Law Firm Wants Transparency in Medicare Opioid Policy
By Pat Anson, Editor
A Washington-based legal firm is calling for more openness and transparency by the Centers for Medicare and Medicaid Services (CMS) as it establishes new rules that are likely to limit access to opioid pain medication for millions of Medicare patients.
“While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management,” wrote Michelle Stilwell, a staff attorney for the Washington Legal Foundation (WLF), a non-profit law firm that generally supports business groups and companies in litigation against government agencies.
At issue are mandatory rules being developed by CMS for 2018 that would bring Medicare opioid policies into alignment with the “voluntary” prescribing guidelines released last year by the Centers for Disease Control and Prevention.
CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a “soft edit” that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. Pharmacies would have to check with the prescribing physician to make sure the higher dose is warranted.
Stilwell wrote on the WLF’s blog that patients and providers were given little opportunity to see and comment on a Call Letter announcing the rule changes, while the insurance industry was.
“CMS’s changes will inevitably lead to even tighter restrictions on opioid prescriptions—which directly affects the patient community. Many patients, doctors, and healthcare providers already complain that rules designed to prevent the improper prescribing of opioids are complicating patients’ legitimate access to appropriate medication,” said Stilwell.
“But instead of directing this Call Letter at the affected patient community and granting that community an adequate opportunity to comment on the new opioid overutilization criteria, CMS directed it only to insurance companies. In reality, opioid consumers and providers are given little to no notice or opportunity to comment.”
As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS rules, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of insurers, law enforcement agencies and government regulators formed to combat insurance fraud. The HFFP met to discuss the white paper in a “special session” last October that was not open to the public.
Stilwell said the HFFP “operates largely in the dark” and may be in violation of the Federal Advisory Committee Act (FACA), which requires open meetings for all federal advisory panels. This week the WLF filed a Freedom of Information Act Request seeking more information about HFPP membership and meetings.
Major insurers such as Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation participate in the HFPP.
“It is time for CMS to bring HFPP into compliance with FACA requirements. Doing so will reduce the risk that a court may invalidate any CMS policies found to have been adopted at least in part in reliance on HFPP recommendations. It would also enable any patients affected by changes in opioid reimbursement policies to play a role in the development of HFPP’s opioid-related recommendations,” Stilwell wrote.
CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policies often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.
In addition to limits on opioid prescribing, CMS plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who regularly prescribe high doses of opioids. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged. Insurers would be required to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.
FDA to ‘Take Whatever Steps We Can’ to Stop Opioid Abuse
Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”
In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.
“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.
Gottlieb wants the committee to focus on three areas:
scott gottlieb, MD
- Consider mandatory education for health care professionals about opioid prescribing recommendations and how to identify patients at risk of abuse.
- Establish limits on the dose and quantity of opioid medication that are more closely tailored to the medical condition a patient is being treated for.
- Review the process the FDA uses to evaluate and approve new opioid medications.
Gottlieb cited some questionable statistics to dramatize the extent of the opioid prescription problem.
“In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids,” he wrote.
The new FDA commissioner may want to check his facts. As PNN has reported, a news release last December from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids.
A CDC news release a few days later provided an an even lower estimate; that over 12,700 Americans died from pain medications in 2015.
When asked to explain the discrepancy, PNN was given a third estimate by the CDC, which put the number of deaths involving prescription opioids at 15,281 in 2015.
Gootlieb’s post links to a CDC website that provides a fourth estimate, which is based on a “standard analysis approach” that combines all overdoses caused by natural, semi-synthetic, and synthetic opioids. Such an approach is misleading, because it counts overdoses caused by illicit fentanyl as prescription drug deaths.
“Unfortunately, information reported about overdose deaths does not distinguish pharmaceutical fentanyl from illegally-made fentanyl,” the CDC said, which Gottlieb neglected to mention in his blog post.
One needs to read the warnings in some of these conversion programs… that by and large.. they are AT BEST… FUZZY MATH… unless you are talking about Methadone conversions… then they are FUZZIER MATH. Any healthcare professional that believes that opiate conversions are BLACK & WHITE… is – IMO – a healthcare professional that should not be trusted in dosing opiates.
And these tables don’t even consider the CYP450 enzyme system .. which can cause a person to metabolize opiates fast/slower that “normal”.. it is estimated that 20%-30% of pts are fast/ultra fast opiate metabolizers.. They also ignore pts with GI issues that will affect absorption.. like IBS with/without diarrhea, short gut, crohn’s disease and others issues.
IMO, this is just another example of our healthcare system moving toward treating pts/disease(s) by a simple check lists and/or “cookie cutter methodology”.. which means that those pts that are at 10%-20% at each end of the “bell curve” will end up getting medically “screwed” by the system. Remember, nearly all health insurance companies are publicly held FOR PROFIT companies… their primary interest is to the stock market and their stock holders. Policy holders are just a means to generate revenue and if they can place obstacles – prior authorization, declaring treatment is experimental, first fail step therapy and other tactics to “deny care that should be covered”. Pts need to be made aware that everything denied by a insurance companies can be APPEALED and the majority of pts that go thru their entire appeal process will get their treatment approved. They don’t have to tell you about their appeal process, unless you ask, then they have to provide their appeal process is some form of printed format – could be a website.
Single-dose studies: Early studies determining equianalgesia were based on single doses, not chronic administation.8 Due to drug accumulation, half-life, tolerance, and active metabolites, subsequent chronic administration studies often vary greatly from the original single-dose data.
Bidirectional conversions: When converting between certain opioids, the direction of conversion (eg, morphine to hydromorphone versus hydromorphone to morphine) will produce a different conversion ratio. These bidirectional differences are not captured in a traditional equianalgesic table.5,7
Dose-dependent conversions: The conversion ratio of certain opioids can be dependent on the dose of the original opioid. In the case of converting morphine to methadone, methadone has a relative potency of 4:1 at lower morphine doses, but becomes much more potent (12:1) in patients converting from very high morphine doses.5,7
Cross-tolerance: Many references recommend a cross-tolerance reduction between 25-50% when converting between unlike opioids.9 In patients with very high opioid requirements, the difference between 25% and 50% can be a very significant discrepancy.
Equianalgesic Discrepancies: There are significant discrepancies in equianalgesic dosing tables, with even FDA-approved drug labels not demonstrating agreement.10 These discrepancies are a factor of both references using old data (single-dose studies) and an overall paucity of data in chronic dosing studies.
Patient-specific factors: No equianalgesic table is able to take into account patient-specific factors — primarily hepatic function, renal function, and age. Opioid metabolism and excretion do differ among the opioids; therefore, alterations in drug disposition will alter the relative potencies of different opioids.
Filed under: General Problems
My pain meds are being covered by Medicaid and they are doing the same. I was supposedly “grandfathered in” at the low dosage I was already at, even though it was above the RECOMMENDATIONS put forth…..and then Medicaid (in my doctor’s state) stepped in and told doctors in the neighboring state (Wa state) that I go to for care, that was no longer acceptable. So my doc apparently now has to cut me down to the recommended levels. Then Medicaid in MY state state stepped in, because my doc had not yet started my downward spiral. According to my doc’s nurse, Medicaid THREATENED my doctor with the loss of license, if my prescriptions continued at that dosage, causing my doc to panic and tell me I had to just be cut, with no taper. Well, my husband called Medicaid in my state and talked to them. They said if there was a taper in place, as long as they see me moving down, they’ll cover the meds. Let me back up a bit. Last month, we paid out of pocket because we went to go pick up my meds and they were denied. Then we are told that my doc is not even allowed to write them, this is what caused the panic, but when we asked them why, since I am on a taper, that they wouldn’t cover them, they said they would and it took SEVERAL phone calls between us and Medicaid and my doctor’s office before we got it straightened out. But the original denial said and I quote “DENIAL OF COVERAGE FOR MEDICATION: REASON- PRESCRIPTION DOSAGE EXCEEDS FDA INDICATIONS”. So now the FDA is apparently my doctor’s supervisor. Because they know ALL about my health issues and medical information…..RIGHT? It is not appropriate for a doctor that has never seen you to recommend treatment for you, WHY is it okay for an agency that has never seen or heard of me to do so??? Now my doctor has also informed me that by next year, at the direction of Washington Medicaid, all patients will be reduced to 50MME. Yet another cut. So all of those of you in Washington State, be warned, you’re not safe at 90MME! They’re going to cut us again next year! And the year after that, I’m guessing it will be weaning everyone off that isn’t a cancer patient. From what I have seen, even if you have cancer, you’ll be lucky if you can get anyone to prescribe pain meds, but I believe the state won’t stop until no one with “non-cancer chronic pain” gets anything prescribed for pain. This is even after a lady I know went to speak to the panel that created this law or whatever it is, about folks with chronic pain. She took letters from cpp’s and read them to those people. It apparently did not matter. That disgusts me. If you can’t say that you DONT KNOW how the cuts are effecting people and you still do it anyway, with no regard to HOW it effects people, that makes you no better than “insert any bloody dictator’s name here” in my most honest opinion. I’m sure that other states are to follow, unless something is done to stop this. We have GOT to get it together, people. We have got to unify somehow. One person’s voice can get lost in the din, but they can’t ignore a chorus! Not without making it known to everyone that is paying attention that we are deliberately being ignored, anyway. That’s my opinion, of course. I’m willing to do whatever I can lawfully do, to get something done because this is my life hanging in the balance. Once they get us all tapered off, they’re not likely to put us back on, no matter what we do, so I believe that we can’t let that happen. I know there are a lot of folks working on this issue right now, but we all have to speak up. Say nothing and that is what you will get.
U know,,,,they willfully are not recording ANY the the harmful effects denial of opiate MEDICINE causes,,refuse to document our death TRUTHFULLY,,,,On purpose,,,I believe,,,Thee other thing,among many,,,here is Wisco,,University Of Wisconsin is A primary Doctor making University,,,Huge,,,,,,and they have not stated ANYTHING against our medicine ,,,quite thee opposite,,,this opiate phobia here is coming from Aspiris,,which is a little rinky-dink ,”thingy,” up in Northern Wisco,,,which is less populated,,,,,Now West Allis,,is in the southern part of the state,,Thats where our opiate phob gov.rep adult off spring o.d’d.,,,,Another off topic a little,,,when u use Dr.Cheeks Map of arresting Doc;s,,,,,I think there is literally NONE,,NOT 1,, in the State of North Dakota,,why??Now Vice T.V,,,just did a whole show on the Native Americans up their,,the oil pipeline,,and thee boom towns everywhere in North Dakota for recently found oil up there..The female Native Americans have been raped,,held against their will,,sold off for weekend gang rapes,,as young as 13,,,,and the COPS DO NOTHING, furthermore,,if a rape occurs on a reservation,,the elders cannot arrest a white man on reservation land,,The Native Americans also state,,there boom town ,so-called ,”men,” have brought drugs,,,lots of drugs,,heroin coke etc,,,,The overtime up there is huge,,earning many men 5,000 a week,,,,,my point is,,,,WHY when their is amble evidence of drug abuse up their,,,why the dea has stayed out of North Dakota?????great for honest Doctors,,,but could it have to do with rich oil tycoons’ paying off our government,dea,fda,hhs,,or someone high up,,,,to stay out of North Dakota,,while the rich our getting billions???????maryw
MaryW, they have long since ignored the issues on reservations. They want to take away tribal sovereignty now, but will they do anything to help the Rez clean up the rampant drug/alcohol issues? I highly doubt it. Those issues on our reservations have long been treated like a dirty little secret and swept under the proverbial rug. Whether it is the rapes, the murders or the substance abuse issues, it’s apparently our problem to deal with. Now they’re talking about cutting funding off to much needed Indian Health programs so with that being done, these issues are only going to escalate. For instance, there are a lot of people on the reservations that have pain issues and have been denied pain control based on the stereotype that ALL natives abuse substances. Minorities are statistically more likely to be denied pain control. Yet, if there is no help nor funding for curbing substance abuse, that stereotype is likely to stick around. It’s like chasing our tails. For those that don’t have substance abuse issues, you’re just lumped into the pile with everyone else and there is no help available to you if you have chronic pain. Ive seen people that did not drink or touch drugs, start, because they couldnt get help anywhere else. By and large, that is what is fueling the current problem in the rest of the nation, where people are turning to things like illicit fentanyl to self-medicate. Just because no one wants to help does not mean the people won’t try to find a way. I am not saying that everyone on the Rez with a substance abuse problem has chronic pain, I’m just saying that it’s part of the issue. As for the other issues, there being no jobs or not enough jobs, doesn’t do a whole lot of good. It’s just sad that when the tribes reach our for help, there is none to be found with them citing that it’s a tribal issue but when the tribes try to stand up against something that directly affects them, their generally overruled. Makes a person tend to think that the so-called sovereignty that the tribes have is an illusion. A bone thrown to a dog to shut them up. But then, that’s the way it’s always been since the first broken treaty, hasn’t it? As far as outsiders coming in and bringing in a flow of drugs and commiting other criminal acts that never get looked into, that is the job of the FBI to look into but it seems like they never do unless it’s a native that has committed a crime or at least, when that is what they think. One of my good friends was shot and killed on the Rez. He was a native. Why? Because he went into his house and came out with a video camera because he was chased home, on the Rez, by a policeman that was not tribal police. This story relates because it shows the lopsided approach to justice on the Rez. I have wondered if he had been non-native, if it would have happened that way. But then, I know it wouldn’t.