Thursday, January 31, 2019

CMS Writes: Overpayment Rule Applies Despite Tardy NCD and LCD Implementation

81 FR 7956-7 (February 12, 2016)


A number of commenters requested that overpayments not caused by the provider or supplier or that were otherwise outside of the provider or supplier’s control should be excluded from our proposed definition of overpayment.

Examples of this situation offered by commenters included—
(1) a CMS system error classifying a Medicare beneficiary as fee-for-service when the beneficiary was enrolled in a MA Plan; or
(2) if the Medicare contractor makes a duplicate payment,
pays for a noncovered service due to a contractor system edit problem, or
fails to implement a national or local coverage decision correctly, resulting in an erroneous payment.


We disagree with the commenters that certain types of payments, including those made as a result of an error by any particular party, should be excluded from the definition of an overpayment.

We do not see any basis to exclude an overpayment from the requirements of section 1128J(d) of the Act because it may not have been caused by or was otherwise outside the control of the provider or supplier.

The plain language of section 1128J(d)(1) of the Act states that providers and suppliers are obligated to report and return any overpayment that they have received within the specified statutory timeframes.

We do not believe it is necessary for providers or suppliers to make determinations regarding whether they were the cause of an overpayment in lieu of reporting and returning any identified overpayments as required by this rule.


CMS also states, on the following page, that not only are repayments due, after a carrier payment error interpreting an NCD, but also, CMS may issue clarifications that in some "circumstances" clarify that a past payment should now be viewed as an overpayment.  Adding that, overpayments are usually charged based on the effective date of a policy.

click to enlarge

Tuesday, January 22, 2019

A Quirk When BRCA Policies Require Common Mutation Screening First

For some recent client research, I had cause to go back to a 2008 Medicare LCD for BRCA testing and other germline testing.

The LCD is here.

The LCD requires Ashkenazi patients to be first screened for the 3 founder mutations, then if they are negative, reflex to sequence testing:

This actually loses money for Medicare.  It doesn't save money.

Using current codes, under direct BRCA sequencing, for 100 patients you'd pay 100 x $2027 (code 81162), or $202,700.

Under the recommended screening test, you pay more.  You'd pay for 100 patients at 100 x $440 (code 81212), and 5 would be positive.  The other 95 now progress to BRCA sequencing, 95 x $2027 (code 81162), or $192,565.  Adding together, this pathway costs $236,565. 

It's cheaper to move to direct sequencing than to hotspot mutations followed by sequencing, when the hit rate is so low (1-5%) as here.

I've seen this in more recent BRCA policies but I haven't made a systematic study of it.  A lab would have no reason to point out the anomaly to the policymaker.  You just have to count on the policymaker being unable to do fourth-grade math.

Thursday, January 17, 2019

2019/1/17 Clonoseq Assay Coverage Article A56270

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Local Coverage Article: 
MolDX: Clonoseq® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies (A56270)

Article Text:

Medicare published a National Coverage Decision, 90.2 Next-Generation Sequencing for Patients with Advanced Cancer with an effective date of 03/16/208. This coverage decision allows Medicare Administrative Contractors to cover a next generation sequencing test for cancer diagnoses in beneficiaries with advanced cancer who are seeking additional treatment. Contractors may cover up to one test per beneficiary per cancer diagnosis.
Minimal Residual Disease (MRD) refers to a measure of cancer cells that remain in a person during and following treatment. Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). (1,2)
The clonoSEQ Assay was granted de novo designation by the FDA and is the only MRD assessment tool to have received FDA clearance for the measurement of MRD in patients with B-Cell ALL or MM. (3) The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies Corporation using multiplex polymerase chain reaction and next generation sequencing of DNA, which is able to detect lower quantities of MRD than flow cytometry (4).
Testing for MRD using the clonoSEQ Assay is constituted by a series of assays in time, starting with a baseline assay that identifies clonal sequences, which will be tracked. Measurements of residual disease based on quantification of clonal sequences identified during the baseline are then reassessed in subsequent assays, allowing a provider to monitor response to therapy. Information obtained from this testing is recommended to be used to decide on whether and when to pursue additional treatment.
Effective 03/16/2018, molDX has determined that clonoSEQ Assay testing is reasonable and necessary when performed on bone marrow specimens in patients with B-Cell acute lymphoblastic leukemia (ALL) or multiple myeloma. Medicare will pay for a single episode of testing using clonoSEQ in these patients. For a patient with ALL or multiple myeloma in whom clonoSEQ is being used according to its FDA cleared indications and clinical guidelines, it is anticipated that an episode of testing will typically require a baseline assay and 3 follow-up assays. This service should be billed at the start of the episode of testing.
Coverage of clonoSEQ for other lymphoid cancer indications and episodes of care, and modifications to the definition of an episode of care will be evaluated on an annual basis.
To report a clonoSEQ episode of testing service, please submit the following claim information:
  • Select the CPT 81479 for claims on or after 3/16/2018.
  • Enter 1 unit of service (UOS)
  • Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Box 19 for paper claim
  • Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form
The following diagnoses are appropriate for the test. Select the appropriate ICD-10-CM code:
Multiple Myeloma
  • C90.00 Multiple myeloma not having achieved remission
  • C90.01 Multiple myeloma in remission
  • C90.02 Multiple myeloma in relapse
Acute Lymphoblastic Leukemia (ALL)
  • C91.00 Acute lymphoblastic leukemia not having achieved remission
  • C91.01 Acute lymphoblastic leukemia, in remission
  • C91.02 Acute lymphoblastic leukemia, in relapse
  1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Acute Lymphoblastic Leukemia (Version 1.2019). Accessed 12/16/2018
  2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Multiple Myeloma (Version 2.2019). Accessed 12/16/2018
  3. Food and Drug Administration. FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma. Accessed 12/17/18
  4. Adaptive Biotechnologies. clonoSEQ® Technical Information. Accessed 12/17/2018

Tuesday, January 15, 2019

Free Powerpoint Maps You Can Color (And I Hope Safe)

Review of site:

POWERPOINT you can color:

 Web site banner:

 Safety site (I hope):

Tuesday, January 8, 2019

Very Brief Blog: Decibio Issues Market Report on Liquid Biopsy

With my offices being based in SF and Los Angeles, I frequently have a chance to work with Decibio, a Santa Monica-based life sciences consultancy.  I had a chance to contribute to their new report on liquid biopsy markets both US and world wide, and covering both cfDNA and other modalities like circulating tumor cells. 

Read more about the offering here.

BCBS Evidence Street Announcement 201612; Belinson Interview 201808

Blue Cross Blue Shield Association Launches Evidence Street Website to Streamline Evaluations of Medical Devices, Diagnostics and Pharmaceuticals

CHICAGO – Blue Cross Blue Shield Association (BCBSA) announced a new web-based platform that provides health care decision-makers easy access to impartial medical evidence reviews for devices, diagnostics and pharmaceuticals.

The platform Evidence Street™ was created to make BCBSA’s evidence review process of medical technologies and therapies more transparent, efficient and comprehensive. BCBSA collects and analyzes available peer-reviewed evidence on devices, diagnostics and pharmaceuticals, then synthesizes that data and ascertains if the evidence is sufficient or insufficient to determine the effect on health outcomes.

By developing an online platform, health care product manufacturers are able to monitor when BCBSA is reviewing particular medical categories and are able to easily submit their peer-reviewed evidence for consideration during the review process. In addition, those subscribers who submit evidence will receive a customized report providing feedback about any relevant gaps in the findings from BCBSA.

Reviews are subsequently published on the Evidence Street website, which is accessible to Blue Cross and Blue Shield (BCBS) companies and subscribing health care device, diagnostic and pharmaceutical manufacturers. Medical societies, health care associations and academic medical research centers may also subscribe to the service.

“Today, as medical technology, treatment protocols and new discoveries accelerate and continue to evolve, Evidence Street provides an efficient platform to facilitate collaborative exchange of information between health care decision makers about the state of the evidence to inform health care decisions,” said Dr. Trent Haywood, senior vice president and chief medical officer for BCBSA. “Blue Cross and Blue Shield companies have long been committed to improving population health outcomes, and one of the most important ways we do that is by determining if current use of devices, diagnostics and pharmaceuticals is rooted in clinical evidence.”

BCBSA, which will provide about 460 medical reviews a year, does not determine whether each of the 36 Blue Cross and Blue Shield companies nationwide cover a medical technology. However, it provides BCBS companies with evidence opinions they often use as an input into those decisions.

Evidence Street builds on BCBSA’s history and commitment to evidence-based medicine and technology assessment. BCBSA pioneered the development of scientific criteria for assessing medical technologies through objective, comprehensive reviews of clinical evidence with a mission to provide health care decision-makers with rigorous and credible assessments from available evidence.

"Evidence Street is a destination where the market meets the evidence," Haywood added. “Our goal is to create clarity, efficiency and transparency for health care decision-makers regarding the current state of the evidence.”

About Evidence Street® (“Site”) Disclaimer
Evidence submitted to BCBSA via the Site is considered in the same impartial manner as other evidence provided manually by Subscribers, non-Subscribers, and other sources. Subscription or use of this Site will not enhance review of the submitted evidence or influence BCBSA’s impartial evaluation of all relevant evidence from all appropriate sources.

This Site and BCBSA do not determine medical policy, provide health insurance benefits information, or adjudicate coverage claims for any Blue Plan; do not provide medical, legal, or financial advice; and are not intended for consumer use.

Each local Blue Plan, as an independent entity, determines its own medical policies and benefits, adjudicates its own members’ claims, and may accept or reject information on this Site in its own discretion.

Neither BCBSA nor any Blue Plan recommends, endorses, warrants, or guarantees, nor are they responsible for damages based on any program, provider, product, or service whose information may appear on this Site. Site content expresses the opinion of BCBSA and/or the respective authors cited therein, not those of any Blue Cross Blue Shield Plan. For details, see Terms of Use and Privacy Policy.No subscriber or manufacturer may promote a BCBSA Evidence Review finding without the consent of the Strategic Services Department at BCBSA.


Walking Down Evidence Street™: Where the Market Meets Evidence

Mana Chandhok:
Hi everyone. Welcome to this podcast from Cambridge Healthtech Institute for the Next Generation Diagnostic Summit, which runs August 15th to the 18th in Washington D.C. I'm Mana Chandhok, an associate producer. We have with us today one of our keynote speakers from the coverage and reimbursement of Advanced Diagnostics Tract, Dr. Susanne Belinson, executive director of clinical markets at Blue Cross Blue Shield Association. Dr. Belison, thank you for joining us.

Susanne Belinson:
My pleasure. Thank you.

Mana Chandhok:
Would you mind telling us a little bit about the Evidence Street program that you are leading?

Susanne Belinson:
So Evidence Street is a web-based platform that was launched out of the Blue Cross Blue Shield Association's office of clinical affairs. It focuses on providing a place where the market can meet the evidence, a place where stakeholders in the evidence review process can come and access a standard set of evidence reviews and access a transparent process by which those evidence reviews get updated. The primary vision around that process is that if we can get all of the evidence out into the market, that benefits all stakeholders through transparency and engagement in an efficient process.

Mana Chandhok:
We are also planning a panel discussion on evidence with payers like yourself and Alberto Gutierrez from the FDA. Do you think it is possible to come up with more standardized requirements for the evidence that companies need to generate for payers and regulators?

Susanne Belinson:
I do think that it is possible to get to a place of greater standardization, and I think that that is part of the vision of Evidence Street and the work that we are undertaking at this time. I do think that at times the requirements of a regulator such as the FDA and the evidentiary requirements for payers may be slightly different or they may require some elements that are the same and some elements that may be different. I do think that it is essential as we move forward to provide very clear and actionable information to manufacturers and those researchers who may work with them that the FDA collaborates with other HTA organizations and payers collaborate together to begin to generate a common set of standards that can be communicated out into the marketplace.

Mana Chandhok:
We are looking forward to the summit and hope it to be productive for each and every participant. What do you expect to gain from the meeting as a speaker and an attendee?

Susanne Belinson:
I think what I always look to gain in these types of interactions is just engagement and the opportunity to hear others' perspectives. I think that we often work in very siloed environments and I've had the great opportunity and pleasure over the last couple of years to engage with a lot of stakeholders across the market and I find that all of these opportunities really provide me an opportunity to grow in my understanding of other peoples' businesses and the way in which my business fits into the overall marketplace. I really just look forward to the open engagement and dialogue and hopefully learning a few new things.

Mana Chandhok:
Dr. Belinson, thank you for your time and insights today.

Susanne Belinson:
Thank you very much.

Mana Chandhok:
That was Dr. Susanne Belinson of the Blue Cross Blue Shield Association. She'll be speaking at the Coverage and Reimbursement of Advanced Diagnostics Track at the upcoming Next Generation Diagnostics Summit, taking place August 15th to the 18th in Washington D.C. Thank you for listening.

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Friday, January 4, 2019

CMS Request for Info on SUPPORT 2005 New Medicare Benefit (83 Fed Reg 59497, 2018/11/23)

Federal Register
Friday, November 23, 2018
CMS PFS Final Rulemaking for CY2019
83 Fed Reg 59497

Request for comment on how to implement SUPPORT Section 2005, New Opioid Abuse Benefit for CY2020. 

(Comment closed 12/31/2018).

Statute Section 2005, Text here.

b. Medicare Payment for Certain 
Services Furnished by Opioid 
Treatment Programs (OTPs)—Request 
for Information 

Section 2005 of the SUPPORT Act
establishes a new Medicare benefit
category for opioid use disorder
treatment services furnished by OTPs
under Medicare Part B, beginning on or
after January 1, 2020.

This provision
requires that opioid use disorder
treatment services would include:

  • FDA-approved opioid agonist and antagonist treatment medications, 
  • the dispensing and administration of such medications (if applicable), 
  • substance use disorder counseling, 
  • individual and group therapy, 
  • toxicology testing, and 
  • other services determined appropriate (but in no event to include meals and transportation). 

The provision defines
OTPs as those that enroll in Medicare
and are certified by the Substance
Abuse and Mental Health Services
Administration (SAMHSA), accredited
by a SAMHSA-approved entity, and
meeting additional conditions as the
Secretary finds necessary to ensure the
health and safety of individuals being
furnished services under these programs
and the effective and efficient
furnishing of such services.

We note that there is a 60-day period
for the public to comment on the
provisions of the interim final rule
described previously to implement
section 2001 of the SUPPORT for
Patients and Communities Act. During
that same comment period, we are 
requesting information regarding 
services furnished by OTPs, payments 
for these services, and additional 
conditions for Medicare participation 
for OTPs that stakeholders believe may 
be useful for us to consider for future 
rulemaking to implement this new 
Medicare benefit category.


(CMS request for information on how to implement, comment period closed 12/31/2018, see request here.)

SEC. 2005. 

(a) Coverage.—Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—
(1) in subparagraph (FF), by striking at the end “and”;

(2) in subparagraph (GG), by inserting at the end “and”; and

(3) by adding at the end the following new subparagraph:
(HH) opioid use disorder treatment services (as defined in subsection (jjj)).”.

(b) Opioid Use Disorder Treatment Services And Opioid Treatment Program Defined.—Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:
(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment Program.—
“(1) OPIOID USE DISORDER TREATMENT SERVICES.—The term ‘opioid use disorder treatment services’ means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—
“(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder;

“(B) dispensing and administration of such medications, if applicable;

“(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;

“(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);

“(E) toxicology testing, and

“(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

“(2) OPIOID TREATMENT PROGRAM.—The term ‘opioid treatment program’ means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—
“(A) is enrolled under section 1866(j);

“(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

“(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

“(D) meets such additional conditions as the Secretary may find necessary to ensure—
“(i) the health and safety of individuals being furnished services under such program; and “(ii) the effective and efficient furnishing of such services.”.

(c) Payment.—
(1) IN GENERAL.—Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—
(A) by striking “and (BB)” and inserting “(BB)”; and

(B) by inserting before the semicolon at the end the following “, and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary”.

(2) PAYMENT DETERMINATION.—Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(w) Opioid Use Disorder Treatment Services.—
“(1) IN GENERAL.—The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program.

“(2) CONSIDERATIONS.—The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code.

“(3) ANNUAL UPDATES.—The Secretary shall provide an update each year to the bundled payment amounts under this subsection.”.

(d) Including Opioid Treatment Programs As Medicare Providers.—Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is amended—
(1) in paragraph (1), by striking at the end “and”;

(2) in paragraph (2), by striking the period at the end and inserting “; and”; and

(3) by adding at the end the following new paragraph:

“(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section).”.