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With the Centers for Medicare & Medicaid Services (CMS) considering changes to laboratory regulations, the CAP advocated to protect the integrity of CLIA regulations and maintaining requirements for qualified clinical laboratory personnel.

On March 12, the CAP responded to the CMS request for information (RFI) on proposed CLIA regulations. In addition to personnel regulations, the CMS may consider further updating regulations on proficiency testing (PT) referrals and histocompatibility regulations under CLIA.

Revisions to Personnel Regulations

In the request for information, the CMS sought input on whether a bachelor’s degree in nursing should be considered equivalent to a bachelor’s degree in biological science or should be considered a qualifying degree to run moderate-and high-complexity tests. In addition, the CMS wanted feedback on whether to consider a physical science degree or having that educational background such that all or some should be considered as a qualifying degree to meet the intent of the CLIA education requirements.

In its advocacy in response to the CMS, the CAP opposed a nursing degree as an equivalent to a biological science degree. The CAP believes that laboratory personnel should have appropriate laboratory training, experience, and skills for CLIA requirements, and what comprises appropriate documentation to verify training, experience and skills. The CAP recognizes that specific updates to CLIA are needed to address changes in the health care delivery system and emerging technology in order to accommodate current practice settings.

Proficiency Testing

The CMS also sought feedback on proficiency testing (PT) on whether the use of alternative sanctions will create parity for all types of labs involved in PT referral, and the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver determined to have participated in PT referral. The CAP has continued to engage on the issue of PT referral regulations. In 2014, the CMS implemented changes mandated by the Taking Essential Steps for Testing (TEST) Act. The CAP strongly advocated for the law because laboratories faced draconian sanctions for inadvertent PT referrals. Regulations as a result of the Test Act included three-tiered categories of sanctions for PT referral based on the severity and extent of the violation, and created an exception to the one-year laboratory owner ban. The changes included a more reasonable approach for the CMS to use during its enforcement discretion for PT referral infractions.

Histocompatibility Regulations

The CMS is also seeking input to update the existing CLIA histocompatibility to better reflect current knowledge, changes in transplant medicine, and advancements in laboratory testing. The CAP advocated for recognition of virtual crossmatch.

STATLINE will continue to provide updates on CLIA regulations.

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On March 9, the CAP joined the American Clinical Laboratory Association (ACLA) and 12 other clinical laboratory stakeholders in urging the CMS administrator Seema Verma to discourage states from making cuts to Medicaid rates for clinical laboratory tests. The letter notes that with the flawed implementation of the Protecting Access to Medicare Act (PAMA) significantly reducing Medicare rates for clinical laboratory tests, states moving forward with additional Medicaid cuts for laboratory services will exacerbate an already clear and present threat to patient access.

The letter asks, "We urge you to educate state Medicaid agencies by issuing a State Medicaid Director letter and an Informational Bulletin regarding the recently-implemented PAMA cuts and remind them of their obligation to provide Medicaid reimbursement for laboratory services that is sufficient to ensure access to those services. Patient access to laboratory services is already at risk due to PAMA cuts, especially for vulnerable patients and patients in rural and underserved areas where there are relatively few laboratory providers."

States that base their Medicaid reimbursements for clinical laboratory services on the federal Medicare Clinical Laboratory Fee Schedule (CLFS) are already expected to realize significant savings due to PAMA cuts without taking any action of their own. Congress enacted PAMA in 2014, which aimed to establish a market-based system for determining lab payment rates. However, the CMS instituted a flawed data collection methodology that excluded the vast majority of U.S. laboratories and instead relied on a tiny, non-representative sample to determine rates.

In addition to the CAP, ACLA was also joined by the American Medical Technologists, the American Society for Clinical Laboratory Services, the American Society for Clinical Pathology, the Association of Public Health Laboratories, the Clinical Laboratory Management Association, the Medical Group Management Association, the National Association of the Support of Long Term Care, the New York State Clinical Laboratory Association, the New York State Society of Pathologists, the National Independent Laboratory Association and the Point of Care Testing Association.

In response to the flawed PAMA data collection methodology, the CAP filed an amicus curiae brief on February 21 in support of a motion by ACLA for summary judgment to set aside how the Department of Health and Human Services (HHS) implemented market-based reforms to clinical laboratory fees mandated by PAMA. The CAP has strongly supported ACLA’s lawsuit against the HHS and efforts to correct the administration’s execution of PAMA’s clinical laboratory payment reforms.

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The CAP and the Rhode Island Society of Pathologists opposition to legislation that would essentially legalize markup of clinical laboratory and pathology services in the state, has resulted in the Rhode Island House sponsor withdrawing the bill.

Rhode Island House Bill 7421, introduced February 2, and withdrawn on March 5, would have permitted entities other than laboratories to bill or receive payment for laboratory or pathology services they did not perform. In a February 21 letter to Rep. Susan Donovan, a member of the House Committee on Health, Education and Welfare, the CAP and the Rhode Island Society of Pathologists argued that the bill would void fundamental anti-fraud and anti-markup protections for patients.

Since 1979 the current direct billing requirements for pathologists and laboratories have been in existence in Rhode Island and in 19 other states, as well as the Federal Medicare program. When the Medicare program began, physicians billed Medicare for laboratory services they purchased at a discount from hospitals and independent laboratories. Many physicians routinely “marked up” the cost of their purchased laboratory services. Congress addressed the issue in 1984 by prohibiting physicians in the Medicare program from billing for laboratory or pathology services they did not perform.

"The nature of the markup abuse not only creates profiteering on laboratory and pathology services by physicians who order these services, but also presents an unethical incentive to order more laboratory and pathology tests than are medically necessary in order to accrue the largest possible profit," write the CAP and the Rhode Island Society of Pathologists. "This unethical profiteering is unlawful and largely impossible under the current Rhode Island law that prohibits ordering physicians from being paid for these services."

Even the American Medical Association (AMA) deems such markup practices as unethical and calls for direct billing by the provider of the services, note the CAP and the Rhode Island Society of Pathologists. The AMA policy states, in part, "Physicians must not charge a markup or commission, or profit on services rendered by other healthcare professionals."

"In the more than 25 years since these anti-markup laws were first enacted, no state has repealed such a direct billing law," write the groups. "Moreover, for the most part, states have expanded the purview of the laws to cover more pathology services in order to address concerns over health care fraud and abuse. For these reasons, we urge opposition to House Bill 7421."

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Donald Karcher, MD, FCAP

Wednesday, April 4, 2018 1:00 PM ET/ Noon CT

If you are one of the many pathologists concerned about practice or patient care implications from emerging policies and regulations, join us in this 60 minute webinar on April 4, 2018 at 1 pm ET/ 12 pm CT to learn the most effective ways you can ensure your voice is heard in Washington on issues that matter to you.

Gain insight on best practices and understand the difference you can make by engaging with your colleagues in protecting scope of practice and the quality of care for patients.

Joe Saad, MD, FCAP

Already registered to attend this year’s Policy Meeting? This is a great webinar for CAP members who are attending the Policy Meeting, especially those attending for the first time, as you’ll gain a general understanding of grassroots advocacy before you arrive in Washington.

Whether you are DC bound or looking to get involved in your district, you’ll want to hear from experienced advocates Donald Karcher, MD, FCAP, Chair of the Committee of Government and Professional Affairs, Joe Saad, MD, FCAP, Federal and State Affairs Committee Chair, and moderator Michael Giuliani, CAP Advocacy Senior Director.

Register Today.

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