On Capitol Hill: CSRO Joins Hill Briefing to Urge Congressional Action on PBM Reform | |
|
On February 25, CSRO co-hosted a congressional briefing on Capitol Hill, joining forces with the ERISA Industry Committee (ERIC), the National Community Pharmacists Association (NCPA), and other key stakeholders to push for urgent reforms to pharmacy benefit managers (PBMs). CSRO’s Vice President of Advocacy & Government Affairs Dr. Madelaine Feldman (pictured left) participated as a panelist in the event, which featured remarks from Representatives James Comer (R-KY), Jake Auchincloss (D-MA), and Debbie Dingell (D-MI). The discussion underscored the need for Congress to pass bipartisan PBM reform, including delinking and rebate pass-through provisions, in the upcoming March 14 funding package.
With strong bipartisan support for these measures in the 118th Congress, the briefing served as a rallying call to finalize reforms in the 119th Congress that aim to lower prescription drug costs and foster competition in the drug supply chain. Senate Democrats are expected to introduce a standalone health care package in the coming days, which would include PBM reform and other provisions that had bipartisan support in the last Congress.
| |
CSRO Advocacy in Action: Underwater Biosimilars Hilighted in Politico Briefing | |
|
On February 27, CSRO's Vice President of Advocacy & Government Affairs Dr. Madelaine Feldman participated in a roundtable, “From Policy to Patients: Shaping the Next Era of Biosimilars,” hosted by Amgen and the politics and policy news outlet Politico. The discussion focused on the challenges, opportunities and policy solutions facing the biosimilar marketplace and included perspectives from CSRO, IQVIA Institute for Human Data Science, Johns Hopkins Bloomberg School of Public Health, Association of Accessible Medicines, Alliance for Patient Access, Arthritis Foundation, PhRMA, and others.
Dr. Feldman highlighted the existing barriers to a vibrant biosimilar market, both present day and into the future. She discussed two concerning issues influencing road biosimilar uptake – the "underwater biosimilar" situation and the "white label" partnerships between subsidiary companies of the Big 3 PBMs and certain biosimilar manufacturers.
Feldman explained how the "underwater biosimilar" issues of provider administered medications allows commercial insurance companies to mandate the use of only one or two biosimilars whose manufacturers have over-rebated their drugs to get fail first positioning on the formulary. Unfortunately, this over-rebating has caused the ASP to drop to the extent that providers are unable to afford those medications as the reimbursement is much lower than the acquisition cost. Far too often, no other biosimilar can be used except for the one that providers cannot afford, often resulting in patients getting switched to an entirely different medication that has no biosimilar. Dr Feldman explained that this will stifle the interest of manufacturers to do the R&D required to bring a biosimilar to market, only to be shut out of formularies by those manufacturers who have chosen to over rebate their product and get fail first position. Feldman stated that, sadly, none of this brings down the cost for patients and in fact it leads to higher costs when patients are sent to the hospital to receive the medication or even worse, their disease is uncontrolled because they have lost access to the medication that had stabilized their condition.
Dr. Feldman discussed the white label issue. She said that the big three pharmacy benefit managers (PBMs)/insurance companies have started subsidiaries that ‘co-produce’ white-label biosimilars in partnership with specific biosimilar manufacturers. This results in the PBMs only covering the biosimilars of the companies they have partnered with. These PBM subsidiaries make money from selling the drug, at the same time their vertically connected PBMs prefer that drug on their formulary. She explained how this is bad for the future of the biosimilar market as it limits coverage of biosimilars to just a chosen few. According to Dr. Feldman, “this creates a disincentive for other biosimilar manufacturers to continue to enter the market if they are blocked for coverage by the white-label partnerships.” She explained that this has not brought down cost share for patients, but it has increased the revenue for the health insurance companies.
When the question was asked regarding biosimilars in general bringing down any costs for patients, she stated that the only decrease in cost would have been for MC beneficiaries who were responsible for the 20% cost share on provider administered drugs - those on MA plans and those without gap insurance. She stated that, unfortunately, because providers and infusion centers have been unable to afford the mandated over-rebated infliximab product, patients are not seeing the benefit of a reduction in cost share.
To learn more about underwater biosimilars, read CSRO's Explanatory Statement on the issue.
| |
New: OIG Report Reinforces Concerns Over Medicare’s Self-Administered Drug Policies | |
A new report from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) highlights how Medicare’s Self-Administered Drug (SAD) Exclusion List has resulted in higher costs and access challenges for patients that rely on physician-administered therapies. This latest report focuses on Stelara (ustekinumab), which was covered under Medicare Part B until it was added to the SAD Exclusion List in 2021. Based on its analysis, Medicare Administrative Contractors (MACs) overestimated self-administrated Stelara use by up to 16 percent, leading to this change. OIG’s findings add to growing concerns that the SAD Exclusion List criteria lacks transparency, is inconsistently applied, and ultimately results in unnecessary financial and administrative burdens for beneficiaries and providers.
Since 2014, CSRO has been leading efforts to address flaws in the process used to include drugs on the SAD Exclusion List, engaging with Congressional and Agency leaders to ensure that patients with complex conditions are not unfairly burdened by coverage reclassifications that increase out-of-pocket costs and limit provider-administered treatment options. CSRO is currently working with a group of likeminded stakeholders to continue the discussion on reforms to the SAD Exclusion List criteria with the new Administration.
| |
Take Action: Urge Congress to Address Medicare Fee Schedule | |
CSRO continues to be a vocal advocate for addressing the recent cuts to the Medicare Physician Fee Schedule, urging members of Congress to swiftly pass legislation that would replenish the recent cuts. As reported previously, the Centers for Medicare and Medicaid Services (CMS) cut physician reimbursement by 2.83% on January 1, 2025. This was the 5th straight year of reductions in physician Medicare payments. To make matters worse, CMS also estimates that medical inflation costs will increase by 3.5% this year.
CSRO urges rheumatologists and their practice partners to join us in taking action and help ensure members of Congress understand the immediate need to replenish this reimbursement cut. Visit the CSRO Action Center and encourage your member of Congress to cosponsor and advance H.R.879!
| |
Happening Monday: 340B Drug Pricing Program Webinar | |
The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Unfortunately, the program also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology.
Register to join CSRO this Monday, March 10, for this unique webinar to hear from advocates and policy experts about the critical need for broad reform of the federal 340B program, how state and federal legislation is shaping the program, and how CSRO is working to protect rheumatologists and their practice partners.
| |
Feedback Opportunities: Biomarker Testing Coverage Laws & Biosimilar Reimbursement | |
|
Are Biomarker Testing Coverage Laws Working?
CSRO is partnering with the American Cancer Society Cancer Action Network (ACS CAN) to understand providers’ experiences with biomarker testing. Several states have passed legislation that requires biomarker testing coverage, including: AZ, CA, GA, IL, IN, IA, KY, MD, MN, NM, NY, OK, PA, RI, TX, AR, CO, CT, FL, LA.
Rheumatologists and their practice partners from the above states are encouraged to complete this anonymous, 10-minute survey to share how these laws are working and any obstacles you’re encountering as you work to provide these tests to your patients, and seeks to understand any challenges that you may be facing.
| |
|
Help Fight for Sustainable Biosimilar Reimbursement
The Underwater Biosimilars Coalition, co-led by CSRO and the American College of Rheumatology, represents more than 50 provider and patient advocacy organizations working to address unsustainable reimbursement rates for biosimilars that are leaving many physician practices “underwater” when administering these medications.
To ensure that policymakers and payers understand the real-world impact of current reimbursement rates, we are requesting your input via a brief 5-question survey to collect data from practices that administer medications in the office. This information will be essential in shaping our advocacy efforts and securing needed reforms.
| |
Fellow-at-Large: Professional Development Opportunity for Rheumatology Fellows
| |
CSRO is recruiting for a Fellow-at-Large to serve as a non-voting member of our Board of Directors for a one-year term beginning May 1.
This position provides a unique experience for a rheumatology fellow to engage with CSRO's Board members, who are rheumatologists from across the United States with years of varied career experiences, and to be a liaison to other fellows as they learn more about the importance of advocacy in rheumatology.
The application deadline is March 27. Interested or know someone who might be? Check out our website to learn more and apply.
| |
|
Legislation Around the Country
VA: Join Physician Letter Opposing PDAB
The Virginia Society of Rheumatology (VSR) and CSRO have been actively opposed to the state’s proposal (HB 1742), which would establish a state Prescription Drug Affordability Board with the ability to place upper payment limits on physician administered medications. In a letter to Governor Youngkin, VSR and CSRO outline concerns regarding patient access and physician reimbursement, and the societies urged the Governor to veto this legislation.
VSR President and CSRO Board Member Dr. Harry Gewanter has organized a sign on letter for Viriginia-based physicians, encouraging the Governor to veto this harmful legislation. Virginia-based physicians, practices, and medical specialty societies are encouraged to sign on. Click here to read the letter, and sign on by using the button below.
| |
|
VA: PDAB Webinar Resource
Last month, VSR President and CSRO Board Member Dr. Harry Gewanter joined the Coastal Virginia Medical Society (CVMS) for a webinar on the topic of “Prescription Drug Affordability Boards (PDABs): Inigo Montoya Was Right.” Slides from his presentation are available to view here.
Email info@csro.info with questions or for additional information.
| |
Want to learn more about the legislation introduced in your state? Visit CSRO’s Map Tool to find all of the new and enacted bills within CSRO’s policy priorities.
| |
| |
|
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.
| Interested in learning more about CSRO’s engagement in the states? Visit our State Legislation Correspondence page to review the letters submitted to state legislatures on CSRO’s priority issues. | |
|
AR
- Prior Authorization (HB1300): Reported Correctly Engrossed
AZ
- Non-Medical Switching (SB1102): House Health & Human Services Action: Do Pass
- Prior Authorization (HB2130): Senate Second Read
- Prior Authorization (HB2175): Senate Second Read
CT
- Biomarker Testing Coverage (HB6771): Filed with Legislative Commissioners' Office
FL
- Prior Authorization (HB1531): Now in Health Care Facilities & Systems Subcommittee
- Step Therapy | Prior Authorization (HB899): 1st Reading (Original Filed Version)
- Step Therapy (SB264): Introduced
- Prior Authorization (SB1798): Filed
- Biomarker Testing Coverage (HB975): 1st Reading (Original Filed Version)
- 340B Drug Pricing Program (HB1527): Now in Health Care Facilities & Systems Subcommittee
- Prior Authorization | Step Therapy (SB1342): Filed
GA
- Prior Authorization (SB5): House Committee Favorably Reported
HI
- 340B Drug Pricing Program (HB712): Referred to House Committee on Health & Human Services/Senate Committee on Commerce and Consumer Protection, Senate Committee on Ways and Means/Senate Committee on Judiciary.
- Prior Authorization (HB250): Referred to House Committee on Health & Human Services, Senate Committee on Commerce and Consumer Protection/Senate Committee on Ways and Means.
- Rebate Pass Through | PBM Reform (SB1509): Received from Senate (Sen. Com. No. 360) in amended form (SD 1).
IA
- 340B Drug Pricing Program (HF590): Introduced, referred to Health and Human Services. H.J. 423.
IL
- Prior Authorization (SB1258): Added as Co-Sponsor Sen. Rachel Ventura
- Prescription Drug Affordability Board (HB1443): Added Co-Sponsor Rep. Anne Stava-Murray
- White Bagging (SB1746): Added as Chief Co-Sponsor Sen. Christopher Belt
- Rebate Pass Through | PBM Reform (HB4008): Referred to Rules Committee
- Prescription Drug Affordability Board (SB66): Added as Co-Sponsor Sen. Celina Villanueva
- 340B Drug Pricing Program (HB3350): Added Co-Sponsor Rep. Maurice A. West, II
- 340B Drug Pricing Program (SB2385): Added as Co-Sponsor Sen. Mary Edly-Allen
- Prior Authorization (SB2152): Postponed - Insurance
IN
- PBM Reform (SB3): First reading: referred to Committee on Insurance
- Prior Authorization (SB80): First reading: referred to Committee on Judiciary
- Prior Authorization (SB473): First reading: referred to Committee on Public Health
- Step Therapy | Prior Authorization (SB480): First reading: referred to Committee on Insurance
KY
- 340B Drug Pricing Program (HB685): to Health Services (H)
MD
- Biomarker Testing Coverage (HB1013): Hearing 2/28 at 12:00 p.m.
- Prior Authorization (HB1314): Hearing 3/06 at 2:00 p.m.
- Prescription Drug Affordability Board (HB424): Referred Finance
- Copay Accumulator Adjustment Program Ban | Out-of-Pocket (HB1246): Hearing 2/27 at 2:00 p.m.
- Biomarker Testing Coverage (HB553): Referred Finance
- Biomarker Testing Coverage (HB1086): Hearing 3/06 at 2:00 p.m.
- Biomarker Testing Coverage (HB1489): Rereferred to Health and Government Operations
- Biomarker Testing Coverage (HB1301): Hearing 3/10 at 11:00 a.m.
- Biomarker Testing Coverage (SB94): Referred Health and Government Operations
MI
- 340B Drug Pricing Program (SB94): Placed on Order of Third Reading
MN
- Prior Authorization (SF1739): Author added Boldon
- Copay Accumulator Adjustment Program Ban (HF1808): Introduction and first reading, referred to Commerce Finance and Policy
MO
- Prior Authorization (HB618): Reported Do Pass (H) - AYES: 10 NOES: 0 PRESENT: 0
- Copay Accumulator Adjustment Program Ban (SB512): Second Read and Referred S Families, Seniors and Health Committee
MT
- Prior Authorization | Step Therapy (SB449): Scheduled for 2nd Reading
- Step Therapy (SB483): Fiscal Note Unsigned
- Prior Authorization (HB399): Transmitted to Senate
- Prior Authorization (SB447): 2nd Reading Passed as Amended
| |
|
NC
- Rebate Pass Through | PBM Reform (H163): Ref to the Com on Health, if favorable, Regulatory Reform, if favorable, Rules, Calendar, and Operations of the House
ND
- 340B Drug Pricing Program (HB1473): Received from House
- Prior Authorization (SB2280): Introduced, first reading, referred to Industry, Business and Labor
NE
- 340B Drug Pricing Program (LB168): Cavanaugh, M. MO59 Indefinitely postpone pursuant to Rule 6, Sec. 3(f) filed
- Biomarker Testing Coverage (LB253): Fredrickson name added
NH
- Prescription Drug Affordability Board (HB645): Committee Report: Ought to Pass with Amendment # 2025-0505h 02/19/2025 (Vote 17-0; RC)
- White Bagging (SB256): Committee Report: Rereferred to Committee, 03/06/2025; Vote 5-0; CC; SC 11
- Prescription Drug Affordability Board (HB570): Minority Committee Report: Inexpedient to Legislate
- Copay Accumulator Adjustment Program Ban (SB17): Committee Report: Ought to Pass with Amendment # 2025-0531s, 03/06/2025; Vote 5-0; CC; SC 11
- Biomarker Testing Coverage (SB120): Committee Report: Ought to Pass with Amendment # 2025-0554s, 03/06/2025; Vote 5-0; CC; SC 11
NM
- Prior Authorization (SB39): STBTC: Reported by committee with Do Pass recommendation with amendment(s)
- 340B Drug Pricing Program (HB78): House Judiciary : Reported by committee with Do Not Pass but with a Do Pass recommendation on Committee Substitution
NV
- Step Therapy | Prior Authorization (AB295): From printer. To committee.
- Step Therapy | Prior Authorization (AB290): From printer. To committee.
NY
- PBM Reform (A3008): PRINT NUMBER 3008A
- Biomarker Testing Coverage (S3009): PRINT NUMBER 3009A
- Biomarker Testing Coverage (A3009): PRINT NUMBER 3009A
- PBM Reform (S438): REFERRED TO INSURANCE
OK
- Prior Authorization | Step Therapy (HB1808): Authored by Senator Rader (principal Senate author)
- Biomarker Testing Coverage (HB1810): CR; Do Pass Health and Human Services Oversight Committee
- 340B Drug Pricing Program (SB1030): Coauthored by Representative Deck
RI
- Copay Accumulator Adjustment Program Ban (S477): Introduced, referred to Senate Health and Human Services
- Prior Authorization | Step Therapy | Non-Medical Switching | PBM Reform (H5429): Scheduled for hearing and/or consideration (03/06/2025)
SC
- Copay Accumulator Adjustment Program Ban | Alternative Funding Program Ban | Maximizer Program Ban (HB3934): Member(s) request name added as sponsor: Bernstein
SD
- 340B Drug Pricing Program (SB154): Health and Human Services Do Pass, Passed, YEAS 8, NAYS 5
TN
- Biomarker Testing Coverage (SB435): Sponsor(s) Added.
- Biosimilars (HB1198): Placed on s/c cal Insurance Subcommittee for 3/12/2025
- Biomarker Testing Coverage (HB484): Placed on s/c cal Insurance Subcommittee for 3/12/2025
- 340B Drug Pricing Program (HB1242): Rec. for pass. if am., ref. to Finance, Ways, and Means Committee
- 340B Drug Pricing Program (SB1414): Placed on Senate Commerce and Labor Committee calendar for 3/11/2025
TX
- Out-of-Pocket (SB1287): Referred to Health & Human Services
- 340B Drug Pricing Program (HB3265): Filed
UT
- 340B Drug Pricing Program (SB69): House/ received from Senate
WA
- Biosimilars (SB5594): Passed to Rules Committee for second reading.
WV
- Alternative Funding Program Ban | Maximizer Program Ban (HB3092): To House Finance
- Prescription Drug Affordability Board (HB2831): To House Health and Human Resources
- White Bagging (HB3067): To House Health and Human Resources
WY
- Prior Authorization (HB76): H:Died in Committee Returned Bill Pursuant to HR 5-4
| |
Mark Your Calendar: Upcoming Events
| |
|
340B Drug Pricing Program: March 10, 2025
A webinar exploring the critical need for broad reform of the federal 340B program and how state and federal legislation is shaping the program.
| |
|
Advocacy Conference: September 12-14, 2025
Mark your calendars to join us in Dallas, Texas, for CSRO's annual Advocacy Conference!
| |
|
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.
Explanatory Statement: “Underwater” Biosimilars
To aid in addressing the issue of "underwater" biosimilars with payers, CSRO has created a document to illustrate the extent of the problem.
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 authored by Dr. Madelaine Feldman and 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.
| | | | |
