#HPM Crash Course in Submitting Comments to CMS
 
(nb. If you have questions or would like feedback on a draft of your comment before submitting it to CMS, please leave a comment here and I'll be happy to get back to you. I can also be reached on twitter @mattbc. And if my work is helpful, consider becoming a patron.)


I. Proposed Changes to Medicare

CMS has published their proposed changes to Medicare for 2019. Here are the changes that, in my view, may be the most concerning to Hospice & Palliative Medicine (HPM) clinicians:  

1. Starting to crack down on opioid 'potentiator' drugs – like gabapentin and pregabalin.

2. Limiting opioids to 90 MME per day.

3. Making it more difficult for patients to fill two or more long-acting opioids.


II. Why Comment on These Changes?

These changes are not final, yet. Before CMS issues the final rules for 2019, it must accept and respond to feedback.  

This is from the "Health and Human Services Regulations Toolkit"

"Federal regulation is one of the basic tools the government uses to carry out public policy. Agencies issue regulations (also known as "rules") through the rulemaking process when Congress provides the authority to do so. 
The public plays an extremely important role by commenting on proposed rules and other documents that solicit public input, such as requests for information that sometimes lead to formal rulemaking. These comments can help shape the Department’s decisions." 

Comments from HPM clinicians are incredibly important – CMS might actually listen to you.

Comments are due by March 5th 2018, at 11:59 PM ET.


Why should you listen to me?

Lawyers are trained to work with regulatory materials - read, understand, comment on. (Although I am not your lawyer.) And this particular lawyer focuses on healthcare and healthcare adjacent issues. But you don't have to rely on me, here are the main sources that inform my approach to commenting:

I've also spent several hours reading through the 2019 Advance Notice Part I [pdf] and Part II [pdf].


III. How to Comment Effectively

This is not a comprehensive guide to commenting. This post is rather narrowly aimed at HPM clinicians commenting on the "Improving Drug Utilization Review Controls in Medicare Part D" provisions of the CMS proposal. We're going to focus on 17 pages of this pdf out of a total of 218. And we're going to focus on the kinds of arguments HPM clinicians are best positioned to make. 


A. Organizational Tips

1. Use heading and subheadings
Make your comment as user-friendly for the reader as possible by using headings and sub-headings as sign-posts to guide your reader through your points.


2. Topic sentences
Don't hide the ball. Your reader should be able to understand the crux of your comment from the first sentence of each paragraph.  


3. Tell, don't ask questions
Make statements, don't ask questions. Questions leave the reader with wiggle-room. If the text is unclear or ambiguous, say so.


4. Be persuasive
Obviously, belligerence or snark aren't likely to persuade the reader. But examples from clinical practice are immensely powerful. (They can be generic examples that don't violate any particular patient's right to privacy.)


5. Start with your qualifications
As HPM clinicians, you're experts – let the reader know. Do you have a medical degree? Are you board certified? Fellowship trained? Have you been providing hospice nursing care as an RN for 15 or 20 years? Are you the CNO for a visiting hospice service? Are you the MSW who has to help families navigate Medicare payment issues? Whatever your qualifications, tell them to CMS right up front, at the beginning of your comment. You're not bragging, you're establishing your credibility to maximize your effectiveness as an advocate for your patients.


B. Logistics – How do you actually submit a comment?

1. Go to https://www.regulations.gov/document?D=CMS-2017-0163-0007

2. Click on "Comment Now"


3. Either enter your comment in the text box (must be fewer than 5000 characters)


4. Or upload your comments as a pdf (this is the option I recommend)


5. Complete the form and "Continue." Keep in mind comments are public. 


 
C. Facts Matter

"When the law is on your side, argue the law. When the facts are on your side, argue the facts. When you have neither, pound the table." 

If you're a legal expert and you've got a legal argument to make, what are you doing here? Go make it! You don't need me. Everyone else...

Facts matter. As HPM clinicians you're factual experts – you are experts in the medical facts of your specialty. I'm going to point out the places where CMS is asking for your factual expertise or making factual assertions/conclusions that seem suspect to me.  I'll go in order through the document, page-by-page, highlighting areas where I think your factual expertise as a HPM clinician can do the most good. Pound the facts. 



Page 202 - Introduction

CMS begins with a recap of the steps it has taken to address opioid overutilization in Medicare. Setting the stage, CMS says they care about this: 

"policy has evolved incrementally to address prescription opioid overuse in Medicare Part D from a medication safety perspective while preserving beneficiary access to medically necessary drug regimens." 

This is crucial – CMS is telling us that it cares about "preserving beneficiary access to medically necessary drug regimens." Presumably, you're commenting on the CMS proposal because you care about that too. 

  • Tell CMS whenever any piece of their proposal would make it more difficult for a patient to access medically necessary drug regimens.
  • Explain how the proposal would make it more difficult. (e.g. by overwhelming you with phone calls from Medicare prescription drug plans to justify your treatment choices, overwhelming your staff with paperwork, creating stigma for patients, making it more difficult for patients at the pharmacy counter, etc. etc. etc.)
  • If there's research to support your point, cite it. If you have examples that will illustrate your point, provide them.


Page 203 - Introduction, cont. 

(Footnote 31 goes to CDC Guideline for Prescribing Opioids for Chronic Pain. OMS stands for "Overutilization Management System.") 

"Over time, CMS has modified the OMS opioid overutilization criteria based on stakeholder feedback and on the CDC Guideline for Prescribing Opioids for Chronic Pain. 31 With regard to the latter, the OMS criteria incorporate a 90 morphine milligram equivalent (MME) threshold cited in the CDC Guideline, which was developed by experts as the level that prescribers should generally avoid reaching with their patients."

Later in the document, CMS will explain how they're going to use the 90 MME threshold (i.e. it will become more difficult to fill scripts above 90 MME per day), and we'll get to that section. But here CMS tells us how they are using the CDC Guidelines as the rationale and basis for the 90 MME per day threshold for their overutilization criteria. Here are some points to possibly comment on:

  • In your opinion as a HPM clinician, is CDC using the Guidelines appropriately? If they aren't, explain how they're being misused.
  • Does using the CDC Guidelines in this way burden (make more difficult) patient access to medically necessary drug regimens?
  • Is it the consensus of HPM experts that the patients HPM clinicians take care of should "generally avoid" 90 or more MME per day? Or are there entire patient populations (e.g. folks with cancer or folks on hospice) for which it is not actually the case that there's an expert consensus to "generally avoid reaching" 90+ MME per day? In other words, is CMS making an incorrect factual assertion at odds with your knowledge and medical expertise? If so, tell them.


Page 205 - OMS Metrics

As you can see, CMS is using 90 MME from the CDC Guidelines to change the way opioid use is reported, pushing towards setting 90 MME as the de facto standard for responsible prescribing.


Page 205 - "Opioid Potentiator Drugs"

CMS talks about how benzodiazepine-opioid co-prescribing is dangerous. (What expertise does OIG have in this area? I have no idea.)

Page 206 - "Opioid Potentiator Drugs" cont

This paragraph is quite something. First, CMS tells us that gabapentin has been reportedly misused for euphoria and is a risk factor for opioid related deaths. CMS cites only two pieces of literature:


CMS tells us that gabapentin is increasingly being used off-label. As you know, off-label use of drugs is beyond commonplace. While we might want high quality RCTs of all drugs for all indications, that simply is not the reality we live in. The intimation, it seems to me, is quite clear: the use of gabapentin off-label is somehow suspect. CMS cites these two articles:

CMS points to lower back pain with this reference:

And then CMS tells us that as it becomes more difficult to use opioids, people are looking for alternatives to manage pain.

Yes? So? Of course they are! (One wonders if anyone responsible for this document has lived with significant pain or taken care of someone who has.)

And then CMS makes plain the point of this paragraph by telling us gabapentin is only FDA-approved for "treatment of postherpetic neuralgia in adults and the treatment of partial onset seizures." CMS' intimation is clear: off-label use of gabapentin to control pain is somehow suspect.

And then CMS tell us what they're requesting comment on, it's important to note that you're comments need not be confined to the specific questions CMS asks:

This is what CMS is asking for:

"We are requesting feedback from stakeholders about what their experience has been with the potential overuse of gabapentin and pregabalin with opioids, whether this additional flag would be useful for Part D sponsors, and how the case management approach could help with gabapentin/pregabalin-opioid misuse and also with other potentiators.  Furthermore, we seek comment on other potentiator drugs that should be added to the OMS and the utility of adding such drugs that may increase the risk for overdose when used with opioids"



What does this mean? Why might you care?

First, generally, policy making is a laborious process. By the time an agency like CMS announces it is doing something like limiting claims for opioids to 90 MME per day, usually there have already been a bunch of steps in the run up to that decision. For example, CDC decided to issue Opioid "Guidelines." Then, over the last several years, CMS has increasingly incorporated those "Guidelines" into CMS' own policies, tracking how many patients are exceeding the guidelines. And now CMS is proposing to use the Guidelines as justification for a formulary limit at 90 MME. So now is a good time to influence the approach CMS takes to gabapentinoids - before the train leaves the station.

Second, notice that CMS is writing about case management but doesn't actually describe the case management requirements. We do know from other CMS requirements what case management might look like. This is from a separate CMS notice:


[source]

I can find no exception to this proposed gabapentinoids policy for cancer, hospice, or end-of-life care.

You may want to tell CMS:

  • whether you, as an HPM clinician, are concerned about the potential overuse of gabapentin and pregabalin with opioids.
  • whether you believe there should be a cancer, hospice, end-of-life care exception to any restriction or regulatory action CMS might take with regard to the co-prescription of gabapentin/pregabalin with opioids.
  • whether you believe any such exception should universally apply to other  'opioid potentiators' CMS might identify.
  • what sort of effect the kind of case management outlined above would have on your practice and on your patients - what sort of burden would case management impose on providers? what sort of burden would it impose on patients?   

(I'm going to skip the remainder of page 207, although if you have questions about it, please ask in the comments.)



Page 208 - Limiting opioids to 90 MME / day

A soft edit is a limit that the pharmacist filling the prescription can override. A hard edit is a limit that the pharmacist filling the prescription cannot override, but rather requires action by the Medicare prescription drug plan before the claim can be covered. 


Page 209 - Limiting opioids to 90 MME / day, cont.

We know these limits have been used incorrectly because CMS has told us so. Even in its own document, which has clearly been written in a light intended to be most favorable to CMS' desired policy outcomes, CMS admits these edits were improperly used to deny patients their medically necessary prescriptions.

The next paragraph:


"Given the public health emergency and the fact that half of sponsors are already implementing hard MME edits"
  • Is it the case that physician prescribed opioids are still driving the public health emergency?
  • Should medical practice and the standard of care be dictated by what insurers and PBMs do?


"sponsors can and should do more to address chronic, high prescription opioid overuse."
  • Are all patients who are on long term doses above 90 MME "overusing," as this sentence seems to imply?


"we propose that all sponsors should implement a hard edit in 2019 that is triggered when a beneficiary’s cumulative daily MME reaches or exceeds 90 mg (meaning the MME threshold should only be set at 90 MME)."

That's the text that proposes the 90 MME limit. The next paragraph goes on to read: 

Some further questions:

  • Is this an appropriate use of the CDC Guidelines?
  • What burden will this create on HPM clinicians and providers?
  • How will HPM clinicians notify Medicare prescription drug plans that a patient is on hospice or has a cancer diagnosis? Is there a method of notification that will not burden you or your staff?
  • What about patients who require more than 90 MME per day but who are not on hospice and do not have a cancer diagnosis? are they not entitled to medically appropriate palliative care? is it the case that medically appropriate palliative care definitionally does not include more than 90 MME per day?
  • Are there patient populations who would be disproportionately impacted by this 90 MME / day limit? 



Page
210 - Limiting opioids to 90 MME / day, cont.

Again, CMS tells us they are concerned with "beneficiary access to medically necessary drug regimens" and reducing "the potential for unintended consequences."

CMS proposes to allow a 7 day grace period of sorts if a patient exceeds 90 MME. But if  the prescription is only available in packaging of greater than 7 day supply, the patient will not be able to use that 'grace period.'

Some questions:

  • does this proposal from CMS strike the proper balance in protecting patient access to medically necessary treatment?
  • is the one-time 7 day exception sufficient protection? what will that one-time 7 day exception mean for your practice? and for your patients?  
  • are pharmacists adequately positioned to help your patients "assess immediate needs" in order to determine which prescription to fill?
  • what sort of protections are required in order for the exclusion for patients with cancer or on hospice to be meaningful? are such exclusions, in your experience, always effective? or do they sometimes not work properly?



Page 211 - Limiting opioids to 90 MME / day, cont.

"We also request common on other solutions to address prescription opioid overuse while balancing access to medically necessary drug regimens and reducing the potential for unintended consequences."

Tell CMS what you think about prescription opioid overuse as HPM clinicians. What unintended consequences have you already seen? Are patients refusing opioid therapy because of misguided fear or stigma? Are patients already having trouble accessing medically necessary opioids? What unintended consequences have you already experienced? have your patients experienced? 


Some questions:

  • What has been your experience with coverage determinations? with expedited coverage determinations? What impact do coverage determinations have on your practice and your patients? What sort, if any, burden do they impose on you? (How much of your time do they take? how much of your staff time do they take? how much patient / caretaker time do they take?)
  • Do Medicare prescription drug plans proactively reach out to you prior to a dose escalation to pre-approve the therapy?
  • Do you have any concerns that, in actual practice, Medicare prescription drug plans may not simply rely on your attestation that more than 90 MME per day is medically necessary?
  • What sort of burden, if any, does (or would) this process impose on you, your practice, your staff, your patients, etc when it is repeated at the beginning of every plan year? ("The authorization of the higher MME level should be considered an approved exception and be valid through the remainder of the plan year")

Page 213 - Making it more difficult to fill two or more long-acting opioids.

"Clinically, there is little support for maintaining a patient on multiple different opioids and such use creates other health care issues."

Is this true for the patients HPM clinicians take care of?

"Beneficiaries who receive multiple LA and/or multiple SA opioids may lack coordinated care and be at higher risk of opioid overdose."

Is this true for the patients HPM clinicians take care of?

Page 214 - Making it more difficult to fill two or more long-acting opioids, cont.

Here's a glimpse into the thinking behind CMS' concern - an Rx for methadone 10mg and an Rx for methadone 5mg. What inferences, if any, do you draw from their example?  Is this an area that is concerning to you? 

Page 215 - Making it more difficult to fill two or more long-acting opioids, cont.

Which is it? 

"Clinically, there is little support for maintaining a patient on multiple different opioids and such use creates other health care issues."

or

"Lastly, we recognize that multiple LA opioid prescriptions of different strengths can be clinically appropriate so we examined the impact of requiring different opioid prescribers"

Again, there's no exception that I've found for hospice, cancer, or end-of-life care. CMS seems to be throwing everything at the wall in order to see what sticks.

Those are the major pieces of the policy proposal that I think may be of interest to HPM clinicians. What questions do you have? How can I help?

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