medicine-focused bills is favorable in that more legislators are increasingly aware of the discipline. However, the prospects for any bill on Capitol Hill are currently uncertain from an economic standpoint.
"The great news is that many more members of Congress are interested in personalized medicine than ever before and moving personalized medicine forward enjoys support from both Republicans and Democrats," she said. "However, the challenge for any legislation is that these are times of fiscal restraint. Although most of our suggestions cost little or no money, Congress is seriously considering the costs of all legislative proposals before acting on them."
Although the PMC doesn't provide an estimate of how much it would cost to implement its personalized medicine recommendations, one of its proposals is for federal grants and tax credits to encourage the development of such technologies and to facilitate patient access to them.
The PMC, however, highlights in its proposals that although there are costs associated with implementing any new legislation, personalized medicines that enable doctors to administer drugs that are more efficacious and less toxic to patients would reduce healthcare costs in the long run.
"Recent legislation established programs that aim to improve the quality of care while reducing costs through the development of new healthcare delivery models," the PMC states in the document outlining its recommendations for the GPMA. "Incorporating incentives to appropriately use personalized medicine into these programs will further Congress’ goals of reducing costs and improving healthcare quality."
The PMC proposes that Congress extend to developers of personalized drugs and diagnostics tax credits and grant programs established under the Patient Protection and Affordable Care Act for smaller life sciences companies developing interventions for unmet medical needs or chronic conditions. Additionally, the PMC asks congress to amend the Internal Revenue Code to establish a R&D tax credit for drug and diagnostics firms collaborating to advance personalized medicines for molecularly defined patient subsets, particularly if development of the product creates jobs in the US or provides treatment for a patient group with limited options.
Cognizant of constraints on the federal budget, the PMC's recommendations for a new version of the GPMA also attempt to cut superfluous spending. For example, the old bill included provisions to fund a project to look at incentives for personalized medicine. The PMC suggests "that provision be eliminated because the question of 'what will incentivize personalized medicine' has already been studied," Miller said.
"If enacted, we believe that our ideas could move personalized medicine forward in a way that another new study could not."
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