The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.
The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.
In the letter, the ACR applauded CMS’ recent decision to assign unique J-codes to each biosimilar of a reference product and encouraged HHS to continue to support biosimilar innovation. Allowing biosimilars to have their own unique J-code ensures better monitoring of their effectiveness while allowing for sufficient pharmacovigilance.
ACR urged Congressional leaders to reverse a recent decision to adjust providers’ reimbursement for Part B drug costs based on their performance under the Merit-Based Incentive Payment System (MIPS), despite these drugs’ costs being outside physician control. ACR claims that both reforms are essential to advancing the current administration’s goals of promoting healthcare choice and competition.
“This dangerous policy penalizes the doctors who administer Part B therapies and will ultimately reduce patient access to treatments for diseases like arthritis and cancer, particularly in rural and underserved areas of the United States. This is in direct conflict with the Administration’s goal of promoting patient choice,” said David Daikh, MD, PhD, president of ACR, in a statement.
ACR also called on HHS to address the problem of prior authorizations. The letter cites a 2016 American Medical Association (AMA) survey that found that medical practices on average complete 37 prior authorization requirements per week, per physician. This process takes about 16 hours (or 2 full business days). ACR says that CMS (and other entities that are engaged in reform) should follow a group of principles outlined in the letter:
“The current prior authorization process leads to a waste of valuable resources that delays care and does not add value to the healthcare delivery system. We encourage HHS and all agencies involved in utilization management to follow a set of best practices that ensure utilization management programs are reasonably designed and implemented,” said Daikh.
Another area of concern for ACR is the need for increased transparency from pharmacy benefit managers (PBMs). The ACR suggested that CMS consider policies that provide more transparency about PBMs payment practices, including the true cost of drugs. ACR also encouraged HHS to require more consistency in the way PBMs structure their rebate programs, including uniform definitions for terms used in disclosures, such as specifying what constitutes a rebate, discount, fee, and amount received from a manufacturer.
Along with ACR, more than 100 healthcare organizations sent letters to congressional leaders urging them to reverse the CMS policy, cautioning that it will create a tremendous financial risk for specialists that administer Part B drugs and lead to significant access problems for patients that rely on these therapies.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
2 Commerce Drive
Cranbury, NJ 08512