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:

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  • 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.

Will ‘Secret Deliberations’ Lead to Lawsuit Against CDC?

By Pat Anson, Editor

The Washington Legal Foundation is “keeping its options open” on a potential lawsuit to block the Centers for Disease Control and Prevention (CDC) from implementing its controversial guidelines for opioid prescribing. At issue is whether the CDC violated the Federal Advisory Committee Act (FACA) by developing the guidelines in secret and with little public input.

The CDC contends the guidelines are urgently needed to stop the so-called epidemic of opioid addiction and overdoses, while millions of chronic pain patients fear they will lose access to opioids if the guidelines are adopted.

Last week a “workgroup” appointed by the CDC recommended to the agency’s Board of Scientific Counselors (BSC) that the guidelines by adopted with few changes. The 10-member workgroup spent only three weeks reviewing a dozen complex guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The panel met four times during that period and all of its meetings were closed to the public.

“Why is CDC so afraid of transparency here? That’s my question,” asked Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of FACA.

FACA clearly states that “each advisory committee meeting shall be open to the public,” as well as any records, reports, minutes or other documents provided to or created by the committee.

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The CDC has taken the position that the BSC is an advisory committee, but the workgroup is not.

“The BSC charged the workgroup with developing a report of its observations on the draft guideline and its underlying evidence,” said CDC spokesperson Courtney Leland. “Under FACA, the time for public input is when the BSC meets to deliberate on the work prepared by the workgroup.  This meeting, held on January 28, was a public meeting announced in the Federal Register, and included a public comment period.“

But the WLF’s legal team disputes that interpretation of the law.

“I don’t see why you can provide input to the government through secret deliberations simply because you’re providing your advice to an advisory committee rather than to the government itself. The whole point of the law is to make sure that advice that comes to the government and is relied on by government is a product of open deliberations,” said WLF chief counsel Richard Samp, who believes the guidelines were quickly reviewed to prevent any further delays in their implementation.  

The CDC planned to adopt the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the guidelines' development.

“They want this to go on quickly. Obviously their existing advisory committee doesn’t have the expertise on its own, so it had to go outside of its ranks to do it,” said Samp. “But it realized that if the group was going to meet four or five times, it was going to drag on for months. And so the only way to do it quickly was to do what they have done.”

“If one wanted to test the legality of this sort of working group workaround on FACA, this is an excellent fact pattern on which to test it,” said Chenowith.

Asked by Pain News Network if the WLF would go to court before or after the guidelines are implemented, Chenowith and Samp were non-committal, but hinted they were prepared to take action in federal court in Atlanta, where the CDC is based.

“It never does any good to wait until final agency action. By that time people have really suffered some severe damage,” said Samp. “I assume one’s interest in these sort of cases is to prevent the agency from adopting guidelines and that’s why you sue early to try to prevent them from taking into account the recommendations before they make their final decision. One could easily file that in federal district court in Atlanta if one wanted to.”

WLF has a lengthy history of taking the government to court for regulations and laws effecting free speech, the environment, health care, and drugs. WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.” It often supports business groups and companies in litigation against  government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin. 

"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.

That connection to a major opioid producer has led to insinuations that WLF and other organizations that accept funding from the so-called “opioid lobby” are somehow tainted. That charge is often made by Physicians for Responsible Opioid Prescribing (PROP), which supports the guidelines and had some of its board members on CDC committees that helped draft them.

A recent story by the Associated Press pointed out that nearly a third of the members of the Interagency Pain Research Coordinating Committee have financial connections to opioid makers. That same committee criticized the CDC for developing the opioid guidelines with little scientific evidence to support them.

The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving,” the AP story said.

The article failed to point out that some of the committee members most critical of the CDC are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence,” said Richard Ricciardi, AHRQ, during a December meeting. “That’s an embarrassment to the government.”

The AP story also didn’t mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer, some of which stand to benefit from stricter opioid guidelines because they offer non-opioid treatments for chronic pain. The CDC Foundation accepted over $157 million from donors last year.  

CDC Needs to Obey the Law

By Mary Maston, Guest Columnist

I am a chronic pain patient. I do not hold a law degree, and quite frankly with the pain I am always in, reading complicated law jargon makes my head ache. That being said, I was blessed with common sense.

The way that the CDC is holding secret meetings about the agency's proposed opioid guideline  is a direct violation of federal law. This has been pointed out by Mark Chenoweth of the Washington Legal Foundation, as well as other professionals that are better versed than I.

The real question here is how long are they going to be allowed to get away with it?

“Workgroup meetings are not open to the public,” a CDC spokesperson told Pain News Network, referring to two meetings recently held in secret by a newly appointed advisory group.

The Federal Advisory Committee Act (FACA) says differently:

(1) Each advisory committee meeting shall be open to the public.

(2) Except when the President determines otherwise for reasons of national security, timely notice of each such meeting shall be published in the Federal Register, and the Administrator shall prescribe regulations to provide for other types of public notice to insure that all interested persons are notified of such meeting prior thereto.

(3) Interested persons shall be permitted to attend, appear before, or file statements with any advisory committee, subject to such reasonable rules or regulations as the Administrator may prescribe.

I have yet to see President Obama, CDC director Tom Frieden or anyone else claim “national security” is the reason these meetings are not open to the public. But I know why they want to do this behind closed doors. They know that the guidelines are wrong and have upset millions of people with hundreds of incurable diseases and conditions that are already struggling under heavy scrutiny. They don’t care about that and continuously turn a deaf ear to those who are pleading for them to stop what they are doing.

Are they even going to read and take to heart over 4,300 comments left mostly by actual patients and caregivers of chronic pain patients on regulations.gov? Do you want to know why more comments weren’t left and why many were written anonymously? It’s because many people are terrified to go against the government and they are afraid of retaliation. They already have such a difficult time finding a doctor that is willing to prescribe opioids that they don’t want to do anything to further rock the boat.

If you join any support group for any chronic illness – just pick one – there are hundreds of them, it won’t take long to realize that overprescribing is not the issue. Join my group, where pain is grossly undertreated, if treated at all, and it’s a daily discussion by a multitude of people from all sorts of backgrounds. Overprescribing may have been an issue in the past, but not anymore. The DEA made sure of that.

The CDC and the addiction specialists that helped draft the guidelines don’t care that in their efforts to save thousands of people from addiction they are sentencing millions of pain patients to a life of agony. They’ve admitted that the overdose numbers that they spout off as validation for their actions aren’t correct, but they continue to use them as a scare tactic to advance their agenda. You can’t lump heroin users in with legitimate patients who take their medications responsibly. This is flat out lying and it is fraud.

“We have heard some concerns about the process. We’ve done a lot, but want to be sure there will be no concern about the final guidelines when released,” said Debra Houry, MD, director of the CDC's National Center for Injury Prevention and Control, who is the administrator who oversaw development of the guidelines.

Some concerns? Is this woman for real!?! They obviously had the intent to release the guideline in its original form with no thought of the millions of people it would impact so drastically. They intended to just roll with it and to hell with the consequences to people in pain. The Veterans Administration is already being required to follow the guidelines. How many post war veterans do we have that have sustained life altering injuries in battle? “Just take a Tylenol or Aleve. You’ll be fine.”

Some members of Congress think this entire covert process by the CDC is dirty, that’s why they are opening an investigation into their practices and the process by which they appointed the initial advisory panel. 

It’s about time, but it isn’t enough. I hope Congress also addresses how the CDC continues to conduct itself. It’s obvious to me and many others that have voiced “some concerns” that legal action needs to be taken against those who have intentions to knowingly and willingly hurt more people than they help, and breaking the law while doing it.

Tom Frieden and Debra Houry are allowing this circus to continue. They need to be held accountable and replaced. Enough is enough.

Mary Maston suffers from a rare congenital kidney disease called Medullary Sponge Kidney (MSK), along with Renal Tubular Acidosis (RTA) and chronic cystitis. She is an advocate for MSK and other chronic pain patients, and helps administer a Facebook support group for MSK patients.

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.

CDC Still Holding Secret Meetings on Opioid Guidelines

By Pat Anson, Editor

A newly appointed advisory committee to the Centers for Disease Control and Prevention (CDC) has met twice in recent meetings that were not open to the public, Pain News Network has learned, a possible violation of federal open meetings law.

The committee of outside advisors – which the CDC calls a “Workgroup” – was appointed to review the agency’s controversial opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

“Workgroup meetings are not open to the public,” said CDC spokesperson Courtney Leland in an email to PNN. “CDC anticipates the workgroup will meet four times. Two meetings have been held to date and two are scheduled in the coming weeks.”

Ironically, the opioid guidelines were put on hold and the new workgroup was appointed after widespread complaints about the CDC’s lack of transparency and secrecy in developing the guidelines. None of the agency’s prior meetings about the guidelines were open to the public either.

“It sounds like the CDC hasn’t learned what a federal advisory committee is,” said Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA).

In November, the WLF sent a letter to CDC Director Tom Frieden warning that the agency “was required to comply with each of the numerous obligations that FACA imposes on such committees – including open all meetings to the public,” as well as publicly releasing minutes of the meetings and documents provided to advisory committees.

The new 10-member workgroup was appointed by the agency’s Board of Scientific Counselors (BSC) last week. Critics say a previous workgroup called the “Core Expert Group” had too many members biased against opioids, including one who had a financial conflict of interest. None of its meetings were open to the public.

“CDC developed its Draft Guideline with considerable input from an improperly established federal advisory committee,” said WLF chief counsel Richard Samp. “Any new, properly constituted committee should be directed to take a fresh look, rather than simply being asked to judge the existing proposal. In the absence of such a fresh look, any final guidance document issued by CDC will be tainted inescapably by the major role played in its formation by an illegally constituted federal advisory committee.”

Unlike the previous workgroup, the new advisory committee has broader experience in pain management, pharmacy, and primary care practice. One member is a longtime advocate for pain patients. Two were members of the original Core Expert Group, and two others were part of a "Stakeholder Review Group" that also advised the CDC. A complete list of members for the new workgroup can be found here.

The workgroup’s two meetings were held via conference call and an online meeting platform, according to Leland. The group’s chair is expected to present a report to the BSC on January 28. That short schedule suggests the new panel is only reviewing the work of the old one and is not initiating guidelines of its own.

Further information about the January 28 conference call, which is open to the public, can be found here. Ninety minutes have been set aside for public comments, with a maximum of two minutes per speaker.

Online Public Comment Period Ends

Meanwhile, today was the deadline for the public to submit online comments about the CDC’s draft guidelines. Over 4,000 comments have been received, many opposing the guidelines as being too restrictive, while others wish they were stronger.

The passionate and sometimes painful stories shared by commenters demonstrate the toll opioids can take, both when they are denied patients who need them and when they are abused.

“My son Luke was polite, popular, multi-sport, all-star athlete,” wrote Stacy Watson, who said her teenage son started taking opioids for a sports injury, but became addicted to painkillers and then heroin.  “Seemingly overnight, he became one of the hundreds of thousands of teens in our country addicted to prescription (Rx) painkillers. His life CHANGED & SO DID OUR FAMILIES. He went from being the person I described above to a stranger; the addiction devoured him and our family. It has been heartbreaking. He is 28 years old and now sits in a prison cell.”  

“My wife suffered from chronic pain. It was so heartless that you tied the hands of her doctors to prescribe the pain medication that she needed,” wrote Charles Martens. “You were not the ones that watched her suffer day in and day out until the day she died. Have some mercy and knock this restrictions crap off. Let the Doctors be Doctors for gosh sake.”

You can read more comments here.

Although the CDC’s voluntary guidelines are meant for primary care physicians, many experts say they will quickly be adopted by many prescribing doctors, medical societies and regulatory agencies. As Pain News Network has reported, under a recently enacted federal spending bill the Veterans Administration will be required to adopt them.

As many as 11 million American take opioids daily for chronic pain. Many pain patients report they already have trouble obtaining opioids or getting their prescriptions filled by pharmacies.

CDC Accused of ‘Blatant Violations’ of Federal Law

By Pat Anson, Editor

A pro-business legal foundation with a history of taking government agencies to court is asking the Centers for Disease Control and Prevention (CDC) to withdraw plans to release new guidelines for the prescribing of opioid pain medications.

In a letter to CDC Director Tom Frieden, the Washington Legal Foundation accused the agency of “blatant violations” of the Federal Advisory Committee Act (FACA), which requires federal agencies to identify members of advisory committees and hold committee meetings in public. As Pain News Network has reported, the CDC has refused to publicly disclose the identities of the “Core Expert Group” that initially drafted the guidelines.

“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote Washington Legal Foundation (WLF) chief counsel Richard Samp in his letter to Frieden.

“More importantly, CDC’s repeated violations of the Federal Advisory Committee Act call into question the viability of the entire enterprise and dictate that any guidelines adopted as a result of the current administration process could not withstand judicial scrutiny. We call on CDC to withdraw the Draft Guideline and to generate reliable data on ways to ensure adequate treatment of patients while preventing opioid abuse before renewing efforts to write a guideline.”

The CDC’s draft guidelines for primary care physicians recommend “non-pharmacological therapy” as the preferred treatment for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended when the drugs are prescribed for acute or chronic pain. Many pain sufferers fear they will lose access to opioids when the CDC plans to adopt the guidelines in January 2016. A complete list of the guidelines can be found here.

The identities of the CDC’s Core Expert Group (CEG) were leaked soon after the draft guidelines were released in September.  The group includes Jane Ballantyne, MD, President of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioids. PROP Vice President Gary Franklin, MD, is also part of CEG. Critics say Ballantyne, Franklin and several others who advised the CDC have a conflict of interest and never should have served as consultants on the guidelines.

The CDC says it withheld the identities of the Core Expert Group so its members could “provide honest and independent comment and feedback.” The agency also maintains that CEG does not qualify as a FACA advisory committee.

“CDC’s secrecy, and its apparent indifference to conflicts of interest by those likely to support news restrictions on opioids, have led many to conclude that CDC is uninterested in conducting administrative proceedings that give all interested stakeholders an equal opportunity to attempt to influence the agency’s decision making. If CDC is to overcome its tarnished image, it must immediately eliminate its culture of secrecy and apply its conflict-of-interest rules in an even handed manner,” Ramp wrote in his letter to Frieden and Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, which oversaw development of the guidelines.

A spokesman for the Washington Legal Foundation told Pain News Network the CDC had not yet responded to the group’s complaint. He also declined to say how the foundation would respond if the guidelines were not withdrawn.

WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.”  The non-profit foundation generally supports business groups and companies in litigation against  government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin. 

"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.

WLF does not disclose the names of its donors. According to Greenpeace, WLF has accepted over $1 million in donations from foundations representing Charles and David Koch, two billionaire brothers who actively support conservative causes.

Senators Support CDC

With the CDC under fire from pain patients and advocacy groups, eight U.S. Senators have written a letter to Frieden expressing their support for the CDC’s guidelines.

“We are committed to doing everything in our power to bring this (opioid) epidemic under control because our communities are hurting. The problem will only grow worse if we fail to act,” the letter says. “We applaud the CDC for developing prescribing guidelines and for your efforts in the fight to end prescription drug abuse. We strongly urge you to maintain this commonsense approach when you release the final guidelines early next year.”

The letter is signed by Sens. Joe Manchin (WVa), Ed Markey (Mass), Tammy Baldwin (Wisc), Dianne Feinstein (Calif),  Jeanne Shaheen (NH), Bill Nelson (Fla), Richard Blumenthal (Conn) and Angus King (Maine).