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Advocacy: CSRO, the Alliance Ask FDA to Prioritize “Notice and Comment” in Guidance Practices

Last week, CSRO joined the Alliance of Specialty Medicine (the Alliance) in responding to the Food and Drug Administration‘s (FDA) Draft Report and Plan on Best Practices for Guidance, expressing concerns about a proposal to limit notice-and-comment for certain guidances, namely those that “include initial interpretations of a statute or regulation, changes in interpretation or policy that are of a more than minor nature, complex scientific issues, or highly controversial issues.


In this letter, CSRO and the Alliance said, “[w]ithout prior notice-and-comment, it would be difficult, if not impossible, for FDA to fully appreciate how its guidances may impact affected stakeholders, including patients,” and urged the agency “to prioritize advance notice-and-comment when issuing Level 1 guidances.” Read more in our comments available here.

Read Letter

In the News: Winter Policy Update

The Winter edition of CSRO's bi-annual Policy Update is here!


The newsletter is available on our website and features exclusive updates on CSRO's state and federal advocacy activity.

 

If you're interested in a more in-depth discussion of the content shared in this edition, we encourage you to save the date to join us this September 20-22 in Nashville for our annual Advocacy Conference.

View Policy Update

Expert Insight: CSRO In the News

Alternative Funding Programs

Insurers and pharmacy benefit managers have long waged a war against copay assistance through accumulator adjustment and copay maximizer programs. Now, a new tactic has entered the mix – alternative funding programs.


In an effort to better inform employers about these programs, CSRO Vice President of Advocacy & Government Affairs Dr. Madelaine Feldman joins nine other co-authors in a new white paper titled Alternative Funding Programs: What Employers Need to Know.


This paper explains the unintended consequences of alternative funding programs, raises attention to the possible risks for employers and employees, and offers more ethical cost-containment strategies for self-funded health plans.

Read Paper

Fixing the PBM Industry

“Congress is in the process of negotiating a set of bipartisan health policies, including pharmacy benefit manager (PBM) reform. On the table for inclusion are two policies that will provide immediate relief for patients in the form of reduced out-of-pocket costs for drugs: delinking drug prices from PBM income and requiring PBMs to pass through the discounts, rebates and other price concessions they obtain from drug companies.”


Read more in this InsideSources piece written by Alliance for Transparent and Affordable Prescriptions (ATAP) leadership and featuring co-author Dr. Robert Levin, CSRO Board Member and ATAP President.


Fact Friday: ATAP was started by CSRO and officially founded in 2018 to bring attention to PBMs.

Read Article

Resource: Presentations for Employers

Healthcare is a primary benefit offered to employees, often at great expense to employers. While just a part of the total equation, the pharmacy benefit can be a significant element of the overall outlay.


Through CSRO’s employer education program, presentations are available to provide employers with insights into benefit administrator practices and the systems driving their behavior.


Request a presentation from CSRO for your organization or company to learn more about these hidden realities today.

Request a Presentation

Save the Date: 2024 Events

CSRO Fellows Conference: March 1-3, 2024

An annual event to help rheumatology fellows prepare for their future roles as practicing rheumatologists.


CSRO Advocacy Conference: September 20-22, 2024

Mark your calendars to join us in Nashville for CSRO's annual Advocacy Conference


State Society Conferences:

CSRO's state rheumatology society members host their own annual meetings throughout the year – find a listing of these state conferences on our website.

Legislation Around the Country

What's Happening in the States

CSRO tracks legislative activity relevant to the rheumatology community and their patients. Check out the list below to see the status of CSRO priority bills from the past two weeks, and click here to view a full status report of CSRO priority bills.


Be sure to check out our interactive legislative map tool for additional details.

View Full Status Report

Arizona

Non-medical Switching

  • SB 1164: Reported do pass

California

Rebate Pass Through

  • SB 966: Referred to committees

Georgia

White Bagging

  • HB 924: Favorably reported by committee 

Illinois

White Bagging

  • SB 3225: Referred to Insurance committee

Indiana

Biomarker Testing

  • SB 273: Approved by House committee

Iowa

Biomarker Testing

  • HF 2157: Committee recommends passage, renumbered as HF 2492
  • HF 2492: Introduced

Prescription Drug Affordability Board

  • HF 2408: Referred to Commerce committee

Gold Card

  • HSB 641: Approved by committee, renumbered as HF 2488
  • HF 2488: Introduced

Kentucky

White Bagging

  • SB 188: Referred to Banking and Insurance Committee

Maryland

White Bagging

  • SB 754: Hearing scheduled for 2/28
  • HB 1368: Hearing scheduled for 2/29

Minnesota

Gold Card

  • SF 3532: Referred to Commerce and Consumer Protection Committee
  • HF 3578: Referred to Health Finance and Policy

Minnesota

Gold Card

  • SF 3532: Referred to Commerce and Consumer Protection Committee
  • HF 3578: Referred to Health Finance and Policy

New Mexico

Step Therapy

  • SB 135: Passed the House 

New Hampshire

Rebate Pass Through

  • SB 555: Hearing held 2/14

Oregon

White Bagging

  • HB 4012: Amended to only oncology products

Accumulators

  • HB 4113: Passed the House

Rhode Island

White Bagging

  • S2086: Placed on Senate calendar

Utah

Accumulators

  • SB 152: Approved by committee, motion to circle

Virginia

Prescription Drug Affordability Board

  • SB 274: Reported favorably by Labor or Commerce committee
  • HB 570: Referred to committee on Education and Health

West Virginia

Prescription Drug Affordability Board

  • HB 5682: Referred to Health and Human Resources

Wisconsin

Accumulators, Non-medical Switching, & PBMs

  • AB 773: Committee hearing held 2/14

Wyoming

Gold Card and Step Therapy

  • HB 14: Referred to Health, Labor, and Social Services committee

CSRO Resources for You

Action Center

Use CSRO's convenient online platform to easily find out who your elected officials are and engage with them directly.


Advocacy Council

Amplify your voice by assembling with other like-minded individuals to enhance CSRO’s advocacy initiatives.


Career Center

Locate the perfect fit whether you're looking for new career opportunities or trying to find the right candidate.


Legislative Map Tool

Find your state on our interactive map tool to learn about current or proposed policy and ways you can take action to make an impact.


Payer Issues Reporting Form

Request assistance with any payer relation issues that may be impacting your patients or office.


Policy Correspondence

Easily access all of CSRO’s policy letters submitted to payers, state, and federal governments as an informational resource.


Rheum for Action

Learn about the latest advocacy issues in CSRO's advocacy column produced in partnership with Rheumatology News.


Step Therapy Cover Sheets

Review CSRO's state-specific step therapy materials that help guide practices in gaining an exemption from step therapy protocols.

Questions?

Please visit the CSRO website for other news and updates, and do not hesitate to contact us with any questions at info@csro.info.

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