Advocacy Update

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In This Issue:

The CAP, the American Medical Association (AMA), and 100 other medical societies raised concerns in a recent letter to the Secretary of the Department of Health and Human Services (HHS) regarding a proposal to loosen current Medicare scope of practice restraints. The scope of practice provision was included in a recent executive order, which among other things, called for the HHS within a year to release regulations to eliminate or weaken Medicare supervision requirements for non-physician professionals.

The CAP, the AMA, and others argue that altering the Medicare supervision requirements, as directed in the executive order, will undermine the well-established Medicare supervision requirements for non-physician professionals.

In the letter, the groups claim that current Medicare supervision requirements are “a critical safeguard to ensure the health and safety of Medicare patients and the cornerstone of the widely adopted team-based approach to health care.” Moreover, the groups think that the scope of practice standards should be based on standardized, adequate training and demonstrated competence in patient care.

On October 3, the Trump administration issued an executive order titled “Protecting and Improving Medicare for Our Nation’s Seniors,” which directed the HHS to improve several aspects of Medicare Advantage plans and included a call for scope of practice changes. The CAP and other groups are concerned that the executive order could result in unintended negative consequences for traditional Medicare, and specifically, scope of practice issues.

The CAP will continue to engage with the administration on this issue.

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On November 1, the Centers for Medicare & Medicaid Services (CMS) released the 2020 Medicare Physician Fee Schedule and Quality Payment Program regulations, which will affect reimbursement of your services in 2020.

The CAP issued an exclusive special report following the release with initial analysis, including the 2020 Final Medicare Physician Fee Schedule Impact Table for pathologists.

Key highlights from the 2020 final Medicare regulation include:

  • CMS finalized deep payment cuts to pathologists beyond recommendations from the American Medical Association (AMA), with an estimated 8% cut to pathology in 2021.
  • Because of the CAP’s advocacy and efforts to correct errors affecting Medicare reimbursements for pathology services, the CMS updated 36 direct practice expense supplies and equipment prices, adding $30 million to Medicare payment to pathology services in 2020.
  • The CAP protected the pathology measure set, giving pathologists the current slate of reporting options to use in the 2020 Quality Payment Program.
  • The CAP successfully advocated to reduce the burden of the Merit-based Incentive Payment System (MIPS), ensuring that pathologists can participate fairly in the program.

Read the full special report.

Have questions on how the 2020 Medicare payment regulation will impact your practice? Join CAP experts on November 8 at 1 PM ET for a live webinar where they will review the final regulation changes that impact your pay and pathologists’ participation in the Merit-based Incentive Payment System (MIPS). Our experts will also answer your questions.

Webinar presenters will be the Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Measures & Performance Assessment Subcommittee Chair Diana Cardona, MD, FCAP; and Economic Affairs Committee Chair W. Stephen Black-Schaffer MD, FCAP.

Register today for the webinar.

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The CMS agreed with the CAP’s advocacy in the final 2020 Medicare Hospital Outpatient Payment Regulation by shelving two proposals impacting molecular pathology testing from laboratory date of service policy. Instead, the CMS adopted the CAP’s recommendations to the date of service policy for blood bank services. In addition, due to the CAP’s sole advocacy and its understanding of both the physicians and laboratory perspectives, the CMS abandoned a proposal to lower the hospital outpatient payment assignment in 2020 for pathology services reported with CPT code 88307.

The CAP was successful in turning back the CMS’ proposal to specify that the ordering physician would determine whether or not the results of the advanced diagnostic laboratory tests (ADLTs) or molecular pathology tests are intended to guide treatment provided during a hospital outpatient encounter. If the ordering physician considered the test would guide treatment during the hospital outpatient encounter, the test would be regarded as a hospital service.

The agency also proposed removing molecular pathology tests from the laboratory date of service exception and limiting it only to ADLTs. The CMS stated that they “no longer believe the same beneficiary access concerns that apply to ADLTs also apply to molecular pathology tests.” The CAP disagreed and advocated for the exception to continue to apply to molecular pathology tests, highlighting the point that the tests are still not commonly performed by hospitals, as they are not always practical or cost-effective due to lower test volumes.

The CAP also successfully worked with the American Association of Blood Bankers to urge the CMS to finalize a date of service proposal for laboratory testing. In the final regulation, the CMS decided that the date blood banks perform the laboratory test on specimens collected from a hospital outpatient during a hospital outpatient encounter will be the date of specimen collection. As a result, the hospital will bill Medicare for the laboratory test, and the blood bank performing the test would seek payment from the hospital.

The agency also agreed to define a blood bank as an entity whose primary function is the performance or responsibility for the performance of the collection, processing, testing, storage and/or distribution of blood or blood components intended for transfusion or transplantation.

CMS Retains the Current Hospital Outpatient Payment for 88307

Because of our individual advocacy, the CMS retained its payment assignment for 88307 pathology services. Initially, the CMS had proposed to lower the Hospital Ambulatory Payment Classification (APC) by 46%. After consideration of the CAP’s further analysis of the updated claims data for this final rule, the CMS will maintain the ambulatory payment classification assignment for 88307 in 2020.

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The CMS responded to the CAP’s concerns in its proposed revisions to its National Coverage Determination (NCD) for Next Generation Sequencing (NGS) panels for breast and ovarian cancer patients. The proposed changes lift restrictions on NGS tests for patients with “recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancers,” and extends the coverage of NGS testing to earlier stage cancers and patients whose genetics may put them at risk for developing cancer. The action followed the CAP and other groups’ concerns about CMS’ restrictions of NGS testing and the prohibited use of NGS tests for germline mutations in early-stage cancers.

Under the new national coverage, the CMS proposed payment will be for patients with ovarian or breast cancer. Moreover, the proposed expanded coverage will also include patients that have clinical indications for germline testing, risk factors for inherited breast or ovarian cancer, and if the patient has not been previously tested using NGS. Laboratory tests using NGS must be approved or cleared by the US Food and Drug Administration (FDA), have an FDA-approved or -cleared indication for use in that patient’s cancer, and the results must be used for managing the patient treatment options.

The proposal also gives Medicare Administrative Contractors (MACs) more discretion to cover NGS tests that are not FDA-approved for patients with breast or ovarian cancer. Furthermore, the MACs have increased discretion for those patients who have risk factors indicating a need for hereditary cancer risk testing for other cancers, if the patient has not previously received an NGS test.

In our May comment letter, the CAP strongly urged the CMS to revise its current NGS national coverage by allowing the MACs increased discretion for Medicare beneficiaries with early-stage cancers.

The CAP will continue to engage with CMS and expects a final coverage decision by January 27, 2020.

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Stephen Hahn, MD, was recently nominated by President Donald Trump to be the next FDA commissioner. Dr. Hahn will replace acting FDA commissioner Ned Sharpless, who had been the interim FDA commissioner since Scott Gottlieb, MD, departed earlier in 2019. Dr. Hahn will still need to be confirmed by the Senate as the Commissioner.

Currently, Dr. Hahn is the Chief Medical Officer of MD Anderson Cancer Center in Texas. Previously he was the chairman of the radiation oncology department at the University of Pennsylvania medical school until 2015. As a radiation oncologist, Dr. Hahn specializes in treating both lung cancer and sarcoma.

Dr. Hahn served as the chief of the National Cancer Institute's prostate cancer clinic in 1994 and 1995.

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On November 14 at 2 PM ET, the CMS will host a conference call on data reporting where laboratories can learn how to report data as required by the Clinical Diagnostic Test Payment System final rule. The Protecting Access to Medicare Act (PAMA) requires certain laboratories to collect and submit private payor rates for clinical laboratory tests. The CMS will use data collected in 2019 and reported in 2020 to set Medicare payment rates effective January 1, 2021.

Laboratories, including physician office laboratories and hospital laboratories that bill using a 14X TOB, are required to report if they:

  • Have more than $12,500 in Medicare revenues from laboratory services on the clinical laboratory fee schedule (CLFS), and
  • Receive more than 50 percent of their Medicare revenues from CLFS and physician fee schedule services during a data collection period.

Still have questions? The CAP has PAMA resources for pathologists.

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Join hundreds of your colleagues by following CAP’s Advocacy Twitter account. The Twitter account will complement the news and information you already receive from the CAP and provide you with additional opportunities to engage in the issues pathologists care about most. Click here to go to the account.

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Want to test your Advocacy know-how? Take the new November Advocacy News Quiz and see how you compare to your fellow CAP members by sharing your results on social media.

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