Thursday, March 14, 2019

CMS Hospital Outpatient Circumsion

I was making the point that CMS usually gives outpatient (APC) coding and pricing to any procedure, even if it is uncommon under Medicare.

54150 is circumcision, any age, clamp.  54160 is other method, <28d, and 54161 is other method, >28d.   These are coded in APC 5373, $1739, except for 54160, which is APC 5372, $562.

Leaving aside CMS, the AMA RVU for 54150 is $159 (office, $101 facility).  CMS utilization was 237 in 2017, 70% outpatient, 11% inpatient, 10% office.

AMA RVU for 54160 is $227 (office, $150 facility).  Recall this is "<28d" of age.  CMS utilization was 4 in 2017, having peaked at 17 in 2007. 

54161 was by far the busiest code.  Payment is $205, facility only, with utilization in 2017 at 9,294.  85% were beneficiaries by age (15% by disability or ESRD).  The main diagnosis code was N47 (disorder of prepuce), and location was 72% outpatient, 18% ASC, 5% inpatient, 3% office.  98% of surgeons were urologists.

I haven't research all the various L&D codes further, but code 59400 for antepartum care & normal L&D had 3,383 uses in CY2017.  RVU's tally $2177 for 739 minutes (12 hours) of MD time.  With antepartum care and cesarean, 54510, $2414, for 817 minutes, with 2,853 uses in CY2017.

Wednesday, March 13, 2019

T2 - Infectious Disease Molecular Diagnostics - 201812 CMS NTAP and 201901 PAC CARB

This is my document archive blog.  For my regular blog see .

T2 Biosystems is a Massachusetts based molecular diagnostics company focused on culture-free blood-based detection of pathogens.   This allows rapid direct molecular pathogen ID before culture, and facilitates assignment of correct antibiotic classes in cases of sepsis. Product T2Direct.

T2 presented at CMS in December 2018 for a New Technology Add On Payment (NTAP).   T2 also presented at PAC CARB in January 2019, representing the potential and the challenges of a startup company in the infectious disease space.

In a zip file in the cloud, I've placed four documents:

201812:  One pager summarizing T2 NTAP application, and unofficial transcript with screen shots of their ten minute presentation.

201901:  Ten page PDF deck and one hour transcript of their presentation at PAC CARB.


Another innovative company in this space is Accelerate Diagnostics with the "Accelerate Pheno" system.  Here.  Once a culture is positive, this produce produces rapid antibiotic sensitivity profiles in a few hours. 

As of March 2019, AXDX has a market cap of $1.1B. (5-year, $11 to $28, $20 current; 4Q2018 revenue $5.6M, income -$88M.)   TTOO has a market cap of $125M (5-year, $23 to $2.80 current, 4Q108 revenue $10M, income -$50M.)

Friday, February 22, 2019

CMS First Beyond the Policy Podcast: Kate Goodrich MD, CMO, on E&M

Welcome to the CMS Beyond The Policy Podcast.

Today's edition of CMS Beyond The Policy Podcast will focus on the 2019 Physician Fee Schedule Final Rule. This is just one effort, among many, that the agency has taken to reduce burden so that clinicians can focus more on their patients, rather than dealing with cumbersome paperwork.

Today I'm meeting with Dr. Kate Goodrich, the Chief Medical Officer at the Centers for Medicare and Medicaid Services, and a Clinical Professor of Medicine at George Washington Hospital Center, along with Dr. Anand Shah, Chief Medical Officer of The CMS Innovation Center, and a Radiation Oncologist at the FDA and NIH.

Each year at CMS we issue a Final Rule to update payments and policies in the upcoming calendar year for doctors and other clinicians participating in Medicare. One of our most recent published Final Rules is the Physician Fee Schedule for 2019. This is a complicated topic for sure, so we wanted to focus our first ever CMS Podcast on discussing what's in the PFS Final Rule.

I'm pleased to be here with Dr. Kate Goodrich, CMS Chief Medical Officer.

Dr. Goodrich, what is CMS trying to address with these policies?


Thanks Bill. We're trying to address a number of things, but in particular we're really focusing on reducing regulatory burden on clinicians. CMS has heard from physicians and other clinicians, for some time now, that excessive paperwork and unnecessary regulations, including coding requirements for evaluation and management, or E&M as we call it, our detracting from patient care.

The current 1995 and 1997 E&M framework was built on a model of clinical care involving complaint or symptom based face to face encounters between a patient and a clinician. But since the 1990s, the nature of clinical care has really changed. There's a much greater emphasis on patient centered collaborative models of care, with clinical teams that work together to manage chronic conditions, the current way that clinicians work, which often requires complex medical decision making and care coordination.

For example, a primary care doctor who's caring for a Medicare patient with multiple chronic conditions, and is coordinating that care between the patient and the multiple specialists helping to care for that patient. That framework just isn't well represented in the current E&M codes.

As a result, clinicians find themselves having to perform and document clinical activity that may be of only marginal relevance to the visit, but is required in order to receive the level of payment that their effort deserves.

The current system includes five levels for E&M for office visits. Level one is used primarily by non-physician practitioners, whereas physicians and other clinicians, such as nurse practitioners or physician's assistants, typically use codes for levels two through five. There are different documentation requirements for each level. That's a lot to remember.

Since the significant majority of visits are reported at levels three and four, most visits require documentation of complexity well beyond the minimum. The policies in this Final Rule will help to reduce administrative burden by simplifying documentation requirements, and they will improve interoperability so that Medicare providers can operate with greater flexibility and coordination with other providers, in order to allow them to keep their focus where it should be on the patient.

In addition, we are taking new approaches to enhancing the ability of Medicare patients to make use of telecommunications technology for other types of services.

Dr. Shah.
How do you think these changes will impact your relationships with the patients you see?


These Final Rules restore the vital patient doctor relationship by giving clinicians and their staff flexibility in documentation for billing purposes and freeing up more time for them to see and care for their patients.

We integrated the extensive input we received from the medical community, and other stakeholders, and we look forward to the improvements these phased in changes will bring in terms of allowing clinicians to spend more time with their patients and enhance the care they provide.

Dr. Goodrich, can you give us some specifics that will matter to clinicians?

Absolutely. First, it's important to note that one of the things that we really tried hard to do in this effort was to listen. We listened both to practicing clinicians. We also listened to the organizations that represented them. And while they recognize and appreciate our burden reduction efforts, they did urge us to take more time before implementing significant payment changes. They also identified several concerns about various aspects of our proposals. We listened to all of these concerns and we finalized policies that will be implemented over several years.

Starting in January of 2019, we will be reducing burden to provide some immediate relief for doctors and other clinicians. These include removing redundancy in the E&M documentation. For example we'll no longer require clinicians to re-enter certain information into the medical record that was already entered by support staff or even by Medicare patients themselves. CMS also will reduce unnecessary physician supervision of radiologist assistants for diagnostic tests, and we are removing burdensome and overly complex functional status reporting requirements for outpatient therapy.

We're also finalizing other documentation, coding and payment policies for 2021, instead of 2019, in order to give stakeholders more time to prepare. And we're also making important changes to the proposed policies based upon the comments we received.

I know some of the evaluation and management documentation guidelines have been in place since 1995 and updated guidelines issued in 1997.

Dr. Shah, are they being updated now?

Bill, we're actually giving physicians a choice in how to document ENM office visits, as we proposed. Physicians will be able to use medical decision making, or time, instead of applying the current 1995 or 1997 ENM documentation guidelines, or, alternatively, they could continue using the current framework.

I should also add that we're simplifying payments by establishing a single payment rate for ENM levels two through four, office visits, with one rate for new patients and another rate for established patients. Related to this, we're requiring that physicians will only need to meet documentation requirements associated with level two visits when performing these office visits, except when time defines a service. Clinicians can document additional information in the chart for clinical and other purposes.

Again, most of the hundreds of millions of Medicare visits are billed at levels three and four, so this will result in a significant burden reduction for the majority of visits.

And I know that based on comments received, we are keeping payments for level five ENM office visits separate, in order to better account for the care and needs of particularly complex patients.

Dr. Goodrich, can you talk a little bit more about this?

Yes, I'd be happy to. We are finalizing additional adjustments that account for extended visits, as well as for the complexities of primary care and specialty care that is non-procedure based.

In fact, in response to comments, we broadened the definition of the non-procedural specialty care, and we designed these add-on payments so that for most clinicians additional documentation will not be necessary in order to report the codes.

That's something many commenters raised concerns about and we are committed to making that work. After considering concerns raised by commenters in response to the proposed rule, we are not finalizing other aspects of our proposal, such as reduced payment when E&M office visits are furnished on the same day as procedures, or separate podiatry E&M visit codes.

We'll also continue to work with a clinician community to make sure we get it right. We want clinicians to be fairly compensated for taking care of Medicare patients, and in particularly, the most complex patients.

I'd also like to note that in addition to reducing burden, this final rule makes a real effort at improving access to care. We're modernizing the medicare benefit to improve access to care with coverage for new telehealth benefits, and also new options for virtual. It's not easy for people to get to their healthcare provider, whether they live in urban or rural communities. This is a way to get more accessible care and will create more opportunities for patients to connect with providers by leveraging the latest advances in technology.

How do you think this will impact how you as physicians deliver care?

When I take care of Medicare patients, I'll be separately paid for interactions to assess whether or not a face to face visit is needed. If I do a brief phone call or a Skype call, or I review a picture that a patient texts me, I can submit a claim for that. Same goes for consultations with other professionals and remote physiologic monitoring that are currently bundled together.

I should add, we're also continuing to expand the list of services that clinicians can provide through telehealth, including prolonged preventive services that account for additional time when services like the welcome to Medicare preventive visit or the annual wellness visit are furnished.

Very interesting and in impactful stuff.

Dr. Goodrich and Dr. Shah, thanks for making the time to speak with me about these important policy changes. And thanks to you and our audience for listening.

For the CMS Beyond The Policy Podcast, I'm Bill Polglase.

You can subscribe to this podcast through iTunes or whatever podcast service you use. We'll be back soon with another edition of CMS Beyond The Policy. This podcast is brought to you by the US Department of Health and Human Services.

Tuesday, February 19, 2019

Cloud Archive: HHS Statement that USPSTF BRCA Benefit Includes BOTH counseling AND the gene test
Web capture 2/19/2019.

The Center for Consumer Information & Insurance Oversight

Affordable Care Act Implementation FAQs - Set 12

Set out below are additional Frequently Asked Questions (FAQs) regarding implementation of various provisions of the Affordable Care Act. These FAQs have been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments). Like previously issued FAQs, these FAQs answers questions from stakeholders to help people understand the new law and benefit from it, as intended.


Q6: Does the recommendation for genetic counseling and evaluation for routine breast cancer susceptibility gene (BRCA) testing include the BRCA test itself?

Yes. HHS believes that the scope of the recommendation includes both genetic counseling and BRCA testing, if appropriate, for a woman as determined by her health care provider.

PHS Act section 2713 addresses coverage for evidence-based items or services with a rating of “A” or “B” in the current recommendations of the USPSTF, as well as coverage for preventive care and screenings as provided for in comprehensive guidelines released by HRSA.

The USPSTF recommends with a “B” rating that “women whose family history is associated with an increased risk for deleterious mutations in the BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for BRCA testing.”

The HRSA Guidelines, released by HHS in August 2011, incorporate by reference relevant portions of an Institute of Medicine (IOM) Report, released on July 19, 2011. In some instances, the IOM Committee Report provides additional interpretation of USPSTF recommendations.

For the USPSTF BRCA recommendation, the IOM Committee interpreted the recommendation to include “referral for genetic counseling and BRCA testing, if appropriate.”

Thus, genetic counseling and BRCA testing, if appropriate, must be made available as a preventive service without cost-sharing.


Wednesday, February 13, 2019

February 2019: Myriad's Comments on CMS Issue re NCD and Germline Testing

Myriad recent investor call
February 6, 2019

Doug Schenkel

Okay. And another recent controversy is CMS seemingly moving to apply the NGS NCD the germline test, such as myRisk. Clearly, there's a lot of debate in the community, meaning the clinical community about the appropriateness of this change, but the final outcome definitely remains unclear as we sit here today.

So for Myriad specifically, recognizing those questions whether the supplies to you given that you use CE sequencing for at least a part of myRisk that remains even more unclear. So can you just provide us with your view, how your treating this development in guidance and comment on whether or not any commercial payers have indicated that they are contemplating following on (inaudible)?

Mark Capone

Yes. So let's start with the commercial payer part first. I think it's -- I appreciate the question because there's been some confusion. I want to be very clear. There is 0 chance, and I mean, absolute ZERO chance, that commercial payers would in any way preclude early-stage breast cancer patients from getting hereditary cancer testing. First of all, remember hereditary cancer is already in the -- BRCA testing is in the USPSTF requirements.

It must be offered to patients that no patient out-of-pocket cost. It has been in NCCN Guidelines regardless of cancer stage for a decade or more. And so there is no chance that commercial payers would in any way try to remove that benefit from patients. That's just not going to happen. Now from a Medicare perspective, as you know, the industry as a whole was quite surprised by these.

Obviously, you're well aware Doug, the NCD as originally approved -- was approved, it was really viewed as a somatic tumor test, whereas the germline tests were all done on an LCD at a local contractor basis. So the fact that you took what was to everybody in the industry a somatic test and merged that into the germline test that's where we end up today with next-generation sequencing only applying for patients that are late stage for breast cancer.

Obviously, that's under significant discussion from the entire industry. To your point, what is true though is that Sanger sequencing can still be used for all stage breast cancer patients that meet Medicare eligibility. That's early-stage, that's late stage. And as you also mentioned, we, of course, have Sanger sequencing capability. BRACAnalysis is the only FDA-approved product from the FDA and it is based on Sanger sequencing and BART technology.

So for us, none of this has changed what we've been doing. We continue to do what we always have been. And there was no change from a Myriad perspective. There will be no change from a commercial perspective, but we, along with the rest of the industry, are very actively engaged in making sure the confusion from the merger of the LCD and the NCD gets resolved.

Tuesday, February 12, 2019

My UCSF Talk / Intro to Reimbursement for Entrepreneurs / Feb 13, 2019

For my regular medical business blog, see DiscoveriesInHealthPolicy.

Deck on a presentation I gave to a UCSF course, Startup 101, for bio-entrepreneurs here.

Summary notes (patter) that go along with the deck, here.

Short link:

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

(Screen capture 1/17/2019)*1&DocType=All&s=48&bc=ABAAAAIAAAAA&

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).”.