Restless Legs Syndrome Foundation Blog

Contact the Department of Health and Human Services and ask them to maintain access to low total daily doses of opioid therapies for RLS patients

As the nation moves to address the nationwide opioid crisis, many people with severe RLS are finding it difficult to access opioid medications to treat their symptoms. Your help is needed by March 25 to ensure this vital treatment option continues to be available to RLS patients.

Decision-makers at the US Department of Health and Human Services (HHS) are requesting comments from patients who use opioid therapies to manage their chronic conditions. Agency officials want to hear from RLS patients on how they manage their condition, and barriers that are affecting their access to treatment.

Background

On Dec. 18, 2018, the Pain Management Best Practices Inter-Agency Task Force issued a draft report on “Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations.” This Task Force was established to provide guidance on policy for the use of opioid therapies to treat pain and other chronic conditions. HHS is overseeing this effort with the Department of Veterans Affairs and the Department of Defense.

RLS Foundation leaders met with the chair of the Task Force, Dr. Vanila Singh, earlier in 2018. Dr. Singh is the chief medical officer at the HHS Office of the Assistant Secretary for Health and has been overseeing a major portion of the federal government’s response to the opioid abuse crisis. She confirmed that RLS patients will need to comment on the Task Force’s draft report, so that the use of low total daily doses of opioids to treat severe RLS is incorporated when the recommendations are finalized later this year.

RLS is not a chronic pain condition; its underlying mechanisms and neuropathology are very different. It is vital for the RLS community to take part in this effort, however, because the perspectives shared will inform the Task Force’s guidance on regulations that will affect RLS patients who take low total daily doses of opioid medications to manage their condition.

HHS is requesting written feedback from the public on the draft report. The public will have 90 days to comment. Once the comment period ends, the Task Force will consider comments received and compile a Final Report with its proposed updates and recommendations.

Please submit your comments before March 25, 2019. RLS patients and caregivers must make their voices heard at this critical stage in the policy making process!

Take action: Submit your comments

Step #1: Go to the HHS online portal for submitting electronic comments and click on “Comment Now” at the right of the page.

Step #2: Tell the Task Force about RLS, how you manage your symptoms, and what kind of barriers have affected your access to treatment.

You can use the suggested discussion topics below to inform your comments. Feel free to answer the questions directly or simply review them to help guide your response:

• How long have you had RLS, and what were the steps you took to get diagnosed?
• How would you describe your RLS symptoms? (Characteristics could include location, intensity, duration, constancy or intermittency, triggers etc.)
• Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your RLS? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
• How has your RLS changed over time? (Considerations include augmentation and the severity and frequency of symptoms.)
• What are you currently doing to help treat your RLS? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)
• How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)
• How well does your current treatment regimen manage your RLS?
• What challenges or barriers to accessing or using medical treatments, including low total daily doses of opioids, have you or do you encounter or are you concerned about?

If you have any questions about submitting comments, please contact Peter Herzog at herzog@hmcw.org or (202) 544-7499.

Electronic comments must be submitted on or before March 25, 2019.

U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health
200 Independence Avenue SW, Room 736E
Attn: Alicia Richmond Scott, Pain Management Task Force Designated Federal Officer
Washington, DC 20201

Step #3:If you wish to let us know that you completed Step #1 and #2 click here, your information will remain confidential. Thank you for participating in this important Action Alert!

Please note that providing your name is optional, and comments may be publicly viewed on regulations.gov. Any personally identifiable information you include in the comment form or an attachment will be provided to the department or agency, and may be publicly disclosed in a docket or on the Internet.

Other Ways to Submit Your Comments

Email written comments to: paintaskforce@hhs.gov

Mail written comments to:

U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health
200 Independence Avenue SW, Room 736E
Attn: Alicia Richmond Scott, Pain Management Task Force Designated Federal Officer
Washington, DC 20201

More information

• Learn more about RLS advocacy and how to take action.
• Learn how to participate in the National Opioid RLS Registry.
• Make a financial gift in support of the RLS Foundation Advocacy Initiative.

RLS Foundation Returns to Washington

In November, an RLS Foundation delegation again joined the Health and Medical Counsel of Washington (HMCW) in Washington, DC, to visit the offices of legislators and federal agencies involved in health care policy.

The meetings took place at a critical juncture in the midst of the nationwide opioid crisis. The government is moving to implement H.R. 6, the SUPPORT for Patients and Communities Act. This law, passed in October, calls for tactics to promote treatment and recovery from opioid addiction, and to improve prevention.

Many people with severe RLS find themselves caught in the crossfire. Even though there is no federal legislation or policy that prohibits prescribing opioids for RLS, the increased scrutiny of prescribing practices has physicians increasingly reluctant to use them; some have stopped prescribing opioids altogether.

"The Foundation's opioid advocacy initiative has already made significant progress, but the issue is far from resolved,” says Lew Phelps, chair of the RLS Foundation Board of Directors. “We were successful in ensuring that Congress didn't include anything in the recent opioid legislation that would have harmed the ability of RLS patients to obtain needed and appropriate treatment. However, the implementation of this legislation still presents potential challenges. We have to stay engaged to help ensure that physicians continue to be allowed to prescribe opioids for RLS."

In the DC meetings, a Foundation team led by Executive Director Karla Dzienkowski emphasized that opioids are a legitimate and critical treatment for severe RLS. About 1 in 33 Americans – 3 percent of the US population – has RLS that is severe enough to need daily medical treatment. When all other treatments have failed, opioids at low total daily doses are highly effective at alleviating RLS symptoms, and clinical guidelines are available for healthcare providers to use them appropriately.

“It’s important to spread the word that there are medically appropriate uses of opioids taken in low total daily doses,” says John Winkelman, MD, PhD, director of the RLS Quality Care Center at Massachusetts General Hospital. “We need to help doctors with safe prescribing – not overprescribing, but more effective and safe prescribing.” With support from the RLS Foundation, Dr. Winkelman is conducting a study to better understand the long-term safety of opioids in RLS.

Dr. Winkelman and Jeffrey Durmer, MD, PhD, of Fusion Health, joined the delegation on behalf of the Foundation’s Scientific and Medical Advisory Board. Sandra Katanick represented the RLS Foundation Board of Directors, and also the RLS patient community.

In the meetings the Foundation also stressed the importance of federal funding for research for the National Institutes of Health and the Department of Defense, both of which have growing portfolios in sleep disorders research.

Agency meetings: Making the RLS patient voice heard

The Foundation team met with the US Department of Health and Human Services (HHS) Pain Management Inter-Agency Task Force, led by Vanila Singh, MD.

The new opioid legislation requires HHS to study the impact of federal and state laws and regulations that limit opioid prescribing and submit a report to Congress. The Pain Management Inter-Agency Task Force is specifically charged with finding any gaps or inconsistencies in existing clinical best practices for managing acute and chronic pain.

It is critical for this report to acknowledge that opioids are used differently to treat RLS than to treat chronic pain, so that RLS patients continue to have appropriate access to opioid medications. Dr. Singh and her colleagues showed a strong understanding of RLS and the need for this accommodation, says Dzienkowski. “They were very receptive to the needs of the RLS community.”

The HHS Task Force will soon publish a draft of its recommendations, and the public will have the opportunity to comment over a 90-day period. The Foundation will notify the RLS community when this comment period begins with a call to action through its eFriends monthly newsletter and other channels. (Sign up to receive eFriends.)

The Foundation also met with the Centers for Disease Control and Prevention (CDC), which has issued a guidelines for prescribing opioids for chronic pain; and with the Substance Abuse and Mental Health Services Administration (SAMHSA), whose representatives sit on advisory groups to health care policy committees and working groups throughout the federal government. These meetings were a strong first step in building relationships within the two agencies. In follow-up, the Foundation will meet again with the CDC in December.

Congressional visits: ‘We now have RLS champions in Congress’

The RLS Foundation met with staff in the offices of Sen. Lamar Alexander (R-TN), Sen. Elizabeth Warren (D-MA), Sen. Bill Nelson (D-FL), Sen. Kamala Harris (D-CA), Sen. John Cornyn (R-TX), Sen. Johnny Isakson (R-GA), Rep. Rosa DeLauro (D-CT), Rep. Frederica Wilson (D-FL), Rep. John Yarmouth (D-KY) and Rep. John Lewis (D-GA).

Many of the Congressional staff members said that they are hearing from their constituent communities about barriers to treatment or providers unwilling to prescribe opioids in light of the new law.

Katanick observes, “I think we made a very compelling argument for the safe prescribing of opioids for conditions other than chronic pain, and the legislators’ duty to be certain that any rulemaking is not so restrictive that it actually harms patients.”

“We now have RLS champions in Congress,” says Dzienkowski. “In this round of meetings in Washington, we’ve seen a definite increase in awareness and support for the RLS community.”

“I want to thank everyone who has made donations to the Foundation’s advocacy initiative, responded to our calls to action, or met with their elected officials. At the Foundation, we are hearing from many people with severe RLS who are having trouble accessing their opioid medications. With your help, we are making a difference – for the RLS community today and for generations to come.”

The meetings were coordinated by HMCW, a government relations organization with nonprofit and health care industry expertise that is partnering with the RLS Foundation to guide its advocacy efforts. Also attending were Kris Schanilec of the RLS Foundation; and Dale Dirks, Dane Christensen, and Peter Herzog of HMCW.

To make a financial gift in support of the RLS Foundation Advocacy Initiative, visit www.rls.org.

More information

• Learn more about RLS advocacy and how to take action.
• Learn how to participate in the National Opioid RLS Registry.
• Read about the Foundation’s advocacy trips to Washington in February and June 2018.
• Watch for a complete update on RLS advocacy in the next issue of NightWalkers magazine, coming in February.