Wednesday, December 26, 2018

CMS Gene Language for 2019: Existed Nov 21-Dec 12, 2018

6. All genomic sequencing procedures and molecular
multianalyte assays (e.g., CPT codes 81410-81471), many
multianalyte assays with algorithmic analyses (e.g., CPT codes
81493-81599, 0004M-XXXXM), and many Proprietary Laboratory
Analyses (PLA) (e.g., CPT codes 0001U-XXXXU) are DNA or RNA
analytic methods that simultaneously assay multiple genes or
genetic regions.  A physician shall not additionally separately
report testing for the same gene or genetic region by a
different methodology (e.g., CPT codes 81105-81408, 81479,
88364-88377).  CMS payment policy does not allow separate
payment for multiple methods to test for the same analyte.


7. A Tier 1 or Tier 2 molecular pathology procedure CPT 
code shall not be reported with a genomic sequencing procedure, 
molecular multianalyte assay, multianalyte assay with 
algorithmic analysis, or proprietary laboratory analysis CPT 
code where the CPT code descriptor includes testing for the 
analyte described by the Tier 1 or Tier 2 molecular pathology 

8. If one laboratory procedure evaluates multiple genes 
utilizing a next generation sequencing procedure, the laboratory 
shall report only one unit of service of one genomic sequencing 
procedure, molecular multianalyte assay, multianalyte assay with 
algorithmic analysis, or proprietary laboratory analysis CPT 
code.  If no CPT code accurately describes the procedure 
performed, the laboratory shall report CPT code 81479 (unlisted 
molecular pathology procedure) with one unit of service.  The 
laboratory shall not report multiple individual CPT codes 
describing the component test results.  If a single procedure is 
performed, only one HCPCS/CPT code with one unit of service may 
be reported for the procedure. 

9. Procedure-to-procedure edits bundling two Tier 1 
molecular pathology procedure CPT codes describe procedures that 
should not routinely be performed and reported together.  For 
example CPT code 81292 describes full sequence gene analysis of 
MLH1, and CPT code 81294 describes duplication/deletion variant 
gene analysis of MLH1.  In evaluating a patient with colon 
carcinoma (vs. constitutional genetic disorder), it may be 
appropriate to perform duplication/deletion testing if the 
disease variant(s) is (are) not identified by performing full 
gene sequencing.  The same principle applies to other code pair 
combinations of testing for the same gene (e.g., 81295/81297, 

Thursday, December 13, 2018

December 2018 Parrish CGM Case Filed in Court

Medicare Coverage Class Action Filed Against Health and Human Services Secretary on Behalf of Diabetes Patients

Case here (36pp):

Lowenstein Sandler and Parrish Law Offices filed a class action in the U.S. District Court for the District of Columbia today against Alex Azar in his capacity as Secretary of the U.S. Department of Health and Human Services (HHS) on behalf of diabetic Medicare recipients denied reimbursement coverage for use of medically prescribed continuous glucose monitors (CGMs). The complaint seeks a declaration that federal law requires HHS to reimburse for CGMs; compensation for Medicare beneficiaries’ past out-of-pocket costs to purchase these devices, the claims for which HHS improperly denied; and a ruling to establish a precedent for all Medicare beneficiaries filing claims for CGMs in the future.
This action asserts that HHS has routinely ignored past court and administrative law decisions and improperly denied CGM users’ Medicare reimbursement requests on the contention that CGMs do not qualify as durable medical equipment (DME) that is primarily or customarily used to serve a medical purpose. As the plaintiffs detail in their complaint, HHS’s decisions violate several federal statutes and are arbitrary and capricious, disregard Congressional intent, and ignore the fact that these devices meet Medicare coverage requirements. Plaintiffs ask the court to reverse HHS’s erroneous past decisions and issue an order finding that a CGM and its related supplies do, in fact, serve an essential medical purpose.
Jointly filed by the Parrish Law Offices and Lowenstein Sandler, the class action complaint asserts that HHS’s coverage denials have serious consequences for patients’ health outcomes and have an impact on health care costs at both the individual and national level. For many who suffer from diabetes, the only way to adequately and consistently monitor their glucose levels is through a CGM, which continually tests those levels and transmits detailed data to patients and caregivers. Such data, especially in instances of dramatic changes in glucose levels, can mean the difference between just-in-time treatment and serious, even fatal, complications that can result from the delays in care that are all too common with older, more traditional monitoring methods.
“The Department has continued to deny diabetes patients potentially lifesaving and cost-reducing medical devices and care,” said James Pistorino, a lawyer with the Parrish Law Offices and lead representative for the plaintiff class. “Nonsensically, the department has claimed that CGMs do not serve a medical purpose and are not necessary, despite their being an FDA-approved and verified method for preventing those with diabetes from facing dangerous consequences, such as falling into a diabetic coma or, even worse, death.”
More than 98 percent of private insurance companies cover CGMs, which are FDA-approved, lifesaving devices providing a proven, 24/7 way to test glucose levels and
prevent complications and, potentially, death from diabetes. Nevertheless, in too many instances, Medicare will not cover CGM use, which means that patients must pay for this costly equipment on their own. Those who simply cannot afford the cost must forgo the device completely and risk acute health complications.
“Health and Human Services has a duty to live up to its name and provide coverage to the distressed populations it claims to assist,” said Jeffrey Blumenfeld, partner at Lowenstein Sandler. “Providing adequate medical coverage to those in need makes common and ethical sense and, in the case of CGMs, is also exactly what Congress intended. By improving and saving lives and boosting positive health care outcomes, CGMs also save the general public, the government, and the economy in terms of short- and long-term costs.”
Plaintiffs Carol A. Lewis and Douglas B. Sargent are both filing the suit after being denied coverage from the Medicare Appeals Council and are represented by James Pistorino and Debra Parrish of the Parrish Law Offices in conjunction with Jeffrey Blumenfeld and Gavin J. Rooney of Lowenstein Sandler.
To see a copy of the complaint, click here.

Debra M. Parrish
Parrish Law Offices
Phone: 412-561-6250

Quinn local file as: 2018 Court Parrish 1213 CGM Case Filed Against HHS 36pp.pdf

Monday, December 10, 2018

Cloud Posting: Five Amazingly Complex SEP1 Documents

As of 2018.12.10, links to five amazingly complex SEP1 process documents. 

Also in one ZIP file here.

This is a document file only.

I wrote actual essays on CMS SEP1 in August (first data release) and in November (performance of academic hospitals).

For a contrasting 2018 article by Walkey on the value of keeping it simple in Sepsis measures, here.

63 page CMS measure guide

256 questions (73pp)

62 page webinar slides

4 page SEP1 tabular summary

4 page SEP1 flow chart diagram

Sunday, December 9, 2018

1997 Balanced Budget Act, Section 4554: Uniform CMS Lab Claims Policies


    (a) Selection of Regional Carriers.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this section referred to as the ``Secretary'') shall--
                    (A) divide the United States into no more than 5 
                regions, and
                    (B) designate a single carrier for each such region,
        for the purpose of payment of claims under part B of title XVIII 
        of the Social Security Act with respect to clinical diagnostic 
        laboratory tests furnished on or after such date (not later than 
        July 1, 1999) as the Secretary specifies.
            (2) Designation.--In designating such carriers, the 
        Secretary shall consider, among other criteria--
                    (A) a carrier's timeliness, quality, and experience 
                in claims processing, and

[[Page 111 STAT. 461]]

                    (B) a carrier's capacity to conduct electronic data 
                interchange with laboratories and data matches with 
                other carriers.
            (3) Single data resource.--The Secretary shall select one of 
        the designated carriers to serve as a central statistical 
        resource for all claims information relating to such clinical 
        diagnostic laboratory tests handled by all the designated 
        carriers under such part.
            (4) Allocation of claims.--The allocation of claims for 
        clinical diagnostic laboratory tests to particular designated 
        carriers shall be based on whether a carrier serves the 
        geographic area where the laboratory specimen was collected or 
        other method specified by the Secretary.
            (5) Secretarial exclusion.--Paragraph (1) shall not apply 
        with respect to clinical diagnostic laboratory tests furnished 
        by physician office laboratories if the Secretary determines 
        that such offices would be unduly burdened by the application of 
        billing responsibilities with respect to more than one carrier.

    (b) Adoption of National Policies for Clinical Laboratory Tests 
            (1) In general.--Not later than January 1, 1999, the 
        Secretary shall first adopt, consistent with paragraph (2), 
        national coverage and administrative policies for clinical 
        diagnostic laboratory tests under part B of title XVIII of the 
        Social Security Act, using a negotiated rulemaking process under 
        subchapter III of chapter 5 of title 5, United States Code.
            (2) Considerations in design of national policies.--The 
        policies under paragraph (1) shall be designed to promote 
        program integrity and national uniformity and simplify 
        administrative requirements with respect to clinical diagnostic 
        laboratory tests payable under such part in connection with the 
                    (A) Beneficiary information required to be submitted 
                with each claim or order for laboratory tests.
                    (B) The medical conditions for which a laboratory 
                test is reasonable and necessary (within the meaning of 
                section 1862(a)(1)(A) of the Social Security Act).
                    (C) The appropriate use of procedure codes in 
                billing for a laboratory test, including the unbundling 
                of laboratory services.
                    (D) The medical documentation that is required by a 
                medicare contractor at the time a claim is submitted for 
                a laboratory test in accordance with section 1833(e) of 
                the Social Security Act.
                    (E) Recordkeeping requirements in addition to any 
                information required to be submitted with a claim, 
                including physicians' obligations regarding such 
                    (F) Procedures for filing claims and for providing 
                remittances by electronic media.
                    (G) Limitation on frequency of coverage for the same 
                tests performed on the same individual.
            (3) Changes in laboratory policies pending adoption of 
        national policy.--During the period that begins on the date of 
        the enactment of this Act and ends on the date the Secretary 
        first implements national policies pursuant to regulations 
        promulgated under this subsection, a carrier under such

[[Page 111 STAT. 462]]

        part may implement changes relating to requirements for the 
        submission of a claim for clinical diagnostic laboratory tests.
            (4) Use of interim policies.--After the date the Secretary 
        first implements such national policies, the Secretary shall 
        permit any carrier to develop and implement interim policies of 
        the type described in paragraph (1), in accordance with 
        guidelines established by the Secretary, in cases in which a 
        uniform national policy has not been established under this 
        subsection and there is a demonstrated need for a policy to 
        respond to aberrant utilization or provision of unnecessary 
        tests. Except as the Secretary specifically permits, no policy 
        shall be implemented under this paragraph for a period of longer 
        than 2 years.
            (5) Interim national policies.--After the date the Secretary 
        first designates regional carriers under subsection (a), the 
        Secretary shall establish a process under which designated 
        carriers can collectively develop and implement interim national 
        policies of the type described in paragraph (1). No such policy 
        shall be implemented under this paragraph for a period of longer 
        than 2 years.
            (6) Biennial review process.--Not less often than once every 
        2 years, the Secretary shall solicit and review comments 
        regarding changes in the national policies established under 
        this subsection. As part of such biennial review process, the 
        Secretary shall specifically review and consider whether to 
        incorporate or supersede interim policies developed under 
        paragraph (4) or (5). Based upon such review, the Secretary may 
        provide for appropriate changes in the national policies 
        previously adopted under this subsection.
            (7) Requirement and notice.--The Secretary shall ensure that 
        any policies adopted under paragraph (3), (4), or (5) shall 
        apply to all laboratory claims payable under part B of title 
        XVIII of the Social Security Act, and shall provide for advance 
        notice to interested parties and a 45-day period in which such 
        parties may submit comments on the proposed change.

    (c) Inclusion of Laboratory Representative on Carrier Advisory 
Committees.--The Secretary shall direct that any advisory committee 
established by a carrier to advise such carrier with respect to coverage 
and administrative policies under part B of title XVIII of the Social 
Security Act shall include an individual to represent the independent 
clinical laboratories and such other laboratories as the Secretary deems 
appropriate. The Secretary shall consider recommendations from national 
and local organizations that represent independent clinical laboratories 
in such selection.