College of American Pathologists

  STATLINE — CAP’s Bi–Weekly Federal and
  State Advocacy E–Newsletter

August 15, 2013  •  Volume 29, Number 17
Next Issue: August 29, 2013
© 2013 College of American Pathologists

In This Issue:

CAP Campaigns to Reverse CMS Proposed 2014 Cuts

As the September 6 deadline for comments to the Centers for Medicare and Medicaid Services (CMS) on the proposed 2014 physician fee schedule cuts approaches, CAP members and staff are focused on preventing these misguided cuts from taking effect.

The CAP is coordinating with the American Medical Association (AMA) and other impacted medical specialty organizations. The AMA hosted a strategy session last Friday for the impacted groups to calibrate strategy. Urging Congress to intervene with CMS, the AMA is creating a specialty society sign-on letter on the proposed rule and has already issued a strong criticism of the proposed 2014 Medicare physician fee schedule.

CAP’s Washington office hosted an additional strategy session for the clinical laboratory and diagnostics industry groups last week to coordinate strategy and outreach. Representatives included the American Clinical Laboratory Association, AdvaMed-Dx, Quest Diagnostics, American Society for Clinical Pathology, Association of Pathology Chairs, American Association Clinical Chemistry, General Electric, and Becton Dickinson.

Several of these groups are scheduling individual meetings with CMS, and we are sharing our economic analyses with them, as well as coordinating grassroots efforts. CAP staff will be meeting with CMS on August 20 to protest this rule and highlight the faulty methodology that resulted in these drastic cuts.

The Washington office also sent a letter to every congressional office opposing the cuts and asking Congress to intervene. The letter is signed by virtually every major pathology organization and our state pathology societies. ASCP sent an action alert on Wednesday to activate its network in support of withdrawing the rule and we are working with APC to mobilize its membership.

Our grassroots team is working with CAP members to educate Members of Congress and engage CMS to prevent these cuts from being implemented. To date, over five hundred CAP members have sent 1,703 emails to Congress and hundreds of comments to CMS. In addition, meetings are taking place in congressional districts where CAP members are meeting with their Member of Congress or congressional staff.

The ongoing efforts of CAP members are crucial in fighting these proposed cuts. The 60-day public comment period expires Friday, September 6, 2013. To submit comments to CMS and your Member of Congress, visit the Medicare 2014 Physician Fee Schedule Resource Center. You will find a summary of the issue, a position statement from the CAP, and resources that will be helpful in engaging CMS and Congress.

Stay Informed via Webinars

Understanding the 2014 Proposed Medicare Physician Fee Schedule
On July 8, 2013, CMS proposed a change to link payment for 211 physician services, including 39 pathology services, to hospital outpatient rates as part of its “misvalued code” initiative. If finalized as proposed, Medicare will radically cut the technical component (TC) and global payments (TC and professional component) for many pathology services by over 50% and as much as 80% for certain services performed on non-hospital patients.

ABP Approved to Participate in MOC:PQRS

Pathologists Can Now Qualify for PQRS Incentive Payments By Participating in Maintenance of Certification Activities

CMS recently approved American Board of Pathology (ABP) maintenance of certification (MOC) programs. The approval creates a pathway for pathologists to qualify for additional incentive payments in the Medicare Physician Quality Reporting System (PQRS) by participating in the MOC:PQRS Additional Incentive Program. In 2013, participation in the program allows board-certified pathologists already participating in the PQRS incentive program to earn an additional 0.5% incentive payment on their total Medicare Part B allowed charges for 2013, above the PQRS incentive alone. To qualify, pathologists must participate in the ABP MOC program “more frequently” than is required to maintain board certification.

For pathologists with time-limited board certificates, “more frequently” means participating in certain continuing medical education programs, board exams, performance improvement programs, or patient safety courses.

Pathologists with lifetime certificates can meet the “more frequently” requirement by voluntarily enrolling in the ABP’s MOC program. Enrollment costs $100. There is no jeopardy to the lifetime certificate if a pathologist chooses not to participate in either the PQRS or the MOC:PQRS programs.

To earn the incentive payment, all pathologists—both time-limited and lifetime certified—must complete an attestation module by December 31, 2013. The module is available online and costs $30.

More details on the PQRS and MOC:PQRS programs are available on the PQRS Resource Center on the CAP website, and here.

Connecticut Acts to Ban Laboratory EHR Donations

The Connecticut Department of Health issued a declaratory ruling last week clarifying that the donation of electronic health records (EHRs) by clinical laboratories to referring physicians, generally permitted under the current federal safe harbor, is prohibited under the state’s anti-kickback law. The ruling is in response to a petition request submitted by the Connecticut Society of Pathologists (CSP) and supported by the CAP. The CSP petition request, originally made in September 2012, was subject to formal administrative process for adjudication.

At a May hearing on the issue, the Connecticut Hospital Association (CHA) opposed the CSP request for an opinion over concerns the request did not supply sufficient information for the Department to issue a ruling, and the potential implications for hospital donation of EHRs. In its ruling, the Department of Health rejected the arguments of the CHA and unequivocally prohibited clinical laboratories’ donation of EHRs, while preserving the donation of laboratory interface systems and software:

“The difference between the cost of a software interface that permits electronic communication between the physician’s office and the lab and the amount donated towards the cost of an EHR system is what takes the donation out of the Safe Harbor provision. Thus, donating or offering to donate any amount above the cost of an applicable software interface takes the donation of an EHR system out of the Safe Harbor provision and violates the Regulation regardless of the donor’s intent.”

Connecticut is now the eighth state to prohibit or limit the donation of EHRs by clinical laboratories, joining Tennessee, West Virginia, New York, New Jersey, Pennsylvania, Missouri and Washington. Under a proposed U.S. Department of Health and Human Services regulation, that the CAP supports, the federal safe harbor for EHR donations by clinical laboratories is scheduled to sunset December 31, 2013. The final adoption of the federal regulation is pending.

CAP Supports Ambry and Gene by Gene in Patent Suit

The June Supreme Court decision in Association of Molecular Pathology et al. vs. Myriad Genetics continues to have ripple effects in the marketplace and in the courts. In mid-August, the CAP submitted a declaration in support of two laboratories, Ambry and Gene by Gene, in litigation of the cases University of Utah Research Found. v. Ambry Genetics Corp., and University of Utah Research Foundation, et al. v. Gene by Gene.

Both laboratories began testing for the breast cancer genes BRCA1 and BRCA2, and were sued by Myriad for patent infringement. Further, Myriad asked the court for a preliminary injunction that, if granted, would stop Ambry and Gene by Gene from doing the testing while the litigation is in process. The CAP’s declaration states that permitting Ambry and Gene by Gene to continue the testing is in the public interest. The declaration was submitted on the CAP’s behalf by Debra Leonard, MD, PhD, FCAP, chair of the CAP’s Personalized Healthcare Committee and a member of CAP’s Council on Government and Professional Affairs.


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