arthritis advocacy news and regulatory letters

Advocacy News & Regulatory Letters

December 1, 2016

Arthritis Foundation Comments on a Proposal for the 2018 Federal Exchange Insurer Requirements

The Arthritis Foundation submitted comments to the Centers for Medicare and Medicaid Services (CMS) in response to its 2018 Draft Letter to Issuers in the Federally-Facilitated Marketplaces (FFM). We emphasized the crucial role the FFM plays in providing protections for people with arthritis from prohibitive-cost sharing requirements, burdensome administrative and utilization management policies, and discriminatory practices that often result in limited access to care. Read the letter here.

November 18, 2016

Arthritis Foundation Supports 21st Century Cures Act

The Arthritis Foundation, along with 217 chronic care organizations, signed a letter to leaders of the U.S. Senate and U.S. House of Representatives in support of enacting the 21st Century Cures Act by the end of 2016. This legislation will help deliver treatments and cures to people who desperately need them. Read the letter.

November 1, 2016

Arthritis Foundation Comments on the Biosimilar User Fee Act (BsUFA) Proposed by the U.S. Food and Drug Administration (FDA)

The Arthritis Foundation submits comments to the U.S. Food and Drug Administration (FDA) in response to its proposals on the Biosimilar User Fee Act (BsUFA). We reiterated our position that there should be unique names for biosimilar products, high priority devoted to patient engagement in decision making on biosimilars and guidance set forth by the FDA on substitution of non-interchangeable biosimilar products. Read the comments.

October 5, 2016

Arthritis Foundation Comments on the Proposed HHS Notice of Benefit and Payment Parameters Rule for 2018

The Arthritis Foundation wrote to the Department of Health and Human Services (HHS) providing comments on the HHS Notice of Benefit and Payment Parameters for the 2018 proposed rule affecting the Insurance Exchanges. The comments include the need for patient safeguards, limits on co-insurance and maintaining stable patients on their medications. Read the comment letter.

September 13, 2016

Arthritis Foundation Continues to Work with ICER to Assess Medication Values

The Arthritis Foundation continues to engage with the Institute for Clinical and Economic Reviewer (ICER). ICER has developed a value assessment framework to assess the cost and value of medications. ICER will make public recommendations about the value of the drugs they review. The Arthritis Foundation has called for more transparency in ICER’s process and wants to make sure the value framework includes robust input from patients, providers, and caregivers. Engagement with ICER is of vital importance because insurers follow their recommendations on drug value, potentially affecting coverage options for patients. Read the comments.

August 23, 2016

Arthritis Foundation Submits Additional Comments to the Institute of Clinical and Economic Review (ICER) on Rheumatoid Arthritis Medications

The Arthritis Foundation submitted a second round of written comments to ICER on rheumatoid arthritis medications (RA). ICER is looking at the  cost and effectiveness of RA drugs and will make recommendations to insurers on drugs that they believe are worthy of coverage. The Arthritis Foundation wants to make sure the ICER review includes the patient perspective and highlights that  treatment for RA patients is very individual. A drug that works for one patient may not work for another. ICER recommendations on drug value are followed by about 59% of insurers, potentially affecting coverage options. The review process is scheduled to be completed in 6 months with a draft evidence report, scheduled for release November 14, 2016. At that time here will be a public comment period and a public meeting allowing for additional comments from the Arthritis Foundation. Read the full comment letter.

August 23, 2016

AF Writes Letter to FDA on Prescription Drug User Fee Reauthorization Act (PDUFA)

The AF has been an active stakeholder for the past year as FDA has put together its recommendation letter to Congress on the reauthorization of PDUFA. On Aug 22nd, the AF sent a final comment letter to FDA on its draft recommendations to Congress, reiterating our position on the need for robust patient engagement in the drug development process, and supporting the emphasis on biomarker qualification and post-market surveillance, among other things. Congress will consider FDA’s recommendations as it writes legislation next year, and AF will continue to engage in the process with both FDA and Congress. Read the comment letter.

August 1, 2016

Arthritis Foundation Submits Comments to the Institute of Clinical and Economic Review (ICER) on Rheumatoid Arthritis

The Arthritis Foundation submitted written comments to Steven Pearson, the President of ICER regarding their upcoming review of rheumatoid arthritis medications (RA). The ICER review will develop a report assessing the clinical effectiveness and value of new and emerging drug therapies for RA. The Arthritis Foundation comments urged ICER to consider the critical need for adherence to drug regiments, and the perspective of patients and stakeholders to ensure that the scoping document and subsequent final report has the broadest possible relevancy. The draft scoping document is scheduled for release August 1, 2016, followed by a public comment period allowing for additional comments from the Arthritis Foundation. Read the full comment letter.

July 28, 2016

Arthritis Foundation Supports NY Legislation Regulating Step Therapy

The Arthritis Foundation recently wrote a letter to New York Governor Andrew Cuomo urging him to sign legislation that would protect New York patients by improving step therapy or “fail first” protocols. The legislation would require the use of evidence-based guidelines for protocols and a clear process for prescribers to override a fail first protocol. Read the letter.

June 28, 2016

Arthritis Foundation Writes to Senate Regarding the CMS Part B Proposal

As part of our ongoing activity to raise concerns about CMS' Part B proposal, the Arthritis Foundation wrote to the Committee on Finance addressing a number of issues about the proposal. Read the letter.

June 28, 2016

Arthritis Foundation Comments on the Medicare Access and CHIP Reauthorization Act (MACRA)

The Arthritis Foundation wrote to the Acting Administrator of the Centers for Medicare & Medicaid Services to provide input on CMS' proposed rule that significantly alters physician-focused payment models. Comments included opinions on alternative payment models (APMs), MIPS performance categories, quality performance and more. Read the comments.

June 1, 2016

Arthritis Foundation Fights to Preserve Arthritis Research at the DoD

The Arthritis Foundation signed on to a letter with other organizations in support of preserving research at the Department of Defense.  Two provisions on the 2017 National Defense Authorization Act could jeopardize funding for research. This could include arthritis research, even though arthritis affects 1 in 3 veterans and is one of the leading causes of medical discharge from the military. Read the letter and be sure to send a letter to your Senators asking them to keep the research program intact. A breakthrough in research at the Department of Defense means a breakthrough for everyone with arthritis.

May 10, 2016

Arthritis Foundation Pushes for CMS to Withdraw Part B Proposal

The Arthritis Foundation has been actively involved in raising concerns about a new proposal from the Centers for Medicare and Medicaid Services (CMS), which would change the way Medicare providers are paid for provider-administered drugs, such as infusions, and which could harm patient access to needed medications. The Arthritis Foundation is leading the way in making sure policymakers know the negative impact this proposal would have on patients. With the help of thousands of patients who wrote to their members of Congress, our efforts are getting attention. Specific ways the Foundation has been involved include:

  • Arthritis Foundation CEO Ann Palmer wrote an op-ed, along with the American College of Rheumatology, for the April 21 issue of The Hill, asking CMS to withdraw its proposal. 
  • An action alert included in our Advocacy in Action newsletter resulted in more than 1,700 letters being sent by patients to their representatives, asking them to sign onto a Congressional letter opposing the proposal. Over 240 representatives signed onto the letter.
  • The Arthritis Foundation led a patient-provider letter signed by more than two dozen groups, letting Congress know about our serious concerns with the proposal.
  • The Arthritis Foundation signed onto a Coalition for Accessible Treatments letter to CMS, expressing concern about patient access issues that could result from the proposal.
  • The Arthritis Foundation wrote a formal comment letter to CMS, outlining our concerns with the proposal and asking CMS to withdraw the proposal and address the issue of high drug costs in consultation with patient groups like the Foundation. 

April 21, 2016

CMS: Don’t Turn Back the Clock on Rheumatic Disease Care

The Centers for Medicare and Medicaid (CMS) recently announced a major proposal affecting infusion therapy that many physicians are saying will eliminate their ability to provide these services in their offices. With 10,000 people aging into Medicare daily, this proposal has broad implications for current Medicare patients, those about to join Medicare and all patients receiving infused medications.

While the Arthritis Foundation understands that health care costs are not sustainable and will require creative solutions, we don’t believe that decisions should be made without input from patients and providers.  The Arthritis Foundation has asked CMS to withdraw this proposal and meet with patient and provider organizations, like the Arthritis Foundation, to develop a proposal that is focused on the needs of patients and providers. Read more.

April 21, 2016

Arthritis Foundation Submits Testimony in Support of Increased Public Health Funds

The Arthritis Foundation submitted testimony to the House and Senate Appropriations Committees asking for a strong investment in the CDC Arthritis Program and National Institutes of Health. Read the written testimony to the House and to the Senate.

March 23, 2016

Congressional Arthritis Caucus Co-Chairs Ask for DoD Exclusive Funding for Arthritis Research

Arthritis Caucus Co-chairs Reps David McKinley (R-WV) and Anna Eshoo (D-CA) led a Congressional sign-on letter asking the Defense Appropriations leadership for exclusive funding for arthritis research at the Department of Defense. The letter was signed by 45 Representatives, many as a result of our Advocates’ efforts at the Summit. Read the letter.

March 23, 2016

Arthritis Foundation Writes to Defense Appropriations Subcommittees

The Arthritis Foundation, alongside eight other health care groups, wrote a letter to the Defense Appropriations Subcommittees asking for a $20 million arthritis research program at the Department of Defense. The letter detailed the severe consequences of arthritis in the military and talked about the need for dedicated research to find interventions, and, ultimately a cure. Read the letter.

February 19, 2016

Arthritis Foundation Writes to the House and Senate Regarding the FY17 Labor, HHS and Education Appropriations Bill

The Arthritis Foundation wrote letters to the U.S. Senate and to the U.S. House of Representatives asking Chairman Blunt and Ranking Member Murray (from the Senate) and Chairman Cole and Ranking Member DeLauro (from the House of Representatives) to provide an appropriation of $16 million to the CDC Arthritis Program in the FY17 Labor, HHS and Education Appropriations bill, which is a $5 million increase from FY16. The letters express the need for increased CDC funding, and explain what the funding will provide, including investing in public health research, improving access and availability of proven interventions for those with arthritis and more. Read the letters to the Senate and to the House of Representatives.

February 10, 2016

Arthritis Foundation Asks Congress to Help U.S. Service Members Fight the War Against Arthritis

One out of every three veterans and service members in the United States lives with arthritis. The Arthritis Foundation is asking Congress to increase Department of Defense funding to address the impact arthritis has on our service members. Read more about this in a recent article by Joan M. Von Feldt, MD, the president of the American College of Rheumatology, Ann Palmer, President and CEO of the Arthritis Foundation, and John W. Becher, president of the American Osteopathic Association, featured on The Hill. You can also learn more about how you can help protect our veterans and service members from arthritis.

February 9, 2016

Arthritis Foundation Volunteer Provides Testimony at the FDA Arthritis Advisory Committee Meeting

Liz Smith, a volunteer with the Arthritis Foundation, spoke at the FDA Arthritis Advisory Committee Meeting to provide testimony regarding the real-life complexities of treating arthritis and to reiterate the Arthritis Foundation's position on biosimilars. The objective of the meeting was to consider approval of Celltrion's infliximab, the biosimilar of Janssen's Remicade. Read Liz's compelling testimony, as well as our blog post about the outcome.

February 2, 2016

Arthritis Foundation Comments on Chronic Care Working Group Policy Options Document

The Arthritis Foundation wrote to Senators Hatch, Wyden, Isakson and Warner to provide comments to the Senate Finance Committee on the Chronic Care Working Group policy options document. Comments include addressing the need for behavioral health among chronically ill beneficiaries, adapting benefits to meet the needs of chronically ill Medicare Advantage enrollees, and more. Read the comment letter.

January 19, 2016

Arthritis Foundation Comments on the Draft Letter to Issuers in the Federally-Facilitated Marketplaces

The Arthritis Foundation wrote to the Centers for Medicare & Medicaid Services to provide comments on the draft letter to Issuers in the Federally-Facilitated Marketplaces. Comments include information about standardized options, network adequacy, provider transitions, network transparency, out-of-network cost-sharing, decision-maker tools, descriminatory benefit design and prescription drugs. Read the comment letter.

January 19, 2016

Arthritis Foundation Comments on Biosimilar User Fee Act of 2012 Reauthorization (BsUFA II)

The Arthritis Foundation has provided comments to the Food and Drug Administration regarding the BsUFA II process, providing considerations on patient experiences, naming and labeling, patient engagement and resources. Read the comment letter.

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