College of American Pathologists

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

September 26, 2013  •  Volume 29, Number 20
Next Issue: October 10, 2013
© 2013 College of American Pathologists

In This Issue:

CAP Reaches Key Members of Congress at Capitol Hill

Last week, 12 CAP members packed in visits with Members of Congress and staffs of 41 Congressional offices to encourage them to oppose proposed cuts by the Centers for Medicare and Medicaid Services (CMS) that threaten patient access to pathology services.

U.S. Rep. Marsha Blackburn (R-TN) discusses proposed CMS cuts to pathology services with CAP member Dr. Kathryn Knight in Washington, D.C. on Sept. 18. During CAP’s September 18 Capitol Hill “fly-in,” held in conjunction with the American Clinical Laboratory Association (ACLA), the College connected with key Members of the Senate Finance, House Ways and Means, and House Energy and Commerce Committees, garnering support for the withdrawal of CMS’ proposed rule, CMS-1600-P, which drastically cuts Medicare payments for pathology services.

As a result of last week’s meetings on Capitol Hill and additional efforts by CAP’s legislative team, 42 Congressional offices have agreed to sign on to a joint letter by U.S. Congressmen Jim Gerlach (R-PA) and Bill Pascrell, Jr. (D-NJ) calling on CMS to withdraw the proposed rule. U.S. Senator Johnny Isakson (R-GA) has agreed to serve as the lead signatory for Senate Republicans and discussions are ongoing with potential Democratic senators to lead the letter. Representatives Gerlach and Pascrell are set to deliver the letter to CMS at the end of September. In the meantime, CAP is working to secure additional Congressional support.

CAP remains committed to pushing for the elimination of the cuts within CMS’ proposed rule. If finalized, the cuts could harm patient access to vital pathology services, which are critical to the diagnosis and treatment of diseases such as cancer.

The proposed rule by CMS would link payment for pathology services on the Physician Fee Schedule to lower rates under Medicare’s Hospital Outpatient Prospective Payment System, the fee schedule used for hospital outpatient services. This change would sharply lower Medicare payments for pathology services, reducing reimbursement for 39 services for non-hospital patients by as much as 80 percent. CAP members said that, in many cases, the proposed reimbursement rate would not even cover the hard costs of test materials.

CAP and its partners, such as ACLA, steadfastly continue advocacy efforts on Capitol Hill, increasing awareness of Congress’ oversight role on the matter and the clear threat the rule would pose to patient access to needed medical services.

CAP Meets with CMS Officials to Reform Clinical Laboratory Fee Schedule

On September 12, CAP representatives joined members of the Clinical Laboratory Coalition (CLC) in a meeting with CMS representatives to discuss reform efforts around the Clinical Laboratory Fee Schedule (CLFS).

Members of the coalition, including CAP’s Jonathan Myles, MD, FCAP, practicing pathologist at the Cleveland Clinic, Chair of the CAP Economic Affairs Committee, Member of the Council on Government and Professional Affairs, and Jen Madsen, MPH, Senior Director of CAP’s Economic and Regulatory Affairs, as well as representatives from the National Independent Laboratory Association (NILA); American Association of Bioanalysts (AAB), American Society for Microbiology (ASM); American Clinical Laboratory Association (ACLA); AdvaMed; American Society for Clinical Laboratory Science (ASCLA); American Society for Clinical Pathology (ASCP); Clinical Laboratory Management Association (CLMA); and the American Association for Clinical Chemistry (AACC), suggested that CMS engage all stakeholders in the broader reform process from start to finish to establish a transparent process beyond the current process of responding to a published rule. CMS officials expressed interest in hearing more feedback from the coalition after final regulations are published in November.

Following the meeting, the coalition is working to draft recommendations for establishing a more transparent process and will reconvene with CMS officials in the coming months to discuss these findings.

Massachusetts Opines on Electronic Health Record Donations

On September 16, CAP and the Massachusetts Society of Pathologists (MSP) received an opinion from the Massachusetts Department of Public Health on electronic health record (EHR) donations or “EHR donations,” an exception made under the Stark Law that allows clinical laboratories to donate EHR software to physicians.

According to the Massachusetts department’s opinion, state law is “implicated̶ when a clinical laboratory makes an EHR donation to a referring physician. The department noted that a decision on a violation of the law is “fact-specific and made after review of the particular investigative findings.”

CAP believes the financial benefits associated with EHR donations could adversely influence physician medical decision-making and choice of laboratory providers. Therefore, CAP, in partnership with state pathology societies, has been successfully securing state agency opinions that have limited or prohibited EHR donations under the purview of the respective state’s anti-kickback or anti-inducement law. Massachusetts is now the ninth state, following New York, New Jersey, Missouri, Connecticut, Pennsylvania, Tennessee, Washington and West Virginia, to have issued an opinion asserting state authority to regulate this practice. Under a proposed U.S. Department of Health and Human Services (HHS) regulation, which CAP supports, the federal safe harbor for EHR donations by clinical laboratories is scheduled to sunset on December 31, 2013. The final adoption of the federal regulation is pending.

Palmetto Revises Molecular Pathology Coverage List

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Medicare Jurisdiction 11, recently posted updates to its list of covered and non-covered molecular pathology tests under the Molecular Diagnostic Services Program (MolDx). CAP’s Council on Scientific Affairs and Council on Government and Professional Affairs have collaborated on comments to Palmetto’s medical director, Elaine Jeter, MD, expressing concerns about coverage limitations for many molecular pathology tests.

All pathologists who submitted claims for tests that were previously denied but appear on the revised list are encouraged to resubmit their claims to Palmetto for reevaluation and consideration of payment. Please visit the Palmetto website for the full list of services covered under the update.

These updates also apply to MAC JE, previously called Jurisdiction 1, following Noridian’s decision to continue the Palmetto MolDx Program. For more information about MAC JE, please visit Noridian’s website.

Molecular Pathology Gap-Fill Pricing to be Released by CMS

On September 30, CMS is expected to release final gap-fill pricing of Tier 1 and Tier 2 molecular pathology codes established by the MACs for 2014.

CMS held a 60-day comment period on proposed pricing, which ended on July 8. During the comment period, CAP submitted a letter requesting that CMS reconsider placement of the molecular pathology services from the clinical laboratory fee schedule (CLFS) to the physician fee schedule (PFS); provide more transparency into the price determination process by using data approved by the AMA/Specialty Society Relative Value Scale Update Committee (RUC); and provide greater coverage for molecular pathology tests necessary for diagnosis and patient management, in order to improve patient access to these services.

CMS shared select comments with the MACs as it began developing final prices. After receiving comments from CMS, the MACs began preparing revisions of their proposed prices. Palmetto GBA was recently the first MAC to submit its price revisions to CMS.

CMS will post the final decisions to its website, which will determine prices for the applicable test codes beginning on January 1, 2014. Following the release of the final rates at the end of September, CMS has indicated that the public will have an additional 30 days to request reconsideration of any of its decisions.

Please visit the CMS website for instructions regarding the 30-day reconsideration process, as well as the final pricing decisions upon their release at the end of the September. More information about pricing proposed by the MACs, and rate-setting for tests from several MACS, including Cigna Government Services, Wisconsin Physician Services, Noridian, First Coast Service Options, and Palmetto GBA, is also available on the CMS website.

HHS Delays HIPAA Enforcement for Certain Laboratories

The Office for Civil Rights at HHS has announced an indefinite delay in enforcement of a requirement that certain laboratories covered by HIPAA revise their notices of privacy practices (NPP).

The NPPs of other HIPAA-covered entities must still be revised by September 23 to comply with the modifications made to the HIPAA rules that were published January 25 in the Federal Register, more commonly known as the “Omnibus Rule.”

The delay applies to specific types of laboratories that fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as well as some types that are exempt from CLIA.

Visit the HHS website to learn more about these changes.


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