RheumWATCH Archives

”RheumWatch

Read the RheumWATCH archives on topics such as rheumatology advocacy, policy updates, insurance advocacy, and practice management.

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ACR Applauds FDA Draft Guidance on Biosimilars Naming; Message from Government Affairs Chair

ACR Applauds FDA Draft Guidance Requiring Distinct Naming for Biosimilars

Last week the ACR praised the Food and Drug Administration (FDA) for issuing draft guidance that would require separate and distinct names for biosimilars and biologic therapies. This naming protocol would help ensure patient safety and transparency.

The guidance, Nonproprietary Naming of Biologic Products, would designate separate and distinct, non-proprietary names for originator biologic products, related biological products, and biosimilar products.

“The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Doug White, MD, chair of the ACR’s Committee on Rheumatologic Care. “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved—pharmacists, providers, and patients—which drug the patient is receiving.”

The ACR previously issued a position statement calling on the FDA to enforce distinct names for biosimilars, and has spoken with FDA officials and submitted comment letters expressing its concerns for patient safety in instances where biosimilars are substituted without proper patient and physician notification.

Rheumatologists prescribe biologics to help patients with arthritis, lupus, and other forms of rheumatic disease to manage symptoms, ease pain, and avoid long-term disability. Concerns about the complexity of biologics and the potentially life-threatening adverse reactions when biosimilars are substituted without physician and patient notification have led the rheumatology community to call for stricter oversight and more transparency in the notification and substitution process.

“The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective, without compromising their health or safety,” Dr. White concluded.

ACR Issues Physician-Driven Position Statement on ABIM’s Maintenance of Certification Requirements

Late last month the ACR released a statement outlining the ACR’s position on the American Board of Internal Medicine’s (ABIM’s) Maintenance of Certification (MOC) requirements. The position statement was drafted and vetted during a three-month collaboration between ACR leadership and its members where nearly 1,100 rheumatologists provided feedback that was used to formulate the final statement.

“Rheumatologists without a doubt believe in the value of continuing medical education,” said E. William St.Clair, MD, American College of Rheumatology president. “However, our members strongly feel the ABIM MOC program not only fails to appropriately assess their competence but lacks evidence that patients are benefiting from their involvement with it.”

The statement contains seven positions the College requests the ABIM to consider when developing any future MOC requirements. Highlights include strong beliefs that:

  • The current ABIM MOC program does not meet the educational needs of rheumatologists and should be modified to allow physicians to develop and implement a continuing professional development plan relevant to his/her professional roles and responsibilities.
  • The ABIM should not reinstate the Practice Assessment, Patient Voice, and Patient Safety requirements as part of the recertification process, because they are redundant with existing requirements that measure and report the quality of care patients receive such as PQRS, Meaningful Use, and Value-Based Modifier reporting. Additionally, patient voice and patient safety are already assessed by health institutions, accountable care organizations, and state and local licensing requirements.
  • The secure, closed-book, high-stakes MOC examination should be eliminated, because it is not an appropriate means of assessing clinical knowledge or decision-making for the purpose of recertification.
  • The ABIM should fund an independent, external review to examine the performance and impact of its program, including all policies, procedures, organizational structure, and governance; and commit to revising the program if the independent evaluation does not identify a substantial benefit to patient care.

The position statement also addresses the redundancy of physicians being required to obtain both CME and MOC medical knowledge credits, the need to reduce program costs, and the desire for evidence the program is improving physician competence.

“We are encouraged by the recent changes the ABIM has made and hope the ABIM will strongly take into consideration the position of the College and our members as it continues to reform the MOC program,” said Joel Block, MD, ACR Committee on Education chair. “We share the same goal of ensuring our patients receive the highest quality of care available, but we have identified numerous areas where the current MOC process fails in this aim while substantially adding to physicians’ administrative and cost burdens. It is our desire to see barriers that prevent our members from pursuing meaningful educational activities in order to meet MOC requirements removed.”

View the position statement in its entirety >

Confirm Your PECOS Information Today

Medicare’s Provider Enrollment, Chain, and Ownership System (PECOS) allows registered users to electronically submit and manage Medicare enrollment information. Please ensure that the information reflected in your PECOS account is accurate, including NPI, TIN, organization name, and address. This information may be used by CMS for upcoming communications.

You can review or change Medicare enrollment information online.

If you have any questions, please contact ACR staff at programs@rheumatology.org.

Message from the Government Affairs Chair

Will HarveyWhile Washington, D.C., was a ghost town in August with lawmakers back home for the month-long work period, members of Congress get back in town next week and they will be back to work. If there’s one thing I’ve learned from meeting with lawmakers, it’s that constituents sharing their stories with lawmakers is incredibly important.

We need you to help us get your issues on their radar and on the agenda for the crucial legislative days coming up. And the good news is, members of Congress are eager to hear from their constituents. As a rheumatologist or health professional, you have the unique opportunity to show your lawmakers how their policy decisions affect your ability to provide high-quality care and necessary treatments to your patients.

Here are just a few of the current policy issues that may affect your patients’ access to care and treatment, and ways you can take action right now:

1. High Price of Specialty Medications

It’s likely some of your patients are among the thousands of U.S. patients experiencing sticker shock when it comes to the cost of their co-pays. That’s because a growing number of insurers are placing biologic treatments on so-called “specialty tiers” that require patients to pay a percentage of the drug cost instead of a fixed co-payment. Patient co-pays for these specialty tier therapies can range from $500 to more than $5,000 each month. In fact, one in six patients with rheumatic arthritis has reported reducing their medications due to cost.

H.R. 1600, the Patients’ Access to Treatment Act (PATA), has been introduced in the U.S. House of Representatives by Reps. Lois Capps (D-CA) and David McKinley (R-WV). If enacted, PATA would limit patient cost-sharing requirements for expensive specialty tier drugs and increase access to life-saving biologics.

Voice your support for the Patients’ Access to Treatment Act >

2. Access to Specialists

Across the U.S., patients are unable to access vital health services due to overly restrictive insurer practices. Insurers are changing drug formularies between open enrollment periods without advance notice to patients, dropping providers from networks without just cause or notice for removal, and deciding to no longer reimburse for the cost of care and forcing doctors to turn away returning patients.

Patients deserve access to care, accurate and timely information, and transparency from their health insurance plans.

The Medicare Advantage Bill of Rights Act is an important first step to address the problem of unfair and overly restrictive insurer practices. If enacted, the legislation would require advance notice and more transparency when it comes to Medicare Advantage coverage decisions.

Voice your support for the Medicare Advantage Bill of Rights Act >

3. Investment in Medical Research

Medical research funded by the National Institutes of Health (NIH)—the largest source of funding for medical research in the world—has led to extraordinary improvements in the lives of patients living with rheumatic diseases. Yet, the NIH receives nearly 25 percent less funding today than it did in 2003. Increased federal funding is crucial to advancing treatment and cures.

Arthritis research is particularly important for U.S. veterans. One in every four veterans has been diagnosed with arthritis, which is the second leading cause of discharge from the U.S. Army. Although the Department of Defense (DOD) has a dedicated research budget for more than 20 specific diseases, arthritis does not yet have a dedicated research program.

Voice your support for investment in medical research >

Other Ways to Get Involved

Looking for even more ways to get involved? Here are some other ways to advocate:

  • Schedule a meeting with your members of Congress in their local district office with the ACR’s easy guide for local Congressional meetings.
  • Share your story with us about challenges you have experienced accessing specialists or medications.
  • Join the conversation on social media by following the Simple Tasks Facebook and Twitter accounts, and by using the hashtag #Act4Arthritis to talk about policy issues affecting your healthcare.
  • Visit the ACR’s new website and self-identify as a rheumatology Key Contact for your local lawmakers or as an advocacy microvolunteer.

Thanks to everyone for your work as advocates. With all of us working together, I have no doubt that Congress will notice our efforts and understand the importance of our requests.

Will Harvey, MD, MSc
Chair, Government Affairs Committee