CSRO Secures Major Win: Medicare Finalizes Manual Update for Drug Administration “Down Coding” | |
CSRO successfully led a coalition of physician and infusion providers in advocating for critical changes to the Medicare Claims Processing Manual, which the Centers for Medicare and Medicaid Services (CMS) has recently published. The revisions, included in Section 30.5 of the manual, clarify that Medicare Administrative Contractors (MACs) must assess multiple factors beyond just “drug names” when determining drug administration complexity. The updated language emphasizes that chemotherapy administration services, including the administration of complex biologic therapies, require physician or qualified health professional oversight well beyond that of standard injections and infusions. It also reinforces that these services demand specialized training, close patient monitoring, and direct supervision due to the high incidence of potential adverse reactions.
As a reminder, this clarification was finalized as part of CMS’s CY 2025 Medicare Physician Fee Schedule (PFS) annual rulemaking, and follows CSRO’s persistent advocacy on this issue. In August 2022, CSRO's efforts led CMS to issue a Technical Direction Letter (TDL) to its MACs, effectively pausing the down coding of complex drug administration services. The publication of the substance of the TDL came shortly after, in program transmittal #R12397OTN in December 2023. CSRO continued to engage with CMS and MACs to ensure proper implementation of these directives, including direct correspondence with MACs to retire conflicting articles.
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On Capitol Hill: CSRO Urges 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. CSRO has been advocating for changes to the Fee Schedule long before the January 1 cut was implemented and continues to stress the urgency of fixing this reimbursement reduction.
As highlighted in our last bi-weekly update, 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.
In a recent letter to Representative Greg Murphy, MD (R-NC-03), Representative Jimmy Panetta (D-CA-19), and several members of the House, CSRO thanked them for their leadership in reintroducing the Medicare Patient Access and Practice Stabilization Act (H.R. 879), which would eliminate the 2.83% cut to the Medicare Physician Fee Schedule and provide a 2.0% payment update to help stabilize physician practices.
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!
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340B Drug Pricing Program Webinar: Exploring the Impact on Rheumatologists |
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 on 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.
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Advocacy in Action: Capitol Hill Briefing on PBM Reform |
CSRO Vice President of Advocacy & Government Affairs Dr. Madelaine Feldman will be joining members of Congress and other PBM reform advocates for a Capitol Hill Briefing "Finish the Job: Pass PBM Reform Now" on Tuesday, February 25. During this event, leadership will be urged to include critical bipartisan PBM reform legislation in the anticipated March funding package.
In-person registration is available – if you will be in DC next week, you can click here to learn more and sign up. Stay tuned for a full recap in our next bi-weekly update!
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Recording Available: National Town Hall |
On February 10, CSRO gathered with the rheumatology community to provide updates on our state policy priority issues and a 2025 legislative forecast. CSRO's government affairs team reviewed anticipated trends in the states and legislation to watch for, including policies on Prescription Drug Affordability Boards, 340B drug discount program, Pharmacy Benefit Manager reform, and more. A recording of the discussion, as well as the presentation materials, are available to view on CSRO's website.
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Legislation Around the Country
340B Expansion Legislation Advances
State legislative sessions are in full swing and several bills that would expand the 340B Drug Pricing Program have already advanced. This February, CSRO submitted comments in Kentucky, Nebraska, New Hampshire, New York, North Dakota, Oregon, South Dakota and Utah urging legislators to not advance legislation that would make private practices that buy-and-bill more susceptible to hospital acquisitions and further limit patient options for their care.
Covered entities, such as hospitals and their off-campus facilities, have a competitive advantage over private practices as they can purchase drugs at a 20-50% discount through their 340B status. These covered entities can then impose markups on the drug reimbursement submitted to private insurance, pocketing the difference. After accounting for drug, patient, and geographic factors, price markups at 340B eligible hospitals are over 6 times as high as those in independent physician practices. The additional revenue pocketed by these covered entities provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016-2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.
To learn more about CSRO’s position on the 340B Drug Pricing Program, read the our Policy Position and Explanatory Statement.
MD | VA: PDAB Legislation Plows Ahead
Maryland and Virginia are moving quickly to advance legislation regarding state Prescription Drug Affordability Boards (PDABs). Maryland first established its PDAB in 2019, but the scope of the Board was limited to state employees only. Now, the state legislature is looking to expand the Board’s powers to all state regulated health plans. CSRO submitted comments several times, including a letter to the full House of Delegates urging the legislature to reconsider advancement of this legislation, especially as the existing PDAB has failed to address many of CSRO’s concerns. The House passed the legislation and the bill will advance to the Senate for consideration.
In Virginia, the legislature is swiftly moving to pass legislation that would establish a PDAB with jurisdiction over all state regulated health plans. In letters to the House Labor & Commerce Committee and Senate Commerce & Labor Committee, CSRO warned the state legislature that this bill may actually limit patient access and drive up the cost of physician administered medications instead of making them more affordable for patients. Simultaneously, PDABs can cause significant financial strain on physician practices that buy-and-bill throughout Virginia. CSRO Board Member Harry Gewanter, MD, FACR testified several times in Virginia and has been a vocal advocate on the ground, educating legislators and other stakeholders on the realities of these policies as seen in other states.
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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.
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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. | |
AZ
- Prior Authorization (SB1512): Senate Second Read
- Prior Authorization (HB2175): Transmitted To Senate
- Non-Medical Switching (SB1102): Transmitted To House
- Prior Authorization (HB2130): Transmitted To Senate
CO
- PBM Reform | Delinking (HB1094): House Committee on Health & Human Services Refer Amended to Appropriations
CT
- Biomarker Testing Coverage (HB6771): Public Hearing 02/20
GA
- Prior Authorization (SB5): House Second Readers
HI
- 340B Drug Pricing Program (HB712): Report adopted; referred to the committee(s) on House Committee on Judiciary & Hawaiian Affairs
- Rebate Pass Through | PBM Reform (SB1509): Re-Referred to House Committee on Health & Human Services/Senate Committee on Commerce and Consumer Protection.
- Biomarker Testing Coverage (HB553): House Consumer Protection & Commerce recommend(s) measure be deferred.
- 340B Drug Pricing Program (SB480): House Health & Human Services deferred the measure.
IA
- PBM Reform (SSB1017): Committee report approving bill, renumbered as SF 315.
- Rebate Pass Through | PBM Reform | Copay Accumulator Adjustment Program Ban (HSB99): Committee vote: Yeas, 23. Nays, 0. H.J. 294.
- Rebate Pass Through | PBM Reform | Copay Accumulator Adjustment Program Ban (SSB1074): Committee report approving bill, renumbered as SF 383.
- Prescription Drug Affordability Board (SF264): Subcommittee: Klimesh, Celsi, and Costello. S.J. 302.
- Prior Authorization (HSB19): Committee report approving bill, renumbered as HF 303.
IL
- 340B Drug Pricing Program (HB3350): Referred to Rules Committee
- White Bagging (SB1746): Assigned to Insurance
- Rebate Pass Through | PBM Reform (HB1171): Assigned to Executive Committee
- Rebate Pass Through | Biosimilars | PBM Reform (HB3794): Referred to Rules Committee
IN
- Step Therapy | Prior Authorization | Indiana ONS (SB480): Second reading: ordered engrossed
- PBM Reform (SB3): Referred to the House
KS
- Prescription Drug Affordability Board (SB212): Referred to Committee on Financial Institutions and Insurance
KY
- 340B Drug Pricing Program (HB685): to Committee on Committees (H)
- 340B Drug Pricing Program (SB14): to Committee on Committees (H)
MD
- Prescription Drug Affordability Board (HB424): Second Reading Passed with Amendments
- Maximizer Program Ban | Alternative Funding Program Ban | Copay Accumulator Adjustment Program Ban (SB773): Hearing 2/26
- Biosimilars (SB393): Withdrawn by Sponsor
- Biosimilars (HB529): Withdrawn by Sponsor
MO
- Copay Accumulator Adjustment Program Ban (HB982): Public Hearing Completed (H)
- Biosimilars (SB13): Voted Do Pass S Families, Seniors and Health Committee
- Copay Accumulator Adjustment Program Ban (SB45): Voted Do Pass S Families, Seniors and Health Committee
- Copay Accumulator Adjustment Program Ban (HB840): Public Hearing Completed (H)
- Prior Authorization (SB230): Hearing Conducted S Insurance and Banking Committee
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ND
- 340B Drug Pricing Program (HB1473): Reported back, do pass, place on calendar
- Copay Accumulator Adjustment Program Ban (HB1216): Second reading, passed
- Prior Authorization (SB2076): Introduced, first reading, referred to Human Services
- Step Therapy (SB2249): Introduced, first reading, referred to Political Subdivisions
NE
- 340B Drug Pricing Program (LB168): Banking, Commerce and Insurance AM225 filed
NH
- 340B Drug Pricing Program (SB253): Hearing: 02/19/2025
- Prescription Drug Affordability Board (HB570): Executive Session: 02/19/2025
NM
- 340B Drug Pricing Program (HB78): H House Health : Reported by committee with Do Pass recommendation with amendment(s)
NY
- Step Therapy (A443): SIGNED CHAP.20
SC
- Alternative Funding Program Ban | Maximizer Program Ban (SB330): Referred to Committee on Banking and Insurance
- Alternative Funding Program Ban | Maximizer Program Ban | Copay Accumulator Adjustment Program Ban (HB3934): Referred to Committee on Labor, Commerce and Industry
SD
- 340B Drug Pricing Program (SB154): Health and Human Services Do Pass Amended
TN
- 340B Drug Pricing Program (HB1242): Placed on s/c cal Insurance Subcommittee for 2/26/2025
- Maximizer Program Ban | Alternative Funding Program Ban (HB870): Assigned to s/c Insurance Subcommittee
- Biosimilars (HB1198): Assigned to s/c Insurance Subcommittee
- Biosimilars (SB436): Passed on Second Consideration, refer to Senate Commerce and Labor Committee
- Alternative Funding Program Ban | Maximizer Program Ban (SB420): Passed on Second Consideration, refer to Senate Commerce and Labor Committee
TX
- Non-Medical Switching (SB959): Referred to Health & Human Services
UT
- 340B Drug Pricing Program (SB69): Senate Comm - Motion to Recommend Failed
- Copay Accumulator Adjustment Program Ban (HB52): Bill Substituted by Sponsor in House Rules Comm
VA
- Prescription Drug Affordability Board (HB1724): Fiscal Impact Statement from Department of Planning and Budget (HB1724)
- Prior Authorization (HB2525): Passed Senate (40-Y 0-N)
- Prior Authorization (HB2099): Fiscal Impact Statement from State Corporation Commission (HB2099)
- Step Therapy (HB2258): Passed Senate (40-Y 0-N)
- Prior Authorization (SB1215): Fiscal Impact Statement from State Corporation Commission (SB1215)
VT
- PBM Reform (H156): Read first time and referred to the Committee on Health Care
WA
- Biosimilars (SB5594): Passed to Rules Committee for second reading.
- Biosimilars (HB1725): Public hearing in the House Committee on Health Care & Wellness
WY
Prior Authorization (HB76): No report prior to Committee of the Whole Cutoff
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Mark Your Calendar: Upcoming Events
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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.
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Advocacy Conference: September 12-14, 2025
Mark your calendars to join us in Dallas, Texas, for CSRO's annual Advocacy Conference!
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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.
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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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