Medicare Plan Would Require Insurers to Report Suspicious Opioid Prescribing

By Pat Anson, PNN Editor

Doctors, patients and advocates are reacting with alarm to a proposal by the Centers for Medicare and Medicaid Services (CMS) that would require insurance companies to report “substantiated or suspicious activities” by healthcare providers, including “inappropriate prescribing of opioids.” Insurers would also be authorized to unilaterally suspend payments to pharmacies for “credible allegations of fraud.”

If adopted, critics say the sweeping rule changes would have a chilling effect on providers and put insurance company profits ahead of patient well-being.

At issue is a notice published in the Federal Register last month, which details changes proposed for Medicare and Medicaid programs for 2021 and 2022. The notice has drawn little attention from the public, news media or healthcare organizations, which have been preoccupied with the coronavirus pandemic.

Many of the rule changes proposed by CMS are being made to implement the SUPPORT Act, which was passed by Congress in 2018 to reduce opioid abuse and promote substance abuse treatment.

Current CMS policy allows insurers – known as “plan sponsors” -- to voluntarily report potential fraud by doctors and pharmacists. The proposed rule change would require such reporting, when there is “credible evidence of suspicious activities of providers or suppliers related to fraud, and other actions taken by the plans related to inappropriate opioid prescribing.”

Insurers would report allegations to CMS through an internet portal, while the public would be encouraged to call a fraud tip hotline. Credible cases of “bad actors” would then be referred to law enforcement, according to CMS:

"Implementing these provisions will allow CMS, MA (Medicare Advantage) organizations and Medicare Part D plan sponsors to share data and information regarding bad actors, take swift action based on such data and information, and achieve enhanced outcomes in our efforts to fight the opioid crisis. In addition, this regulation will provide the means for more effective referrals to law enforcement based on plan sponsor reporting, ultimately resulting in reduced beneficiary harm and greater savings for the Medicare program.” 

Insurers would be allowed to consider a wide range of factors to determine if opioid prescriptions are inappropriate, including a patient’s health condition, medical records, opioid dosage, refills, and even the “time and distance between a prescriber and the patient.”

Patient advocates say the plan gives too much power to insurers and wrongly assumes that prescription opioids play a major role in the opioid crisis.

“The regulations planned here will constitute a major regulatory burden on the practice of medicine and implicitly make the assumption that sponsors or pharmacists are better judges of patient benefit and risk than prescribers,” said Andrea Trescot, MD, Stephen Nadeau, MD, and patient advocate Red Lawhern, PhD, in a joint statement. 

“These rule changes assign major responsibilities and powers to Medicare Part D sponsors. Since these sponsors have a pecuniary interest in minimizing the drugs they pay for, profit rather than patient well-being will be the major driver of their procedures and protocols. Both physicians and advocates spend hours each week dealing with denial of care, including medications, by sponsors. The people denying the care are often not physicians and they make no attempt to access patient medical records to develop informed judgments.”

Under the CMS proposal, insurers would also be required to enroll patients deemed at risk for opioid abuse into “Drug Management Programs” that would limit which doctors and pharmacies they can see to obtain prescriptions for opioids and benzodiazepines, a class of anti-anxiety medication.  

‘Big Brother’ Approach

Although the CMS proposals have been publicly available on the Federal Register for over a month, only a few dozen comments have been received to date.

“This sounds like we (chronic pain patients) will be targeted for simply getting the care we need to sustain a basic level of living,” wrote one poster. “Often times, assumptions are made that we are drug seekers, drug abusers, and such. Sometimes it takes trying different medications and different doses to get to where we need to be in order to live life. This may look bad on paper to someone without clinical training, education, or experience. Things aren't always what they seem.” 

“My gosh you people are trying to fix a non-existent problem. The issue now is not prescription drugs that us senior citizens take. It is heroin and fentanyl analogs,” said another. “IT IS TIME WE AS A COUNTRY STOP TRYING TO FIX A MEDICAL ISSUE WITH LAW ENFORCEMENT. There is no need for the government to get between me and my doctor when it comes to my pain medication.”

Many posters are concerned that providers and patients could face sanctions over unproven allegations.

“I am EXTREMELY concerned for this ‘Big Brother’ approach you are taking yet again,” said another poster. “I do not have an addictive personality. What if someone decides to say I do? Then my doctor who is already living in fear of the DEA may go along with whatever determination this government decides to make about me.”   

“So the idea is to shut down doctors with a mere investigation? Based on accusation? Not even charged but only accused? This is truly a new low in individual rights,” said another. “I would think that doctors would almost entirely abandon controlled substances prescribing altogether. Perhaps the motivation for this.”  

While CMS says “a fraud hotline tip, without further evidence, is not considered a credible fraud allegation,” some worry that unsubstantiated claims could still result in sanctions against a provider.   

It was a complaint from a woman in upstate New York that recently led to a North Carolina doctor losing his DEA license. The woman doesn’t know Dr. Thomas Kline or any of his patients, but reported Kline to the state medical board because she didn’t like his tweets defending the use of opioid medication. Kline sees several patients from out-of-state, one of the red flags that CMS would consider suspicious.

“I think the sticky wicket is probably the words ‘credible allegations of fraud.’ Such as the Dr. Kline fiasco. THAT wasn't credible but the Board sure made it out to be,” says Rick Martin, a retired pharmacist and pain patient.   

What do you think of the CMS proposal? The public comment period ends April 6. To leave a comment, click here.

Medicare to Cover Acupuncture for Back Pain

By Pat Anson, PNN Editor

The Centers for Medicare & Medicaid Services (CMS) has finalized a decision to cover acupuncture for Medicare patients with chronic low back pain. Up to 12 visits in 90 days to an acupuncture therapist will be paid by Medicare, but no more than 20 treatments annually.

Acupuncture is an ancient Chinese treatment in which practitioners stimulate specific points on the body by inserting thin needles through the skin. About 3 million Americans receive acupuncture treatments, mostly for chronic pain. Some private insurers already cover acupuncture, but there is little consensus in the medical community about its value.

Lower back pain is the world’s leading cause of disability. CMS researchers reviewed clinical studies and found evidence that older adults with chronic back pain showed small improvements in pain and function after acupuncture treatments, although the exact mechanism of action was “unclear” and there was “inconclusive evidence” about the most effective acupuncture technique.

“Expanding options for pain treatment is a key piece of the Trump Administrations’ strategy for defeating our country’s opioid crisis,” Health and Human Services Secretary Alex Azar said in a statement. “Medicare beneficiaries will now have a new option at their disposal to help them deal with chronic low back pain, which is a common and sometimes debilitating condition.”  

The decision to cover acupuncture overturns decades of previous rulings that took a dim view of the procedure. In 1980, CMS said the use of acupuncture as an anesthetic was “not considered reasonable and necessary.”

In 2004, the agency rejected acupuncture as a treatment for fibromyalgia and osteoarthrosis because there was “no convincing evidence for the use of acupuncture for pain relief.”

CMS said it was “keenly focused” on finding alternatives to opioid painkillers.

“We are dedicated to increasing access to alternatives to prescription opioids and believe that covering acupuncture for chronic low back pain is in the best interest of Medicare patients,” said CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt.

“We are building on important lessons learned from the private sector in this critical aspect of patient care. Over-reliance on opioids for people with chronic pain is one of the factors that led to the crisis, so it is vital that we offer a range of treatment options for our beneficiaries.”

A recent study of over 140,000 Army veterans with chronic pain found that non-drug therapies such as acupuncture significantly reduce the risk of suicide, as well as alcohol and drug abuse.  

Medicare Patients Face New Rx Opioid Rules in 2019

By Pat Anson, PNN Editor

The Centers for Medicare and Medicaid Services (CMS) will implement new safety rules on January 1 that could make it harder for over a million Medicare beneficiaries to get prescriptions filled for high doses of opioid pain medication. Prescriptions for opioid “naïve” patients – those who are new to opioids -- will also be limited to an initial 7-day supply, regardless of dose.

The new rules, which are modeled after the 2016 CDC opioid guideline, are intended to reduce the risk of opioid abuse and addiction. They only apply to patients enrolled in Medicare’s Advantage and Part D prescription drug programs, and exempt patients in palliative and hospice care or those being treated for “active” cancer-related pain.

But patients and advocates fear the rules give too much power to insurers and pharmacies, and could result in widespread confusion or patients being denied medications they’ve taken safely for years.

“I am concerned, just as happened with the CDC Guideline, the new CMS rules starting January 1 will be totally misinterpreted, misunderstood, and possibly weaponized to deny patients opioid pain meds,” says Rick Martin, a retired Las Vegas pharmacist disabled by chronic back pain. 

In recent weeks, Martin says he’s spoken with three pharmacists at major chains in the Las Vegas area and none of them had been briefed about the new CMS rules or how they will be implemented by insurers. 

“Maybe the sponsors (insurers) are so overwhelmed, nothing will happen after January 1 or maybe some obscure person in the basement is waiting to install a computer program that will kick in January 1 and nobody will be expecting it. That would be utter chaos,” said Martin. 

CMS contracts with dozens of private insurers to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved. 

‘Safety Edit’ for High Dose Prescriptions

Starting January 1, Medicare insurers will adopt drug management programs (DMPs) designed to flag patients who are deemed high risk – such as those who take opioids with anti-anxiety benzodiazepines or get opioid prescriptions from more than one doctor.

Any opioid prescription at or above 90 MME (morphine milligram equivalent) will trigger an automatic “safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose. If satisfied with the explanation or if a prior authorization was already granted, the pharmacist could override the safety edit and fill the prescription. About 1.6 million Medicare beneficiaries met or exceeded a dose of 90 MME in 2016.

Insurance companies can impose their own “hard edit” for patients getting 200 MME or more, which will require pharmacists to contact the insurer before filling a prescription.  Insurers will also be given greater authority to identify patients at high risk of addiction and can even require they use “only selected prescribers or pharmacies.”

The bottom line for patients is that pharmacists and insurers – not doctors -- could be the final arbiters of whether a prescription is appropriate and should be filled.

“If you get opioids from multiple doctors or pharmacies, your plan may talk with your doctors to make sure you need these medications and that you’re using them safely,” a Medicare advisory tells patients.

“If your Medicare drug plan decides your use of prescription opioids and benzodiazepines isn’t safe, the plan may limit your coverage of these drugs. For example, under its DMP your plan may require you to get these medications only from certain doctors or pharmacies to better coordinate your health care.”

“The process they decided on -- having pharmacists confer with prescribers -- is really a good idea in the abstract, but in practice it's going to be very burdensome,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. 

“I think that the mandated phone conversations between pharmacists and prescribers will turn out to be such a time-consuming endeavor that many prescribers will decide just to prescribe a low enough dose that those phone calls aren't triggered. The net effect, in many cases, I think, will be to encourage prescribers to drop their doses below that threshold.”

If a prescription is rejected by an insurer or pharmacist, patients have the option of paying for the medication in cash and/or filing an appeal.

“CMS officials have confirmed that Medicare prescription drug coverage involvement is limited to payment for medications. If a patient receives a denial of coverage, the patient has the right to pay out-of-pocket for that medication. A Medicare denial only applies to financial coverage. It has no authority to deny the prescription itself,” says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP). 

ATIP is encouraging patients denied medication to contact a little-known CMS agency called the Beneficiary and Family Centered Care-Quality Improvement Program, where they can file an appeal or make a complaint.   

Medicare patients can also be proactive by talking with their doctor and pharmacist about the new rules before getting a prescription filled. They can also seek a prior authorization from their insurer to avoid the delays of a safety edit at the pharmacy.

Medicare Finalizes Plan to Reduce High Dose Opioids

By Pat Anson, Editor

The Trump administration has finalized plans that will make it harder for many Medicare patients to obtain high doses of opioid pain medication. Medicare beneficiaries will also be limited to an initial 7-day supply of opioids for acute pain.

Under new rules released today for the 2019 Medicare Part D prescription drug program, a ceiling for opioid doses will be established at 90mg morphine equivalent units (MME).  Any prescription at or above that level would trigger a “hard safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose. If satisfied with the explanation, the pharmacist could then override the edit and fill the prescription.

Under an earlier proposal that was widely criticized, only insurers could decide whether to override a safety edit – a requirement that would have essentially made insurers the final arbiters in deciding who gets high doses of opioid pain medication.

The new rules adopted by the Centers for Medicare and Medicaid Services (CMS) will still allow insurers to implement safety edits, but only at a much higher dose of 200 MME or more.  Insurers will also be given greater authority to identify beneficiaries at high risk of addiction and to require they use “only selected prescribers or pharmacies.”

CMS is also adopting a new policy that requires all new opioid prescriptions for short term acute pain to be limited to no more than 7 days’ supply. Several states have already adopted similar measures.

CMS says this “tailored approach” to opioid prescriptions was needed to address what it called “chronic opioid overuse” at the pharmacy level and to encourage support for the CDC’s 2016 opioid prescribing guideline.

“CMS believes it is important that (insurers) set expectations for prescribers to implement the CDC’s recommendations as a best practice through their provider contracts. PDPs (prescription drug plans) should also reinforce these messages through interactions with prescribers as an integral component of sponsors’ drug utilization management program,” CMS said.

“We also recommend that beneficiaries who are residents of a long-term care facility, in hospice care or receiving palliative or end-of-life care, or being treated for active cancer-related pain are excluded from these interventions.”

About 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. The 90mg MME ceiling established by the CDC was only meant as a recommendation for primary care physicians, but has been widely adopted as a rule by other federal agencies, insurers, state regulators and prescribers.

'Cruel' Limits on Opioid Prescribing

"The 90 mg dose they set as a threshold for 'high' or overuse is flawed and not scientifically based.  It is totally arbitrary," says Lynn Webster, MD,  a pain management expert and past president of the American Academy of Pain Medicine.  "It is cruel to impose such a limit on people with involuntary dose reductions who have been functioning well without signs of abuse for years.

"Even the 7 day limit is misguided at best. The average length of time a person requires an opioid post-op involves several factors and include the type of operation, the genetics of the person and the type of medication. The literature states the duration of pain requiring treatment with an opioid post-operatively is 4-9 days for general surgery, 4-13 days for women's health procedures and 6- 15 days for musculoskeletal procedures.  This means half of the Medicare patients will receive less than half of what they will need."  

Over 1,200 people left public comments in the Federal Register about the Medicare proposal, most of them sharply critical of CMS.

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals.”

A joint letter opposing the rule changes was also submitted by 180 doctors and academics, including some who helped draft the CDC guidelines. The letter points out that a steep reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing the number of high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients…and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

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 policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.  The new Medicare regulations will go into effect on January 1, 2019.

Critics Pan Medicare Plan to Reduce High Dose Opioids

By Pat Anson, Editor

Over 1,200 people have left public comments in the Federal Register about changes to Medicare's Part D prescription drug plan, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication.

Under the proposed regulations for 2019, a ceiling for opioid doses would be set at 90mg morphine equivalent units (MME) for all Medicare beneficiaries.  Any prescription at or above that level would trigger a “hard edit” rule requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose – with the insurer being the final arbiter in deciding who gets the higher dose.  

If adopted, critics say the rule would force many high-dose opioid patients to be abruptly tapered to lower doses, causing severe pain and withdrawal symptoms -- and possibly leading to illegal drug use and suicide.

“Suddenly dropping opioid doses will cause acute opioid withdrawal, exacerbation of pain, and increased disability with decreased productivity. It also increases the risk that patients will migrate to riskier alternatives such as heroin or fentanyl,” wrote David Kan, MD, an addiction psychiatrist.

“The proposed rule change is in the right spirit but very, very risky in reality. I urge CMS to reconsider the arbitrary dose limit on opioids. The unintended consequences are potentially devastating to our patients and community.”

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people... You are complicit in the pain, suffering, and documented damage that will result.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals. Each person who needs medication deserves the best care possible, and that will depend on both condition and need.”

“I think it is absolutely ludicrous to imagine that a third party could presume to place a maximum daily or monthly limit on my, or any other chronic pain patient's, medication. Each person's tolerance for and requirement of medication varies tremendously. How could you possibly imagine that you could come up with a generic formula which could fit every chronic pain patient across the board?” wrote Cyrynda Walker.

A joint letter opposing the rule change was submitted by 180 doctors and academics, including some who assisted in drafting the CDC’s controversial 2016 opioid prescribing guidelines. The letter points out that a 48 percent reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients in the context of multiple regulatory initiatives, and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

The public comment period on the CMS proposal ended March 5. To see the comments that were posted, click here.

CMS Seeking ‘Dialogue’ About Opioids

According to CMS, 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Medicare officials said the goal of the “hard edit” rule is to get pharmacists, doctors and insurers to “engage in a dialogue” about the risks associated with high dose opioid prescriptions.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said CMS deputy administrator Demetrios Kouzoukas in announcing the rule changes last month. “We believe these actions will reduce the oversupply of opioids in our communities."

To reduce the risk of “unintended consequences” from the hard edit rule, CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

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 policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Unless changes are made, the proposed Medicare Part D rules for 2019 will be finalized April 2.

Tell Medicare to Stop Its War on Pain Patients

By Richard A. Lawhern, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published a deeply biased and scientifically unsupported guideline for the prescription of opioid pain relievers.  Congress made this “guideline” mandatory in the Department of Veterans Affairs three months before it was even published.  The VA has since enacted practice guidelines that effectively eliminate opioids as a treatment option for many veterans. 

Now the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) are doubling down on this bureaucratic atrocity.

CMS has posted in the Federal Register and is inviting public comment on its plans to change the rules for Medicare Part D prescription drug plans in 2019.  

They propose that "all sponsors [are] to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME)" – which is the dose ceiling recommended by the CDC.

The so-called “sponsors” are insurance companies that provide health care coverage funded by taxpayers to 54 million Medicare beneficiaries. If implemented, this proposal will effectively deny reliable pain treatment to millions of seniors, poor and disabled people.  When applied to private health insurance and Medicaid as they inevitably will be, these regulations will damage all U.S. citizens.

As I have commented to CMS, their proposals “mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These … changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.”   

Few pain patients ever display diagnostic symptoms of opioid use disorder. Yet drug-related overdoses have risen steadily in the past ten years -- despite restrictions on the medical supply of opioids -- a death toll largely associated with illegal opioids and nonprescription drugs. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis.”

Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced into opioid doses below therapeutic levels.  Mandated VA restrictions on opioid prescribing are directly responsible for hundreds of deaths among veterans. 

All for nothing.  And CMS is about to do more of the same.

A major study in the British Medical Journal illustrates the foolishness of the CMS proposal.  Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients between 2008 and 2016. Only 0.6% were later diagnosed with Opioid Abuse Disorder (OAD).  Less than 1% renewed their prescriptions up to 13 weeks.  OAD incidence was only weakly sensitive to dose level from less than 20 to over 120  MME  per day.   

Another large study in JAMA Internal Medicine shows the incidence of extended post-surgical opioid prescriptions at just 0.174% to 0.9%, depending on the type of surgery.

CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.

The CDC Guidelines ignored the natural variability in liver enzymes governing the way opioids are broken down in the body.  Imposing hard limits on MME in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and CMS. 

In January 2018 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics.  Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.  CMS has ignored both recommendations.

Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond seven days is inappropriate and dangerous nonsense.  Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels.  The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.

There is no one-size-fits-all patient or treatment plan.  CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.  

What Can Patients and Caregivers Do?

First, you can register your protest and concern with CMS before March 6th by selecting the “Comment Now!” buttons at this link.

You don’t have to be a doctor or researcher to do this.  Here are some examples of comments you might make.  Please edit them to fit your own situation.  Don’t copy these words exactly, as CMS will delete them.

    A. I am a chronic pain patient with ___________ (one or more diagnoses)

    B. My medical care will be greatly damaged by your regulation.

    C. I rely upon opioid medications to: (fill in)

• Preserve my way of life            
• Manage my incurable pain
• Allow for increased function
• Remain productive

     D. If CMS enforces a hard limit for opioid doses per day, this will give private insurance companies and pharmacies  an excuse to stop paying for my necessary prescriptions or dispensing them at all. 

     E. The proposed regulations are unsupported by any reliable science

     F. If enacted, these policies will: 

• Force even more doctors away from treating pain          
• Force more patients onto disability
• Create more demand for emergency room services
• Increase the rate of expensive and often ineffective surgical procedures
• Increase the rate of suicides

To review the comment process, feel free to visit the Facebook page for the Alliance for the Treatment of Intractable Pain (ATIP).

The second thing you can do is look up the Washington DC phone numbers of your House and Senate representatives. It’s easy. Just Google your state and the word “senators” or “Congress.”

Then call their office.  Tell the staffer who picks up that “I’m a pain patient and I vote in (name the state).  I want the Senator (Congressman or -woman) to tell the Centers for Medicare and Medicaid Services to withdraw their proposed regulation limiting the treatments I can receive.  If accepted, these regulations will destroy my life.”

It is time for people in pain and caregivers to speak up.  If we do not, then we will live – or die – as victims of a medical bureaucracy that doesn’t care about the damage it does to us.

Richard A Lawhern, PhD, is the co-founder and corresponding secretary for the Alliance for the Treatment of Intractable Pain (ATIP). He is a technically trained non-physician patient advocate with over 20 years experience in direct support to patients and caregivers in social media.  His work on public policy for pain management is widely published in multiple online and print media.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

High Dose Opioids Targeted Under New Medicare Rules

By Pat Anson, Editor

The Trump administration has proposed new rules that will make it harder for Medicare patients to obtain high doses of opioid pain medication. If adopted, critics say the regulations could force many high-dose pain patients to be abruptly tapered to lower doses, a risky procedure that could lead to severe pain and withdrawal symptoms, or even illegal drug use and suicide.

The rules proposed by the Centers for Medicare & Medicaid Services (CMS) would also make health insurers the final arbiters in deciding who gets high doses of opioid medication.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said Demetrios Kouzoukas, CMS deputy administrator. “We believe these actions will reduce the oversupply of opioids in our communities."

Under the proposal for the 2019 Medicare Part D prescription drug program, a ceiling for opioid doses would be established at 90mg morphine equivalent units (MME).  Any prescription at or above that level would trigger a “hard edit” requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose.

Medicare officials claim the goal of the rule is to get patients, doctors and insurers to “engage in a dialogue” about the risks associated with opioids. But regardless of how that dialogue goes, ultimately the final decision on whether to override the hard edit would be left to insurers – known as plan sponsors.

"The trigger can only be overridden by the plan sponsor after efforts to consult with the prescribing physician," said Kouzoukas.

The 90mg MME ceiling was established in 2016 by the CDC’s much criticized opioid prescribing guidelines. Those “voluntary” guidelines were only meant as recommendations for primary care physicians, but have been widely adopted as rigid rules by other federal agencies, insurers, state regulators and prescribers.

High Dose Patients at Risk

CMS says 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Many suffer from chronic or intractable pain and have been on high doses for years.

“If this CMS proposal is adopted, it will accelerate an ongoing pattern of involuntary opioid tapers,” says Stefan Kertesz, MD, a practicing physician and professor of medicine at the University of Alabama at Birmingham School of Medicine. “I have great concern for today’s high dose patients, many of whom have complex disabilities. Their disabilities often reflect a combination of underlying physical disease, mental conditions, harm from the health care system and opioid dependence, even if those same opioids confer some degree of relief.

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide.” 

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or acknowledged by anti-opioid activists.

To reduce the risk of these “unintended consequences,” CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

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 policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Public comments on the proposals must be submitted by Monday, March 5, 2018. To submit comments or questions electronically, go to www.regulations.gov, enter the docket number “CMS-2017-0163” in search  and follow the instructions for submitting a comment. 

The 2019 proposed rule changes may viewed by clicking here.

Medicare Expands Opioid Monitoring After GAO Report

By Pat Anson, Editor

The General Accounting Office (GAO) – now known as the Government Accountability Office – was established by Congress in 1921 to act as an independent, nonpartisan watchdog of the federal government.  

“We provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced. Our core values of accountability, integrity, and reliability are reflected in all of the work we do,” the GAO says in its mission statement. 

Fair and balanced? Not always – at least not when it comes pain patients and their medication.

Two months ago, PNN reported on a GAO audit that recommended the Centers for Medicare and Medicaid Services (CMS) greatly expand its monitoring of Medicare patients who receive high doses of opioid pain medication.  

Over 700,000 Medicare beneficiaries currently receive opioids in excess of 90mg morphine equivalent doses, and the GAO thinks it would be a good idea to have private insurers track these patients and their doctors to look for signs of “inappropriate prescribing.”

Critics say such a policy would have a chilling effect on many doctors, who already fear government sanctions for prescribing opioids.

FOIA Request Rejected

We were struck by a footnote in the GAO report, which indicated the agency had never consulted with pain sufferers, patient advocacy groups or professional organizations that represent prescribers while preparing its audit. But the GAO did reach out to insurers, regulators, law enforcement, addiction treatment specialists, anti-opioid activists, and surgeons who specialize in spinal injections:

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group. We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO said it did not identify any of the “stakeholders” by name because the interviews were conducted on a not-for-attribution basis to encourage frank discussion. Pain News Network filed a Freedom of Information Act (FOIA) request to get the agency to disclose those names – which was quickly rejected.

“As an agency responsible to the Congress, GAO is not subject to FOIA,” Timothy Bowling, the GAO’s Chief Quality Officer, wrote to PNN. “Please be advised that while conducting the audit engagement above, GAO obligated itself not to disclose any names or identifiable information related to these stakeholder groups.”

This is certainly not the first time pain patients and pain management experts have been denied a seat at the table when federal decisions are made about pain care.

In 2015, the Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians when it drafted its opioid prescribing guideline. The CDC even refused to disclose who served on its expert advisory panel until it was threatened with a lawsuit.  

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in a 2016 "special session" to discuss Medicare's opioid prescribing policies. More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

Medicare Tracking Opioid Prescriptions  

What became of the GOA report and its recommendations? Many are now being implemented by CMS.

In testimony before a House committee this month, a GAO official said CMS had agreed to start collecting data on all Medicare beneficiaries prescribed high dose opioids, as well as doctors who are “inappropriately and potentially fraudulently overprescribing opioids.”  

“A large number of Medicare Part D beneficiaries use potentially harmful levels of prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” said Elizabeth Curda, Director of Health Care for GAO.

“Access to information on the risks that Medicare patients face from inappropriate or poorly monitored prescriptions, as well as information on providers who may be inappropriately prescribing opioids, could help CMS as it works to improve care.”

CMS is also considering rule changes for Part D prescription drug plans in 2019 that would designate most opioids as “frequently abused drugs,” and would require some Medicare beneficiaries to obtain their opioid prescriptions from prescribers and pharmacies selected by CMS.

The Secret Role of Insurers in Medicare Opioid Policy

By Pat Anson, Editor

This month marks the one year anniversary of a closed door meeting between law enforcement agencies, federal and state regulators, and health insurance companies in a Baltimore suburb – a “special session” of an obscure advisory group to the U.S. Justice Department and the Department of Health and Human Services.

Although the mission of the Healthcare Fraud Prevention Partnership – HFPP for short -- is to prevent healthcare fraud, the October 20, 2016 meeting went much further. It gave the insurance industry – so-called “Partner Champions” -- a direct role in drafting recommendations that could decide how millions of pain patients will be treated by their doctors and what opioid medications will be prescribed to them, if any.

Major insurers like Aetna, Anthem, Cigna, Humana, Blue Cross Blue Shield and Kaiser Permanente were invited to attend, but no other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were asked to appear or share their insights. Few details about the meeting were made public, until now.

Pain News Network has obtained documents through the Freedom of Information Act (FOIA) that shed some light on how the meeting was organized and what was discussed, but we were denied access to a list of individuals that attended, who they represented, or any recordings of what they said.

“The nature of some of the information provided during the Special Session on opioids would be of the sort that could have a negative impact on the competitive posture or business interests of a company if made public,” Jay Olin, Director of FOIA Analysis for the Centers for Medicare and Medicaid Services (CMS), wrote in a letter to PNN.

CMS COMMAND CENTER IN WOODLAWN, MD

“The release of this sensitive information could put the company at significant financial risk if interested parties use this information to develop and execute schemes and individuals and organizations use this information to game the system and reap financial or other benefit.”

Olin also said the HFPP is not a federal advisory committee and therefore not subject to federal open meeting laws, even though the October 20 meeting was called by CMS, organized by CMS, funded by CMS, and held on federal property at the CMS Command Center in Woodlawn, Maryland.

“Furthermore, most (HFPP) partners are from the private sector and private industry is not subject to FOIA, nor is CMS authorized to release such information,” Olin wrote.

PNN is appealing that decision.

‘Government-authorized use only’

CMS may be trying to distance itself from the HFPP, but it’s clear they work closely together in their unusual “public-private partnership.”

A CMS website hosts a portal for HFPP members to sign-in that plainly states “this system is provided for Government-authorized use only.” The website also goes into detail on how to become an HFPP partner, the benefits of membership and provides an extensive list of partners that includes 45 different insurance companies.

According to a recent report from the General Accounting Office (GAO), CMS has spent over $30 million funding the HFPP since 2012, the year the partnership was created by the Obama administration to help the federal government detect and prevent healthcare fraud. A side benefit for insurers is that it helps them lower the cost of healthcare coverage. A CMS flyer plainly states that one of the reasons the HFPP exists is to help payers “identify potential savings.”       

The goals and activities of the partnership are important to understand because CMS contracts with dozens of insurers to provide Medicare coverage to about 57 million elderly and disabled Americans, at an annual cost of nearly $700 billion. And if the insurance industry is making healthcare decisions while being subsidized with billions of taxpayer dollars, Americans have a right to know what’s going on.

Yet CMS won’t even say who attended that October 20 meeting.

“A total of 58 participants across 26 federal, state, public and private organizations, including CMS, attended the event,” is all that an executive summary of the meeting says about the attendees.

The first half of the daylong meeting wasn’t even about opioids. It focused on the HFPP’s mission: combating fraud. According to the executive summary, a CMS technical advisor briefed attendees about common fraud schemes in the addiction treatment and drug testing industries, such as “substance abuse facilities that may be exposing their patients to physical or other harm” and insurance claims from treatment facilities “for services not rendered and unnecessary service, including lab claims.”

Another fraud scheme flagged by CMS was “physicians who appear to be referring Marketplace (Medicare/Medicaid) members, as well as other individuals who may be paid by substance abuse facilities to sign people up for Marketplace coverage.”

After a break for lunch, the discussion veered away from fraud prevention and into treatment decisions normally left between a patient and their doctor. A CMS official “emphasized the need to look at improving the quality of care” and identified several priority areas, including “best practices for acute and chronic pain.”

“Eliminate or restrict opioid prescribing for acute conditions,” was one of the many strategies discussed. So was the concept of “pay for performance,” in which doctors would receive payments from insurers “for following guidelines or quality practices, not for prescribing opiates.”

“Higher copay for opioid prescriptions” was another recommendation, as was “step therapy and dosage control.”

"Media outreach" and “social media and digital advertising tools” were suggested as ways to promote patient and provider compliance through “social normalizing.”

It is not clear from the documents provided to PNN if these were strategies advocated by insurers, law enforcement or CMS.

‘Serious Conflict of Interest’ for Insurers

Attendees were told the ultimate goal of the meeting was “to produce an HFPP-branded White Paper that identifies best practices payers can take to effectively address and minimize current and future opioid abuse.”

In other words, the meeting was not just about fraud prevention. The insurance industry was being asked to help design federal policy on opioid prescribing and “encourage practices that connect patients to the level of care best suited to their needs…. while avoiding unnecessary services or opioid prescriptions.”

“It is very disturbing to see CMS working with insurance companies to reduce the amount of opioids prescribed without physician and organized medicine's input,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine (AAPM). 

“It is a serious conflict of interest to have insurance companies determine what medications are appropriate and how much to use.”

Webster was also alarmed by some of the strategies discussed at the October 20 meeting.  

“The proposal that insurance might eliminate opioids for acute pain would leave many patients without any effective treatment. That is not helpful and will produce a huge backlash,” he said.

“To encourage CMS to reward doctors to not prescribe opioids is a very ominous trend, knowing that untreated pain can have lethal effects on the body,” said Ingrid Hollis, a patient advocate and mother of a chronic pain sufferer. “To perpetuate these myths about reining in the addiction crisis, when in fact it is looking more and more like cost saving measures, is a conflict of interest for sure.

“I also find it disturbing that a private group with so much influence on insurance would not disclose to you who was in attendance at their meetings. Because they are influencing public programs and healthcare funded by taxpayers, they need to disclose who they are.”

When asked why the October 20 meeting was closed to the public, a CMS spokesman said "all HFPP meetings are limited to members of the Partnership, as they deal with sensitive issues relating to fraud, waste and abuse in the healthcare sector."

Payer ‘Partner Champions’

The HFPP white paper was released in January on the CMS website. The 62-page report -- Healthcare Payer Strategies to Reduce the Harms of Opioids -- begins by praising the “Partner Champions” who helped draft it. 

Among the payers listed as “champions” were Aetna, Anthem, Blue Cross Blue Shield, Cigna, Centene, Highmark, Horizon, Humana, and Kaiser Permanente.

“To overcome the problems of prescription opioid misuse, it is also vital to understand that provider prescribing practices and patient drug seeking behavior can exacerbate the development and persistence of OUD (opioid use disorder),” the white paper warns.

“Providers may write prescriptions without assessing their patient’s risk for misuse, prescribe opioid analgesics for minor pain, prescribe a greater medication quantity or dose than warranted by the patient’s medical indication, or provide opioids fraudulently with the knowledge they are likely to be misused. Patients may exaggerate or falsify symptoms to obtain opioid prescriptions, seek prescriptions from multiple physicians, forge prescriptions, or obtain prescriptions for resale on the black market.”

The white paper goes on to endorse the CDC’s opioid prescribing guideline, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as alternatives to opioids, as well as non-drug therapies such as cognitive behavioral therapy, chiropractic care and TENS nerve stimulation units. Few of these treatments are covered by insurance.

The white paper also encourages pharmacists to “deny payments for (opioid) prescriptions that do not conform to general prescribing practices” and to profile doctors and patients to identify “problematic actors and schemes.”

Patients could be profiled in one of three ways, according to the HFPP:

1. Stewards (those who follow guidelines)
2. Stockers (those who hoard medication)
3. Demanders (those who ask for medication)

The white paper does not discuss fraud in the addiction treatment industry, the initial focus of the October 20 meeting. Also unmentioned is a recent HFPP policy decision that allows insurers to share information about Medicare beneficiaries.

Individual patient data on 57 million Americans is now being pooled, studied and analyzed by the insurance industry, something that payers were previously reluctant to do.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies,” the GAO report says.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies.”

— GAO Report

Is the HFPP overstepping its authority? Do insurers have any business sharing and analyzing the personal health information of millions of Americans? No one at HFPP would comment. CMS referred us to this statement in the white paper:

“Payers can help to combat the opioid crisis by identifying and sharing strategies, such as reimbursement and coverage policies, conditions for provider plan participation, and dissemination of information to a variety of audiences, to address the large-ranging issues that lead to fraud, waste, and abuse in the healthcare system. Such interventions are particularly suited to payers due to their relationships with providers of healthcare services, pharmacies, insured patients, employers, and law enforcement (in cases where potential fraud is identified). Payers collect and administer a large amount of healthcare information that can be used to identify and intervene on behalf of patients at risk of opioid-related harm, as well as to target fraud, waste, and abuse in opioid prescribing.”

CMS announced plans to align its Medicare Advantage and Part D prescription drug plans with the CDC guideline soon after receiving the HFPP white paper. But some of the more extreme strategies discussed by the HFPP were not adopted. CMS won’t be paying doctors to follow the guideline or be eliminating opioids as a treatment for short term, acute pain.

But the agency is moving ahead with plans for a new monitoring system to identify opioid “overutilizers” -- physicians who prescribe high doses, patients who get them, and pharmacies that fill their prescriptions. Payers are authorized to drop suspicious pharmacies, doctors and patients from Medicare coverage and their insurance networks.

How many overutilizers are there? At last count, there were 15,651 Medicare beneficiaries getting multiple high dose opioid prescriptions. That may sound like a lot, but it amounts to only 0.04% of the 41.8 million patients enrolled in Medicare Part D plans.

Why are insurers targeting Medicare beneficiaries when only a tiny percentage may be abusing prescription opioids? Dr. Webster suspects the real motive is money.

“Clearly the insurance companies are benefiting from tunnel vision and a laser focus on Pharma companies and doctors,” says Webster. “There is a vast under appreciation that commercial insurers are also driven by the bottom line.  This is why they should not be making medical decisions without input from pain physicians and organized medicine.”