Medicare to Cover Acupuncture in Pilot Program

By Pat Anson, PNN Editor

A week after a federal report documented a significant decline in opioid prescriptions among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has taken a tentative step to cover acupuncture as an alternative treatment for chronic low back pain.

Under a CMS proposal, patients enrolled in clinical trials of acupuncture sponsored by the National Institutes of Health (NIH) or in studies approved by CMS would be covered under Medicare’s Part D program. CMS has been collaborating with the NIH in studying acupuncture as a treatment of chronic low back pain in adults 65 years of age and older.

In a statement, CMS acknowledged that while “questions remain” about acupuncture’s effectiveness, interest in the therapy had grown in recent years as a non-drug alternative to opioids.  

Acupuncture is an ancient Chinese form of treatment that involves the insertion of fine needles into various points on the body to alleviate pain and other symptoms.


“Chronic low back pain impacts many Medicare patients and is a leading reason for opioid prescribing,” said CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt. “Today’s proposed decision would provide Medicare patients who suffer from chronic low back pain with access to a nonpharmacologic treatment option and could help reduce reliance on prescription opioids.”

Currently, acupuncture is not covered by Medicare. CMS is inviting public comment on the proposal to gather evidence and help determine if acupuncture is appropriate for low back pain. Comments will be accepted through August 14.

“Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.” said Health and Human Services Secretary Alex Azar.

Spending on Opioids Peaked in 2015

Medicare Part D spending on opioid prescriptions has been falling for years. It peaked in 2015 at $4.2 billion and now stands at its lowest level since 2012, according to a report released last week by the HHS Office of Inspector General.

The decline in opioid prescriptions appears to be accelerating. Last year, 13.4 million Medicare beneficiaries received an opioid prescription, down from 14.1 million in 2017.



The Inspector General identified over 350,000 Medicare patients as receiving high amounts of opioids, with an average daily dose great than 120 MME (morphine milligram equivalent) for at least three months. The CDC opioid guideline recommends that daily doses not exceed 90 MME.  

The report highlighted the case of an unnamed Pennsylvania woman who received 10,728 oxycodone tablets and 570 fentanyl patches in 2018. Her average daily dose was 2,900 MME. She received all of her opioid prescriptions from a single physician.

The report said there were 198 prescribers who “warrant further scrutiny” because they ordered high doses of opioids for multiple patients.

“Although these opioids may be necessary for some patients, prescribing to an unusually high number of beneficiaries at serious risk raises concerns. It may indicate that beneficiaries are receiving poorly coordinated care and could be in danger of overdose or dependence,” the report found.  “Prescribing to an unusually high number of beneficiaries at serious risk could also indicate that the prescriber is ordering medically unnecessary drugs, which could be diverted for resale or recreational use.”

Under a new federal law, CMS is required to identify and warn “outlier prescribers of opioids” on an annual basis about their prescribing patterns. Medicare insurers could also require high-risk patients to use selected pharmacies or prescribers for their opioid prescriptions.

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. 

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“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.

Spinal Injection Bill Would Raise Healthcare Costs

By Pat Anson, Editor

Republicans and Democrats often claim that reducing the cost of healthcare is one of their major goals. But a bipartisan bill that is sailing through Congress with little debate will do just the opposite, raising the cost of some epidural, facet joint and other spinal injections used to treat pain by as much as 25 percent for Medicare beneficiaries.

Critics say the legislation is little more than a money grab by doctors who perform the procedures, under the guise of preventing opioid addiction.

The “Post-Surgical Injections as an Opioid Alternative Act” (HR 5804) is one of nearly 60 bills to combat the opioid crisis approved last week by the House Energy and Commerce Committee. It moves to the full House for a vote.

The bill would partially reverse a decision made by the Centers for Medicare and Medicaid Services (CMS) in 2016 to cut the Medicare reimbursement rate for epidurals and other injections.  The interventional procedures – which do not involve opioids -- can cost several hundred dollars per injection.

The American Society of Interventional Pain Physicians (ASIPP) lobbied unsuccessfully to get the reimbursement cuts overturned – until it found two Illinois Republican congressmen willing to sponsor HR 5804, Rep. John Shimkus and Rep. Raja Krishnamoorthi.


“We first went to the CMS, then HHS, with no success in reversing draconian cuts for interventional techniques. CMS and the administration told us that it requires an Act of Congress,” ASIPP says on its website. “As a first step toward this, Shimkus and Krishnamoorthi have introduced H.R. 5804, which reverses some of the cuts for Ambulatory Surgery Center procedures. This is only the beginning. We have many other cuts to be reversed.”

According to, Shimkus and Krishnamoorthi have both received $10,000 in campaign donations from ASIPP. The organization has spent over $500,000 on lobbying and donations so far in the 2017-2018 election cycle.

‘I Find It Hard to Trust CMS’

Shimkus introduced the ASIPP bill on May 15th and two days later helped shepherd it through its first and only hearing before the House Energy and Commerce Committee.


During the hearing, Shimkus claimed that by cutting the cost of spinal injections, CMS created a disincentive for doctors to perform the procedures and encouraged them to prescribe opioids instead.

“A lot of us were surprised to see CMS reduce the reimbursement rate for non-opioid pain treatments like epidurals for post-surgery pain,” Shimkus said. “I find it hard to trust CMS when those of us in this arena think their cut has led to more opioid use.

“A lot of us believe the inability to use epidurals to treat pain and prescribe opioids is not healthy for our country.”

To be clear, the CMS reimbursement cuts do not prevent any doctor from performing injections – it only made the shots less profitable. And Shimkus offered no evidence that the lower reimbursement rates encourage more opioid use – although he convinced many of his colleagues that they did.  

“I do think it's important in this crisis to be specific with CMS to make sure that we are not discouraging the use of non-opioid alternatives based on reimbursement-related issues,” said Rep. Larry Bucshon, MD (R-IN), who is a cardiologist. “In my experience over the years, CMS makes reimbursement decisions based on the financial incentives to do so, not necessarily, in my opinion, based on what is the appropriate therapy.”

“I don't agree that epidurals are not an alternative (to opioids) already. They are. They are. I just had a conversation with a surgeon about that. So that's not so,” said Rep. Anna Eshoo (R-CA).  “Imagine being able to manage pain without taking an opioid. We could do 20 other things together and it wouldn't equal that."

Rep. Frank Pallone (D-NJ) wasn’t buying any of it.

“I don’t think we have gotten any objective criteria to suggest that what CMS did is going to lead to more people taking opiates,” Pallone said. “I don't think there is any evidence to suggest that this legislation will lead to decreased opioid prescribing or a decreased prevalence of addiction.

“I think we are setting a bad precedent with the bill. I don't think that we, as Congress, are in a good position to pick and choose winners amongst therapies and procedures. I just don't think we know enough to understand the consequences of doing that to understand the relative value and the efficacy of different therapies and procedures on the market.”

Despite those concerns -- and after just 30 minutes of debate that included no public testimony -- committee members overwhelmingly supported the bill by a vote of 36 to 14. Nine Democrats joined with all Republicans on the committee in voting yes.

“What we are doing is temporarily reversing cuts to non-opioid treatment that we all agree save money and lives, then collecting to help ensure we are reimbursing providers at the most appropriate levels possible,” Shimkus said.

“That’s ASIPP talking,” says Terri Lewis, PhD, a researcher and longtime advocate for the pain community. “What does Shimkus know? Shimkus doesn’t know anything. There is no data to support that.”

Health Risks of Spinal Injections

There was no discussion by the committee about the effectiveness of epidurals and other spinal injections -- or of the health risks associated with their use.

Epidural injections have long been used to relieve pain during childbirth, but they are also increasingly being used to treat back pain, despite reports there is little evidence the shots are effective.

The FDA has also warned that the use of steroids in spinal injections – a procedure that’s never been approved by the agency -- “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

“Here we have a procedure that they’re trying to slip under the swimming pool fence that is not FDA approved, that relies on materials that are not regulated and/or contraindicated, and they’re trying to pull a fast one. And they could very easily do it in this climate of opioid hysteria,” said Lewis.

As PNN has reported, some pain management experts believe spinal injections are overused – in part because they’re more profitable for doctors than using opioids or other procedures.  


“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

A 2012 report by the General Accounting Office – a report requested by Rep. Pallone – found that unsanitary injection practices in ambulatory care clinics expose thousands of patients every year to blood borne pathogens such as hepatitis and HIV.  A perfectly sanitary needle can also go astray and puncture sensitive membranes in the spinal cord, leaving patients with serious and sometimes permanent injuries.      

“When it comes to spinal injections after surgery the risk to the patient, related to adverse events, increases substantially because spine surgery comes with risks of dural tears and accidental cuts,” says Terri Anderson, a Montana woman whose spine was damaged after receiving steroid injections for a ruptured disc in her back.  She now suffers from adhesive arachnoiditis, a chronic inflammation in the spinal membrane that causes severe pain.

“It is unconscionable that harmful injections would be pushed on unsuspecting pain patients,” Anderson said in an email to PNN. “It looks like the large hospital corporations and interventional pain professional societies have been busy lobbying our congressional representatives.  Apparently our healthcare system has become a profitable venture that indirectly contributes to many election campaigns in the U.S.”

No date has been set for a full House vote on HR 5804. To become law, it must pass both the House and Senate and then be signed by President Trump.  There is little opposition to the bill because many critics only recently learned that it was even being considered by Congress. 

“If this is allowed to stand, we have a problem,” says Lewis. “Another thing is Congress directing the practice of medicine. We’ve had just about enough of that.”

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.

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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.

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."

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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, 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.

GAO Seeks Expanded Tracking of Medicare Rx Opioids

By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use 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,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”


Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”


Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

"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 would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.



“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.

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. 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.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberationsThe CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

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 "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

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.

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.



“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.”       

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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.

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“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.”