By Turna Ray
The efforts of a healthcare industry coalition to stall implementation of certain aspects of the Genetic Information Non-Discrimination Act have personalized healthcare stakeholders worried.
DMAA: The Care Continuum Alliance, representing more than 200 corporations and individual members, wrote a letter on Nov. 2 to the heads of three government agencies — the Department of Health and Human Services, the Department of the Treasury, and the Department of Labor — requesting an "immediate moratorium on the implementation and enforcement of" GINA until an inter-agency investigation determines how the law's restriction on the use of genetic information for "underwriting" purposes would impact wellness and chronic disease management programs under health plans.
On the same day, DMAA also issued a letter to members of the US Senate requesting "clarification of the definition of 'underwriting' as included in the original GINA statute." It is the coalition's view that the law's definition of "underwriting" overreaches Congressional intent, and as such will "have dramatic and unintended consequences on programs designed to support at-risk and chronically ill individuals."
The Personalized Medicine Coalition, for one, has taken a position against any such moratorium on GINA.
"One of the founding principles of the PMC is that individuals should not be discriminated against based on their genetic information," Public Policy Director Amy Miller told Pharmacogenomics Reporter this week. "We support implementation of GINA as passed and signed into law."
GINA, which former President George W. Bush signed into law in May 2008, prohibits insurers and employers providing health care coverage from using genetic data for "underwriting" purposes, defined as making coverage and benefits decisions, determining premium amounts, and applying pre-existing condition exclusions under a plan.
"Without these protections, people might not take advantage of genetic testing," Miller noted.
Similarly, Rick Schatzberg of Generation Health, a company that is working with employers, insurers, and pharmacy benefit managers to offer genetic testing within their systems, noted that its clients do not view GINA to be a barrier to implementing wellness programs. Rather, Generation Health's discussions with employers and health plans have revealed that they prefer to have an independent third party to handle genetic information related to benefit programs.
In an email Schatzberg explained that while Generation Health is not opposed to seeing clarifications made to the definition of “underwriting” in GINA, "we just don’t believe that on balance, it’s beneficial to delay the implementation of GINA."
Without this law protecting people genetic discrimination, "our clients will struggle to find willing participants in our genetic benefit management programs," Schatzberg said.
Generation Health recently announced it was collaborating with CVS Caremark to offer pharmacogenetic testing services to PBM customers [see PGx Reporter 11-11-2009]. As a genetic testing benefits manager, it is conceivable that programs crafted by Generation Health for employers and health plans may incorporate genetic testing into wellness programs and disease management schemes.
In response to criticism, DMAA CEO Tracey Moorhead asserted that the coalition supports the overarching aim of GINA to prohibit insurers and employers from using genetic information to make coverage and employment decisions. DMAA is only taking issue with the broad underwriting restriction within the law, fearing it will restrict employers' and insurers' ability to offer incentives for completing health risk assessments, or HRAs, Moorhead told Pharmacogenomics Reporter this week.
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"The interim final regulations state that a wellness program that provides rewards for completing an HRA that requests family medical history would violate the prohibition against requesting genetic information for underwriting purposes, even if the rewards or incentives are not based on the outcome of the assessment," the DMAA states in its letter to government agency heads. "The interim final regulations provide no exception to this rule, regardless of the amount of the reward or incentive or whether the HRA meets the HIPAA wellness plan requirements."
Furthermore, DMAA also takes issue with the provision under the law that would restrict the use of HRAs to determine eligibility for a disease management program using family medical information. "This prohibition holds even if the HRA does not otherwise contain a financial reward or incentive," DMAA criticizes.
HHS, DoL, and DoT published their interim final rules for GINA in the Federal Register Oct. 7. The departments are accepting public comments on the interim final rules until Jan. 5, but the law goes into effect Dec. 7. Since the law has not yet been implemented by all health plans and employers, its real-world impact is not immediately known.
Amid the uncertainty, DMAA is requesting a hold on implementing the law, asking that the government essentially conduct a risk/benefit analysis of wellness programs with the underwriting restrictions required by GINA. On the other hand, personalized medicine stakeholders feel the law should not be amended before it is fully implemented and its impact observed over time.
Generation Health's Schatzberg acknowledged that while the impact and interpretation of GINA is difficult to predict at the moment, the law should still be implemented as is and "any necessary amendments [can] be worked out over time."
Schatzberg suggested that it may still be possible for health plans to offer wellness programs and comply with GINA.
"It is certainly feasible to bifurcate a health risk assessment into its component parts – those questions that have to do with personal medical history and those that have to do with family medical history or genetic information," he said. "The latter falls under the rubric of a genetic risk assessment, which can and should be analyzed by a trusted third party who operates with the correct privacy and security protections in place, as well as protocols for aggregating information and limiting individually identifiable genetic information to licensed healthcare providers and board-certified genetic counselors."
In its collaboration with CVS Caremark, Generation Health will serve as this trusted third party offering genetic testing services. Although Generation Health will discuss individuals' genetic risk data with doctors and genetic counselors, insurers and employers will be blinded to this information in situations mandated by GINA. There are gaps in the protections provided by GINA, particularly in the case of genetic information related to a pre-existing condition.
According to Schatzberg, Generation Health is establishing policies and practices in order to offer payors a "trusted third party that can protect a patient’s genetic information while helping patients, providers, and payors realize the clinical and economic benefits of testing." He added that the "pharmacogenomics … programs [Generation Health is] developing with CVS Caremark are far less affected by this debate because they depend upon prescription information rather than self-reported family medical history."
Counter to DMAA members who fear GINA will limit access to wellness programs, employers Generation Health has been speaking to feel it is "problematic for them or their health plans to have access to employees' genetic information and consistently recognize the value [of a] third party who can protect and appropriately aggregate this information while analyzing it and creating actionable benefit programs that improve patient outcomes and lowers healthcare costs," Schatzberg noted.
The evidence may be lacking on how GINA's provisions will impact chronic disease management and wellness programs, as DMAA suggests. However, there is plenty of available data showing that the absence of federal laws restricting genetic discrimination in employment and for insurance coverage negatively impacted genetics research.
In a 1997 survey of more than 1,000 individuals, 63 percent of the participants said they would refuse to take genetic tests for diseases if health insurers or employers could get access to the results. In 1999, a national survey by the California HealthCare Foundation found that 15 percent of adults surveyed took steps to keep genetic information private, by paying for testing out-of-pocket or withholding medical history from physicians.
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Another study, cited by the National Council on Disability, showed 57 percent of surveyed individuals with a risk for breast or ovarian cancer chose not to be genetically tested, and 84 percent of that group cited fear of genetic discrimination as a major reason for their decision to forego testing.
This experience suggests that consumers may not want to participate in wellness programs that request genetic information without assurance of genetic non-discrimination.
"As long as providing genetic information to employers is voluntary, GINA promotes wellness programs by protecting individuals against discrimination," PMC's Miller pointed out. Critics of DMAA's position hold that a financial incentive for participating in a wellness program that requests genetic information would unduly influence a person into revealing such information to employers or insurers.
Furthermore, "a moratorium on the implementation and enforcement of the GINA regulations, and any protracted debate on the matter, would undermine the protections that are essential for patients to comfortably proceed with testing and for providers to recommend genetic tests," Schatzberg added.
DMAA's 200 members include disease management organizations, health plans, hospitals, employer organizations, pharmaceutical and device companies, pharmacy benefit managers, health information technology firms, physicians groups, and others. DMAA's Moorhead noted the coalition has joined with several employer organizations to lobby for a moratorium on GINA.