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CAP members are urging their members of Congress to sign a letter calling on the Centers for Medicare & Medicaid Services (CMS) to reconsider key provisions in its reforms to the Medicare clinical laboratory fee schedule (CLFS).

A CAP Action Alert was sent to members on December 4. Reps. Bill Pascrell, Jr. (D-NJ) and Patrick Meehan (R-PA) are circulating a "Dear Colleague Letter" in the House of Representatives to CMS Acting Administrator Andy Slavitt. The letter calls for several changes to the Medicare Clinical Diagnostic Laboratory Tests Payment System Proposed Rule, which implements the laboratory provisions of Protecting Access to Medicare Act of 2014 (PAMA). Sen. Sherrod Brown (D-OH) also is circulating a similar letter in the Senate.

The deadline to urge your elected officials to sign the letters is December 9.

The PAMA legislation institutes significant reforms to the CLFS, including a new mandatory reporting system beginning in January 2016. PAMA requires applicable laboratories to report private payment rates and test volume to the CMS, which is scheduled to replace the current CLFS beginning in 2017. Failure to comply could result in penalties of up to $10,000 per violation per day.

However, the proposed rule was not released until September 25, missing the June 30 statutory deadline for the final rule and making the proposed timeline for implementation unrealistic given the delays in the rulemaking process.

The Pascrell-Meehan and Brown letters request that the CMS make appropriate changes to the implementation timeline in the final rule to provide laboratories reasonable time to comply and avoid financial penalties. The letters also request that the CMS broaden its definition of applicable laboratories subject to reporting to ensure the data reflects market prices.

Ask your legislators to sign the Pascrell-Meehan letter in the House and the Brown letter in the Senate.

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The Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections called for substantial revisions to the proposed "Common Rule" on December 3. The advisory committeeā€™s recommendations come as the CAP engages with its committee structure and prepares formal comments on the proposal.

The CAP has several concerns with the changes including those affecting consent for use of biospecimens. The proposal would require informed consent for secondary research with a human biospecimen, such as a blood sample, even if the specimen is not individually identifiable.

After evaluations are completed, there are, in many instances, residual specimens remaining. Residual specimens are needed by clinical laboratories to conduct quality assurance-quality control activities mandated by CLIA. Laboratories, for example, run immunohistochemistry controls for laboratory blood and tissue assays and instrument validation studies. Third party accrediting agencies, such as the CAP, also depend on availability of residual specimens to administer proficiency testing.

The CAP had previously requested that the proposed rule specifically exempt these uses of biospecimens from the research definition and clarify that they are not subject to the Common Rule. But the proposed rule does not contain an exemption.

During the December 3 meeting of the HHS advisory committee, the panel also raised several concerns about the proposed Common Rule changes. The committee recommended the proposal be rewritten due to "opaque language, unclear concepts, the overlapping nature of various elements, and the intricate relationships of elements to one another."

The proposed changes to Common Rule were first proposed on September 8. After input from the public, HHS extended the public comment period for the rule until January 6, 2016.

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Downloads from the CMS include measure specifications for the 2016 Medicare Physician Quality Reporting System (PQRS) with updates to measures developed by the CAP.

The new measure specifications include the transition to the ICD-10 diagnosis codes. In addition, the following cytology codes were added to the Lung Cancer Reporting (Biopsy/Cytology Specimens) measure:

  • 88104 Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation
  • 88108 Cytopathology, Cytopathology, concentration technique, smears and interpretation (eg, Saccomanno technique)
  • 88112 Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid based slide preparation method), except cervical or vaginal
  • 88173, Cytopathology, evaluation of fine needle aspirate; interpretation and report

Patient encounter code 88307 also was removed from the Lung Cancer Reporting (Resection Specimens) and the Lung Cancer (Biopsy/Cytology Specimens) measures. For consistency, the description for the G-codes for medical exclusions in the lung cancer and melanoma measures will be changed as follows (the italics indicates new text, while the strikethrough shows what was deleted):

Documentation of medical reason(s) for not reporting including pT Category and a statement on thickness and ulceration and for pT1, mitotic rate (e.g., negative skin biopsies in a patient with a history of melanoma or other documented medical reasons)

Finally, the denominator criteria, or eligible cases, will be changed for the lung cancer and melanoma measures to remove the upper age limit. The measures can be reported for patients at or over the age of 18.

Download information on the 2016 PQRS measures.

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