Breaking News: Federal Appeals Court Once Again Upholds Gene Patents, Invalidates Comparison Method Patents
As Statline was going to press, the U.S. Court of Appeals for the Federal Circuit announced that it once again partially reversed a lower court’s ruling in the Myriad gene patent case. In a 2-1 decision, the federal court of appeals ruled that companies can patent genes, but cannot patent methods to compare those gene sequences.
This is the second time the Federal appeals court has considered this lawsuit. The Supreme Court vacated this court’s July 2011 decision following the high court’s unanimous ruling in favor of Mayo Collaborative Services in its medical patent suit against Prometheus Laboratories. The Supreme Court then remanded it back to the Federal appeals court in light of the Mayo decision.
The American Civil Liberties Union (ACLU) is representing plaintiffs (including the CAP) in a suit challenging gene patents on human DNA, specifically Myriad Genetics’ patent claims on BRCA 1 and BRCA 2 genes. CAP and other medical societies and organizations provided amicus briefs in support of Mayo at various points in the litigation.
“It is extremely disappointing that despite the Supreme Court’s ruling, the appeals court has failed to fully re-consider the facts of this case,” said ACLU attorney Chris Hansen. “This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.”
The ACLU declined to comment on what this means for the future of the case, except to say their attorneys are weighing all legal options and will discuss future strategies with the plaintiffs.
Watch for continuing coverage of the Myriad gene patent case in future issues of Statline.
Mass. Gov. Patrick (D) Signs Landmark Health Care Reform Bill Into Law
Sweeping health care reforms, including the promotion and certification of accountable care organizations (ACOs), will now move forward in Massachusetts, after Gov. Deval Patrick (D) signed a landmark bill into law on Aug. 6.
Slated to cut health care costs in the state by $200 billion over the next 15 years, the ACO provisions in the new law specify that clinical laboratory and pathology services are included in the patient’s care continuum. Establishing this continuum is the goal of coordinated care. In addition, the law includes a provision empowering the state to assess ACOs regarding provider integration within and outside the model, including the extent to which the laboratory?s medical director is integrated into the coordinated care entity.
The Massachusetts Society of Pathologists and the CAP both urged the inclusion of both of these pathology-related elements in the law over the course of several years. This language emphasizes the role of pathologists in appropriate medical test selection and in patient diagnosis and treatment in ACOs, explained Richard C. Friedberg, MD, PhD, Chair of CAP’s Council on Government and Professional Affairs.
“In our discussions with key legislators, it became clear that they were concerned about underutilization, as well as overutilization, as incentives under coordinated care models change,” Dr. Friedberg told Statline. “Because of these concerns, it was clear that physicians specializing in laboratory medicine needed to be central to these models, in order to ascertain appropriate utilization.”
Medical Consumer Group Urges Veto of New York Self-Referral Bill
The New York-based Center for Medical Consumers (CMC) is joining with the CAP, the New York State Society of Pathologists (NYSSP), and other laboratory groups in calling for Gov. Andrew M. Cuomo (D) to veto legislation weakening the state’s current self-referral law. New York lawmakers from both chambers approved the legislation (Assembly Bill 3551)/Senate Bill 4660) in June; Gov. Cuomo is expected to receive the bill this month (see box).
Follow @CAPDCAdvocacy on Twitter for Bill Updates
Gov. Cuomo is expected to receive the bill this month, and he has 10 days from receipt (with the exception of Sundays) to veto the bill or sign it into law.
CAP will be providing updates on the bill’s status on Twitter. Follow us at @CAPDCAdvocacy.
“We believe the evidence that financial self-interest may influence physician referrals in ways that erode shared decision-making and may actually prove harmful to patients is stronger than ever,” stated the letter from CMC Director Arthur A. Levin. “This evidence is derived from published studies of a wide range of medical practices, including clinical laboratory and pathology services, screening and diagnostic tests, imaging and radiation oncology.” CMC is a non-profit advocacy organization focused on ensuring safe and effective medical treatments. The group receives no funding from providers of medical services.
Also opposing the bill is the New York Blue Cross Blue Shield plans, as well as the Alliance for Integrity in Medicare (AIM), whose members include the American College of Radiology (ACR), the American Physical Therapy Association (APTA), and the American Society for Radiation Oncology (ASTRO), among others, including the CAP.
In a July 20 coalition letter, AIM members noted that “the existing New York prohibition of physician self-referral, which exceeds that provided under federal law, provides critical protections against abusive business practices that demonstrate the state’s commitment to protect patients from overutilization of medical services and increased health care costs.”
Blue Cross and Blue Shield Assoc. Clarifies New Laboratory Policy
The Blue Cross and Blue Shield (BCBS) Association recently “clarified” its policy regarding Blue Card claims for laboratory services. All independent clinical laboratories must submit claims to the local Blue plan in the state where the biopsy was taken (ultimately where the ordering provider is)—not where the laboratory is located, the College has learned. In addition, they are only in-network providers if they are contracted with a local Blue plan in the state where the ordering physician is located.
The CAP has joined the American Academy of Dermatology in expressing concern that this policy change, implemented by Blues plans in some states as early as mid-July, prevents ordering physicians from having specimens on their BCBS patients interpreted by their chosen pathologist or dermatopathologist. Furthermore, the College has heard reports of unsuccessful attempts by independent laboratories to become participating providers with Blue plans local to the ordering physician.
Watch for further updates on this issue in future issues of Statline.
AdvocateCare Pathologists Bolster Growth, Savings in ACO
Pathologists at one of the country’s leading health systems, Advocate Health Care in Chicago, are playing a key role in both the commercial and Medicare ACOs by maintaining a “laser focus” on both quality and cost containment, explains Michael Weldon-Linne, MD, FCAP, in a new profile featured on the CAP ACO/Coordinated Care Resource Center.
New Resources on the CAP ACO Resource Center
- New report from the Commonwealth Fund on Strategies from Premier’s ACO Collaborative
- CMS Guidance Document on Quality Measures for ACOs Starting in 2012
On Jan. 1, the system launched a commercial three-year-partnership called AdvocateCare with Blue Cross Blue Shield of Illinois, the system’s largest payer. AdvocateCare also began participating in the MSSP beginning July 1, according to Dr. Weldon-Linne, who is a member of the CAP-ACO Network.
Coordinated care has always been a fundamental aspect of patient care at Advocate. And there has been a robust pathology endeavor dating back ten years ago, when Advocate partnered with Aurora Health Care in Wisconsin to establish a consolidated centralized laboratory operation—ACL Laboratories—to provide laboratory and pathology professional services to the two health systems.
“The reality is that coordinated care is the direction that health care is going,” said Dr. Weldon-Linne, who is Chairman, Department of Pathology at Advocate’s Illinois Masonic Medical Center (IMMC). “Pathologists need to be at the heart of this movement, particularly when it comes to driving clinical integration.”
For more about how pathologists are furthering the goals of AdvocateCare, read the profile on the CAP ACO/Coordinated Care Resource Center.
Interested in joining the CAP-ACO network? CAP members who work in a facility that is currently—or will be—part of an ACO are encouraged to join the network. For more information—or if you have a question about ACOs—please email us.
Justice Department Blames Forensic Pathologist Shortage on Low Pay, Limited Training Programs
Too few accredited training programs along with lower salaries compared to other specialties are top reasons for the shrinking supply of forensic pathologists in the U.S., found a recent draft report from the Justice Department. The College’s Forensic Pathology Committee is currently analyzing these findings.
The report, “Increasing the Supply of Forensic Pathologists in the United States,” was prepared by the Scientific Working Group for Medicolegal Death Investigation. The working group found that while there are 131 medical schools in the U.S., there are only 37 forensic pathology training programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). Furthermore, most medical school curriculum provides little to no exposure to forensic pathology. The variance of forensic pathology fellows is also problematic. If salaries are geared to post-graduate year (PGY levels), this can translate into $50K-$60K for a PGY5 or PGY6 trainee. Many institutions do not adhere to the PGY guidelines in order to offer higher salaries. However, the report found that these salaries typically come in around $100K, which is still not competitive with other specialties.
The report also estimated that the national autopsy rate is a low 8.5% with only about 4.3% of disease-caused deaths undergoing the procedure.
To address these issues, the working group is recommending greater exposure of forensic pathology and death investigation in medical school curriculum, and offering financial incentives, including loan forgiveness, to attract more students and pathology residents into this specific field.
These recommendations are largely in line with resolutions backed by the CAP Board of Governors to improve the quality and consistency of forensic laboratory and death investigation practices in the U.S. However, the CAP also endorses limiting the performance of autopsies falling under Medical Examiner/Coroner jurisdiction to forensic pathologists certified in at least Anatomic and Forensic Pathology by the American Board of Pathology or to pathologists under their supervision whenever possible.
The College supported a proposed resolution before the AMA House of Delegates in June to develop model state legislation to facilitate the nationwide transition from a coroner systems to medical examiner systems. The AMA delegates agreed to work with states interested in introducing legislation to facilitate this transition.
CAP Discusses Advocacy Priorities with State Lawmakers at NCSL
CAP members discussed issues impacting pathologists with state lawmakers at this year’s National Conference of State Legislatures (NCSL) Annual Summit, held August 6-9 at the McCormick Place West Convention Center in Chicago.
This year’s gathering was attended by 5,500 lawmakers, exhibitors, and staff. The College was represented by leaders of the Illinois Society of Pathologists (ISP): Stephen G. Ruby, MD, FCAP (ISP President); Jack E. Garon, MD, FCAP; and Robert P. DeCresce, MD, FCAP. These members highlighted CAP’s state advocacy agenda, the pathologists’ transformational role in health care initiatives supporting patient care, including My Health Test Reminder and mybiopsy.org. CAP’s presence at the meeting also featured an exhibit booth with a microscope and slide projection.
“By attending NCSL, I had the opportunity to discuss how issues and legislation impacts pathologists at the state level,” Dr. Ruby told Statline. “I was also able to stress to state lawmakers the importance of including pathologists in any ACO or similar coordinated care model, as we are physicians who can truly help trim costs in relationship to laboratory utilization.”
Expanded Medicare Three-Day-Window Payment Modifier Now in Effect
The Centers for Medicare and Medicaid (CMS) recently expanded its “Three-Day Payment Window” rule for certain outpatient services provided by hospital-affiliated physician groups within the three days prior to an inpatient admission.
Effective July 1, 2012, a new PD modifier must be used for any diagnostic or related non-diagnostic service that is provided by a wholly owned or operated entity to a patient who is admitted to a hospital within three days. The PD modifier applies to all services that are deemed clinically linked to the reason for admission, regardless of whether the inpatient and outpatient diagnoses are the same. Physician non-diagnostic services that are unrelated to the hospital admission are not subject to the payment window.
If the PD modifier is used, the technical component of the claim will be paid to the hospital. Medicare will pay through the Physician Fee Schedule for the professional component (PC) for service codes with a Technical/Professional Component (TC/PC) split that are provided within the payment window, and at the facility rate for service codes without a TC/PC split.
Affected wholly owned entities will need to develop effective communication mechanisms in order to successfully coordinate the new billing modifier.
Registration Now Open for 2013 CAP Policy Meeting
Online registration is now open for the CAP 2013 Policy Meeting, to be held May 6-8, at The Fairmont in Washington, DC. This meeting is an important opportunity for CAP members new to politics, ready to learn more, or already involved in ever-evolving local, state or national healthcare issues to engage directly with lawmakers and policy leaders.
Meeting registration is free and includes all meeting materials, CME, breakfasts, lunches, and cocktail receptions during the meeting. Attendees will be responsible for their travel, hotel and other expenses. Watch future issues of Statline for more meeting details.
Keep Up with the Latest CAP Advocacy News on Twitter
CAP Advocacy is now on Twitter. Follow CAP Advocacy’s daily “tweets” to keep pace with regulatory and legislative news affecting pathology. For the latest health care news, be sure to check out what we are following on Twitter.
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