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

http://www.discoveriesinhealthpolicy.com/2019/02/very-brief-blog-cms-launches-podcast.html


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?

GOODRICH:

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?

Bill

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.

Cloud Archive: HHS Statement that USPSTF BRCA Benefit Includes BOTH counseling AND the gene test

https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12.html
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.

...

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

Myriad recent investor call

February 6, 2019

https://seekingalpha.com/article/4238451-myriad-genetics-inc-mygn-ceo-mark-capone-q2-2019-results-earnings-call-transcript

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.

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

Note:
For my regular medical business blog, see DiscoveriesInHealthPolicy.

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

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

Short link:      tinyurl.com/QuinnUCSFStartup101