A Third of Independent Pharmacies May Close

By Pat Anson, PNN Editor

These are tough times for many retail pharmacies and their customers. Big chain pharmacies like CVS, Walgreens and Rite Aid are closing over 1,500 stores, as they grapple with declining sales, higher debt, drug shortages, fallout from opioid litigation, and an overworked, demoralized workforce.

For many patients who had trouble getting their prescriptions filled for opioids and other controlled substances, small independent pharmacies became a welcome refuge from the big chains.

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” one patient told us.

But now even the independent pharmacies are threatened. About a third of them could close in 2024, according to a dire prediction from the National Community Pharmacists Association (NCPA), a trade group that represents nearly 20,000 independent pharmacy owners in the U.S.

“Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” says B. Douglas Hoey, RPh, NCPA’s CEO.

At issue is a new rule by the Centers for Medicare & Medicaid Services (CMS) that requires insurers and pharmacy benefit managers (PBMs) to implement discounts and price concessions at the point of sale, where a drug is dispensed. The rule is intended to make pricing more transparent for patients, but it’s hurting the bottom line of pharmacies who say the discounts are being unfairly forced on them by insurers.

Part D Prescriptions at Risk

In a recent survey of NCPA members, 32% said they may have to close by the end of the year due to the CMS rule and 93% said they’d consider dropping out of Medicare’s Part D prescription drug program. Most say they are losing money on Part D prescriptions, which don’t compensate the pharmacies for rent, taxes, payroll and other costs of doing business.

“Cash flow for many pharmacies remains in a precarious state, leading to dire concerns for beneficiary access. Our members continue to experience significant harm from egregious Medicare Part D PBM practices,” Hoey wrote in a letter to CMS, which faulted the agency for doing little to stop the PBMs.

Asked which PBMs are causing the most financial stress in the Part D program, almost half the NCPA members identified Express Scripts, with CVS/Caremark coming in at 35 percent.

Hoey says CMS already has the legal authority to change reimbursement practices, but wants Congress to intervene if CMS doesn’t act soon.

“This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy,” Hoey said in a statement.

NCPA says there are about 2,200 fewer retail pharmacies today than there were four years ago. This has created hundreds of pharmacy “deserts,” primarily in low-income rural and urban areas, where access to a pharmacy is limited or non-existent. Alabama alone has lost 300 pharmacies in recent years.

“With every closure, 5,000 Alabamians are left without a critically important health care provider. This is a major issue for every community in our state, but rural Alabama is hit the hardest. In many cases, that local pharmacy is the only healthcare provider in that rural community,” Alabama State Rep. Phillip Rigsby, a pharmacist, wrote in an op/ed published in AL.com.

“In other businesses, if an operating cost increases, the company’s prices increase to compensate. In pharmacy, that just is not possible. A pharmacy cannot pass on that cost to a patient because the contract doesn’t allow for that.”

Breakthrough Medical Devices to Receive Medicare Coverage

By Pat Anson, PNN Editor

Medical device manufacturers are cheering a decision by the Centers for Medicare & Medicaid Services (CMS) to have Medicare begin covering hundreds of “Breakthrough Devices” certified by the Food and Drug Administration.

The FDA’s Breakthrough Device Program was launched in 2018 to speed up the development of innovative technology for the treatment and diagnosis of life-threatening or debilitating medical conditions such as chronic pain. But FDA approval was then followed by a lengthy and costly review process for Medicare coverage, which delayed patient access to the devices.

The Medicare Coverage of Innovative Technology (MCIT) rule change allows Medicare to begin covering breakthrough devices simultaneous to FDA approval, making them immediately available to over 60 million Medicare beneficiaries. The rule change goes into effect March 15.

“Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” CMS Administrator Seema Verma said in a statement. “CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”

The rule change benefits companies like San Francisco-based Bone Health Technologies, which announced last month that its OsteoBoost Vibration Belt had received breakthrough device approval as a treatment for osteopenia, a precursor to osteoporosis.

“We are thrilled by this announcement as it will help us get our potentially life-changing device, affordably into the hands of patients who need it much more quickly,” said Laura Yecies, CEO of Bone Health Technologies. “There is a lack of safe, effective treatments for osteopenia, a condition that effects over 40 million Americans. It is exciting that CMS is supporting the efforts of companies working to solve these important unmet needs."

Another company likely to benefit is AppliedVR, which announced in October that its virtual reality headset had received breakthrough device approval as a treatment for fibromyalgia and chronic intractable low back pain.

“This new rule change means that Medicare recipients in need of pain relief will have access to our novel chronic pain therapy,” said Josh Sackman, co-founder and president of AppliedVR, who believes Medicare reimbursements will help speed up coverage of breakthrough devices by private insurers.  

“The MCIT rule change doesn’t directly impact coverage from commercial payers. They will continue to have their own standards for evidence and require new products to follow the existing evaluation process. However, the mandatory Medicare coverage will accelerate products getting into the market, where real world evidence will be collected on the value of those Breakthrough Devices,” Sackman explained in an email to PNN. 

“This data is extremely valuable for commercial payers to assess coverage. This should have a halo effect with payers that see the benefits of a breakthrough device in their Medicare book of business and may help them choose to expand coverage to their other lines of business, including commercial plans.”

Medicare coverage of a breakthrough device will initially be limited to four years. After the coverage period is over, CMS will reevaluate the devices based on clinical evidence of their effectiveness. Importantly, the four-year window also creates a revenue stream for manufacturers to continue improving their devices or invent new ones.

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 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.

SOURCE: HHS OFFICE OF INSPECTOR GENERAL

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. 

“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 OpenSecrets.org, 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.

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."

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.

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.

ANDREW KOLODNY, MD

“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 deliberations.  The 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.

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.”

Law Firm Wants Transparency in Medicare Opioid Policy

By Pat Anson, Editor

A Washington-based legal firm is calling for more openness and transparency by the Centers for Medicare and Medicaid Services (CMS) as it establishes new rules that are likely to limit access to opioid pain medication for millions of Medicare patients.

“While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management,” wrote Michelle Stilwell, a staff attorney for the Washington Legal Foundation (WLF), a non-profit law firm that generally supports business groups and companies in litigation against government agencies.

At issue are mandatory rules being developed by CMS for 2018 that would bring Medicare opioid policies into alignment with the “voluntary” prescribing guidelines released last year by the Centers for Disease Control and Prevention.

CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist.

Stilwell wrote on the WLF's blog that patients and providers were given little opportunity to see and comment on a Call Letter announcing the rule changes, while the insurance industry was.

“CMS’s changes will inevitably lead to even tighter restrictions on opioid prescriptions—which directly affects the patient community.  Many patients, doctors, and healthcare providers already complain that rules designed to prevent the improper prescribing of opioids are complicating patients’ legitimate access to appropriate medication,” said Stilwell. 

“But instead of directing this Call Letter at the affected patient community and granting that community an adequate opportunity to comment on the new opioid overutilization criteria, CMS directed it only to insurance companies.  In reality, opioid consumers and providers are given little to no notice or opportunity to comment."

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS rules, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of insurers, law enforcement agencies and government regulators formed to combat insurance fraud. The HFFP met to discuss the white paper in a “special session” last October that was not open to the public.

Stilwell said the HFFP “operates largely in the dark” and may be in violation of the Federal Advisory Committee Act (FACA), which requires open meetings for all federal advisory panels. This week the WLF filed a Freedom of Information Act Request seeking more information about HFPP membership and meetings.

Major insurers such as Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation participate in the HFPP.

“It is time for CMS to bring HFPP into compliance with FACA requirements.  Doing so will reduce the risk that a court may invalidate any CMS policies found to have been adopted at least in part in reliance on HFPP recommendations.  It would also enable any patients affected by changes in opioid reimbursement policies to play a role in the development of HFPP’s opioid-related recommendations,” Stilwell wrote.

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

In addition to limits on opioid prescribing, CMS plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who regularly prescribe high doses of opioids. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged. Insurers would be required to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

FDA to 'Take Whatever Steps We Can’ to Stop Opioid Abuse

Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”

In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.

Gottlieb wants the committee to focus on three areas:

scott gottlieb, MD

• Consider mandatory education for health care professionals about opioid prescribing recommendations and how to identify patients at risk of abuse.
• Establish limits on the dose and quantity of opioid medication that are more closely tailored to the medical condition a patient is being treated for.
• Review the process the FDA uses to evaluate and approve new opioid medications.

Gottlieb cited some questionable statistics to dramatize the extent of the opioid prescription problem.

“In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids,” he wrote.

The new FDA commissioner may want to check his facts. As PNN has reported, a news release last December from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids.

A CDC news release a few days later provided an an even lower estimate; that over 12,700 Americans died from pain medications in 2015.

When asked to explain the discrepancy, PNN was given a third estimate by the CDC, which put the number of deaths involving prescription opioids at 15,281 in 2015.

Gootlieb's post links to a CDC website that provides a fourth estimate, which is based on a "standard analysis approach" that combines all overdoses caused by natural, semi-synthetic, and synthetic opioids. Such an approach is misleading, because it counts overdoses caused by illicit fentanyl as prescription drug deaths. 

"Unfortunately, information reported about overdose deaths does not distinguish pharmaceutical fentanyl from illegally-made fentanyl," the CDC said, which Gottlieb neglected to mention in his blog post.

Medicare Modifies Opioid Prescribing Plan

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) is moving ahead with plans to align its Medicare Advantage and Part D prescription drug plans with the CDC’s opioid prescribing guidelines.

However, the agency has modified a policy to ensure that high doses of opioids that are medically necessary can still be prescribed.

Like the CDC guideline, CMS is recommending a daily ceiling on opioid pain medication at 90 mgs of a morphine equivalent dose (MED).  If a dose exceeds that level, Medicare insurers are expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. 

Under a previous proposal, insurance companies could also impose a “hard edit” that could not be overridden on prescriptions that exceed 200 mgs of MED. The modification allows a pharmacist to override the edit if the prescribing physician says the dose is medically needed.

“Point of sale edits are not intended to substitute physician judgment or dictate a prescribing limit. If a sponsor (insurer) chooses to implement a hard edit, CMS expects the sponsor to rely only on prescriber attestation that the MED is medically necessary to override the hard edit, and to not require additional clinical criteria,” a senior CMS official said in a news briefing.

“The edits are not to stop prescriptions. They’re to provide information to sponsors in real time as a preventative step, so that prescribers are aware of the amount of opioids that patients are receiving as well as that they may be receiving opioids from other doctors.  They are not prescriber limits and they are not to substitute for prescriber judgement.”

CMS said there was a “significant number of comments” from the public about its opioid prescribing proposal. Some doctors and patient advocacy groups expressed concern that pain patients who are medically stable on high opioids doses would be forced to taper to lower doses.

“My tentative judgement, based on quickly looking at the documents today, is that CMS carefully stepped back from the absolute requirement that would have caused patients at over 200 (MED) mgs to have a sudden crisis in their care,” said Stefan Kertesz, MD, a practicing physician and Associate Professor at the University of Alabama at Birmingham School of Medicine.

“That doesn’t mean that they have foresworn this course of action in the future, but they clearly registered that they heard concerns from patients, doctors and others, and to me that is a hopeful sign.”

CMS is still moving ahead with plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who prescribe high doses and the patients who receive them. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers are expected to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

As PNN has reported, the insurance industry appears to have played a major role in drafting the OMS plan, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

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.

Should CDC’s Opioid Guidelines Be Revised?

By Pat Anson, Editor

Suicidal patients. Illegal drug use. Hoarding of pain pills. Pharmacists refusing to fill prescriptions. Doctors worried about going to jail. Chronic pain going untreated.

Those are some of the many problems uncovered in a PNN survey of nearly 3,400 pain patients, doctors and healthcare providers, one year after the release of opioid prescribing guidelines by the Centers for Disease Control and Prevention (see "Survey Finds CDC Opioid Guidelines Harming Patients"). The guidelines were meant to be voluntary and are only intended for primary care doctors, but they're being widely implemented throughout the U.S. healthcare system – often with negative consequences for the patients they were intended to help.

Over 70 percent of patients say doctors have either reduced or stopped their opioid medication. Eight out of ten say their pain and quality of life are worse. Nearly half are having suicidal thoughts and some are hoarding opioids or turning to the black market for pain relief.

And hardly anyone believes the guideline has been successful in reducing opioid abuse and overdoses.

“This is astounding, but not surprising,” says Lynn Webster, MD, a leading expert in pain management and a longtime critic of the CDC guideline. “It may be time for the CDC to consider inviting the pain community to help revise the guideline to more align with a public health policy that finds a better balance of avoiding opioid related problems, while also allowing opioids to be used in a responsible way.  

“The CDC should not have issued the guideline without a plan to measure its possible benefits and unintended consequences.”

Does the CDC even have such a plan? PNN asked the agency if one exists and also for a comment on the survey findings. We have yet to get a response. 

The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the guidelines, also declined to comment on the survey findings.

“I’m not going to want to comment either way,” said Andrew Kolodny, MD, before launching into a defense of the guideline.

“Since the CDC guideline came out, the bad news on opioids for chronic pain continues to increase. The evidence keeps getting stronger and stronger that opioids are lousy drugs for most people with chronic pain,” said Kolodny, who is Co-Director of the Opioid Policy Research Collaborative at Brandeis University.

“Opioids for chronic pain should be a rare treatment. And unfortunately the practice is widespread. Millions of people like your readers are victims of this aggressive prescribing,” he told PNN.

CDC Pledged to Revise Guideline if Needed

The closing words of the CDC guideline say the agency is “committed” to revising it if evidence is found that it's not helping patients or doctors.

“CDC will revisit this guideline as new evidence becomes available,” the agency pledged last year. “CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Some critics are skeptical that CDC has any intention to revise the guideline.

“I am not aware of any actions which would demonstrate that the CDC is actually open to revising their guideline, especially when they knew of the problems in advance of its release,” said Stephen Ziegler, PhD, a Professor Emeritus of Public Policy at Indiana University-Purdue University.

“Instead of revising, did they instead opt to hire a PR firm? The negative outcomes, while unintended, were nevertheless foreseeable.”

Ziegler is referring to a contract the CDC signed last year with PRR – a Seattle-based public relations firm – to provide research and analysis for the agency. The research wasn’t focused on the “intended and unintended” impact of the guidelines, but on why they were received so poorly in the pain community.   

“They’ve heard a lot of outrage about this,” a source at PRR told us. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

Lynn Webster thinks the CDC needs to do more than hire a public relations consultant.

“I think it is time for Congress to ask the CDC to provide them a detailed report on the impact the opioid prescribing guideline has had on access to appropriate pain management, quality of care for people in pain, access to insurance coverage of alternative and complementary therapies recommended by the guideline, impact on the number of opioid related overdoses, rate of change reported in treatment for opioid use disorder, and change in possible suicide rate with people in pain due to inadequately treated pain,” said Webster, a former President of the American Academy of Pain Medicine.

Voluntary Recommendations Become Mandatory

Some believe the problem isn’t so much the wording of the guideline as the way it is being implemented by physicians, states, insurers and other federal agencies like the Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). They’ve turned the CDC’s voluntary recommendations for primary care doctors into mandatory rules that all prescribers have to follow. 

“I've said about both the CDC guideline and the Washington state guidelines from years ago, that what they actually say isn't so bad. I can live with most of it. The problem is that people take what is there and turn it into something it shouldn't be,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“With respect to the CDC guideline, the problem is that everyone is trying to turn it into laws, rules, and criteria for prior authorization for payment, and those things absolutely shouldn't be done. If everyone treated it as what it is -- a series of expert-drafted suggestions -- we'd be doing OK. It might even have helped a lot of people.”

Millions of veterans and Medicare beneficiaries are about to learn what Twillman means about the guideline being turned “into something it shouldn’t be.”  

CMS is planning to adopt new rules to “better align” its policies with the CDC’s.  Medicare’s “Opioid Misuse Strategy” not only makes the guidelines mandatory, it allows insurance companies to take punitive action against doctors, pharmacists and patients who don’t follow them.

The VA and Pentagon have also released new guidelines that take the CDC’s recommendations a big step further. They strongly recommend against prescribing opioids long-term to anyone under the age of 30, and urge VA and military doctors to taper or discontinue opioids for any patients currently receiving high doses.

“You should take a look at the VA guideline that just came out, if you don’t like the CDC guideline,” says Andrew Kolodny. “The VA guideline is even stronger. It says don’t give opioids. Opioids are not preferred. Don’t do it.”

Lost in the shuffle of all these new rules and regulations is the voice of pain patients. Many who responded to our survey are fearful of becoming disabled or bedridden if opioids are taken away from them. And some believe the government has an ulterior motive.

“This is a silent genocide aimed squarely at Baby Boomers. An expedited way to avoid paying Social Security benefits to those who are approaching retirement or are receiving benefits. I am ashamed of our country,” wrote one patient.

“Completely wrong approach which will, I believe, result in more addiction as patients experiencing intolerable suffering are forced to look outside the medical system for relief,” said another.

“This is going to backfire on the CDC, Medicare, Medicaid, etc. The CDC is punishing every single person on pain medications,” wrote another patient. “People will die because of this, but they don't seem to care about any of the consequences of these guidelines. Being in pain is a terrible thing, I know from experience. I wouldn't even be able to work if it weren't for my pain medication. This is all very stressing, and I only see bad results coming out of this.”

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11 by Pain News Network and the International Pain Foundation (iPain).

To see the complete survey results, click here.

Are We Near an Opioid Tipping Point?

By Roger Chriss, Columnist

We are fast approaching a tipping point in the opioid medication crisis.

Consider all that is happening:

The Centers for Medicare and Medicaid Research (CMS) wants to adopt the CDC guidelines as mandatory rules for prescribing opioids to Medicare recipients. CMS has proposed a daily ceiling on opioid medication as low as 90 milligrams morphine equivalent dose (MED) for millions of people.

The National Committee for Quality Assurance (NCQA) has proposed a daily limit on opioids of 120 MED for no more than 90 consecutive days.

The Pentagon and the Department of Veterans Affairs are also seeking greater restrictions on opioids, including a recommendation not to prescribe them for chronic pain to anyone under the age of 30.

States are clamping down on the dose and duration of opioid prescriptions. Maine has passed legislation severely restricting opioid prescribing, joining states like New Jersey, Virginia and Washington in tightly regulating opioids. Although there are exceptions for cancer pain and end-of-life care, people with chronic or intractable pain are being forced to taper their dose or replace opioids with less effective options.

Taxes on opioids are under consideration in New York and in California, which is also looking at prohibiting people under 21 from receiving oxycodone.

Rhetoric is reaching propaganda-like levels of hyperbole in the so-called war on opioids. The Hill recently ran a blog post with the headline “Chemical weapons of mass destruction on US soil.” It opens with the statement that “America is under attack. Chemical weapons of mass destruction are now in every city nationwide in the form of opioid drugs.”

The Huffington Post Canada has a similarly alarmist post claiming that “fully one-third of Americans who are given prescription opioids become addicted within two months.” It also claims that "pharmaceutical companies in Brazil and China are bucking the trend by running training seminars urging doctors to prescribe more painkillers rather than less.”

In an interview in MedPageToday, Dr. Daniel Clauw states that "I haven't prescribed an opioid for chronic pain in at least a decade," without ever clarifying what the outcomes were for his patients.

Predictions about the crisis are more dire. A recent article in MarketWatch headlined “America’s battle with drugs: Fatal overdoses spike among white, middle-aged men” said researchers at Columbia University have predicted that fatal drug overdoses “will peak at 50,000 annual deaths in 2017 before declining to ‘a non-epidemic state’ of 6,000 deaths in 2035.”

We are on the verge of an opioid tipping point, approaching the kind of prohibition the U.S. tried with alcohol almost 100 years ago. But rather than a Constitutional amendment, state governments and federal regulatory agencies are coming together like a swarm of angry bees to attack opioid substance abuse by clamping down on people who receive opioid therapy.

This is like trying to stop car thieves from driving recklessly by imposing new rules and regulations on safe drivers in their own cars.

The consequences of these restrictions are easy to see. People forced into rapid tapering to get their opioid dose into compliance with CDC guidelines are enduring dangerous side effects. People abruptly cut off from their pain medication are so overwhelmed by the pain of debilitating medical conditions that they contemplate or even commit suicide.

A column in STAT News recently discussed the “inhumane treatment” of pain patients, which Dr. Lynn Webster anticipated in his 2014 article, “Pain and Suicide: The Other Side of the Opioid Story.”

So why the race to restrict opioid medication? Is it so policymakers and legislators can say they did something? Are they playing defense and trying to pre-empt addiction? Does the rhetoric insulate them from facing the consequences for people with chronic or intractable pain?

Maybe the goal is to prevent addiction no matter the cost. But the cost is being born by the many people currently being successfully treated with opioid therapy.

This tipping point is a misguided step in a pointless direction. Even if it does help prevent a single case of substance abuse, it requires sacrificing the quality of life of thousands of people enduring the pain of chronic illness.

Worse, tipping points can happen very fast. But recovering from a tipping point and restoring balance in a system takes time. Which leads to a final question: How long will chronic and intractable pain patients have to suffer before policymakers and politicians see the harm restrictive opioid prescribing is causing?

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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