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.

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