College of American Pathologists
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June 21, 2013  •  Volume 29, Number 13
Next Issue: July 3, 2013
© 2013 College of American Pathologists

In This Issue:

Clarification of Changes in Aetna’s July 1 Laboratory Fee Schedule

CAP reached out to Aetna for clarification of the laboratory fee schedule change Aetna announced effective July 1 and was able to obtain additional information about the policy.

Aetna is modifying its national laboratory fee schedule effective July 1. The changes apply only to those laboratories that are subject to this fee schedule. If your laboratory did not receive a letter from Aetna announcing the change, you are not subject to it.

The focus is Aetna’s national laboratories. The change does not apply to physicians contracted under Aetna’s local market fee schedule or other non-national laboratory arrangement. Aetna’s national laboratories can be accessed via Aetna’s “docfind” tool on Aetna’s website. Aetna is the 3rd largest insurer in the country.

Aetna advises pathologists to direct any remaining questions to their local market network contact.

Experts Predict More Genomic Breakthroughs In Wake of Gene Patent Decision

Genomic medicine achieved a major victory last week when the Supreme Court invalidated the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, on the grounds that isolated genomic DNA is a product of nature and therefore not patent eligible. The decision also concluded that cDNA is not a product of nature, but explicitly stated that the Court was not expressing an opinion on whether patents on cDNA might be invalid under other parts of the Patent Act.

As a co-plaintiff in the case Association of Molecular Pathology et al, vs Myriad Genetics, Inc., brought by the American Civil Liberties Union (ACLU) in 2009, CAP marked the ruling by inviting a panel of leading experts to discuss the impact it will have on patients and laboratory medicine.

Panelists included Sandra Park, JD, Senior Staff Attorney with the Women’s Rights Project at ACLU, who was a lead attorney on the case against Myriad; Debra Leonard, MD PhD, FCAP, Chair of the CAP Personalized Healthcare Committee, Chair of Pathology at the University of Vermont College of Medicine and Fletcher Allen Health Care and a leading voice opposing gene patents; Margaret Gulley, MD a pathologist at the University of North Carolina who has advocated against gene patents on behalf of indigent and uninsured patients; and Mary-Claire King, PhD, a geneticist at the University of Washington, who is credited with discovering the BRCA1 gene in 1990.

“There’s no question that not having testing available for all breast and ovarian cancer genes has cost lives,” stated Mary-Claire King. It’s an enormous relief that there will now be an open marketplace where a variety of approaches can be used.

The approach that will be used most quickly by all accounts will be next generation sequencing (NGS). “It will allow the detection of all classes of mutations in BRCA1, BRCA2, and multiple other genes that similarly harbor inherited mutations that lead to very increased risks of breast cancer or ovarian cancer or both,” said King. “These tests have been available in the research sphere since 2010, but have not been available to patients clinically until last week.”

Indeed, once the ruling was announced, several laboratories broadcast the availability of BRCA1 and BRCA2 tests, as well as multi-gene test panels.

Since 1987, the Patent and Trademark Office has approved patent claims on thousands of human genes, which are all now invalid back to the date on which they were issued.

“The decision gives pathologists freedom to operate in the genome,” said Debra Leonard. “Although cDNA is still patent eligible, we can invent around patented cDNA because we can use the gene sequences. This will allow us to create test panels based on what is best for patients rather than work around the patented genes.”

In fact, the preemptive effect of the patents was a major consideration in the court decision, according to Sandra Park. “The patents on the isolated genes really meant that you could not work with the DNA or the sequences, and the court was concerned that by allowing these patents, you were locking up the fundamental genetic information that you wanted scientists and medical professionals to be able to work with,” she said.

“It is extremely important for pathologists to be able to freely do molecular and genomic testing and begin incorporating NGS technology into clinical practice,” Leonard said. “Pathologists should be celebrating and looking into what they now have the ability to do in their laboratories without fear of infringement.”

“It’s clear that genetic tests add value to patient care in many instances,” said Margaret Gulley. “However, until last week a major consideration in whether to bring on a new test was not how much it would benefit our patients, but rather whether we would be likely to face a lawsuit for gene patent infringement. This decision opens the door for us to put patient needs first.”

In 2006, Myriad ceased to publish BRCA variant information, and ended their relationship with the open-access Breast Cancer Information Core (BIC) database. Since then, they have assembled a private repository of genotype-phenotype information.

The panel discussed the need for access to databases of clinical variant information. “We must now move forward to put into public domain much of the information that is held by individual providers,” Leonard said.

Gulley agreed, “We need better databases to help us interpret genetic test results. Pathologists need variant databases not just for cancer genes but all genes that we test for, including microbial genes and so forth.”

King noted a consortium run by Dr. Robert Nussbaum at the University of California in San Francisco to collect all of the BRCA variants of uncertain significance that have been identified over the last decade in research settings into a database known as ClinVar. ClinVar is an accessible archive of anonymized genotype/phenotype information hosted by the National Center for Biotechnology Information (NCBI). ClinVar is incorporating all human phenotypes including heritable conditions, cancer classification, and pharmacogenetic drug response predictors.

Panelists also discussed the role of genetic testing in prevention. Dr. King envisioned a population based offering of a genetic test panel about the time a woman begins her family (sometime in her late 30’s – very early 40’s) so that anyone can receive a one-time genetic screen for the potential of inherited damaging mutations for BRCA1, BRCA2 or other genes.

“We know from a very large number of excellent retrospective cohort studies that women in their late 30’s and early 40’s and who carry a damaging mutation in one of those genes and choose to remove their ovaries and fallopian tubes at that time not only reduce the risk of ovarian cancer to virtually 0, but also reduce their breast cancer risk by half,” King said.

Leonard concurred. “We want to move to preventive strategies, rather than reactively treating disease, to use pharmacogenetics to prevent adverse drug reactions as well as to optimize dosing, and treat single gene diseases and common complex diseases such as diabetes and high blood pressure. Genomic medicine offers the possibility of early intervention rather than waiting until the disease is fully developed.”

For more information on CAP’s position on genomic medicine and on the case against Myriad Genetics, see CAP’s Video Issue Brief or visit the CAP’s Gene Patent Resource Center. A recording of the webinar will be posted to the Resource Center as soon as it is available.

CAP Joins Coalition to Improve Molecular Diagnostic Test Pricing Transparency

The College announced this week that it has joined in forming the Coalition to Strengthen the Future of Molecular Diagnostics, in an effort to advance and support sustainable Medicare pricing for molecular diagnostic testing.

The coalition was formed with the objective of informing policymakers and CMS about the value of genetic testing and the impact timely and accurate diagnoses have on treatment decisions and patient outcomes.

The group is urging CMS to provide greater transparency in the process of developing new Medicare prices for existing molecular diagnostic tests. Prior to 2013, molecular diagnostic tests were reimbursed through a method know as code stacking, where each step or process used to perform a test was billed and reimbursed.

In an effort to improve transparency of these tests, CMS announced it would assign individual CPT codes to more than 100 tests. During the ongoing deliberations aimed at determining a permanent pricing structure for 2014, interim pricing derived by the Medicare Administrative Contractors (MACs) using the gap-fill method, effectively cut payments for many critical tests by an average of 20%, and as high as 80% compared to 2012 levels.

Moreover, many diagnostic tests are being non-covered by the MACs outside of the normal coverage decision process, and laboratories that have been performing these tests are discovering that they will not be paid at all. The result is rising uncertainty among physicians and laboratories about how to best meet the needs of patients.

The coalition is asking CMS for immediate relief from below-cost reimbursement for some test and an improved data–driven pricing process that will allow for more transparency and participation from the molecular testing community.

CAP and State Societies Comment on Laboratory EHR Donation Proposed Rules

The CAP and 38 state pathology societies submitted comments urging the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General to remove medical laboratories and pathology practices from the list of approved donors of Electronic Health Record (EHR) software and services.

Both the CMS and the OIG issued proposed rules on EHR donations in April, with an eye toward extending the program with modifications, including possibly removing laboratories as approved donors. See related Statline article.

“We are pleased CMS is proposing to limit the scope of protected donors under the EHR exception to exclude ‘laboratory companies’ and urge CMS to adopt this proposed rule excluding laboratories and pathology practices that provide anatomic and/or clinical laboratory services,” CAP wrote.

The CMS proposed rule cites concerns about the current potential for abuse, and invites comment on narrowing the scope of protected donors to those who have “a direct and primary patient care relationship and a central role in the health care delivery infrastructure.”

“When laboratories are included as protected donors, EHR donations can be used as an inducement to shift patient specimen referrals, retain or even increase existing specimen referrals to the facility that donated the EHR program,” the State Pathology Societies wrote. “This referral relationship between physicians who refer testing and those who provide testing services creates an incentive for practitioners to make decisions about laboratory services based on the highest EHR donation, rather than quality, timely access to test results and the best interest of the patient.”

Based on these concerns, seven states (New York, New Jersey, Missouri, West Virginia, Pennsylvania, Tennessee and Washington) have exerted their authority under each state’s anti-kickback law, to prohibit or limit EHR donations by clinical laboratories to referring physicians, according to the letter.

Indeed CAP members have reported numerous cases of unfair business practices and potential abuses of the program. CAP’s letter describes an escalation of abuse, including EHR vendors pressuring labs to pay for the EHR system or lose the business to another lab; labs that cherry-pick certain ordering physicians for EHR donations based on the volume and value of tests ordered; and ordering physicians who accept EHR donations only to bring specimen testing in-house.

See the comment letters from CAP to the OIG and from the state pathology societies to the OIG.

Avoid Penalties: PQRS Registration Opens July 15 for Individuals and Groups

PQRS registration for the Group Practice Reporting Option (GPRO), the Administrative Claims Option and for the Value-Based Modifier (VBM) Quality Tiering Option opens July 15 until October 15, 2013.

Registration is required for those who plan to report on PQRS measures as a group using any of the reporting options available: claims, registries, the GPRO web-interface reporting option tool or the administrative claims option. Group practices with more than 100 eligible professionals must also either sign up to avoid the -1.0% value- modifier payment adjustment or sign up for the VBM quality tiering option in order to be considered for a potential positive value- modifier payment adjustment.

In addition, individual physicians who do not wish to report measures as a group or as an individual or do not have any applicable measures in the PQRS program must register for the Administrative Claims option during the open registration period in order to avoid a -1.5% payment adjustment in 2015.

Who does not need to register? Eligible professionals who are participating in the PQRS as individuals through claims or registries, or those who are in one of the excluded categories (e.g. a participant in an ACO in the Medicare Shared Savings Program,) do not need to register on the PQRS website.

An active IACS account, which stands for Individuals Authorized Access to the CMS computer System, is needed to register for these PQRS and VBM options. CMS is urging representatives of group practices and EPs to request a new IACS account or modify an existing account on the CMS Applications Portal to name a PQRS representative as soon as possible. In order to register, the practice’s representative will need the group’s Tax ID number (TIN), the eligible professionals (EP) National Provider Identification (NPI) and Provider Transaction Access Numbers (PTANs).

Specific instructions for becoming a PQRS representative are available.


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