New Medicare Opioid Management Initiatives

The Centers for Medicare & Medicaid Services (CMS) held a webinar on December 27, 2018, to help providers understand the new guidance for prescribing opioids to Medicare beneficiaries – and if you didn’t listen in, you missed a good one. Here is the fact sheet for reference. My first thought was, “Can’t we just leave the older citizens alone?!” Are you really going to make all these folks with aches and pains from years of hard work jump through prior authorization, exceptions, and quantity limitation hoops? Well, in short, yes, these safety initiatives are indeed needed. The impact of addiction in the elderly can be even more dangerous than in younger patients. We also cannot forget that senior citizens are not the only demographic in the Medicare population. There are many younger folks with disabilities within the benefit who have a long life ahead of them to be free of dependency or addiction.

is also the problem of diversion. If a senior appears to keep losing her
Vicodin®, is it really she? Or is someone with access helping
themselves to meds from the medicine cabinet in the bathroom? We seem to spend
a lot of time and effort on “child proofing” our homes and products to keep our
children safe. We should also make sure excess and unwanted controlled
substances are not available to help with circumventing diversion issues.

back to the seniors. I also think there is definite need for safety
considerations. We know that opioids cause respiratory depression, drowsiness,
and constipation. These can be lethal side effects for a group whose lungs may
not be working well and are already primed for falls due to the effects of age
on balance. Constipation, causing straining on the toilet, can be a real killer
for those with cardiac ailments. Seniors are also at risk for the deleterious
effects of concomitant usage of benzodiazepines and opioids. It is important to
help educate beneficiaries of the harm that can be caused at the time they pick
up either drug at the pharmacy. I believe the new opioid prescribing guidance,
while a little more work, is a step in the right direction for safe use in
seniors and prevention of diversion.

presentation highlights hinged on a three-pronged approach to the rampant
opioid abuse problem – prevention, treatment, and data utilization. I will
mainly talk about prevention and the myths attached CMS endeavored to dispel.
And as always, unintended consequences will be pointed out so practitioners can
be ready to meet them head on should they arise. It should be noted these new
guidelines will not apply to any beneficiaries residing in long-term care
facilities or who are receiving hospice, cancer, or end-of-life care. Patients
receiving medication assisted treatment (MAT) for dependency such as
buprenorphine or methadone will also not be affected by the new guidelines.

Prevention methods are based mainly at the point of service. They include soft edits and an optional safety hard edit. Soft edits will include a seven-day supply limit for initial fills of opioid medications in the opioid naïve. Opioid naïve is defined as anyone who has not received an opioid medication within a minimum of a 60- day look-back period. CMS 2019 Medicare Part D Opioid Policies: Information for Pharmacies suggests a look-back period may generally be considered to be 60 to 90 days. This makes sense as immediate pain relief needs must be met but should not prime the patient for dependency by providing an extra supply. Another soft edit to be utilized is a flag when cumulative daily doses reach 90 morphine milligram equivalents (MME). An override may be provided by the plan if the pharmacist knows the beneficiary is part of an excluded group or if there has already been a provider consultation. When there are no previously known exclusions or provider consultations, the provider must be informed before an override edit can be used to fill such prescriptions. The consultation is important as the prescriber of the drug pushing the beneficiary over the threshold may not realize the beneficiary is receiving opioids from other providers. This offers the opportunity for earlier intervention before the MME creeps up to cause greater tolerance, dependency, and greater taper and withdrawal problems. Discussions should always be documented to include date, time, name of provider, and short note confirming prescriber’s intent for the beneficiary to receive dosage in question. Number of attempts to reach the provider should also be recorded. Two very important soft edits are the opioid/benzodiazepine use flag and duplicate long acting opioid drug usage. And finally, CMS is allowing an optional hard edit at 200 MME or greater cumulative daily dose. The combination of these safety and prevention edits will keep seniors safer and perhaps lessen diversion of these dangerous drugs.

there is a guided change in prescribing habits, practitioners may worry they
are not following guidance and laws to the extent necessary. This can result in
the pendulum swinging too far the other way and prescribers becoming too
restrictive. CMS has taken great pains to address head-on misconceptions about
the new guidelines. The first “myth” they dispel is that all beneficiaries will
only be able to receive seven days of an opioid at a time. Again, this is only
for opioid naïve patients. And in the case of a beneficiary needing longer
therapy, perhaps from a complex surgery or other trauma, the prescriber and/or
beneficiary can request a coverage determination for receipt of a longer
duration of therapy. The second “myth” to be addressed is that CMS is forcing
all beneficiaries to taper or lower their opioid intake below a certain
threshold. There is no such intention on the part of Medicare. The intent is to
have beneficiaries receive the pain therapy they need at the lowest and safest
effective dose, which includes care coordination between providers and close
regard for all other medications being taken at the same time. And the last “myth”
is that Medicare is effectively tying the hands of prescribers when their
patients may need higher dose therapy. If a patient is in need of higher dose
therapy, the physician should request a coverage determination and attest the
dosage is medically necessary. CMS does not want to see their beneficiaries
miserable and in pain but rather have them, along with their providers, make
informed decisions on effective and safe therapies.

are always unintended consequences. Whenever I think of frail beneficiaries
whose first language may not be English and then juxtapose them with “coverage
determinations” and “appeals,” my mind is boggled. These beneficiaries may not
have the competence or patience to effectuate these patient rights, resulting
in foregoing much needed therapy. It will be important for prescribers and
pharmacists to keep an extra eye out for these beneficiaries to ensure they
receive the pain therapy they truly need. And let’s talk about those
pharmacists and prescribers! They are both overburdened and overwhelmed by the
requirements of hundreds of health plans, the dearth of time that can be
devoted to an individual patient, and having to do more with less in this time
of escalating healthcare costs. CMS states prescribers should make every effort
to take pharmacist calls in a timely manner to prevent delays in receiving
medications and to make the new guidelines work effectively. It is the desire
of every medical practitioner to be able to make care coordination expeditious
and efficient. We may have a ways to go, and I look forward to the continued
creative thinking needed to firm up the “team” concept so all manner of
practitioners can get the information they need to attend to their patients in
a timely manner. There are always challenges with new programs, but I believe
CMS is taking the lead in helping to lessen an opioid problem that has been
growing steadily over the last 10 years.

Gorman Health Group also takes the lead in providing healthcare consulting and has a bevy of creative thinkers. We can help you logically think through and operationalize the new opioid guidelines. Contact us to get this done so our Medicare programs can be the guiding light for other commercial health plans to follow!


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Modernizing Part D & Medicare Advantage to Lower Drug Prices

The Centers for Medicare & Medicaid Services (CMS) has done it again. While everyone was still in a turkey-induced coma after Thanksgiving, they released a 185-page document of proposals/bombshells called Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. The document provides proposals that will help contain costs for both the Part D benefit and the drug spend portion of the Part B benefit. To put some context to the magnitude of this document, CMS stated “Assuming an average reading speed, we estimate that it will take approximately 7.6 hours for each person to review this proposed rule. For each entity that reviews the rule, the estimated cost is $816”. Holy cow, that’s a lot of hours and money for one document!

After shaking off the tryptophan and diving into the document, I came away thinking the majority of these proposals could really work! Some of the proposals are in areas that historically CMS has considered to be “hands-off.” These recommendations will add flexibility to Part D health plan administration and will even give a bit of relief to beleaguered pharmacies that see their reimbursement rates ever diminishing. And, as always, there may be some negative unintended consequences. So let’s take a look at the areas with major ramifications: Protected Class Drugs, Part B Step Therapy, Real Time Benefit Tool, Negotiated Price Definition, and Referencing Lower Priced Drugs on EOBs.

The Protected Class (PC) drug proposals are mind blowing. This is truly an area that has been “untouchable” since the inception of the benefit. The first PC drug proposal is for unrestricted usage of utilization management (UM) to include step therapy (ST) and Prior Authorization (PA) for indication. CMS makes a big point of saying PC guidance should apply to PC “indications” and not just the drug entity. So now plans will be able to cover a drug, for example, for its seizure indication but not for its migraine headache indication. This aligns with their next step in developing indication-based formularies. The second proposal to not require “me too” or “follow on” drugs that pharma develops will also go a long way to contain costs. The document uses an example of a manufacturer that took its original formulation off the market and followed on with a more expensive formulation of the same drug entity that did not represent a unique administration route. Plan sponsors will no longer be required to have these types of drugs on formulary.

CMS intends to allow plan sponsors to remove a PC drug from their formulary if the drug price inflation exceeds the Consumer Price Index for all Urban Consumers (CPI-U) at any time during specified time frames. (The CPI-U is a measure of inflation over time of consumer goods and services prices.) If the drug exceeds this pricing threshold one week, and then the price bottoms out the next week, it will still be eligible for exclusion. CMS points out this is not meant to withhold drugs from beneficiaries but rather give plan sponsors a leveraging tool to work with pharma to receive better rebates on PC drugs. PC drugs have never received the rebate percentages non-PC drugs have enjoyed. So the combination of pricing thresholds and the allowance of UM techniques with PC drugs should help make pricing more competitive as manufacturers vie to get their products on formulary at a preferable tier with limited UM.

ST in Part B and Medicare Advantage Prescription Drug (MA-PD) plans is re-visited. CMS has helped to answer some of the questions of how Part B ST is to be operationalized. The biggest confusing hurdle was the time frames for decision-making. Organization determinations (Part B) have longer decision-making time frames than coverage determinations (Part D). CMS has proposed to change regulations so Part B drug decision time frames will be the same as Part D time frames. This will go a long way to help beneficiaries get their Part B drugs in a timely manner.

The Part B and Part D comingling will be easier for MA-PD plans that already have a Pharmacy & Therapeutics (P&T) Committee in place. MA-only plans will now need to develop and utilize a P&T Committee if they plan to use ST. CMS requires that any time UM techniques are employed, like ST, a P&T Committee review and approve the UM based on sound clinical judgement.

Some unintended consequences of these proposals? For Part B drugs, beneficiaries will now need to go through the exceptions process to get their Part B drug if it is subject to UM and the beneficiary has not satisfied that UM. Previously, beneficiaries just automatically received whatever Part B drug their provider requested. CMS claims all stakeholders are now familiar with coverage/organization determinations, appeals, and grievances, and these processes are a safeguard for beneficiaries to get what they need. My thoughts are the frailest of beneficiaries may actually be harmed. There will still be beneficiaries who don’t understand these processes or don’t have the patience for these processes and will simply decide to forgo therapy – and now this will occur on both fronts: Part B and Part D. There is the potential to increase medical services such as urgent care and hospitalizations as an unintended consequence. This scenario would also apply to the new PC UM allowances.

In thinking about the CPI-U price threshold proposal for PC drugs, it appears pharma may at times be unfairly disadvantaged. Price increases in raw materials pharma has no control over and that might greatly exceed CPI-U will affect drug pricing. There may be times when a drug price increase is warranted through no fault of the manufacturer. It seems as if they will be punished for something they have no control over. I would feel worse for pharma if they hadn’t recklessly and, in some cases, gleefully raised prices to extremes in the past.

A Real Time Benefit Tool (RTBT) would be a dream come true for providers. Plan sponsors would develop the RTBT to integrate with provider e-script and electronic medical records software. This tool would provide real-time, patient-specific beneficiary information such as copayments, formulary status, benefit phase, and therapeutic alternatives. Providers would be able to make better informed therapy choices in conjunction with the beneficiary, and the beneficiary would not have to wait until the pharmacist spun the copay “wheel of fortune” to know what the cost of therapy would be. The dream turns into a nightmare when you start considering the momentous money and effort that would be needed to operationalize the tool by January 20, 2020. CMS estimates putting together one of these tools would cost between $2.1 and $4.2 million. This dollar amount does not include the cost of maintaining the tool further down the line. If CMS intends to put this proposal into effect by January 2020, then plan sponsors need to tell their IT departments to immediately drop what they are doing and get moving on this new tool proposal.

CMS also proposes changing the definition of “Negotiated Price” within regulations and guidance. Currently a negotiated price is to include all rebates and price concessions that can be accounted for but NOT those concessions that are determined after the point of sale of the drug. Pharmacies may receive additional reimbursements to lower the cost of a drug based on performance. These reimbursements are determined after the end of the coverage year, and research shows most pharmacies do not qualify for them. This means the reimbursement amount at the point of sale is artificially inflated. CMS is proposing to change the definition so the negotiated price reflects the absolute minimum price – or worst price scenario –a pharmacy could be reimbursed for any drug.

Plan sponsors and pharmacy benefit managers (PBMs) would use pricing tables based on the lowest possible reimbursement into their claims processing systems that interface with contracted pharmacies. This is beneficial on a number of levels. Pharmacies can now project revenues and develop budgets based on the minimum reimbursements that could be received. This allows for more accurate projections and fewer budget shortfalls.

Beneficiaries will now pay co-shares based on a lower drug price. Beneficiaries will progress through the benefit phases more slowly, which may prevent beneficiaries from entering the Catastrophic Coverage phase. This saves CMS money as they are responsible for 80% of drug costs in this phase. So what’s the down side? The plan sponsor and PBMs will not be able to report Direct and Indirect Remuneration (DIR) at the end of the year to increase profit margins.

Many performance, volume, and market share rebates plan sponsors and PBMs enjoy are only determined at the end of the coverage year. These rebates are then reported as DIR. The DIR dollars add to profit margins which then allow for lower premiums and lower cost of benefit administration for the upcoming coverage year. In essence, bids are lowered each year due to the amounts of DIR reported. The DIR percentages for pharmacy price concessions reported have increased exponentially year over year since 2010. Using pharmacy concessions in this manner puts smaller plan sponsors (who do not have as large DIR reports) at a disadvantage for bid pricing and does not accurately reflect the cost of the drug benefit portion of the health plan. Plans will still report when they give drug pricing rebates based on these end of year concessions but now will be reporting negative DIR.

And lastly, CMS is proposing to have plan sponsors include lower cost formulary drug alternatives on beneficiaries’ Explanations of Benefits (EOBs). A specific field has been proposed to show this lower cost alternative and what the beneficiary might save. CMS is suggesting not only the popular brand to generic switch but also therapeutic substitutions that may have the same copay but a lower negotiated price. Therapeutic substitution includes a different drug that is not within the same category or class but has a medically accepted indication for the condition being treated. This is a first for CMS who in the past has not typically embraced therapeutic substitutions in its guidance.

How does the plan determine therapeutic alternatives? CMS will not require patient specifics be taken into account such as co-morbidities, allergies, etc. Example: A beneficiary currently taking valsartan will see a notation that Lisinopril is cheaper. The patient had already tried Benazepril and developed a cough. The patient may call or visit the doctor with this new information not knowing that Lisinopril will no doubt cause the same cough. Does this waste medical practitioners’ time or cause the beneficiary to make an unneeded doctor visit and copayment? This may be an unintended consequence of this proposal.

Perhaps we have all been lulled into a false sense of complacency with the Part D drug benefit. The times they are a-changin’, and plan sponsors and PBMs should hop on board with these proposals to help contain ever-increasing costs of administering drug benefits. Feeling confused and overwhelmed? Call Gorman Health Group – we’ve already spent the 7.6 hours and $816 per person reviewing the document and can help you operationalize the coming decisions.



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CMS Takes Action to Lower Drug Prices, Permits Step Therapy

I have been known to utter “holy cow” in my day, and the recent Centers for Medicare & Medicaid Services (CMS) Health Plan Management System (HPMS) memo allowing step therapy for Part B drugs was the reason for my most recent exclamation. Who saw this coming?

The first sentence of the memo reads, “CMS is hereby rescinding our September 17, 2012, HPMS memo, “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services.” Holy cow. For some time, the Part B versus Part D issue has been the bane of Medicare Advantage (MA) plans. CMS has tried over the years to ease that pain by issuing guidance on when a drug can be billed as Part B and when it should be billed as Part D. As late as the 2017 Call Letter, CMS reminded us of the new 2016 requirements at 42 CFR §422.112(b)(7), which require all plans to establish and maintain “a process to ensure timely and accurate POS transactions, and to issue a decision and authorize or provide the benefit as appropriate under Part B or Part D when a party requests a coverage determination.” So why the about-face on requiring expediency in dispensing Part B drugs? It all comes down to cost containment.

Step therapy has been a mainstay in Part D drug utilization management to help contain the cost of medications. The idea is for the beneficiary to use an effective and less expensive drug before moving onto more costly therapies. This makes good sense. Why pull out a flame-thrower when a match will work? Historically, Part B drugs have not been subject to step therapy – providers either pulled their preferred drug from the shelf or wrote a prescription the pharmacy filled under Part B. Now Part B drugs will be subject to the same coverage determinations and appeals processes for step therapies Part D drugs have enjoyed. How might this affect what providers stock in their offices? And how about Home I.V. and Long-Term Care pharmacies? These pharmacies have had the luxury of dictating what products would be used in the past, and Part B step therapy will be a game changer as plan sponsors take back control over what is dispensed. Holy cow.

While cost containment is desired, there are also unintended consequences. Beneficiaries may experience a delay in obtaining their drugs due to determinations and appeals processes. Part D drugs are subject to coverage determinations that have a 72-hour time frame for standard determinations and 24 hours for expedited determinations. Part B drugs are subject to organization determinations. These Part B pre-service determinations have a 14-day time frame for standard requests and a 72-hour time frame for expedited requests. In last night’s memo, CMS “strongly encourages that MA plans expedite requests for exceptions in Part B to align with the 72-hour adjudication timeframe for requests in Part D.” Holy cow. Plan sponsors will need to implement a procedure for their organization determinations, appeals, and grievances staff so drugs can be given priority over other requests.

Plan sponsors will also have new Part B issues to deal with. The memo calls out the need for “interactive medication review to discuss all current medications,” which may be code for Medication Therapy Management (MTM). How will these new requirements affect MTM programs and targeting of eligible beneficiaries? Chapter 7, Section 30.2 (2) and (3), of the Medicare Prescription Drug Benefit Manual speaks to targeting Part D drugs only for both numbers of drugs being taken and dollar amount thresholds. Is the expectation that Part B drugs be added to these targeting thresholds?

And last but not least is the job of actually developing Part B step therapy criteria. Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) will still apply, and we know beneficiaries already using a Part B drug will be grandfathered in. CMS is allowing “cross-contamination” of steps. Plan sponsors may require a beneficiary to use a Part D drug before getting a Part B drug and vice versa, requiring a Part B drug before receiving a Part D drug. Can step therapies incorporate both Part B and Part D drugs within a specific step? And who will review exception requests – the organization determination team or the coverage determination team – when both Part B and Part D drugs are incorporated into step therapies? Thinking about the possibilities is absolutely mind-numbing.

And, of course, the window for uploading these new step therapies is fast upon us – August 17 through August 21. Holy cow. So get those Pharmacy & Therapeutics Committees cracking! And while you’re at it, you may want to check with your Marketing Department to see how far along you are in the development of your Annual Notice of Change and Evidence of Coverage. If you can’t hold the presses to add these new step therapies, you will need extra time to develop addendums to be sent to your beneficiaries.

I am looking forward to seeing how this new twist to an already complex benefit will play out in 2019. As always, if you need help navigating the rules, regulations, and best practices, Gorman Health Group has the experts to help you.




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