College of American Pathologists
Printable Version

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

March 29, 2012  •  Volume 28, Number 7
Next Issue: April 12, 2012
© 2012 College of American Pathologists

2012 CAP Policy MeetingIn This Issue:

Mass. Leukemia & Lymphoma Society Supports Pathologists’ Role in ACOs

The Massachusetts chapter of the Leukemia & Lymphoma Society is supporting a legislative proposal (PDF 35 K) requiring the establishment of Clinical Laboratory Testing Advisory Boards be included in forthcoming legislation mandating accountable care organizations (ACOs) statewide for the private sector. These Advisory Boards would include at least one physician—such as a pathologist—who is a medical director of a CLIA–regulated laboratory providing services to the ACO.

Mass. Genetic Testing Reg. Changes Unlikely in ’12

Proposed changes to genetic testing regulations in Massachusetts are not likely to move forward in the state legislature, the CAP has learned.

A state Senate bill (S. 1080) that would no longer exempt pathologists from obtaining consent from patients prior to genetic testing will not advance from the state Joint Committee on Public Health this session, according to a recent vote from the Committee membership.

The CAP is concerned about the removal of this exemption, as former Massachusetts Society of Pathologists President C. Dean Pappas, MD, FCAP, outlined last year in a letter (PDF 143 K) to Committee members and the bill’s chief sponsor, State Senator Harriette L. Chandler (D-Worcester) the chamber’s Assistant Majority Whip.

The legislative proposal (PDF 237 K) was jointly developed by the CAP and the Massachusetts Society of Pathologists (MSP), who have been advocating on it in a series of meeting with key policy makers and legislative leaders for the past year.

“Every ACO should have the benefit of informed medical judgment that can be facilitated by the establishment and formalization of these Clinical Laboratory Advisory Boards within the ACO organizational structure,” states the letter to the Massachusetts state Joint Committee on Health Care Financing from the state Leukemia & Lymphoma Society chapter. “These Boards with pathologists’ input would, in our view, have the requisite medical expertise to help their colleagues within the ACO develop medically sound laboratory testing protocols or algorithms used by the ACO.”

Since Massachusetts Gov. Deval Patrick (D) began his legislative push to establish ACOs two years ago, the College and the state pathology society have been meeting with state policy makers about the potential value of the pathologists’ role in ACOs and the need for Advisory entities to be part of each ACO.

The ACO legislation is expected to be introduced in the Massachusetts state legislature in the coming weeks; stay tuned to Statline for updates.

Colorado Gov. Signs Direct Billing Law

Gov. John Hickenlooper Signs Direct Billing LawColorado Gov. John Hickenlooper (D) has now signed CAP-supported direct billing legislation (HB 1221) into law, protecting patients from having a “mark-up” charge added to their laboratory bill by an ordering physician.

Effective Jan. 1, 2013, the Colorado law ensures that patients are billed for anatomic pathology (AP) services only by the physician (pathologist) performing or supervising the service. In addition, any person receiving a bill in violation of the direct billing law may maintain an action to recover the actual amount paid for the bill.

Prior to the March 22 signing, the legislation unanimously passed both the state’s House of Representatives and the Senate. The College worked with the Colorado Society of Clinical Pathologists (CSCP) to pass the legislation. CSCP members Karim E. Sirgi, MD, FCAP, Ronald B. Lepoff, MD, FCAP, and Christopher Scott Bee, MD, FCAP, attended the bill signing (see photo). Colorado is now the 19th state to have a direct billing law.

CAP Resources Help Members Facing TC Grandfather Changes

While continuing to pursue reversal of congressional action to end the technical component (TC) “grandfather” as of June 30, 2012, the College remains committed to assisting members seeking guidance in negotiating service agreements with affected hospitals. Several resources are now available on the CAP’s Advocacy site to help members plan for the provision’s expiration.

The site features the online document, “‘Grandfather – TC’ Anatomic Pathology Services: Contracting With Hospitals Not or No Longer Covered by TC Grandfather, Effective July 1, 2012,” which provides background on the TC Grandfather and a review of options for independent laboratories negotiating with these affected hospitals.

The Advocacy site also features a Sample Technical Anatomic Pathology Services Agreement that members can use as a vehicle for identifying specific contract provisions that may raise issues.

In addition to these documents, there is also a comprehensive listing of laboratory and pathology-specific ambulatory practice classification (APC) codes. In addition to these resources, the Advocacy site features a frequently asked questions document. For additional assistance in contract negotiation, the CAP’s online Practice Management Directory features a listing of firms referred by CAP members.

Prometheus Ruling Prompts SCOTUS to Remand Myriad Decision for Appeals Court Review

Following the recent unanimous ruling in favor of Mayo Collaborative Services in its case against Prometheus Laboratories’ medical patents, the Supreme Court vacated a lower court’s July 2011 decision in the Myriad gene patent case, remanding it back to the Federal Circuit Court of Appeals for further consideration in light of Mayo v. Prometheus.

The July 2011 ruling from the Federal appeals court found that while companies could patent genes, methods to compare gene sequences were not patent eligible. Those challenging the patents, including the CAP, asked the Supreme Court to review the patenting of genes, and the Court granted the petition and ordered reconsideration in light of the Mayo decision, explained Sandra Park, an attorney with the American Civil Liberties Union (ACLU). The ACLU represents 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. The College, along with approximately 10 other medical organizations, supported Mayo in its case before the Supreme Court with amicus briefs.

The case has now been remanded to the same three-judge panel that issued the July decision. “The Federal Circuit may ask for additional briefing and possibly oral argument about how the Supreme Court’s decision in Prometheus should affect our case,” explained Park. “The judges can issue a decision with the same or a different outcome. Depending on the new judgment, we or Myriad would once again have an opportunity to petition for Supreme Court review.”

CAP Highlights Impact of Gene Patent on Patients, Quality

Gene patents affect the practice of medicine and compromise patient care by limiting the availability of second opinion diagnostic testing, the College outlined in its comments (PDF 180 K) to the Department of Commerce’s Patent and Trademark Office (PTO) in response to a request for comments on second opinion genetic testing.

Patients want to be empowered to obtain second opinions on their pathology results, noted the College in its comments. However, exclusive or restrictive license agreements can prevent physicians and clinical laboratories from performing genetic tests as diagnostic medical procedures. “Patients suffer because diagnostic test services are less readily and affordably accessible,” the College stated. “For second opinions, this factor provides a greater barrier since patents curtail the availability of clinical information which is needed to correlate the independent second diagnosis with the primary diagnosis.”

Patents also impact the understanding of a test’s utility. Indeed, if the genetic test is patented, the underlying disease process also becomes proprietary, which impacts how providers and the public acquire knowledge about these rapidly evolving tests, the diseases diagnosed by the tests, and their clinical utility, stated the CAP’s comments.

New Cervical Cancer Screening Guidelines Raise Issue of Timely Testing

Leading medical groups are now recommending against annual cervical cancer screenings in favor of every three to five years, and pathologists must encourage providers—and patients—to adhere to these evidence-based interval recommendations, according to CAP member Barbara A Crothers, DO, FCAP, who represented the College in an American Cancer Society-led effort to develop new guidelines.

USPSTF Also Revamps Cervical Testing Guidelines

The USPSTF also recently issued new guidelines changing its recommendations for frequency of cervical cancer screening.

Below are some highlights:

  • Women age 21 to 65 should be screened every three years with a Pap smear test.
  • For women age 30 to 65 who wanted to lengthen the screening interval, screen with a combination of Pap smear and HPV test every five years.
  • Women under the age of 21 should not be screened.

“Women are often the caregivers and providers and prioritize the health of their family over their own,” explained Dr. Crothers, who is also the Vice Chair of the CAP’s Cytopathology Committee. “There is a concern that with these new recommendations, women may delay getting screened, and we may see an increase in cervical cancer cases. Pathologists need to emphasize to providers and patients the importance of getting screened at appropriate intervals.”

CAP member Ritu Nayar, MD, FCAP, also participated in this initiative, which was headed up by ACS and co-sponsored by the American Society for Colposcopy and Cervical Pathology (ASCCP) and the American Society for Clinical Pathology (ASCP). The College is also looking at updating its policy on the frequency of cervical cancer screening in the near future.

Highlighting Importance of Cytology

These ACS-ASCCP-ASCP guidelines recommend against annual cervical cancer screening because it generally takes much longer than a year (often 10 to 20 years) for the cancer to develop. Screening on an annual basis could lead to unnecessary invasive diagnostic procedures. Under these recommendations, women between the ages of 21 and 29 should have a Pap test every three years, and should not be tested for HPV unless there is an abnormal Pap test result. For women between the ages of 30 and 65, both a Pap test and an HPV test should be performed every five years. While this is the preferred approach, it is also okay to have a Pap test every three years. The United States Preventive Services Task Force (USPSTF) also recently came out with similar guidelines (see box).

Another issue of concern for pathologists prior to the development of the most recent guidelines was that the HPV test would be the primary screening tool for cervical cancer. While the HPV test is more sensitive, the Pap test’s value lies in its specificity, as the CAP and others emphasized throughout the guideline’s development. “Because of these issues, we think the Pap-HPV test combination for women over 30 is a good strategy, which is reflected in the final recommendations,” explained Dr. Crothers.

IPAB Repeal Bill Passes House, Faces Uphill Battle in Senate

In advance of this week’s Supreme Court debate on the constitutionality of the health care reform law, the House voted on March 22 to repeal one of the law’s most contentious provisions, the Independent Payment Advisory Board (IPAB).

The repeal bill, The Medicare Decisions Accountability Act, passed the House by a vote of 223 to 181. The cost of the bill—estimated at $3.1 billion over 10 years—would be paid for through medical malpractice reforms. Nevertheless, the bill is not expected to gather enough votes in the Democratic-held Senate for approval and the White House has threatened to veto the bill.

The CAP has long been opposed to establishing the IPAB, and last week submitted letters in support of the repeal bill (PDF 237 K) to House leaders.

CAP Joins Physician Groups in Seeking Changes to Physician Sunshine Proposed Rule

The CAP joined AMA and over 50 national and state physician groups in a joint letter (PDF 44 K) to the Centers for Medicare and Medicaid Services (CMS), urging the agency to make significant changes to the proposed rule on reporting physician ownership and investment interests, and delay the reporting requirement until modifications are made, and ample time is allowed to notify physicians and manufacturers of final transparency reporting requirements.

The Affordable Care Act of 2010 (ACA) mandated that each year starting 2012, manufacturers of specified drugs, medical devices and biologicals participating in federal health care programs must begin reporting any transfers of value or payments of $10 or more to physicians and teaching hospitals; and manufacturers and group purchasing organizations (GPOs) must report ownership interests held by physicians and their close family members. CMS has proposed that only drugs and biologicals that require a prescription and only devices that require pre-market approval by or notification to the FDA be subject to the requirements. The law also requires HHS to make the majority of the information from the reports available on a public searchable website by Sept. 30, 2013.

With the reporting requirement resting solely on manufacturers and GPOs, physician groups are concerned that the proposed rule does not provide adequate safeguards or oversight to ensure that manufacturer submissions are accurate and timely. Physicians will have the right to review the submissions before publication; however, the physicians groups argue the rule provides no clear process and inadequate time to review and possibly dispute submissions before they are made public. The physicians’ letter also raised concerns with the proposed rule’s handling of individual physician privacy.

Another issue is CMS’s handling of Certified Continuing Medical Education (CME). The proposed rule attempts to gather detailed information from manufacturers and GPOs about physicians who attend CME classes, and would require a manufacturer to report if it has actual knowledge of the identify of a physician who may benefit from the CME they provided.

“This interpretation is inconsistent with congressional intent, is unworkable, and could undermine the independence of certified CME and other activities where manufacturers make grants, but are barred from any control over how funds are used,” the letter from physician groups (PDF 44 K) stated. “In this case, certified CME faculty would have to be listed as receiving a payment from industry despite the fact that manufacturers are explicitly prohibited from having any control over the content, speakers, or attendees.”

Amongst the other categories of payment or transfers of value are charitable contributions, food and beverage, research (bona fide research activities), and speaking engagements.

The proposed rule, the ‘Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests (CMS-5060-P)‘, was published on December 19, 2011. The joint physician letter which CAP signed was sent during the comment period which ended in February 2012. CMS indicates it intends to issue a final rule “as soon as practicable in 2012.”

CAP Continues to Work With CMS to Resolve RAC Audit Problems

CAP continues its efforts with CMS on behalf of members who have been plagued by ill-founded Recovery Audit Contractor (RAC) audits to bring them to complete resolution. In response to follow up and request for additional clarity from CMS, the agency has confirmed to the CAP that the RAC reviews focused on pathology place of service resulting in no improper payments have stopped. The agency’s action came after the CAP notified officials about issues related to confusion over place of service billing for pathologists and laboratories and independent laboratory billing for the technical component (TC) at hospitals covered under the TC “grandfather” provision.

Agency officials said they were working with RAC auditors, including the contractors conducting the review, most significantly, Connolly Healthcare, to ensure pathology claims are not inadvertently denied and to reverse inappropriate recoupments. For providers who had filed appeals regarding place of service or TC grandfather recoupments, CMS cannot unfortunately override the appeals process. CMS confirms that Connelly had posted information on the topic available to providers who log on through their online provider portal.

Former White House Healthcare Policy Advisor Emanuel to Keynote CAP Policy Meeting

Ezekiel J. Emanuel, MD, PhDThe former White House Special Advisor for Healthcare Policy Ezekiel J. Emanuel, MD, PhD, will be a featured keynote at the 2012 CAP Policy Meeting, to be held May 7–9, 2012, at The Fairmont Washington, DC hotel. Dr. Emanuel is now with the University of Pennsylvania, where he serves as the Vice Provost for Global Initiatives and Chair of the Department of Medical Ethics and Health Policy. He is also an Op-Ed contributor to the New York Times. His most recent editorial was entitled, “Could This Be the End of Health Care Reform?”

In addition to his White House post, Dr. Emanuel was also Head of the National Institutes of Health Department of Bioethics at The Clinical Center. Before joining the NIH, he was an Associate Professor at Harvard Medical School and has served on President Clinton’s Health Care Task Force, the National Bioethics Advisory Commission (NBAC), and on the bioethics panel of the Pan-American Healthcare Organization.

Register Now Dr. Emanuel is just one of the well known policy advisors who will speak at the CAP Policy Meeting this year. The CAP Policy Meeting is a members-only event that offers the opportunity to engage and discuss key health policy issues that impact the specialty of pathology with key CAP leaders, health care policy decision makers, and colleagues. The CAP is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians for this event. Stay tuned to Statline for further updates, and visit the meeting website to register and for more 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.


202-354-7100  •  202-354-7155 (fax)  •  800-392-9994


Related Links Related Links

Customize CAP Ads with your laboratory’s logo