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.”

Most Employees Want Insurers to Cover Medical Cannabis

By Pat Anson, PNN Editor

A new survey highlights the divide that often exists between patients, doctors and employers when it comes to using medical cannabis.

EO Care Inc. surveyed 1,027 Americans on their views and use of cannabis. All respondents were employed, either full or part-time, and lived in states where cannabis is legal for medical and/or recreational use.

Nearly one in five (18%) said they had used cannabis for health reasons in the past year, primarily for pain, anxiety, and to help them sleep. A large majority --- 88% --- said it helped them reduce their use of prescription drugs, alcohol or both.

Medical cannabis is so popular that 56% of workers said they would be more likely to take a job at a company that has a health plan that covers cannabis. And nearly half (44%) said they would reconsider applying for a job at a company that tested employees for cannabis or prohibited its use outside the workplace.

Nearly two thirds (65%) said they would feel more comfortable using medical cannabis if they were screened and dosed by a physician. And over half (51%) said they would be likely or very likely to use cannabis if it was covered by their insurer.

Previous surveys have found that doctors and patients are often reluctant to discuss cannabis. Many patients fear they’ll be labeled as drug abusers and lose their jobs if they admit using cannabis; while many doctors don’t consider themselves educated enough to recommend cannabis or have doubts about its safety and effectiveness.

“Finding clinical guidance for medicinal cannabis is difficult because most doctors lack the knowledge and retail dispensaries are not equipped to provide medical advice,” Sean Collins, co-founder and CEO of EO Care, said in a news release. “As a result we have tens of millions of Americans using cannabis for health reasons without guidance on specific product recommendations, dosage amounts, possible drug interactions, or consideration of their health history and other potential health risks.”

EO Care provides its members with access to clinicians who, based on a patient’s needs and medical history, develops a personal cannabis plan for them that includes recommendations for specific CBD and THC products and dosages. Members gain access to EO Care through employers who offer the program as a health benefit.

The company is trying to convince employers that offering cannabis care will help attract and retain good workers. Unguided cannabis use can lead to health issues, bad reactions or even abuse, leading to more sick days and loss of productivity.

“We know a large percentage of Americans have used cannabis in the past year, so this is definitely impacting employees and health outcomes,” said Collins. “With the right medicinal cannabis guidance, employers have an opportunity to help their employees, improve health outcomes and be progressive leaders in offering this important benefit that employees will come to expect.”

Currently, most employers and insurers don’t offer cannabis care, but attitudes are changing. A state court in Pennsylvania recently ruled that workers’ compensation plans must cover medical cannabis when an employee uses it to recover from a workplace-related injury. The court ruled that employees in Pennsylvania had “a statutory right” under state law to be reimbursed for medical cannabis.

Advocacy Group Calls on Insurers to Modify Step Therapy for Migraine Treatment

By Pat Anson. PNN Editor

The National Headache Foundation (NHF) is calling on health insurers to stop using rigid “step therapy” policies and make it easier for migraine patients to get access to new treatments.

Step therapy is a common practice in the insurance industry to control costs. It requires patients to try cheaper and often older medications first, before “stepping up” to drugs that cost more.   

“For too long, migraine patients have been treated differently than others with medical issues as it relates to access to prescription medications. Specifically, clinicians are often forced to use outdated prescription drugs in a stepwise approach to all patients, without considering the needs of the individual patient,” said Thomas Dabertin, Executive Director/CEO of NHF, a non-profit that seeks to raise awareness about migraine and headache disorders.  

“Unfortunately, the current care models adopted by payers have not kept pace with the many advances in treatment. As a result, clinicians are using older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist.”

Migraine treatment has been revolutionized in recent years by the introduction of neuromodulation devices and drugs that inhibit calcitonin gene-related peptides (CGRP), proteins that cause migraine pain. CGRP inhibitors cost several thousand dollars a year, while neuromodulation devices usually cost several hundred dollars.

Older drugs used to treat or prevent migraine, such as triptans, antidepressants and over-the-counter pain relievers, are much cheaper and often come in generic formulations. Many Insurers require patients to try at least two of the older medications first -- and for months at a time -- before authorizing newer therapies.

“NHF believes it is inappropriate to require all patients to follow this ‘try two and fail’ model before they may be offered treatment with any FDA-approved migraine preventive, including neuromodulation devices, with established lower adverse event profiles,” the NHF said in a position statement.

“For patients who are highly impacted or disabled by migraine, clinicians should not be directed to deliver outdated models of care that apply a predetermined algorithm in a stepwise approach to all patients, without considering the needs of the individual patient, and that encourage the use of older preventive drugs when targeted and migraine-specific therapies now exist.”

The NHF wants insurers to adopt modified forms of step therapy for migraine sufferers, based on the severity of their disease and the frequency of their attacks.

For patients who have seven or fewer migraine days per month, the NHF recommends that patients be required to try only one generic drug for migraine prevention. For patients who experience 8 or more migraine days per month, the foundation recommends that providers have “unfettered access” to FDA-approved prevention drugs.

For the treatment of acute migraine pain, the NHF recommends that two generic drugs be tried first, but if the drugs fail to work within two hours or have unwelcome side effects, providers be allowed to select “another suitable therapy” based on a patient’s needs.  

“The NHF advocates that payers adopt care models that are patient-centric, where the clinician, in collaboration with the patient, is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs,” Dabertin said.

Although the NHF accepts donations from the pharmaceutical industry, Dabertin told PNN the foundation’s new position statement was based solely on input from patients and providers.

How to Scrub Up, Stock Up and Hole Up During Coronavirus Pandemic

By Roger Chriss, PNN Columnist

The coronavirus pandemic is now a national emergency. The CDC has a web page specifically for high risk populations, which is older people and those with chronic health conditions. The key advice is to scrub up, stock up, and hole up.

But stocking up on medication (particularly opioids), scrubbing up hands in splints, and holing up safely are going to be hard for people with chronic illness. Here are some useful suggestions.

Stocking Up on Meds

There are ways to stock up on prescription medications and some states are helping. The Washington State Department of Health has asked all insurance companies to allow people to get a one-time refill of their prescription medications before the end of the waiting period between refills.

However, the agency’s website notes that: “Your insurance company may have limitations on refills for certain drugs like opioids.”  

NPR reports that pharmacies may also be able to help, so a talk with your pharmacist may be worthwhile.

Scrubbing Up With Physical Limitations

Scrubbing up is essential, of course, but the need to wear braces and splints makes this difficult for people with Ehlers-Danlos syndrome, arthritis and other health conditions. Cleaning wrist braces is a challenge. One way to reduce the need for cleaning is to minimize use when out, or to use braces that are more easily cleaned.

Another trick is to eschew braces when out and rely on snug winter gloves, which can be easily washed once home. Late winter is often a good time to stock up on gloves because of end-of-season sales. And such gloves may be adequate for stabilization in people with less serious disease.

Of course, it is also important to keep your hands away from your face. People with mobility issues may be in frequent contact with what the CDC calls “high-touch surfaces in public places” (think railings and banisters) in order to maintain stability and walk safely. Hard-hit areas like Washington State are already encourage or require regular sanitizing of such surfaces, but extra caution is required.

Holing Up Safely

Holing up may be something people with chronic illness are well practiced at. But there are important differences because of the coronavirus.

In an article about elder care, STAT News suggests that seniors limit visits with people who may be sick and rely on digital communication instead.

Max Brooks explains why that’s important.

A message from me and my dad, @Melbrooks. #coronavirus #DontBeASpreader pic.twitter.com/Hqhc4fFXbe

— Max Brooks (@maxbrooksauthor) March 16, 2020

But to “hunker in a bunker” safely and sanely for weeks requires more. Hospitals and clinics in coronavirus hotspots are already limiting elective procedures and delaying routine care. Staying safe at home while holing up is key.

This means avoiding triggers that can cause exacerbation, as well as activities that impose undue risks. So no home improvement projects, experiments with new recipes or supplements, tests of new fitness activities, or major changes in daily routines.

Of course, things will go wrong. CNBC reports that 54% of Americans are not financially prepared to handle a contagious disease like coronavirus that may limit their ability to work for a few weeks. CNBC suggests phone consultations, telehealth, and avoiding ERs.

Some states are moving to improve access to health insurance in this critical period. Massachusetts and Washington State have both added a special enrollment period for their Affordable Care Act exchanges for people who need health insurance.

As public health authorities issue more general recommendations, people with chronic pain disorders will need to be mindful and take extra precautions on how to stay healthy and functional in the face of the coronavirus. Resources like the ones listed above may help fill in the gaps during this difficult time.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

AMA: ‘Inappropriate Use’ of CDC Guideline Should Stop

By Pat Anson, PNN Editor

Two and a half years after the release of the CDC’s opioid prescribing guideline, the American Medical Association has finally taken a stand against the “misapplication” and “inappropriate use” of the guideline by insurers, pharmacists, federal regulators and state governments.

Although the guideline is voluntary and only intended for primary care physicians treating non-cancer pain, many pain patients have been forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing addiction and overdoses. The CDC has stood by and done nothing to correct the false portrayal of its guideline by insurance companies and pharmacies such as CVS.

The genie may be out of the bottle, but the AMA is now trying put it back in.

At its interim meeting in Maryland this week, the AMA House of Delegates adopted a series of resolutions that call for restraint in implementing the CDC guideline – particularly as it applies to the agency’s maximum recommend dose of 90mg MME (morphine equivalent units).

RESOLVED that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioids at greater dosages than recommended by the CDC Guidelines for Prescribing Opioids for chronic pain and that such care may be medically necessary and appropriate.

RESOLVED that our AMA advocate against the misapplication of the CDC Guidelines for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.

RESOLVED that our AMA advocate that no entity should use MME thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.

“I was gratified to see these resolutions from AMA. This problem has been developing for some time, but really seems to have picked up steam over the past year, especially with respect to limits placed by pharmacy chains and insurers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It would have been good to see this kind of statement when various entities first began misinterpreting and misapplying the CDC guideline, but I also understand the need to ensure that a problem develops before proposing a solution.”

“Great to see the AMA is finally stepping up to help bring common sense to the ill-conceived and frankly very harmful CDC guideline,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Unfortunately too many people have already been a victim of CDC’s misguided attempt to address the opioid problem.” 

Guideline Not Mandatory

Missing from the resolutions is any recognition by the AMA that many of its own members – the organization represents over 200,000 physicians – have been lying to their patients or remain wilfully ignorant about the voluntary nature of the CDC guideline.  

“Earlier this year my doctor explained that he was required to reduce my pain medications. I was shocked. He explained that new opioid prescribing guidelines were requiring patients to be reduced across the board, regardless of their condition,” pain patient Liz Ott wrote in a recent guest column. 

“My current doctor is currently weaning me off the last of my opioids, stripping me of the last tiny bit of medication that have any effect on my pain,” wrote Michael Emelio in another guest column. “After talking to half a dozen pain management doctors this year, I believe that they have been so programmed by the anti-opioid propaganda that many believe they're doing the right thing and fail to realize the true extent of the suffering they have caused.”

“A pharmacist decided to cut my opioid medication in half without permission from me or my doctor. It took 3 months to fix this and find a pharmacy to fill my medication,” wrote Deann Goudy in her guest column.

Even the AMA’s president had a patient – a man with advanced prostate cancer – who couldn’t get an opioid prescription filled by a suspicious pharmacist.

“The pharmacist suspected my patient was a drug seeker and did not alert me that his prescription was denied. My patient, a very proud man, felt shamed and didn’t know what to do. So, he went home to be as tough as he felt he could be. That worked for about three days and then he tried to kill himself,” Barbara McAneny, MD, said in a speech this week at the AMA meeting.

“My patient suffered, in part, because of the crackdown on opioids… When I visited my patient in the hospital as he was recovering from his suicide attempt, I apologized for not knowing his medication was denied. I felt I had failed him.”

The AMA has failed pain patients in the past. In 2016, just months after the release of the CDC guideline,  the AMA House of Delegates recommended that pain be removed as a “fifth vital sign” in professional medical standards – a move that pain management experts warned against because it could lead to delays in getting a diagnosis and treatment.  

AMA delegates that year also passed a resolution urging The Joint Commission to stop requiring hospitals to ask patients about the quality of their pain care. Medicare has a funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys, but critics contended that questions about pain promoted opioid prescribing. They offered no credible evidence to support their claims, but the pain questions were soon dropped from patient satisfaction surveys.

Insurers Promise More Cuts in Rx Opioids

By Pat Anson, Editor

Less than two weeks before its final report is due, President Trump’s opioid commission held its fourth and final public meeting Friday – hearing testimony from top government officials and insurance industry executives about the nation’s worsening overdose crisis.

“Insurance companies are going to be a very, very important part of whether we will be able to stem the tide here or whether we’re not,” said commission chairman Gov. Chris Christie of New Jersey.

It was clear from their testimony that many insurers are planning to tighten access to prescription opioids even more than they already have.

Aetna’s chief medical officer told the commission the insurance giant was planning to reduce “inappropriate opioid prescribing” to its members by 50 percent within the next five years.  He did not explain what would be considered inappropriate.

Aetna has already sent warning letters to hundreds of physicians and dentists identified as “super-prescribers,” urging them to reduce the number of opioid prescriptions they write.

“We’re now re-running our analysis and planning more aggressive interventions for those providers who haven’t improved their opioid prescribing habits over the past several months,” said Harold Paz, MD.  

The chief medical officer of Cigna said his company was close to achieving a 25 percent reduction in coverage of opioid prescriptions, a priority it set last year.

“That’s only the first of our goals,” said Alan Muney, MD.

Insurer Harvard Pilgrim said its coverage of opioid prescriptions has declined by over 20 percent since 2014.

“That’s not enough.  This feels like a balloon where you tap on one end and it comes out somewhere else. So it doesn’t mean we’re even close to solving this,” said Michael Sherman, MD, chief medical officer of Harvard Pilgrim.

Insurers clearly have the ear of the federal government when it comes to opioids. As PNN has reported, an obscure federal advisory group composed of insurers, law enforcement, and federal and state regulators has discussed eliminating opioid prescriptions for acute pain, as well as paying doctors not to prescribe opioids.

The Healthcare Fraud Prevention Partnership also wants access to the “personally identifiable and protected health information” of 57 million Medicare beneficiaries to see if they are abusing opioids.

Reducing Opioids a ‘Win-Win’

Labor Secretary Alexander Acosta said reducing opioid prescriptions was important to get unemployed Americans back into the workforce. He cited a recent study that found that about a third of unemployed men aged 25 to 54 were using prescription painkillers.   

“Reducing the amount of opioids is a win-win across the board. It’s a win for the individual who doesn’t want to get hooked,” Acosta said. “It’s a win for the insurance companies who don’t want to be paying for medicines that people don’t need. And it’s a win for the American workforce, because if we can get people back to work and paying taxes and participating fully, that’s a win for them and it’s a win for the country.”

Acosta cited no studies that might indicate how many Americans currently taking opioids would become unemployed or disabled if their pain medication was reduced or taken away. 

No pain patients, patient advocates or experts in pain management were asked to appear before the commission. No one from the pain community has testified during any of the commission’s public meetings, although thousands have submitted written comments.

An interim report released by the opioid commission in July focused on expanding access to addiction treatment and developing new ways of treating pain without opioids. Since then, the commission has increasingly focused on limiting opioid prescriptions. The final report from the commission is expected November 1.

The interim report also strongly urged President Trump to declare a national emergency to speed up efforts to combat the overdose crisis, something he has yet to do.  “We’re going to be doing it in the next week,” Trump told reporters on Monday.  However, there appears to be little consensus in the administration about what actions to take after an emergency is declared or how to pay for them.

"Everyone wants opioids to be a priority, but there's a lot of resistance to calling it an emergency," a senior administration official told Politico.