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.”

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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.”

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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

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 deliberationsThe CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

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.

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“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

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.

A Letter to Medicare From a Worried Pain Patient

Editor’s Note: This Friday marks the deadline for the public to comment on opioid prescribing guidelines proposed by the Centers for Medicare and Medicaid Services (CMS). As PNN has reported (see “Medicare Planning to Adopt CDC Opioid Guidelines”), the guidelines are likely to limit access to opioid pain medication for millions of Medicare beneficiaries. They would also empower insurance companies to take punitive action against pharmacies, doctors and patients that don’t follow the guidelines.

The following is a letter written in opposition to the CMS guidelines by Ms. Judith Botamer. She has graciously agreed to let us publish it here in the interest of getting more people to send their own comments to CMS. 

All comments should be emailed to CMS no later than March 3 to this address:

AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

As a disabled chronic pain patient, I strongly oppose the Centers for Medicare and Medicaid Services’ plan to accept policies from the recent CDC Guideline for Prescribing Opioids for Chronic Pain. I implore you to take action so that this mandate does not become a reality for the 100 million Americans who suffer with chronic pain, including many on Medicare.

The CDC guideline is simply a voluntary guide intended for primary care physicians only. The CMS guideline as written gives no margin or credence to pain management doctors who already have strict opioid policies, as well as an established ongoing relationship with their patients.

Your currently drafted policy makes the guidelines mandatory for all doctors, patients and pharmacists, and imposes a ceiling on the highest dose of opioids that can be prescribed. This gives physicians no discretion in determining what is right for their patients. That was never the CDC’s intent, nor is it feasible to expect all chronic pain patients to be able to maintain the level of care that their doctor has established for them.

I am permanently disabled with neuropathy, RA, fibromyalgia, torn disks, TMJD and migraines, as well as many other pain conditions for which there is no cure. At the young age of 53, I sometimes feel my life is over. If not for pain control from opioid medication, it surely would become a reality.

I never asked to be overcome with this much pain from so many “invisible illnesses.”  As a prior athlete, I am challenged daily to accept the reduced quality of life for myself and, in turn, for my family. Fortunately, my empathetic pain doctor will prescribe me enough medication so that I am functioning. If my current regimen were to be lowered to the amount set forth in this guideline, I would not be able to fully care for myself, perhaps be bedridden, and be left with a dramatically diminished quality of life.

This mandate actually takes away my right to a quality of life that I deserve. The burden of being struck with legitimate pain conditions should not equate to the loss of a right to live life with dignity, just as any other patient with any other chronic illness.

Many doctors are now frightened of prescribing pain medication for fear the CDC, DEA or FDA would sanction their license, when they simply want to fulfill their oath of “do no harm.” And let's be clear, not prescribing pain medication to a patient who is suffering, is doing harm! Not only for the patient, but for our communities and society as a whole.

To this point, on June 1, 2016, Dr. Debra Houry, the director of the CDC’s National Center for Injury Prevention and Control, wrote the following:


“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to try taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”
  

I truly hope that there is no collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.” Taking pain medication away from a pain patient will not stop the criminals, drug cartels or addicts. Those issues are worlds away. Pain patients are not addicts or looking for a “high.” They depend on their medication just as a diabetic depends on insulin for life quality.

Please join me and become an empathetic advocate for the millions who suffer in silence as a result of just a few who break the law and displace attention away from the real tragedy: Pain patients being denied medical treatment, being treated as criminals, and their doctors being threatened for only doing the right thing!

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,
Judith A. Botamer

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.

The Magical Opioid Number

By Roger Chriss, Guest Columnist

Numbers can be impressive. They seem like powerful evidence or useful metrics in regulations and legislation.

In 2016, the Centers for Disease Control and Prevention issued its guidelines for opioid prescribing, setting a recommended daily limit on opioid doses at 90 morphine milligram equivalent (MME). Now the Centers for Medicare and Medicaid Services (CMS) is on the cusp of adopting that number as a requirement for Medicare recipients. Physicians around the country have already started using it and so has the Veterans Administration.

In addition, Maine has passed a state law with a maximum 100 MME allowed for opioid prescribing starting on July 1, 2017. New Jersey, Virginia and other states are also passing laws restricting opioid prescribing by dose or duration, often citing the CDC guidelines as justification. 

But this number is all but arbitrary. The CDC guidelines recognize that the 90 MME ceiling was based on limited evidence. Obviously, patients are not safe at either 80 MME or doomed at 100 MME.

Nor can this number be used to calculate the safe number of days or doses for an opioid prescription. It is a magical number. And magical numbers can lead to magical thinking.

In fact, the 90 MME from the CDC cannot even be reliably calculated. The CDC offers an app that allows physicians to calculate the 90 MME. Its basic methodology is described here. Web sites like Practical Pain Management also offer an opioid calculator, and third-party developers have created opioid conversion apps.

But it turns out that the results of these calculators are inconsistent. Dr. Jeffery Fudin and his students have shown that the various methods of calculating MME produce significantly different outcomes.

Thus, how much of a morphine equivalent dose an individual is actually allowed to receive depends on which method is used. This uncertainty makes the 90 MME level clinically less than meaningful and potentially dangerous.

Existing research does show an increased risk of addiction and overdose as the daily dose of an opioid medication rises. But this is exactly what we should see. Most substances are more dangerous in larger quantities, after all. But each patient is different: gender, age, health status, prior opioid exposure, and other factors all play a significant role in determining a safe and effective dose of an opioid medication.

A cutoff like 90 MME is at best arbitrary. At worst it leaves some patients undertreated, and may harm patients who are forced to taper to the 90 MME threshold from a higher dose that has been safe and effective for them.

In addition, it is not entirely clear how the magic number of 90 MME was determined. The CDC developed its guidelines in a largely closed-door process that involved outside consultants whose identity was not revealed at the time. Most magical numbers are like this: their justification is thin and often obscured.

Meanwhile, the CMS and states like New Jersey and Maine are ignoring more important numbers. A recent STAT News article reported that opioid prescriptions have been falling since 2012 and that the misuse of pain relievers bottomed out in 2014. In other words, opioid prescribing is no longer a driving factor in the opioid crisis -- street drugs are.

The magical number of 90 MME is simply not justified. The relative risk of prescription opioids, in particular for people with chronic or intractable pain, is quite low. This fact was ignored in the CDC guidelines and in state government regulation. But it should be obvious: Most Americans have taken opioids at some point in their lives, whether after trauma or surgery or as a part of dental care. And it is abundantly clear that the majority have not become addicted to opioids. Again, the magic number is not real.

On February 9, 1950, Senator Joe McCarthy gave a speech in Wheeling, West Virginia, claiming that the U.S. State Department was infested with Communists, specifically 205 of them. This number helped launch a wave of political repression, fear-mongering, and social paranoia that we now refer to as McCarthyism. Nothing good came of that era, except maybe a cautionary note about how magical numbers can contribute to tragic results.

We are facing a similar risk with opioids, a magical number motivated by magical thinking by regulators and policymakers -- none of which is likely to help address the opioid crisis or the tragedy of addiction.

Instead, millions of people who may benefit from short-term opioid therapy after trauma or surgery will be denied effective medication for pain management, and tens of thousands of people with chronic conditions for whom opioid therapy is a critical component in maintaining a reasonable quality of life will be harmed. These are real numbers that we really need to pain attention to.

Roger Chriss suffers from Ehlers Danlos syndrome. 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.

How We Can Stop Medicare’s ‘Big Brother’ Opioid Policy

By Rick Martin, Guest Columnist

How many readers who leave comments on PNN are doing more than just commenting?

Change takes work if the pain community is going to stop the Centers for Medicare and Medicaid Services (CMS) from making the CDC’s opioid prescribing guidelines mandatory for millions of Medicare patients, including a ban on daily doses higher than 90 mg morphine equivalent (see “Medicare Planning to Adopt CDC Opioid Guidelines”).

We don’t need CMS and the insurance industry dictating what medication a physician can prescribe for pain or the appropriate amount of medication needed (see "Insurers Behind Medicare's 'Big Brother' Opioid Policy").

In my opinion, this is what needs to be done:

We have to start a chain letter.

I propose a form letter that everyone can copy and paste, forward, fax and mail to friends, family, caregivers, bloggers, Facebook, Twitter, and any other viable means of communication.  

You have to send it to at least 10 people. And ask them to send it to 10 people they know.

The letter also needs to be sent to patient advocacy groups like the U.S. Pain Foundation, American Chronic Pain Association, International Pain Foundation and the Alliance for Balanced Pain Management, a coalition of advocacy groups. They can post it in their newsletters and alert their members to what CMS is doing. This is the only way to reach a huge amount of people in a short amount of time. 

Here are their email addresses:

We need to rein in CMS from dictating how we should live and the ability of our physicians to treat us. It won’t be easy. It took me 27 letters to the CDC to get a response from Dr. Debra Houry, who helped draft the agency’s guidelines.  

CMS is only accepting emailed public comments to their proposal until March 3, 2017. They will publish the final rules on April 3, so there is not much time. We must all act NOW.

Here is what I am emailing to CMS at this email address: AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

I oppose the Centers for Medicare and Medicaid Services’ plan to align its policies with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The CDC guideline is voluntary and gives physicians discretion in determining what is right for their patients. However, your policy as presently drafted will make the guidelines mandatory for all doctors, patients and pharmacists, and impose a ceiling on the highest dose of opioids that can be prescribed. That was never the CDC’s intent. 

On June 1, 2016, Dr. Debra Houry, Director of the CDC’s National Center for Injury Prevention
and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

The following are additional quotes from the CDC Guideline itself:

"Clinicians should consider the circumstances and unique needs of each patient when providing
care.”

"Clinical decision making should be based on a relationship between the clinician and patient,
and an understanding of the patient's clinical situation, functioning, and life context."

"The Guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life-care."

Your policy does not provide an exception for palliative care, only patients receiving cancer treatment or end-of-life care. In my opinion, that is a blatant omission.

The facts are also available showing there has been collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.”

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,

Rick Martin

Feel free to copy my letter or make changes to express your own views. It also might be helpful to attach a copy of Dr. Houry’s letter in your email. If anyone wants a copy of her letter, click here to download it.

Time is running out if we want to put a stop to this.

Rick Martin is a retired pharmacist in Nevada who was disabled by chronic back pain.

Pain News Network invites other readers to share their opinions and 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.

Trump Administration Promises Relief to Patients

By Pat Anson, Editor

A spokesman for the Trump administration pledged this week that the Department of Health and Human Services (HHS) would provide relief to patients who are "being harmed by the status quo.”

Matt Lloyd, a former top aide to Vice President Mike Pence, recently assumed the job of chief spokesman for HHS, the federal department that oversees the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services (CMS).

Lloyd made his comment in an unusual statement emailed to reporters after CMS released a report Friday that showed the number of Americans who signed up for insurance during Obamacare’s annual enrollment period had fallen to 9.2 million. That’s down from 9.6 million the year before.  

“Obamacare has failed the American people, with one broken promise after another. As noted in the report today from CMS, premiums in the ACA marketplace have increased 25 percent while the number of insurers has declined 28 percent over the past year,” Lloyd said.

MATT LLOYD

MATT LLOYD

“We look forward to providing relief to those who are being harmed by the status quo and pursuing patient-centered solutions that will work for the American people.”  

Ironically, Lloyd made his statement two days after CMS invited public comment on the agency’s plans to have Medicare adopt the CDC’s opioid prescribing guidelines – a move that could affect thousands of patients who use opioids for pain relief. The CDC guidelines are voluntary and only intended for primary care physicians, but CMS wants to apply them to all doctors who prescribe opioids for non-cancer pain. A strict daily limit on opioids would also be set at 90 mg of a morphine equivalent dose.

Doctors and patients who don’t follow the proposed CMS policy could face punitive action, such as being dropped from Medicare coverage and insurance networks. CMS has estimated that over 15,000 Medicare beneficiaries who receive high doses of opioids for pain relief could be impacted  

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare.

The agency’s “Opioid Misuse Strategy” was developed during the final months of the Obama administration, but could be quickly adopted by the new administration.  CMS is only accepting public comments on its proposals until March 3 and plans to publish the final rules by Monday, April 3, 2017.

Comments on the CMS rule change should be mailed to:  AdvanceNotice2018@cms.hhs.gov.

Comments can be emailed to Matt Lloyd at: Matt.Lloyd@hhs.gov.