Supreme Court Hears Gene Patent Case
When the Supreme Court heard oral arguments in the lawsuit challenging gene patents last week, the justices showed a clear understanding of the public health issues at stake, and said they were highly skeptical of the idea that a company or a scientist can hold a patent on human genes and prevent others from testing or using them.
The case, Association of Molecular Pathology (AMP) et al, vs. Myriad Genetics, Inc, in which CAP is a plaintiff, questions the validity of seven patents held by Myriad Genetics for the genes BRCA1 and BRCA2, which Myriad discovered and whose mutated forms have been identified with a greater risk of breast and ovarian cancers.
Myriad maintains that isolated DNA is patentable, and the biotech industry agrees. CAP and the other plaintiffs, including medical groups, physicians and patient groups represented by the American Civil Liberties Union (ACLU), believe even DNA that has been isolated is an act of nature, and therefore cannot be patented. ACLU filed the lawsuit in 2009. Since then the case has been winding its way through the court system.
At last week’s oral arguments, some of the justices questioned the Patent and Trademark Office’s (PTO) policy of issuing broad patents because such patents can limit innovation and stifle competition. Justice Elena Kagan at one point described PTO as “patent-happy”.
Others questioned the validity of the patent on scientific grounds. Chief Justice John G. Roberts Jr. said Myriad had simply “snipped part of the gene”.
Discussing the broad ramifications of their decision, the justices appeared to favor a middle-ground solution, presented in a Justice Department brief that said only synthetic genes, or cDNA produced outside the body, should be eligible for patent protection.
The Supreme Court’s decision is expected in June. It is likely to impact patents on pharmaceuticals, vaccines and genetically modified foods as well as human gene patents.
Listen to a recording of the oral arguments or read the transcript.
Reminder: Provider Edits Go Into Effect May 1
Starting May 1, referring and ordering physicians listed on claims for laboratory services must be enrolled in Medicare or have valid opt-out status or the claims will be denied, even if the provider submitting the claim is enrolled in the program, according to an announcement issued by CMS in March.
As previously reported in Statline, CMS will now require physicians or other eligible professionals who order or refer items or services for Medicare beneficiaries to be enrolled in the Medicare Program, and each claim must contain the exact name and unique identifier of the ordering or referring physician on all applicable Part B, DME, and Part A HHA claims in order to be paid.
Providers who do not have a Medicare enrollment record must submit an enrollment application to Medicare in one of two ways: via the internet-based Provider Enrollment, Chain and Ownership System (PECOS) or by completing the Medicare paper enrollment application (CMS08550).
HHS Seeks Input on Improving EHR Interoperability and Adoption
Encouraging providers to use certified interoperable electronic health record (EHR) systems that can exchange patient information in real time remains a top priority in the government’s vision of transforming health care. With several years of incentives already paid and new rules taking shape, policy makers are taking stock.
So far the Department of Health and Human Services’ (HHS) has been successful in moving the needle with some providers, reporting last month that adoption and use of at least basic electronic health record (EHR) systems by office-based physicians grew from 2009-2012 to 40%, and adoption by non-federal acute care hospitals jumped an impressive 260% to 44% during the same time. Impressive, but not enough to support the “information rich, person-centered, high performance health care system where every health care provider has access to longitudinal data on patients they treat,” as HHS envisioned.
Citing fee-for-service reimbursement and other business motivations as barriers to sharing patient information, HHS said in a notice last month that it is considering a number of policy levers including incentives and payment adjustments to accelerate and advance EHR interoperability and health information exchange (HIE).
The notice appeared as a joint request from the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator of Health Information Technology (ONC), and invited public comment by April 22, 2013.
CAP’s comments focused on the ways pathologists can improve coordinated patient-centered care with increased access to the EHR and the need for pathologists to have input into sharing and storing laboratory data in interoperable and multi-directional EHRs, and verifying such systems. The CAP discussed the extraordinary expenses laboratories face managing and sharing patient data electronically with each client’s individual EHR system interfaces, and urged HHS to identify funding streams to cover the costs of multi-client laboratory interfaces and maintenance. CAP described the unfair business relationships created by the EHR donation safe harbor, including problems associated with “data lock-in” and urged HHS to remove anatomic pathology laboratories from the EHR donation safe harbor.
Tennessee Legislation Recognizes CAP Accreditation
Under a bill (HB 1164/SB 1269) passed by the Tennessee Legislature, and signed by Governor Haslam on April 23, 2013, certain laboratories will not be required to meet Tennessee personnel licensure requirements if they are accredited by the College of American Pathologists, among other entities prescribed in the legislation. In order to avail the personnel exemption, the laboratory must be “engaged in advanced esoteric applied toxicological, forensic, or biochemical laboratory analysis utilizing emerging technologies” and the laboratory must be licensed, certified or accredited, including state licensed as well. Under prior law, ”forensic and compliance analytical testing facilities” were similarly exempt from certain state personnel supervision and credential requirements when accredited by certain accreditation and licensing entities that did not include the CAP. The CAP and the Tennessee Society of Pathologists took no position on the bill, but negotiated clarifying language to ensure that laboratories eligible for the exemption continue to be subject to state regulation, including laboratory licensure.
Negotiated Washington State Bill Upholds AG Opinion on EHRs
The Washington State Legislature has passed legislation (SB 5601) to ensure that EHR donations by hospitals are allowed under state law while upholding the ban on such donations by clinical laboratories resulting from the November 2012 opinion of the State Attorney General (see Statline December 6, 2012.) The opinion of the Attorney General was successfully secured under a joint effort of the College and the Washington State Society of Pathologists (WSSP). In light of the opinion, both WSSP and CAP opposed an initial effort by the Washington State Hospital Association (WSHA) to entirely void the 2012 Opinion of the Attorney General (See attached letter) by deferring state law to federal. After intense negotiation at the start of the legislative session, the WSHA agreed to legislation (SB 5601) that expressly ensures that all provisions of the Washington State anti-kickback law, including those forbidding such donations, continues to apply to clinical laboratories. Other provisions of the bill, if enacted, will allow hospitals and other entities to be covered under the federal anti-kickback law and avail the current federal safe harbor for such donations, that is scheduled to expire December 31, 2013, but that may be extended under an April 2013 proposed HHS rule.
NC House Considers Release of Pathological Materials
The North Carolina House of Representatives and Senate have passed legislation (HB168/SB240) which would direct the Department of Health and Human Services and the North Carolina Medical Board to develop rules regarding requests for the release of pathological materials. The bills specify the rules must be consistent with CAP’s 2003 Professional Relations Manual and North Carolina Hospital Association Best Practices Principles.
The NCSP, with the support of the College, had opposed legislation requiring health organizations to provide all pathological materials collected from the patient to the patient, upon written request. In a May 2011 letter to members of the North Carolina state Senate and House of Representatives, NCSP President Kevin S. Smith, MD, FCAP, cited several problems with H.B. 795, Patient Access to Pathological Material. These included public health concerns regarding the release of pathological material and the likely impairment of patient diagnosis. In addition, the letter noted the potential conflict between the legislation and state and federal laws, including requirements for specimen retention under CLIA and accreditation standards.
SB240 will now be sent to Governor McCrory for his signature.
It’s Not Too Late! Signup for the CAP Policy Meeting
It’s not too late to sign up for the CAP Policy meeting, just over a week away, May 6-8 in Washington DC.
Your time will be well spent network with your CAP colleagues and hearing from top health policy makers from government, the house of medicine, and the media. Then head up to Capitol Hill and meet with your senators and House members. From talking points to issue briefs and even key “asks”, CAP has everything you need to be a compelling advocate for pathologists.
Download our new meeting app and see more information about the meeting, or read about our speakers. When you’re ready, register here.
202-354-7100 • 202-354-7155 (fax) • 800-392-9994