Friday, December 23, 2016

Myriad on Prolaris and Vectra LCDs - Dec 22 2016

Myriad Genetics (MYGN) Disappointed that the MolDx Program Published a Draft Non-Coverage Decision for Vectra DA 
December 23, 2016 10:45 AM EST

Myriad Genetics (NASDAQ: MYGN) issued the following statement to, saying they are disappointed that the MolDx program published a draft non-coverage decision for Vectra DA and strongly disagrees with the conclusions. News of the non-coverage decision for Vectra DA has shares of MYGN down 5.7%.

Myriad Genetics statement:

We are excited that Palmetto, the Medicare administrative contractor (MAC) in charge of the Mol Dx program, has issued a draft LCD for Prolaris, recommending coverage for Medicare beneficiaries with favorable intermediate localized prostate cancer. The decision is an important step in expanding Medicare reimbursement for this life-saving test and will significantly increase patient access to Prolaris testing in the United States.

Favorable intermediate is defined as prostate cancer patients with: “Predominant Gleason grade 3 (i.e. Gleason score 3+4=7), percentage of positive cores <50%, and no more than 1 NCCN intermediate-risk factor) NCCN intermediate risk factors include T2b-T2c, Gleason score 7, and PSA 10-20 ng/mL.”

We believe this criteria applies to approximately 25 percent of men with prostate cancer. Since Medicare is the payer for approximately 60 percent of men with prostate cancer, this draft LCD if approved would expand coverage for about 15 percent of men or approximately 30,000 additional men per year in the United States.

We believe this LCD will be reviewed at the CAC meeting in February and be subject to a 45 day comment period along with a 45 day waiting period if approved. Consequently we would expect the potential impact of this decision from a revenue perspective to be a fiscal year 2018 event.

At the same time, we are disappointed that the MolDx program published a draft non-coverage decision for Vectra DA based on data from the recently published AMPLE study.[1] Myriad strongly disagrees with the conclusions of this study as published, which had significant limitations and shortcomings as described by Dr. Jeff Curtis in his scholarly response to the paper.[2]

For example, a major shortcoming of the AMPLE publication was an unconventional statistical analysis of radiographic progression. When the data are reanalyzed using a more conventional approach, the findings are consistent with multiple prior studies that show Vectra DA accurately predicts radiographic progression in patients with rheumatoid arthritis (RA).[3]-7

The efficacy of Vectra DA has been demonstrated in more than 20 studies with more than 3,000 patients. The strength of the clinical evidence for Vectra DA has been widely recognized as 3 out of 4 rheumatologists have experience with Vectra DA and have ordered it for ~300,000 patients in the United States. Recently, Vectra DA was included in guidelines published by United Rheumatology and will be evaluated for inclusion in the American College of Rheumatology (ACR) guidelines.

Vectra DA remains an important test for rheumatologists and their patients with RA. The Company stands behind the science supporting Vectra DA, and we will work to ensure continued access to this important molecular diagnostic test for all Medicare patients with RA.

Tuesday, November 29, 2016

SVC Medicaid Web page (2016 11 29)


Managed Care

SVC provides complete support for States considering or implementing a Medicaid managed care strategy. SVC spearheaded a study of managed care for the disabled and for individuals requiring long-term support services in Indiana and helps states develop, design and implement managed care programs including developing managed care RFPs.  The SVC team leads states through the program development process from policy design, stakeholder communications, waiver development, and identifying operational needs through post-implementation.  This includes identifying policy and program options and facilitating state decision-making. Specifically, SVC develops:
• Requests for Information (RFI) and Requests for Proposals (RFP)
• Methods for CMS coordination and negotiation
• MCO and Vendor readiness reviews
SVC develops Requests for Proposals for different States and led a study of managed care for the State of Indiana. In addition, SVC supports States through the procurement process and implementation as well as preparing the necessary federal waivers and State Plan Amendments. SVC provides Medicaid managed care services to Indiana, Idaho and Iowa.

Coverage Expansion

SVC has a long history working with States on Medicaid and health policy issues reform. SVC served as the architect of Governor Mitch Daniels' Healthy Indiana Plan (HIP) and has remained directly involved in HIP program policy and operational developments as well as developing the HIP 2.0 program, under Governor Mike Pence. SVC's role with HIP included not only the design but development including creating the Request for Proposal, drafting the initial 1115 waiver, negotiating the waiver special terms and conditions with the Centers for Medicare and Medicaid Services (CMS), managing the implementation, developing the waiver renewal applications and overseeing the evaluation of the plan.
Additionally, SVC has taken the lead on new 1115 waiver development in states such as IowaIdaho, Tennessee as they consider Medicaid expansion.  SVC has also worked with many states including Maine, Nebraska and South Carolina on Medicaid strategy and policy evaluation, waiver development, ACA and Exchange issues.  SVC has also worked with counties and local health departments as they consider the impact of the ACA and recent coverage expansions on their programming.  SVC has a firm grasp of the nationwide Medicaid landscape and consistently applies our entire breadth of regulatory knowledge and real world experience to our clients projects no matter the scope.

1115 Waivers 

SVC has been instrumental in innovative 1115 wavier demonstration development for several of our clients. In addition to being the architect of Indiana's Healthy Indiana Plan, SVC developed both of Iowa’s Medicaid Expansion 1115 demonstration proposals and assisted Michigan with program implementation.  SVC brings extensive expertise in designing and creating unique Medicaid programs for our State clients. Our 1115 products share common elements of private market coordination, consumer direction, and incentives for prevention and healthy behaviors, but are specific to each State’s market, politics and unique population needs.
SVC has in depth experience:
  • designing 1115 waiver programs
  • supporting the waiver development and negotiation process with CMS
  • assuring that the proposal is structured appropriately, contains all the required elements and aligns with the state’s political needs
  • leading implementation efforts for waiver programs, including implementing policy, eligibility system changes and developing request for proposals to contracting with managed care companies
  • developing stakeholder education materials
  • ensuring vendor readiness for go-live

SVC has led many successful analytic research efforts involving special populations (e.g. long-term care, aging and disability, and home and community based services). SVC has assisted State governments in the research, analyses and development of various Medicaid programs that have included vulnerable populations such as those with disabilities and behavioral health challenges. 
SVC led efforts to develop the State of Indiana's Behavioral and Primary Healthcare Coordination (BPHC)program, a Section 1915(i) home and community-based services program specifically designed to maintain Medicaid eligibility for a portion of Indiana's chronic mentally ill population who would have otherwise lost access to coverage for intensive community-based behavioral health services when the State transitioned from 209(b) to 1634 status. SVC's work included identification of the population at risk of losing services, development of policy options for program design, identification of assessment processes and services package design. SVC provided project management and technical support through implementation including developing the State Plan Amendment, administrative rule draft and stakeholder communication materials.
The SVC team was also a key component of the State of Indiana Aged, Blind and Disabled (ABD) Task Forceconvened to complete a comprehensive review of the current ABD population, expenditures, programming and nationwide trends.  SVC analyzed public input, researched ABD options across the nation and considered Indiana's current managed care landscape in order to create the final Aged, Blind and Disabled Report for the Indiana General Assembly. 

In 2013, Maine's Department of Health and Human Services contracted with SVC, Inc. and Milliman, to provide expertise, research, and data analysis services to the redesign effort and to give a national perspective on Medicaid cost containment strategies in an effort to realize $5.25 million in Medicaid savings. SVC led the Task Force in reviewing the MaineCare program and potential cost containment strategies. Part of this analysis focused on coverage categories, the nature and extent of covered benefits, the cost-sharing requirements, enrollment trends, and analysis of expenditure data. SVC helped facilitate Task Force meetings, prepared analyses and presentations and drafted the final report to be submitted to the State legislature. Recommendations in SVC's report projected total State savings in fiscal years 2013-15 of $35.22 million. Through thorough reviews of strategies nationwide, targeted data analysis, and knowledge of Medicaid program operations, SVC, Inc. was able to help the MaineCare Redesign Taskforce identify and validate strategies to improve care delivery and realize cost savings.

Monday, November 21, 2016

PAMA Section 218: Imaging Appropriate Use Criteria

PAMA as a whole:

PAMA Section 218/Appropriate Use Criteria (Clipped; becomes SSA 1834(q)):

    (b) Promoting Evidence-Based Care.--
            (1) In general.--Section 1834 of the Social Security Act (42 
        U.S.C. 1395m), as amended by subsection (a), is amended by 
        adding at the end the following new subsection:

    ``(q) Recognizing Appropriate Use Criteria for Certain Imaging 
            ``(1) Program established.--
                    ``(A) In general.--The Secretary shall establish a 
                program to promote the use of appropriate use criteria 
                (as defined in subparagraph (B)) for applicable imaging 
                services (as defined in subparagraph (C)) furnished in 
                an applicable setting (as defined in subparagraph (D)) 
                by ordering professionals and furnishing professionals 
                (as defined in subparagraphs (E) and (F), respectively).
                    ``(B) Appropriate use criteria defined.--In this 
                subsection, the term `appropriate use criteria' means 
                criteria, only developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities, to assist ordering professionals 
                and furnishing professionals in making the most 
                appropriate treatment decision for a specific clinical 
                condition for an individual. To the extent feasible, 
                such criteria shall be evidence-based.
                    ``(C) Applicable imaging service defined.--In this 
                subsection, the term `applicable imaging service' means 
                an advanced diagnostic imaging service (as defined in 
                subsection (e)(1)(B)) for which the Secretary 
                          ``(i) one or more applicable appropriate use 
                      criteria specified under paragraph (2) apply;
                          ``(ii) there are one or more qualified 
                      clinical decision support mechanisms listed under 
                      paragraph (3)(C); and
                          ``(iii) one or more of such mechanisms is 
                      available free of charge.
                    ``(D) Applicable setting defined.--In this 
                subsection, the term `applicable setting' means a 
                physician's office, a hospital outpatient department 
                (including an emergency department), an ambulatory 
                surgical center, and any other provider-led outpatient 
                setting determined appropriate by the Secretary.
                    ``(E) Ordering professional defined.--In this 
                subsection, the term `ordering professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                orders an applicable imaging service.
                    ``(F) Furnishing professional defined.--In this 
                subsection, the term `furnishing professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                furnishes an applicable imaging service.
            ``(2) Establishment of applicable appropriate use 

[[Page 128 STAT. 1066]]

                ``(A) <<NOTE: Deadline. Regulations. Consultation.>>  In 
                general.--Not later than November 15, 2015, the 
                Secretary shall through rulemaking, and in consultation 
                with physicians, practitioners, and other stakeholders, 
                specify applicable appropriate use criteria for 
                applicable imaging services only from among appropriate 
                use criteria developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities.
                    ``(B) Considerations.--In specifying applicable 
                appropriate use criteria under subparagraph (A), the 
                Secretary shall take into account whether the criteria--
                          ``(i) have stakeholder consensus;
                          ``(ii) are scientifically valid and evidence 
                      based; and
                          ``(iii) are based on studies that are 
                      published and reviewable by stakeholders.
                    ``(C) <<NOTE: Review. Deadline.>>  Revisions.--The 
                Secretary shall review, on an annual basis, the 
                specified applicable appropriate use criteria to 
                determine if there is a need to update or revise (as 
                appropriate) such specification of applicable 
                appropriate use criteria and make such updates or 
                revisions through rulemaking.
                    ``(D) Treatment of multiple applicable appropriate 
                use criteria.--In the case where the Secretary 
                determines that more than one appropriate use criterion 
                applies with respect to an applicable imaging service, 
                the Secretary shall apply one or more applicable 
                appropriate use criteria under this paragraph for the 
            ``(3) Mechanisms for consultation with applicable 
        appropriate use criteria.--
                    ``(A) Identification of mechanisms to consult with 
                applicable appropriate use criteria.--
                          ``(i) In general.--The Secretary shall specify 
                      qualified clinical decision support mechanisms 
                      that could be used by ordering professionals to 
                      consult with applicable appropriate use criteria 
                      for applicable imaging services.
                          ``(ii) Consultation.--The Secretary shall 
                      consult with physicians, practitioners, health 
                      care technology experts, and other stakeholders in 
                      specifying mechanisms under this paragraph.
                          ``(iii) Inclusion of certain mechanisms.--
                      Mechanisms specified under this paragraph may 
                      include any or all of the following that meet the 
                      requirements described in subparagraph (B)(ii):
                                    ``(I) Use of clinical decision 
                                support modules in certified EHR 
                                technology (as defined in section 
                                    ``(II) Use of private sector 
                                clinical decision support mechanisms 
                                that are independent from certified EHR 
                                technology, which may include use of 
                                clinical decision support mechanisms 
                                available from medical specialty 
                                    ``(III) Use of a clinical decision 
                                support mechanism established by the 
                    ``(B) Qualified clinical decision support 

[[Page 128 STAT. 1067]]

                          ``(i) In general.--For purposes of this 
                      subsection, a qualified clinical decision support 
                      mechanism is a mechanism that the Secretary 
                      determines meets the requirements described in 
                      clause (ii).
                          ``(ii) Requirements.--The requirements 
                      described in this clause are the following:
                                    ``(I) The mechanism makes available 
                                to the ordering professional applicable 
                                appropriate use criteria specified under 
                                paragraph (2) and the supporting 
                                documentation for the applicable imaging 
                                service ordered.
                                    ``(II) In the case where there is 
                                more than one applicable appropriate use 
                                criterion specified under such paragraph 
                                for an applicable imaging service, the 
                                mechanism indicates the criteria that it 
                                uses for the service.
                                    ``(III) The mechanism determines the 
                                extent to which an applicable imaging 
                                service ordered is consistent with the 
                                applicable appropriate use criteria so 
                                    ``(IV) The mechanism generates and 
                                provides to the ordering professional a 
                                certification or documentation that 
                                documents that the qualified clinical 
                                decision support mechanism was consulted 
                                by the ordering professional.
                                    ``(V) The mechanism is updated on a 
                                timely basis to reflect revisions to the 
                                specification of applicable appropriate 
                                use criteria under such paragraph.
                                    ``(VI) The mechanism meets privacy 
                                and security standards under applicable 
                                provisions of law.
                                    ``(VII) The mechanism performs such 
                                other functions as specified by the 
                                Secretary, which may include a 
                                requirement to provide aggregate 
                                feedback to the ordering professional.
                    ``(C) <<NOTE: Deadlines.>>  List of mechanisms for 
                consultation with applicable appropriate use criteria.--
                          ``(i) <<NOTE: Publication.>>  Initial list.--
                      Not later than April 1, 2016, the Secretary shall 
                      publish a list of mechanisms specified under this 
                          ``(ii) Periodic updating of list.--The 
                      Secretary shall identify on an annual basis the 
                      list of qualified clinical decision support 
                      mechanisms specified under this paragraph.
            ``(4) Consultation with applicable appropriate use 
                    ``(A) Consultation by ordering professional.--
                Beginning <<NOTE: Effective date.>> with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service ordered by an ordering 
                professional that would be furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), an ordering 
                professional shall--
                          ``(i) consult with a qualified decision 
                      support mechanism listed under paragraph (3)(C); 

[[Page 128 STAT. 1068]]

                          ``(ii) provide to the furnishing professional 
                      the information described in clauses (i) through 
                      (iii) of subparagraph (B).
                    ``(B) <<NOTE: Effective date.>>  Reporting by 
                furnishing professional.--Beginning with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), payment for such 
                service may only be made if the claim for the service 
                includes the following:
                          ``(i) Information about which qualified 
                      clinical decision support mechanism was consulted 
                      by the ordering professional for the service.
                          ``(ii) Information regarding--
                                    ``(I) whether the service ordered 
                                would adhere to the applicable 
                                appropriate use criteria specified under 
                                paragraph (2);
                                    ``(II) whether the service ordered 
                                would not adhere to such criteria; or
                                    ``(III) whether such criteria was 
                                not applicable to the service ordered.
                          ``(iii) The national provider identifier of 
                      the ordering professional (if different from the 
                      furnishing professional).
                    ``(C) Exceptions.--The provisions of subparagraphs 
                (A) and (B) and paragraph (6)(A) shall not apply to the 
                          ``(i) Emergency services.--An applicable 
                      imaging service ordered for an individual with an 
                      emergency medical condition (as defined in section 
                          ``(ii) Inpatient services.--An applicable 
                      imaging service ordered for an inpatient and for 
                      which payment is made under part A.
                          ``(iii) Significant hardship.--An applicable 
                      imaging service ordered by an ordering 
                      professional who the Secretary may, on a case-by-
                      case basis, exempt from the application of such 
                      provisions if the Secretary determines, subject to 
                      annual renewal, that consultation with applicable 
                      appropriate use criteria would result in a 
                      significant hardship, such as in the case of a 
                      professional who practices in a rural area without 
                      sufficient Internet access.
                    ``(D) Applicable payment system defined.--In this 
                subsection, the term `applicable payment system' means 
                the following:
                          ``(i) The physician fee schedule established 
                      under section 1848(b).
                          ``(ii) The prospective payment system for 
                      hospital outpatient department services under 
                      section 1833(t).
                          ``(iii) The ambulatory surgical center payment 
                      systems under section 1833(i).
            ``(5) Identification of outlier ordering professionals.--
                    ``(A) <<NOTE: Effective date. Determination.>>  In 
                general.--With respect to applicable imaging services 
                furnished beginning with 2017, the Secretary shall 
                determine, on an annual basis, no more than five percent

[[Page 128 STAT. 1069]]

                of the total number of ordering professionals who are 
                outlier ordering professionals.
                    ``(B) Outlier ordering professionals.--The 
                determination of an outlier ordering professional 
                          ``(i) be based on low adherence to applicable 
                      appropriate use criteria specified under paragraph 
                      (2), which may be based on comparison to other 
                      ordering professionals; and
                          ``(ii) include data for ordering professionals 
                      for whom prior authorization under paragraph 
                      (6)(A) applies.
                    ``(C) Use of two years of data.--The Secretary shall 
                use two years of data to identify outlier ordering 
                professionals under this paragraph.
                    ``(D) Process.--The Secretary shall establish a 
                process for determining when an outlier ordering 
                professional is no longer an outlier ordering 
                    ``(E) Consultation with stakeholders.--The Secretary 
                shall consult with physicians, practitioners and other 
                stakeholders in developing methods to identify outlier 
                ordering professionals under this paragraph.
            ``(6) Prior authorization for ordering professionals who are 
                    ``(A) <<NOTE: Effective date.>>  In general.--
                Beginning January 1, 2020, subject to paragraph (4)(C), 
                with respect to services furnished during a year, the 
                Secretary shall, for a period determined appropriate by 
                the Secretary, apply prior authorization for applicable 
                imaging services that are ordered by an outlier ordering 
                professional identified under paragraph (5).
                    ``(B) Appropriate use criteria in prior 
                authorization.--In applying prior authorization under 
                subparagraph (A), the Secretary shall utilize only the 
                applicable appropriate use criteria specified under this 
                    ``(C) Funding.--For purposes of carrying out this 
                paragraph, the Secretary shall provide for the transfer, 
                from the Federal Supplementary Medical Insurance Trust 
                Fund under section 1841, of $5,000,000 to the Centers 
                for Medicare & Medicaid Services Program Management 
                Account for each of fiscal years 2019 through 2021. 
                Amounts transferred under the preceding sentence shall 
                remain available until expended.
            ``(7) Construction.--Nothing in this subsection shall be 
        construed as granting the Secretary the authority to develop or 
        initiate the development of clinical practice guidelines or 
        appropriate use criteria.''.
            (2) Conforming amendment.--Section 1833(t)(16) of the Social 
        Security Act (42 U.S.C. 1395l(t)(16)) is amended by adding at 
        the end the following new subparagraph:
                    ``(E) Application of appropriate use criteria for 
                certain imaging services.--For provisions relating to 
                the application of appropriate use criteria for certain 
                imaging services, see section 1834(q).''.
            (3) Report on experience of imaging appropriate use criteria 
        program.--Not later than 18 months after the date of the 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to Congress a report that includes

[[Page 128 STAT. 1070]]

        a description of the extent to which appropriate use criteria 
        could be used for other services under part B of title XVIII of 
        the Social Security Act (42 U.S.C. 1395j et seq.), such as 
        radiation therapy and clinical diagnostic laboratory services.

                        GROWTH RATE (SGR) REFORM.

Monday, October 31, 2016

MolDX Q&A M00086, V9 (Cached)

MolDX General Questions (M00086, V9) - + 
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Select the category of questions you would like to view:
MolDX General Questions
1. What is the purpose of the MolDX program?To identify tests, determine coverage, and determine reimbursement.
2. How does this program help claim adjudication?Once the required information is received and a unique identifier is assigned, Palmetto MolDX can determine coverage and payment without documentation review. This process removes the need for the provider to submit large amounts of additional information with every claim and expedites claim payment.
3. What laboratories will be affected?All private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare in JE, JF JM, J15 J5, or J8 on a CMS 1500 Claim Form or electronic claims on a 5010-837P are affected by this program. (Please reference the specific jurisdiction MDT policy for effective dates.)
4. What molecular diagnostic assays/tests are included in MolDX?Tests that meet the description for CPT codes 81161-81393, Tier 2 CPT codes, 81400-81408, Genomic Sequencing Providers and Other Molecular Multianalyte Assays (MAA), 81410-81471, *MAA with Algorithmic Analyses, 81490-81595 microdissection codes, 88380-88381, HCPCS professional interpretation code, G0452, Proprietary MAA, 0001M-00010M , and not otherwise classified CPT codes (NOC), 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, and 89398.  For more information review MolDX article Test Registration (M00019). Submit questions about specific tests/assays not described in this chart, to
5. Is the MolDX Program national in scope?The MolDX Program currently covers JE (CA, NV, HI), JF (WA, OR, ID, MT, WY, AZ, ND, SD, UT , Aleutian Islands), JM (NC, SC, VA, WV),  J15(TN, OH), J5 (IA, MO, KS, NE) and J8 (MI, IN). Labs that perform services for patients in those states, must register in order to submit a Medicare claim.
6. Will this project align with the AMA effort to publish CPT codes for MDT?The AMA efforts and the MolDX program are not related or interdependent.
7. How does a lab register a test?  Review MolDX Test Registration (M00019) for instructions and the registration link.
8. What is McKesson’s involvement in the MolDX program?McKesson is the contracted technology provider for the MolDX program. Palmetto will leverage the McKesson Diagnostics Exchange™ (DEX) the online test registry and technical assessment components of the MolDX program. DEX is a web-based service designed to identify tests and help establish transparency in the evidence-based coverage of them. This tool enables labs to confidentially share test information with MolDX online
9. What information will be made available to the public?MolDX information collected for the registry will only be available to those labs electing to submit a Z-Code Identifier application and is consistent with the public/private indications therein.
10. Will the MolDX Program expand to other jurisdictions?At this time CMS has not determined how MolDX will be expanded. Palmetto GBA will continue to administer active LCDs and articles published in JM, Noridian will administer the MolDX in JE and JF, CGS will administer MolDX in J15, and WPS will administer MolDX in J5 and J8.
MolDX Registration (Z-Code applications)
1. Should the manufacturer or the performing lab register an FDA-approved, in vitro diagnostic test that utilizes a kit?The manufacturer and the performing labs should submit an application. The MolDX team will review each submission for accuracy and assign each performing lab that reports the test without modifications the same code. The lab must submit an application in order to obtain an identifier for submission. Without the application information, MolDX cannot determine the kit is unmodified and the labs that intend to use the kit.
2. Should the manufacturer also register for Alternative Summary Reporting (ASR's) that have not been FDA approved?No.
3. If multiple tests may be performed and billed within one assay, is the lab required to register each test within the assay?A unique identifier application is required for a single assay that may involve multiple tests in order to produce a single result.
4. Is a unique identifier application required for each specimen source, i.e. blood and bone marrow, for the same test? No.
5. In addition to the unique identifier application, should labs send peer-reviewed articles to ensure MolDX has enough information to make a positive coverage determination?
No. Peer-reviewed literature used in coverage determination is  required only during the Technical Assessment (TA) process.
6. Is a unique identifier application required for an FDA-approved test?The FDA approval process ensures only the clinical and analytical validity of the test. The FDA does not include clinical utility in their review, which is required to establish Medicare coverage.
7. Is a new unique identifier required for updated tests or a test expansion?
If the updated or expanded test is substantively different, you will need to submit an application and a new identifier will be assigned.
8. After a test is granted a unique identifier, can a hospital bill their respective MAC directly for the test using the assigned code? Yes. Although MolDX has NOT expanded to Part A, hospitals may add the Z-Code Identifier as additional information to help reviewers determine coverage.
9. If a pathologist plans to submit a claim for the professional component of a MolDX test, should the pathologist register the test?No. In the rare instance when an additional and separate professional interpretation is needed, the pathologist must obtain the ID for the interpreted test from the performing lab. A G0452 claim service may ONLY be submitted when the clinician interprets the raw data for a test. The clinician must use the Z-Code Identifier assigned to the test interpreted.
Sample Claim:
CPT Code 
Z-Code Identifier 
 BCR-ABL, major breakpoint
 G0452 (HCPCS)

10. Is a unique identifier required for tests billed with a NOC code?Yes. Review MolDX Test Registration (M00019)
11. Are labs expected to register tests sent to another lab to perform?You are only required to register tests if you plan to submit claims to jurisdictions that implement MolDX.  Please indicate the referenced lab in the application.
12. If a lab performs the same exact test from two different locations, operating under two different CLIA numbers, will the lab be required to submit both tests for unique identifiers?If the test process is standardized and the same method is used to acquire the results in both locations, labs will only have to submit one application for the test. However, if there is a difference in the method, an application will be required from both locations.
13. Should labs that provide lab products alert their lab customers about MolDX registration requirements? Yes.
14. If the kit used in an LDT is not FDA-approved, should the lab apply for a unique identifier for that kit?  
15. How do labs identify test reagents in the MolDX unique identifier application forms?Enter the information in the 'contributing component' field.
16. Are labs required to register tests that use a code in the MolDX code range and a code that is not listed in the MolDX range of codes (i.e., CPT codes 87001-87905)?Yes.
17. When a laboratory modifies an FDA approved kit, will MolDX require a new unique identifier? 
Yes. If a lab modifies a registered test, the resulting test is considered an LDT and will require a separate application.
18.  If a California laboratory is billing for a test referred to a laboratory located outside of the jurisdiction, which lab is responsible for registering the test?It is the responsibility of the billing provider to obtain a unique identifier.
19. If multiple laboratories purchase the same test and each lab registers the test, how will MolDX notify the laboratory regarding the assigned identifier?MolDX will follow the registration process. A review of the MolDX database is performed to ensure a unique identifier has not been previously assigned. If a test has been registered, the lab will receive the assigned identifier. The only difference is the identifier for that particular test has already been established prior to the current lab’s application.
20.  Are hospital labs that file institutional claims and providers that file professional claims exempt from the requirement to obtain a unique identifier?At this time the MolDX Program applies to JE, JF and JM Part B claim submission. J15 Part B claim submission starts in October 2015. Part B includes professional claims or claims submitted by a pathologist for the professional component of a test. Therefore, a pathologist submitting claims for a professional MolDX service would be required to register a test.
Technical Assessment (TA)
1. What types of tests may require a TA?
  • Lab developed tests (LDT’s) performed using either established or novel technology with un-established clinical utility 
  • Molecular or genetic testing that has not been validated for clinical and analytical validity
  • Tests using modified versions of FDA registered kits
  • Tests using a new molecular or genetic technological testing platform
  • Genetic or molecular target with un-established clinical utility 
  • Tests reported with one of the following CPT codes: 
Tier 2 CPT Codes 
Genomic Sequencing Procedures and Other  Molecular Multianalyte Assays (MAA)
 *MAA with Algorithmic Analyses
Not otherwise classified (NOC) CPT Codes
81479, 815999, 84999, 85999, 86849,87999, 88199, 88299, 88399, 89398  
2. What tests may not require a TA?
  • State of New York (NYS) certified tests that are industry accepted and have established clinical utility. However, MolDX may request the package used to determine the NYS certification to make a coverage decision. The approval letter or a copy of the NYS listing may be used to demonstrate NYS approval.
  • Test that use FDA approved kits in an unmodified form
  • New tests approved under a Premarket Approval (PMA)-(which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not
  • Tests that using existing or novel technology for molecular or genetic targets with established clinical utility
3. When should labs submit the clinical data dossier (TA) to MolDX? MolDX will accept a TA after an identifier has been assigned. MolDX will NOT accept any information prior to registration and assignment of a unique identifier. For labs that do not submit the clinical data, MolDX will prioritize according to claims data and make requests.
4. Where do I find guidance on creating a comprehensive TA dossier for submission? All guidance information for the creation of a TA dossier and the review process can be found under Technical Assessment (TA) Process (M00095) on the MolDX website.
5. Where do I find information on the level of evidence I need for a full review of my test?The Clinical Test Evaluation Process (CTEP) (M00096) outlines a process used by the Subject Matter Experts (SME) and the MolDX Executive Committee (EC) to assess new tests.
6. Can I arrange a pre-submission meeting with MolDX to discuss my assay?Yes. After you have registered your test and received a unique ID for the test, follow the steps outlined in the Pre-submission Review Process (M00117). 
7. How do I submit my dossier to MolDX?The Technical Assessment Submission Instructions (M00115) provide the steps to submit your dossier through the registry.  
8. Why was an invalid determination issued on my TA submission?A TA must be submitted with the test ID in the subject line. MolDX will not initiate a TA without an ID.  Additionally, all communication regarding tests MUST have the ID in the subject line. This enables the MolDX staff to accurately track test documents and avoid unnecessary delays and misplaced documents. 
9. How long will it take to complete the TA process and receive a coverage determination? Upon submission of the dossier, there is a 30 day period to determine if the submission is complete. Once the MolDX Team has determined that the dossier is complete, a 90 day review period begins.
10. The information requested by MolDX to support analytical validity may be considered proprietary intellectual property. How will MolDX assure the security and confidentiality of that information?Only MolDX and its subject matter experts will have access to proprietary information submitted through the McKesson DEX account.
11. Are there options in lieu of two published articles that support clinical utility?Review The MolDX clinical Test Evaluation Process (CTEP)-M00096
12. Who will perform the technical assessments (TA)?Subject matter experts (SME) from academia and industry will assess the scientific literature. The MolDX team will perform the assessment for all other components.
13. Will MolDX share the conclusions of one SME with other SME?No. An SME will only have access to their assigned TA. Also, each SME will only have access to the scientific literature submitted with the TA. All other components will be reviewed by the MolDX Team.  Only the MolDX Team will review proprietary information.
14. What are the conflict of interest principles that will guide MolDX in determining whether or not an SME should be permitted to conduct a technical assessment? The conflict of interest principles were developed by Blue Cross Blue Shield of South Carolina and are standard for the industry.
15. What types of disclosures will be required from the SMEs in order to facilitate a conflict of interest determination?The disclosures required by the SME were developed by Blue Cross Blue Shield of South Carolina for government contractors and are standard for the industry.
16. Will there be an opportunity for a laboratory to comment on a TA report before it is finalized?
Yes. Questions/concerns that surface during the TA will be communicated with the test developer.
17. Will laboratories and/or manufacturers be allowed to resubmit a coverage request after they have received a non-coverage determination?Yes. If substantive new information, not included in the initial submission, becomes available, a new request may be submitted 6 months after the initial non-coverage determination was issued.
18. What is the difference in the logistical steps to initiate a formal coverage determination and the process to initiate coverage determination with a TA? It is the same process.
19. When a manufacturer has a new test approved under a PMA (which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not. If the lab billed the same test with an NOC code, both a unique identifier and TA would be required.The NOC is not the only considered fact about the TA. If, as in your example, a test is vetted for science and clinical utility, the information can be collected at the time the unique identifier is assigned. At that time the lab may bill the NOC with the assigned unique identifier.
20. Since the clinical and economic utility data will be reviewed as part of the coverage determination (and not during the TA), will the clinical utility evidence be sent out for subject matter expert review or will that evidence be reviewed only within MolDX? What about the economic utility evidence? If the clinical utility and economic data are in the public domain (published), SME will review it. If it is proprietary, then MolDX Team will review it.
21. Is there a difference in the expected timeline for a coverage determination and a TA?It is the same.
22. Can a lab provide services prior to the TA approval date in anticipation of a favorable determination and then submit the claims after the approval? To avoid overpayment requests, labs should freeze services until coverage is approved and appropriate billing and coding guidelines are published.
23. If a lab plans to submit a test for FDA approval, can the test be submitted for a TA first?If the test is currently in the FDA process, please hold the TA request until the FDA has completed its determination. However, if you have not submitted the test to the FDA, you may request a TA. The FDA submission should be done prior to TA request. Once you receive an FDA determination, you may submit a TA request.
24. Should labs submit applications for Research Use Only Reagents (RUO)?No.
25. Are manufacturers that provide items such as ASR or RUO used in an LDT required to register the items?No. Only the LDT developer and biller of the LDT are required to register for a unique identifier. However, an LDT developer must disclose the ASR and RUO used in the developed LDT on the application.
26. How should labs outline test reagents in the TA?  Submit the package insert for the kit with the materials.
27. When multiple large numbers of reagents are used in a test, how should labs identify the specific details for the reagents?Provide sufficient information to identify the manufacturer and the product specifications (PI).
28. Should protocols for technical evaluation be included in the TA submission?Yes.
29. Will a completed TA be made available on the MolDX website?Only an approved TA will be published. However, MolDX may publish a coverage/non-coverage article or an LCD based on the TA.
30. How should a laboratory designate proprietary information on the TA submission?MolDX will consider any information that is not publicly available to be proprietary information.
31. During the TA process, when should a laboratory submit pricing information to support a payment rate determination?Any pricing information will be requested from the laboratory after a favorable coverage determination has been made.
32. How will MolDX determine reimbursement for a test?Reimbursement is based on accurate submitted codes regardless of the cost of the platform used. For tests that are reported with an NOC code, pricing will be determined based on the information collected in the TA. Each test will be assessed on an individual basis and priced according to the most appropriate method. the MolDX Team will review the pricing method with the individual lab upon completion of the TA.
33. What is the TA process for labs performing and or submitting tests outside a MolDX jurisdiction?  The TA process is open to all lab developers and their tests regardless of geographic location. In order to receive a coverage determination, it is the responsibility of the billing laboratory to submit a TA. Claims paid for tests that do not meet the mandated reasonable and necessary criteria may be subject to overpayment requests.
34. What resources are available to help me determine the best CPT code to bill my new test?      
All test applications are reviewed for correct CPT mapping by the MolDX Team. If an error or a disparity is identified, the Team will notify the test provider for clarification. After a TA is complete, the Team will notify the test provider with the final coding, billing, coverage, and if applicable allowed fee for the test.
Billing and Coding
1. What are the effective dates of the codes ZSB01 and ZB728?Z-Code Identifiers are effective at time of assignment.
2. What action should a lab take if they believe they may have incorrectly billed for a MolDX service?If you believe your practice has made a MolDX billing/coding error, you may take the following corrective actions:
  • Complete a Self-Audit
    • Identify incorrect submissions
    • Prevent further claim submission errors
  • Consider Self-Disclosure Protocol
    • Self-disclosure guidelines available on the OIG website external link 
3. Where do I enter the assigned MolDX test identifier on my claim?If you are submitting a paper claim, this information would be placed in Block 19 of the CMS 1500 claim form. For Electronic claims (5010)837P (Physician/Professional),use the SV101-7 field adjacent to each CPT code used to report the service. This field maps to the Line item Description (This field is required for NOC codes to avoid rejection by the Common Edit Module Front end).
4. If the lab submits a MolDX covered test without a unique identifier after the implementation date, will MolDX reject the claim as 'unprocessable' with no appeal rights or send a denial with a specific or new claim denial message?  Claims received without additional information required to adjudicate the claim will be rejected.
5. If a laboratory performs multiple assays/tests on a single patient on one date of service, will the lab have to split the different assays/tests into multiple claims? MolDX considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a 'panel' of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier.
6. If a CPT code appears on the claim more than once to report an additional test, is a modifier required?
Yes. Append with CPT modifier 91. See the claim example for question 8.
7. How do I submit a claim for ONLY the professional interpretation of a test?Although rare, when an additional and separate professional interpretation is needed, the pathologist must obtain the ID for the interpreted test from the performing lab.
Sample Claim:
Lab A performed BCR-ABL, major breakpoint assigned with Z1234.
Clinician interpretation should be submitted as follows:
 Z-Code Identifier
8. Will CCI edits continue to be in effect on MolDX services?Yes. Because the Z-Code Identifier only acts to label the specific test and is not a code set, MolDX service providers must append CPT codes within the CCI edits with a 59 CPT modifier to indicate the CCI Column II code is a different test.
Note: The 59 CPT modifier should ONLY be appended to CCI Column II codes.
9. There is only one Box 19 on my paper claim form. How do I identify more than one test or assay on my claim? Due to the limitations of the paper claim, labs using this form will be limited to only one test/assay/unique identifier per claim. To bill a MolDX test on a paper claim, enter the unique identifier in Box 19 and then enter only the CPT code(s) for that identifier on the claim. Remember: You may only file one test per paper claim submission.
10. I registered a single gene test performed on a Next Generation Sequencing (NGS) platform that is listed on the MolDX approved gene test list. Why is my claim denied?MolDX does NOT consider the T1 and T2 descriptions appropriate for genes interrogated on an NGS platform. Please reference the coding and billing guidelines in reference article M00130.
1. Will a microarray service be reimbursed at the same rate for all microarrays or will the diagnosis differentiate payment? For example, will 1800+ genes of one array be viewed differently than an 1800+ array with a different algorithm?Diagnosis will not differentiate payment. Payment is based on the accurate CPT/HCPCS codes submitted. However, if there are less than 500 probes in an array, CPT code 83999 must be used and MolDX will price the NOC code.
2. Does the DRG segregate the CPT code to a different payment?No.
3. Will ABN’s be valid with the unique identifier? The unique identifier is only additional information, not a billing code.
4. Will MolDX pay test services provided prior to the TA approval date?All new test services will be denied as noncovered until the test completes the TA process and reasonable and necessary criteria is established. Claims submission for tests in the TA process should be suspended until a final coverage determination is made.
5. If I already have a PTI for my test, how do I switch to a Z-Code Identifier so I can use the online TA feature? 
Send a request to switch the ID to
6. Is the reimbursement for a flow cytometry affected by MolDX?Palmetto GBA has an active LCD for Flow Cytometry and will continue to administer coverage as published in that policy the same as any other active policy.
Coverage Issues
1. Is a confirmatory FISH test a covered benefit?Confirmatory testing is considered a quality check and is not a covered Medicare benefit.
2. If a lab needs a denial for a noncovered test in order to bill a secondary payor, should they submit the test for MolDX registration?Yes.