The College of American Pathologists (CAP) advocates with the Centers for Medicare and Medicaid Services (CMS) and its Medicare Administrative Contractors (MACs), to ensure that pathologists receive coverage for the services they provide to Medicare patients. The CAP also monitors to ensure that CMS and its contractors adhere to the statues and regulations governing national and local coverage processes. Learn more about the ways the CAP is advocating to ensure appropriate coverage on behalf of our members and the patients they serve.
If you have any questions or would like more information about Medicare national and local coverage policies and CAP Medicare coverage advocacy activities, contact Nonda Wilson, CAP’s Manager for Economic and Regulatory Affairs.
National Coverage Determinations
A National Coverage Determination (NCD) is a nationwide coverage determination of whether Medicare will pay for an item or service. NCDs are made through an evidence-based process, with opportunities for public participation. NCD decisions are binding on all Medicare Administrative Contractors (MACs). For example, when an NCD does not exclude coverage for other diagnoses/conditions, MACs should allow individual consideration, unless the LCD supports automatic denial of some or all of those other diagnoses/conditions. The CMS guidance documents contains detailed information on the NCD process and decision-making factors to assist parties or organizations that may request an NCD.
MEDCAC
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) provides independent guidance and expert advice to CMS on specific clinical topics being considered for national coverage. The MEDCAC is used to supplement CMS' internal expertise by reviewing and evaluating medical literature, technology assessments, public testimony, and data information on the appropriateness of medical items and services that may be eligible for coverage under Medicare. MEDCAC is conducted in an open and public forum, but CMS makes the final decision on coverage issues. See the current MEDCAC roster of members.
Local Coverage Determinations
A Local Coverage Determination (LCD) is a decision made by a Medicare Administrative Contractor (MAC) as to whether a particular service or item is reasonable and necessary for coverage. Local Coverage Determinations (LCDs) are applicable only within the issuing MAC's jurisdiction(s). MACs develop an LCD when there is no national coverage determination (NCD) or when there is a need to further define an NCD for the specific jurisdiction. In October 2018, CMS revised the LCD Guidelines, as outlined in Medicare Program Integrity Manual, Chapter 13.
CAP LCD Advisory Panel
Formed in 2015, the coverage advisory panel helps ensures that pathologists are appropriately reimbursed for medically reasonable and necessary services. The panel is a diverse group of experts from the CAP’s Economic Affairs Committee and the Council on Scientific Affairs resource committees. The panel proves analyses of draft or revised LCDs, consults with relevant specialists including outside stakeholders, and makes recommendations to Medicare and commercial payers on proposed coverage policies. In addition to these activities the Panel may collaborate with subject experts from other organizations, societies, and practices, to assist with review of proposed coverage policies.
Contract Advisory Committee
The Contractor Advisory Committee (CAC) is a formal mechanism for healthcare professionals to be informed of evidence used in developing local coverage determinations (LCDs), to discuss and amend administrative policies, and to serve as a link between Medicare and the local provider community. The CAC consists of physicians from each medical specialty, a beneficiary representative, and representatives of other medical organizations. The CAP maintains a CAC network of pathology representatives from each of the 12 Medicare jurisdictions who serve in an advisory capacity as representatives of their constituency.
Contractors select committee representatives from names recommended by state specialty or medical societies. Please contact your state pathology society or Nonda Wilson, CAP’s Manager for Economic and Regulatory Affairs.
CAC meetings are at the discretion of each Medicare contractor and information regarding specific meetings dates and time are listed on each MAC website. Information regarding specific meeting dates and times are also published and distributed through MAC email updates. MACs have the option of hosting in-person, telephonic or virtual meetings. All CAC meetings are open to the public to attend and observe. Portions of the meeting that do not discuss evidence for proposed LCDs may be closed to the public. Some MACs may invite interested parties from within the jurisdiction to also attend and orally present information related to the proposed LCDs.
All CAC meetings are recorded as part of the LCD record and the recordings are maintained on the contractor website.
How to Revise an Existing Local Coverage Determination or National Coverage Determination
The reconsideration process is a mechanism by which a beneficiary or stakeholder (including a medical professional society or physician) can request a revision to an NCD or LCD. The reconsideration process differs from an initial request for an NCD or LCD in that it is available only for final effective coverage policies. The whole coverage policy or any provision of a coverage policy may be reconsidered.
To request a revision to an LCD, a requestor must submit a valid reconsideration request to the appropriate MAC by following the instructions on your MAC websites. Learn more about how to request a LCD revision.
Recent CAP Advocacy
In response to advocacy by the CAP, Palmetto and Wisconsin Physicians Service MACs revised their LCDs for Special Histochemical Stains and Immunohistochemical Stains (‘special stains’) in response to our reconsideration request. The revisions, which become effective July 14, 2024, expand coverage for Lynch Syndrome tumor screening for microsatellite instability (MSI) / DNA mismatch repair by removing the age limitation, and coverage for IHC for breast pathology to include Ki-67 in a specific population of breast cancer patients. Additional modifications to the LCD coverage criteria allows for greater flexibility for testing in areas like breast, lung, and prostate pathology. MACs will now cover IHC testing on morphologically negative prostate cores when the results of the stains “provide additional actionable information to the treating physician” and the need for additional stains are documented.
In general, the LCD is now less prescriptive and offers clearer actionable guidance for pathologists and other physicians seeking to be compliant in reporting a single service. Further, the updates help to restore physician judgment as to the use of stains. Review the LCD in more detail here.
The special stains LCD covers eight different subspecialties within pathology and is shared by four MACs – Cigna Government Services (CGS), Noridian, Palmetto and Wisconsin Physician Services (WPS). The CAP’s advocacy extended to all four MACs who continue to observe the same revisions, and it is anticipated that CGS and Noridian will issue the same revisions to their special stains LCDs as Palmetto and WPS.
The CAP and its network of Contractor Advisory Committee representatives have monitored the LCD process since CMS made its revisions to the LCD guidelines in 2019. While the CMS has made some changes to the LCD process in recent years, the CAP believes the changes do not go far enough. In addition to participating in the LCD Coalition efforts to improve the process, the CAP believes that further changes are still needed, as outlined in CAP’s letter to CMS on February 23, 2024.
The CAP joined 17 organizations in submitting a letter to the Centers for Medicare and Medicaid Services (CMS) on Jan. 18, 2024 expressing concerns with the diminished role of CAC representatives in LCD development and with the lack of a public comment period for LCD-related billing and coding guidelines.
In March 2024, the CAP sent a letter to CMS seeking the removal of a coverage limitation from the MolDX LCD for “Molecular Assays for the Diagnosis of Cutaneous Melanoma”, that
improperly limits the scope of practice of medicine by board-certified pathologists, by imposing restrictions, as a condition of coverage, as to the subspecialty qualifications of those who can order certain tests. At the suggestion of CMS, the CAP met with the Palmetto MAC to discuss our concerns which did not result in a resolution. The CAP Economics Affair Committee is considering next steps.