As CMS Considers Restricting Access to Pain Medication, Greater Opportunities for Public Input Are Required

CMSThe Centers for Medicare and Medicaid Services (CMS) is ramping up efforts to limit patients’ access to pain medication without giving affected parties sufficient notice or opportunity for comment.  Since the start of 2017, CMS has released three separate guidance documents on how insurers and payers should impose new limits on the use of opioids.  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.  CMS also must do more to ensure that it adheres to statutes requiring complete openness whenever it solicits advice from advisory committees that include members who are not federal government employees.      

CMS Should Foster Openness When Issuing Policy Changes

Every year, in accordance with the Social Security Act, CMS releases a Call Letter providing notice to insurance companies interested in the Medicare Advantage program about changes proposed to the payment methodology or any annual adjustments.

CMS released its CY 2018 Call Letter on April 3, 2017.  In addition to the traditional information included in the annual Call Letters, the Call Letter includes significant changes in CMS’s opioid overutilization criteria that mandate considerably heightened scrutiny of opioid prescriptions; the new criteria more than double the number of beneficiaries “whose opioid use may require focused care management.”

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.  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.

Notice of this Call Letter was first given on February 2, 2017 when the draft was published on CMS’s website, and the comment period closed on March 3, 2017.  This truncated 30-day comment period does not foster transparency or allow the affected parties to submit informed comments with reasonable notice.  Besides which, Call Letters are not the typical avenue for communicating to the patient community that CMS is contemplating new restrictions on reimbursement of opioid prescriptions.  The community thus had no indication that it should be on the lookout for proposed restrictions.  Moreover, this Call Letter was not published in the Federal Register or anywhere else aside from CMS’s website, making it that much harder for the affected parties to become aware of the proposal and submit comments.

The Call Letter likely does not qualify as a legislative rule, and thus federal law does not require CMS to adhere to the Administrative Procedure Act’s notice-and-comment requirements when modifying its opioid overutilization criteria.  CMS nonetheless should recognize that those changes can have a significant impact on the patient community, and thus it should take steps to inform that community of the proposed changes and provide them with a meaningful opportunity for comment.

CMS Should Provide Transparency When Using Advisory Committees

In addition to encouraging openness and transparency when making policy changes, CMS should strive to promote openness within the advisory committees it establishes.  In the past, CMS committees have lacked transparency.  The CMS committee called Healthcare Fraud Prevention Partnership (HFPP), which addresses opioid-misuse issues, operates largely in the dark, potentially in violation of a federal statute—the Federal Advisory Committee Act (FACA).

FACA requires that any committee that (1) is created by the federal government; (2) provides advice to the federal government; and (3) includes members who are not federal government employees, must operate in accordance with the law’s procedural requirements.  Those requirements include providing advance notice of all meetings in the Federal Register, opening all meetings to the general public, and maintaining minutes of those meetings.

HFPP does not adhere to FACA guidelines, based on CMS’s apparent belief that HFPP does not meet the statutory definition of a FACA committee.  Created by federal charter, HFPP is a public-private partnership whose members include numerous private-sector employees.  HFPP’s purpose is to improve the detection and prevention of healthcare fraud through data exchange between the public and private sectors.

HFPP regularly issues reports that make recommendations to healthcare payers, employer organizations, law enforcement, and CMS itself.  HFPP’s most recent set of policy recommendations are contained in a January 2017 “White Paper” entitled “Healthcare Paper Strategies to Reduce the Harms of Opioids.”  A near final version of the White Paper—drafted by HFPP’s Executive Committee—was circulated at an October 20, 2016 “Special Session” of HFPP’s general membership.  At that session, HFPP members reviewed the draft White Paper and recommended various changes.  HFPP issued its White Paper in final form a few months later.

On January 5, 2017, months after drafts of the White Paper were first made available to CMS, CMS adopted its own “Opioid Misuse Strategy” that largely mirrors recommendations contained in the White Paper.  Given the vast similarities between the Opioid Misuse Strategy and the policies recommended by the White Paper, one can reasonably conclude that CMS relied at least in part on the White Paper in drafting its Opioid Misuse Strategy.

And yet, despite providing advice and recommendations to CMS, HFPP apparently did not adhere to FACA’s disclosure requirements.  In particular, HFPP did not provide advance notice of its meetings in the Federal Register, nor were any minutes from its meetings disseminated to the public.  Given that this committee includes private-sector members and makes recommendations that are distributed to (and clearly heeded by) CMS, HFPP is by all appearances subject to FACA’s open-access requirements.

In the past, CMS has taken steps self-evidently designed to ensure that HFPP would not be subject to FACA.  In particular, it has stated that HFPP is nothing more than a discussion group at which government officials and private-sector individuals could come together to discuss methods for preventing healthcare fraud.  CMS has mandated, “No group or consensus advice or recommendations will be given by the [HFPP] Partners in the committees or the Executive Board.”  But as HFPP’s White Paper shows, with its detailed recommendations regarding steps that both the public and private sectors should take to reduce opioid misuse, HFPP is no longer simply a discussion group.

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.

In order to hold CMS accountable, Washington Legal Foundation submitted a Freedom of Information Act (FOIA) request to CMS seeking more information about HFPP, including any prior meetings, minutes of the October “Special Session,” notices published in the Federal Register, and other steps taken toward complying with FACA requirements.

CMS, as a federal agency, should actively promote transparency when creating guidelines or altering policies that will have a direct and substantial impact on the public.  The two aforementioned methods accomplish this by allowing for an adequate notice-and-comment period when making significant policy changes and by ensuring that all committees providing advice or recommendations to CMS adhere to the standards required by FACA.

Also published by Forbes.com on WLF’s contributor page.

One thought on “As CMS Considers Restricting Access to Pain Medication, Greater Opportunities for Public Input Are Required

  1. As a chronic pain patients and advocate who represent over two thousand chronic pain patients who suffer with Adhesive Arachnoiditis, Tarlov Cyst Disease and RSD/CRPS, All of which have no cure. Thousands of chronic pain patients across the country have been greatly affected by the CDC Guideline. Patients are loosing their dictors due to fear of the physicians loosing their license for prescribing opioids. Patients have either been weaned down or completely cut off of their opioids after being on a stable dose for many ueaes.
    This is a violation to chronic pain patients rights to receive proper care for pain. The CDC has yet to produce any documentation or studies in regards to prescription opioids being the cause of any epidemic. Thanks to these said guidelines, instead of curving opioid abuse, the CDC Guideline have actually caused a chronic pain pandemic. Suicide rates and over dose rates have actually went up due to fentanyl and heroin drug use, NOT prescription opioid use.
    These guideline are propaganda geared to push invasive procedures such as Epidural steroid injections which are NOT approved by the FDA, and spinal cord srimulators along with the panel members on the CDC board who have an invested interest in addiction rehabilitation centers.
    These guidelines were never put before a public opinion panel before they were implemented, in which case is illegal and should NEVER have been allowed to be implemented in the first place!
    These guidelines need to be thrown out! Patients should not be left to suffer due to these fraudulent guidelines!

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