Critical Values July 2015
ePolicy 300x175

ePolicy News August 2012

Monday, July 30, 2012



ASCP AIDS Efforts Take to the International Stage
Highlights Laboratory Initiatives during 2012 International AIDS Conference

Art and Science: ASCP at the Center of the Laboratory Capacity Building in Resource-Limited Countries, an ASCP sponsored session focused on the laboratory in the fight against AIDS during the 2012 International Conference, in Washington, D.C. Moderated by Shannon Castle, ASCP Director of Global Outreach, the session profiled ASCP’s laboratory and laboratory workforce strengthening activities, such as training laboratory professional faculty, improving the curriculum for laboratory professionals, and enhancing laboratory procedures and facilities to receive accreditation. These initiatives are funded through the President’s Emergency Fund for AIDS Relief (PEPFAR) and other health initiatives. In 2005, the Centers for Disease Control and Prevention (CDC) invited ASCP to provide expertise through its members in laboratory strengthening activities. Since then, the ASCP Institute, Center for Global Outreach has trained laboratory professionals, provided technical assistance, and built laboratory infrastructure in 19 countries.

Panelists at the session included ASCP Consultant, Ian Lemieux, RN, MPH, MLS(ASCP)CM; Tsehaynesh Messele, the CEO of the newly formed African Society for Laboratory Medicine (ASLM), and Charles Gomborojo Massambu, the Director of the Laboratory Support Program for Tanzania's Ministry of Health.



Federal Circuit Court Rehears Gene Patent Case

The legal debate over the patentability of genes continued last month. The Court of Appeals Federal Circuit, heard the case, known formally as Association for Molecular Pathology Et. Al. vs. the United States Patent and Trademark Office Et Al. The case was reviewed by the same three judge panel that last year ruled to partially reverse a lower court ruling challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer.

At issue in the case is whether patents on the BRCA1 and BRCA2 gene variants linked to inherited breast and ovarian cancer, issued to Myriad Genetics, a diagnostic company in Salt Lake City, are valid. The patents grant Myriad exclusive rights to conduct diagnostic testing on the genes. ASCP is among the plaintiffs in the landmark lawsuit. In March, the U.S. Supreme Court set aside last year’s ruling and ordered further review by the lower court in light of a conflicting ruling in a similar case. In that case, Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court unanimously ruled that companies cannot patent observations about a natural phenomenon. The judges are expected to issue a decision by late summer.




Home HIV Test Gains FDA Approval

The U. S. Food and Drug Administration (FDA) has approved the first human immunodeficiency virus (HIV) test developed for use by consumers at home. The CDC estimates that 1.2 million people in the United States are infected with HIV; an estimated 20 percent of those are unaware of their HIV status. The home-use test provides another option for patients that might otherwise not get tested. At an FDA Advisory Committee meeting in May, officials said they thought an additional 45,000 people would learn they have HIV through the test.

The OraQuick In-Home HIV Test, from OraSure Technologies, detects the presence of HIV in saliva using a mouth swab and provides results in 20 to 40 minutes. While the test was found to be highly accurate when performed by laboratory professionals, it was found to be less accurate when performed by consumers. According to the American Medical Association, clinical studies revealed that one in 12 tests give a false negative result, while one in 5,000 tests give a false positive result. Therefore, it is highly recommended that patients follow-up home HIV testing with a confirmatory test performed by an accredited laboratory.

The home test will be available in 30,000 pharmacies, grocery stores, and online retailers by October 2012. The price of the test has not yet been determined.

While ASCP recognizes that home test kits can be a useful tool in providing health care, ASCP also is concerned about the high false negative rate of this test. Consequently, ASCP believes that it is critical for patients to consult with their physician, and pursue appropriate follow-up care.


ASCP Outlines Recommendations for New Laboratory Tests to CMS

Recently, ASCP presented its recommendations for the new tests reimbursed under the Clinical Laboratory Fee Schedule to the Centers for Medicare & Medicaid Services (CMS). CMS hosted a public meeting on July 16 for the purpose of receiving input from interested stakeholders about reimbursing laboratory tests that will have new CPT codes as of Jan. 1, 2013. ASCP Past President Lee Hilborne, MD, FASCP,  presented the Society’s recommendations.

CMS received stakeholder comment on more than 25 new CPT codes, including eight codes each for multianalyte assays with algorithmic analysis and tissue typing. In addition, CMS sought comment on reimbursement for more than 100 new molecular pathology codes intended to replace the current molecular pathology stacking codes, which are set to expire on Jan. 1, 2013. ASCP did not offer any recommendations for the reimbursement of the 100-plus molecular pathology codes because ASCP is urging that these codes be placed on the Physician Fee Schedule.

Typically, stakeholder reimbursement recommendations are “crosswalked,” e.g., tied to the reimbursement of existing tests that are similar in methodology or resources used. On occasion, stakeholders recommend setting reimbursement by the gap-fill method, which means the CMS assigns payment based on the reimbursement being provided by Medicare Administrative Contractors, such as Palmetto GBA.


CMS 2013 Proposed PFS Reduces Pathologist/Lab Reimbursement; Seeks Comments on Molecular Pathology Reimbursement

On July 6, the Centers for Medicare & Medicaid Services (CMS) released its 2013 Physician Fee Schedule Proposed Rule. As expected, the rule outlines a staggering 27-percent cut in reimbursement amounts, caused by the flawed Sustainable Growth Rate, scheduled to go into effect on Jan. 1, 2013. Congress, however, has typically acted to prevent these cuts from being implemented.

In addition, the proposed rule seeks to improve payments to family physicians by approximately 7 percent and other practitioners providing primary care services between 3 and 5 percent. The payment increases for family physicians stems from CMS’s proposal, for the first time, to “pay for the care required to help a patient transition back to the community following a discharge from a hospital or nursing facility.” However, as these increases must be balanced with cuts elsewhere, CMS is proposing to reduce payment amounts for most nonprimary care specialties. Under the proposal, reimbursement amounts for pathologists and medical laboratories would decrease by 1 percent.

The CMS proposal also seeks comment on the fee schedule placement and reimbursement of advance diagnostic molecular pathology services. ASCP supports placing these revised molecular pathology codes on the physician fee schedule, rather than the clinical laboratory fee schedule. Currently these services are billed using a series of stacking codes reimbursed under the medical laboratory fee schedule. These codes will be discontinued on Jan. 1, 2013.

Also being discontinued is the Technical Component (TC) Grandfathering Provisions; however, the TC grandfather provisions actually sunset on June 30, 2013.

The proposal also continues CMS’s efforts to align quality reporting programs to reduce burden and complexity. The programs that would be affected by the initiative are the Physician Quality Reporting System (PQRS), the Electronic Prescribing (eRx) Incentive Program, and the Electronic Health Records (EHR) Incentive Pilot Program.

ASCP is currently analyzing the proposed rule and will comment on those issues of concern to pathologists and laboratory professionals.  



ASCP Urges Veto of Legislation Repealing New York Physician Self-Referral Statute

ASCP has been working to encourage New York Governor Andrew M. Cuomo to veto legislation recently approved by the state legislature to repeal the state’s ban on physician self referral. The measure, AB 3551, would repeal the state’s physician self referral statute and instead defer to the federal Stark law. ASCP’s letter argued that that self referral can “increase the cost of health care, lead to unnecessary utilization, foreclose competition, and compromise the quality of health care.”

New York’s physician self referral ban prohibits physicians from referring their patients to entities in which they have a financial interest. Affected services include anatomic pathology, clinical laboratory, imaging, and radiation oncology. Interestingly, New York’s physician self referral law was signed into law by the Governor’s father, former New York Governor Mario Cuomo.

In a letter to Governor Cuomo, ASCP wrote that “[R]egrettably, the federal Ethics in Patient Referrals Act, commonly known as the Stark law, is an ineffective deterrent against inappropriate physician self-referral arrangements. Widespread abuse of the IOAS exception has substantially diluted the Stark law and its policy objectives, making it simple for physicians to avoid the law’s prohibitions.”

In early July, ASCP sent an action alert to its entire New York membership asking that they write the governor to urge him to veto the legislation. Additionally, ASCP worked with the Alliance for Integrity in Medicare to develop a letter urging Governor Cuomo to veto the measure. This letter brought together all of the member associations of AIM: the American Clinical Laboratory Association, American College of Radiology, American Physical Therapy Association, ASCP, American Society for Radiation Oncology, Association for Quality Imaging, College of American Pathologists, and Radiology Business Management Association.

To learn more about this issue, see ASCP’s position statement on physician self referral.



Back to ePolicy News index



  ASCP ePolicy News is supported by
  an unrestricted grant from Hologic