CMS-4215-P Comment Docket: Manufacturers and Hospitals Clash on IRA Rules

At 5:00 p.m. Eastern Time on Monday, August 17, 2026, the public comment window closed on CMS-4215-P—the Centers for Medicare & Medicaid Services' (CMS) landmark proposed rule titled Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (91 FR 36236; Docket ID CMS-2026-2080).

Published in the Federal Register on June 16, 2026 (Document No. 2026-12059), CMS-4215-P represents the agency's first comprehensive notice-and-comment rulemaking to codify the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022 (IRA; P.L. 117-169). After operating the program's initial cycles through sub-regulatory guidance documents, CMS proposed to formally codify the negotiation framework into federal regulations at 42 CFR Part 429, introducing pivotal policy modifications that will govern Initial Price Applicability Year (IPAY) 2029 and all subsequent cycles.

The close of the 60-day comment period revealed deeply entrenched, opposed stakeholder coalitions. Rather than a generic dispute over drug pricing, the docket reflects precise operational, legal, and economic fault lines across four major constituencies:

1. Industry-Aligned Voices (PhRMA, American Action Forum): Mounting fierce opposition to CMS's proposal to aggregate a narrow class of same-manufacturer fixed-combination products—most consequentially, subcutaneous hyaluronidase co-formulations—with their reference active moiety under a single Qualifying Single-Source Drug (QSSD), arguing it chills lifecycle innovation without empirical evidence of circumvention.
2. Hospitals and Health Systems (American Hospital Association - AHA): Launching an aggressive campaign demanding mandatory point-of-sale (POS) Maximum Fair Price (MFP) effectuation, warning that retrospective refund and rebate models create cash-flow and administrative burdens and set a dangerous precedent for 340B rebate conversions.
3. Health Economists and Academic Policy Experts (Brookings-Affiliated Experts): Defending the fixed-combination aggregation rule as essential to close statutory evasion loopholes, while specifically endorsing the rule's own proposal to trim the published ranked list of negotiation-eligible drugs from 50 to 30 to mitigate commercial distortion.
4. Patient Advocacy and Consumer Groups (Public Citizen, Patients Rising, HIV+Hepatitis Policy Institute): Demanding greater transparency in manufacturer submissions, raising alarms over deemed-biologic transition timing, and insisting that negotiated discounts flow directly to patient cost-sharing at the dispensing counter.

With CMS targeting publication of the final rule (CMS-4215-F) in Fall 2026—ahead of the publication of the IPAY 2029 selected drug list by February 1, 2027—market-access directors, regulatory counsel, and health system pharmacy leaders must understand which proposed policies are most vulnerable to modification.

---

What closed on August 17—and why this rulemaking is structurally different

For the program's first three negotiated cycles (IPAY 2026, IPAY 2027, and IPAY 2028), CMS implemented the program through program instructions and guidance documents issued under sections 1191–1198 of the Social Security Act (42 U.S.C. § 1320f-1 et seq.), rather than through standard notice-and-comment rulemaking under the Administrative Procedure Act (APA; 5 U.S.C. § 553).

CMS-4215-P marks the formal transition from temporary administrative guidance to permanent codified federal regulation.

┌─────────────────────────────────────────────────────────────────────────────────┐
│              CMS-4215-P RULEMAKING & IMPLEMENTATION TIMELINE                    │
├───────────────────┬─────────────────────────────────────────────────────────────┤
│ Date / Milestone  │ Administrative Action & Operational Impact                  │
├───────────────────┼─────────────────────────────────────────────────────────────┤
│ **June 16, 2026** │ CMS published Proposed Rule CMS-4215-P (91 FR 36236)        │
│ **August 17, 2026**│ **Public comment window closed at 5:00 p.m. ET**           │
│ **Sept 18, 2026** │ Comments due on IPAY 2028 MFP Effectuation Draft Guidance   │
│                   │ (issued July 16, 2026; due 11:59 p.m. PT)                   │
│ **Fall 2026**     │ Target publication of Final Rule (**CMS-4215-F**)           │
│ **Nov 30, 2026**  │ Publication of negotiated MFPs for IPAY 2028 Selected Drugs │
│ **Feb 1, 2027**   │ **CMS publishes IPAY 2029 Selected Drug List (up to 20)**   │
│ **Jan 1, 2029**   │ IPAY 2029 Maximum Fair Prices take effect in Medicare       │
└───────────────────┴─────────────────────────────────────────────────────────────┘

Because this rule establishes binding regulations under 42 CFR Part 429, CMS must respond to all significant public comments in the preamble to the final rule. Under the arbitrary-and-capricious standard of APA § 706(2)(A), the agency's factual justifications and economic impact analyses will be subject to direct judicial review in federal court—a vulnerability heightened by the D.C. Circuit's recent ruling in Teva v. Kennedy, which confirmed that facial challenges to generally applicable CMS negotiation standards are ripe for judicial review.

---

The fixed-combination fight: who wants the subQ aggregation kept, narrowed, or dropped

The most contentious substantive battle in the CMS-4215-P docket centers on new proposed 42 CFR § 429.125(b)(4)(i), an exception to the general fixed-combination rule that would aggregate a narrow class of same-manufacturer fixed-combination products with their reference single-source active moiety into a single Qualifying Single-Source Drug (QSSD).

┌─────────────────────────────────────────────────────────────────────────────────┐
│             PROPOSED FIXED-COMBINATION & REFORMULATION AGGREGATION              │
├─────────────────────────────────────────────────────────────────────────────────┤
│                                                                                 │
│   [ Reference Active Moiety NDA / BLA ]                                         │
│                    +                                                            │
│   [ Fixed-Combination / Subcutaneous Hyaluronidase Co-Formulation NDA / BLA ]    │
│                                                                                 │
│   ═══════════════════════════════════════════════════════════════════════════   │
│   GROUPED AS A SINGLE QUALIFYING SINGLE-SOURCE DRUG (QSSD)                      │
│   • Applies to same-holder combinations sharing an active moiety that           │
│     enable an alternative route of administration (e.g., IV to subQ)            │
│   • Combined Medicare Part D / Part B expenditure for selection ranking         │
│   • Selection of reference drug automatically pulls combination into negotiation│
│   • Eligibility clock runs from earliest approval of the shared moiety          │
│                                                                                 │
└─────────────────────────────────────────────────────────────────────────────────┘

Under initial program guidance for IPAY 2026 through 2028, CMS treated fixed-combination products containing two or more active ingredients as separate single-source drugs, provided each combination held a distinct New Drug Application (NDA) or Biologics License Application (BLA). CMS-4215-P would codify that general rule at 42 CFR § 429.125(b)(4) while carving out a new, narrow exception at § 429.125(b)(4)(i): where the same manufacturer holds both a standalone product and a fixed combination sharing that active moiety, and the added ingredient creates a new formulation enabling an alternative route of administration—such as an intravenous biologic co-formulated with recombinant human hyaluronidase for subcutaneous injection—CMS would aggregate the applications into a single QSSD, with the negotiation-eligibility clock running from the earliest approval of the shared active moiety's products.

The Manufacturer Position (PhRMA & American Action Forum)

The Pharmaceutical Research and Manufacturers of America (PhRMA) urged CMS to abandon or substantially narrow the proposal, warning that the policy "could discourage investment in new treatments designed to be more convenient and accessible for patients." PhRMA pointed to subcutaneous formulations as the clearest example at risk—delivery reformulations that can cut administration time from hours in an infusion setting to minutes.

In a detailed economic critique submitted on August 12, 2026, the American Action Forum (AAF) argued that CMS failed to meet basic administrative standards:

• No Empirical Evidence of Circumvention: AAF noted that CMS justified the aggregation exception as a program-integrity measure against manufacturers using new fixed-combination approvals to escape negotiation, yet the agency pointed to no empirical data demonstrating that manufacturers have actually developed combination therapies for that purpose.
• Statutory Overreach: Citing sections 1192(d)(3)(B) and 1196(a)(2) of the Social Security Act, AAF argued that the statute defines qualifying drugs on an application-by-application basis, so grouping distinct NDAs/BLAs containing different pharmacological entities exceeds the agency's authority.
• Chilling Subcutaneous R&D: Converting complex intravenous biologics (such as oncology PD-(L)1 inhibitors or immunology monoclonal antibodies) into subcutaneous co-formulations requires substantial clinical, formulation-engineering, and device-development investment. If the resulting subcutaneous product is automatically swept into the reference biologic's negotiated price ceiling, AAF argued, manufacturers will rationally curtail subQ development.

The Patient-Advocate Nuance (HIV+Hepatitis Policy Institute)

The HIV+Hepatitis Policy Institute echoed concerns regarding reformulation innovation, particularly for chronic infectious diseases where fixed-dose combination (FDC) antiretroviral tablets and long-acting injectable regimens are essential for adherence.

HIV+Hep warned that while closing evasion loopholes is valid, CMS must establish clear guardrails so that true clinical innovations—such as once-daily single-tablet regimens combining multiple novel mechanisms—are not disincentivized. Furthermore, HIV+Hep urged CMS to monitor Part D plan steering and utilization management within grouped drug classes to ensure patients are not forced onto less-tolerated formulations.

The Supporting Camp (Brookings-Affiliated Health Economists)

In a joint comment letter submitted August 17, 2026, leading health economists and legal scholars—including Dr. Richard G. Frank (Brookings Institution), Professor Rachel Sachs (Washington University in St. Louis), and Nicholas Martin—strongly endorsed CMS's aggregation rule:

• Closing the Reformulation Loophole: The authors argued that exempting fixed combinations and delivery reformulations creates an irresistible economic incentive for brand manufacturers to shift patients to minor line extensions shortly before negotiation eligibility, effectively evading the statute's intent.
• Consistency with Statutory Purpose: The scholars noted that the IRA was enacted to lower Medicare spending on high-cost, sole-source therapeutic franchises. Treating distinct dosage forms or minor co-formulations as separate monopolies would undermine the program's primary cost-containment function.

---

Why hospitals made MFP effectuation the loudest ask in the docket

While manufacturers focused on product eligibility, the nation's health systems and dispensing providers waged an intense battle over Maximum Fair Price (MFP) effectuation mechanics.

In CMS-4215-P, CMS proposed codified procedures for how manufacturers must make the negotiated MFP available to dispensing entities (retail pharmacies, specialty pharmacies, hospital outpatient departments, and physician practices). The proposed framework permits manufacturers to effectuate the MFP either through upfront wholesale discounts or through retrospective rebate and refund reconciliations processed via CMS's Medicare Transaction Facilitator (MTF).

┌─────────────────────────────────────────────────────────────────────────────────┐
│               THE HOSPITAL MFP EFFECTUATION DILEMMA (AHA POSITION)              │
├──────────────────────────────────────┬──────────────────────────────────────────┤
│ Upfront Point-of-Sale (POS) Model    │ Retrospective Rebate / Refund Model      │
├──────────────────────────────────────┼──────────────────────────────────────────┤
│ • Hospital purchases at MFP upfront  │ • Hospital purchases at full WAC upfront │
│ • Zero floating capital burden       │ • Massive floating capital requirements  │
│ • Real-time claim adjudication       │ • Complex manual claim reconciliation    │
│ • No manufacturer refund disputes    │ • Manufacturer audit & clawback exposure │
│                                      │ • **Paves way for 340B rebate conversion**│
├──────────────────────────────────────┼──────────────────────────────────────────┤
│ **SUPPORTED BY AHA & HOSPITALS**     │ **REJECTED BY AHA & HOSPITALS**          │
└──────────────────────────────────────┴──────────────────────────────────────────┘

In a comprehensive comment letter submitted August 17, 2026, the American Hospital Association (AHA)—representing nearly 5,000 hospitals and health systems—formally requested that CMS mandate point-of-sale MFP availability and explicitly prohibit retrospective manufacturer rebates.

The AHA presented three operational justifications:

1. Cash-Flow and Working-Capital Liabilities

Under a retrospective model, a dispensing hospital must acquire selected drugs at its usual acquisition cost and then wait for post-sale reconciliation through the Medicare Transaction Facilitator before the MFP discount is actually realized. The AHA letter stresses that this forces providers—particularly safety-net and rural hospitals with limited working capital—to float the difference on high-cost specialty drugs for weeks or months, effectively converting a statutory price concession into an interest-free loan to manufacturers and exposing hospitals to refund disputes and audit risk.

2. Administrative Burden of Dispute Workflows

Dispensing hospitals currently lack the administrative infrastructure to manage complex post-sale reconciliations across dozens of selected drugs, each with different manufacturer third-party administrators. As detailed in our analysis of the MFP refund dispute workflow, discrepancies in 340B duplicate-discount identification, patient residency verification, and Part D enrollment status regularly result in delayed or denied refunds.

3. Precedent for a 340B Rebate Model

Crucially, the AHA connected the CMS-4215-P docket to the ongoing litigation over manufacturer attempts to convert the 340B Drug Pricing Program into a retrospective rebate model. The letter's principal recommendation was unambiguous:

"Require drug manufacturers to make the Maximum Fair Price (MFP) available through a prospective, point-of-sale mechanism and eliminate any option that would permit manufacturers to satisfy their obligations through retrospective rebates or post-sale reconciliations."

This positions the CMS rulemaking directly adjacent to the D.C. Circuit's 340B jurisprudence (see our coverage of the 340B rebate model D.C. Circuit ruling), making MFP effectuation a high-stakes jurisdictional battleground.

---

What the Brookings expert letter supports that manufacturers oppose

The comment letter from the Brookings-affiliated expert group (Frank, Sachs, Martin et al.) provided a rigorous academic counterweight to manufacturer arguments across three key dimensions:

One transparency change in the proposed rule itself—a reduction in the published ranked list of negotiation-eligible drugs from 50 to 30—drew the Brookings group's specific endorsement. Under prior guidance, CMS published a ranked list of the top 50 highest-spend Part D and Part B drugs to provide visibility into future eligibility.

The economists argued that publishing a 50-drug list creates excessive commercial uncertainty for brand teams whose products are years away from actual negotiation, potentially distorting clinical investment and partnering agreements without delivering immediate public benefit.

---

Transparency demands: ranked-list trimming, disclosure, and the deemed-biologic question

Consumer and public-interest advocacy groups utilized the CMS-4215-P docket to demand fundamental increases in program transparency and statutory closing of timing gaps.

Public Citizen on Deemed-Biologic Transition Timing

In its formal submission on August 17, 2026, Public Citizen urged CMS to enforce rigorous transparency standards regarding manufacturer-submitted data on research and development costs, federal funding subsidies, and prior commercial revenues.

Public Citizen also drew attention to a subtle statutory timing issue regarding "deemed biologics"—protein and peptide products (such as insulins and human growth hormones) originally approved as drugs under Section 505 of the FD&C Act and transitioned to Section 351 of the PHS Act on March 23, 2020, under the Biologics Price Competition and Innovation Act (BPCIA).

Public Citizen cited its August 2026 investigative report documenting how certain blockbuster products (including AbbVie's pancreatic enzyme franchise) received what the group characterized as "seven additional years of market protection" before becoming eligible for negotiation, due to ambiguities in how CMS calculates the 11-year biologic statutory eligibility clock from the deemed transition date versus the original FDA approval date. The group urged CMS to clarify in the final rule that eligibility clocks run strictly from the initial FDA approval date regardless of statutory transition mechanisms.

Patients Rising on Direct Patient Pass-Through

Patient advocacy organization Patients Rising emphasized a core consumer principle: "A lower price only counts if it reaches the patient."

Patients Rising highlighted that while Maximum Fair Prices reduce total program costs, Part D plan sponsors and PBMs retain broad discretion over tier placement and utilization management. The organization demanded that CMS:

1. Require Part D plan sponsors to pass through 100% of negotiated MFP savings directly to beneficiary cost-sharing at the point of sale.
2. Establish strict prohibitions against mid-year formulary tier increases for selected drugs.
3. Prohibit aggressive step therapy and prior authorization hurdles designed to steer patients away from selected drugs toward non-selected products that offer higher back-end PBM rebates.

---

Stakeholder Alignment Matrix: Who Wants What in CMS-4215-P

┌─────────────────────────────────────────────────────────────────────────────────────────────────┐
│                               STAKEHOLDER POSITION COMPARISON MATRIX                            │
├──────────────────────┬──────────────────────┬──────────────────────┬────────────────────────────┤
│ Stakeholder Group    │ Fixed-Combination    │ MFP Effectuation     │ Program Transparency       │
│                      │ Aggregation Rule     │ Model (POS vs. Reb)  │ & Ranked List Rules        │
├──────────────────────┼──────────────────────┼──────────────────────┼────────────────────────────┤
│ **PhRMA / AAF**      │ ❌ **Strongly Oppose**│ ⚖️ **Prefer Rebates**  │ 🔒 **Strict Confidentiality│
│                      │ (Chills subQ R&D; no │ (Protects commercial │ Demands redaction of all   │
│                      │ circumvention proof) │ pricing structures)  │ proprietary pricing data)  │
├──────────────────────┼──────────────────────┼──────────────────────┼────────────────────────────┤
│ **AHA (Hospitals)**  │ ⚖️ **Neutral**        │ ❌ **POS Mandatory**  │ ⚖️ **Support Visibility**   │
│                      │ (Focused on provider │ (Rebates cause cash- │ (Needs clear pricing to    │
│                      │ operations)          │ flow & 340B risks)   │ prevent billing disputes)  │
├──────────────────────┼──────────────────────┼──────────────────────┼────────────────────────────┤
│ **Brookings Experts**│ ✅ **Strongly Support**│ ⚖️ **Flexible**      │ ✂️ **Trim List (50 → 30)** │
│                      │ (Closes patent-      │ (Supports automated  │ (Reduces market distortion │
│                      │ evergreening loophole│ MTF settlement)      │ on pipeline assets)        │
├──────────────────────┼──────────────────────┼──────────────────────┼────────────────────────────┤
│ **Public Citizen**   │ ✅ **Strongly Support**│ ✅ **POS Mandatory** │ 📢 **Maximum Disclosure**  │
│                      │ (Maximizes drugs     │ (Ensures immediate   │ (Full publication of R&D   │
│                      │ eligible for cuts)   │ patient relief)      │ costs & deemed dates)      │
├──────────────────────┼──────────────────────┼──────────────────────┼────────────────────────────┤
│ **HIV+Hep / Patients**│ ⚠️ **Qualified Concern│ ✅ **POS Mandatory** │ 🛡️ **Patient Protections** │
│                      │ (Preserve subQ FDC;  │ (Savings must reach  │ (Prohibit step therapy and │
│                      │ monitor formulary)   │ counter directly)    │ steering against MFPs)     │
└──────────────────────┴──────────────────────┴──────────────────────┴────────────────────────────┘

---

What to expect in the Fall 2026 final rule and the February 2027 IPAY 2029 list

With the comment period closed, CMS leadership and the Center for Medicare are reviewing thousands of docket submissions. Based on administrative law constraints, docket evidence, and statutory deadlines, biopharma strategy teams should prepare for the following outcomes in CMS-4215-F:

1. Narrowing or Clarification of the Route-of-Administration Exception

Given the substantial record developed by PhRMA, AAF, and clinical patient groups regarding the chilling effect on subcutaneous drug development, CMS faces meaningful APA litigation risk if it finalizes the new § 429.125(b)(4)(i) exception without addressing the evidentiary record.

Expect CMS either to finalize the exception with a stronger justification and clearer boundaries, or to narrow it further—for example, by adding a clinical-differentiation pathway for co-formulated products that demonstrably eliminate facility infusion requirements.

2. Guardrails on Retrospective MFP Rebates

While CMS is unlikely to completely eliminate retrospective refund mechanisms due to retail pharmacy system complexities, the agency will likely introduce strict operational timelines on manufacturer refunds (e.g., requiring MTF settlement within 30 days) and explicit regulatory language clarifying that Medicare negotiation effectuation mechanics cannot be used by manufacturers as precedent to modify 340B statutory purchasing channels.

3. IPAY 2029 Selected Drug List (February 1, 2027)

The final rule will govern the selection of up to 20 additional Part D and/or Part B drugs for Initial Price Applicability Year 2029, to be announced by February 1, 2027. Building on the IPAY 2028 cycle—the first to bring physician-administered Part B drugs into negotiation alongside Part D orals—the 2029 list makes the codified rules on buy-and-bill effectuation, provider reimbursement, and combination aggregation immediately operational for the nation's largest specialty oncology and immunology franchises (see our forward analysis of the IRA negotiation cycle timeline).

---

Frequently Asked Questions

When did comments on the CMS-4215-P proposed rule close?

The public comment period for CMS-4215-P officially closed at 5:00 p.m. Eastern Time on Monday, August 17, 2026.

Do stakeholders oppose the whole proposed rule or specific proposals?

Stakeholders generally accept that CMS must codify the negotiation program into formal regulations under the APA. Opposition is concentrated on specific high-impact provisions: drug manufacturers oppose the fixed-combination aggregation rule; hospitals oppose retrospective MFP rebate models; and patient groups oppose loose formulary protections that allow plans to restrict access to negotiated drugs.

What is the fixed-combination aggregation change and who opposes it?

CMS proposed to codify the general rule that distinct fixed-combination products are separate Qualifying Single-Source Drugs (QSSDs) at 42 CFR § 429.125(b)(4), while adding a narrow new exception at § 429.125(b)(4)(i) for same-manufacturer combinations that share an active moiety and enable a new route of administration—most consequentially, subcutaneous hyaluronidase co-formulations of intravenous biologics, which would be aggregated with the parent product and share its eligibility clock. PhRMA, the American Action Forum, and the HIV+Hepatitis Policy Institute oppose the exception, arguing it penalizes drug delivery innovation without evidence of circumvention. Brookings-affiliated health economists and consumer groups support it as necessary to prevent reformulation loopholes.

Why do hospitals want point-of-sale MFP effectuation instead of rebates?

Hospitals and health systems (led by the AHA) argue that retrospective manufacturer refunds force providers to purchase high-cost specialty drugs at full WAC upfront, tying up millions of dollars in working capital while waiting months for claims reconciliation. Furthermore, hospitals warn that allowing retrospective rebates in Medicare sets a dangerous precedent that drugmakers will use to dismantle upfront purchasing in the 340B Drug Pricing Program.

When is the final rule and when are the IPAY 2029 drugs selected?

CMS targets publication of the final rule (CMS-4215-F) in Fall 2026. The list of up to 20 Part D and/or Part B drugs selected for Initial Price Applicability Year (IPAY) 2029 will be published by February 1, 2027, with negotiated Maximum Fair Prices taking effect on January 1, 2029.

Does this rulemaking affect the already-negotiated 2026–2028 prices?

No. The negotiated Maximum Fair Prices for IPAY 2026 (10 Part D drugs, effective Jan 1, 2026), IPAY 2027 (15 Part D drugs, effective Jan 1, 2027), and IPAY 2028 (15 drugs spanning Part D and, for the first time, Part B, with prices due by November 30, 2026) were established under sub-regulatory guidance. CMS-4215-F will establish the codified legal framework for IPAY 2029 and all future cycles.

---

Sources

1. Centers for Medicare & Medicaid Services (CMS) — Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (CMS-4215-P). Proposed Rule, 91 FR 36236; Federal Register Doc. 2026-12059 (June 16, 2026; comments closed August 17, 2026). Available at: federalregister.gov/documents/2026/06/16/2026-12059/medicare-drug-price-negotiation-program-and-medicare-prescription-drug-benefit-program.
2. American Hospital Association (AHA) — AHA Comments on CMS Medicare Drug Pricing and Benefit Programs Proposed Rule (CMS-4215-P). Formal Comment Letter, August 17, 2026. Available at: aha.org/letterscomments/2026-08-17-aha-comments-cms-medicare-drug-pricing-and-benefit-programs-proposed-rule.
3. Frank, R.G., Sachs, R., Martin, N., et al. — Public Comment on CMS-4215-P: Medicare Drug Price Negotiation Program Proposed Rule. Brookings Institution / Academic Expert Submission, August 17, 2026. Available at: brookings.edu/wp-content/uploads/2026/08/CMS-4215-P_CommentLetter_Frank_Sachs_Martin_Final.pdf.
4. Pharmaceutical Research and Manufacturers of America (PhRMA) — PhRMA Comments on Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule (CMS-4215-P). Resource Summary, August 2026. Available at: phrma.org/resources/phrma-comments-on-medicare-drug-price-negotiation-program-and-medicare-prescription-drug-benefit-program-proposed-rule-cms-4215-p.
5. American Action Forum (AAF) — Comments to CMS on the Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program. August 12, 2026. Available at: americanactionforum.org/comments-for-record/comments-to-cms-on-the-medicare-drug-price-negotiation-program-and-medicare-prescription-drug-benefit-program.
6. Public Citizen — Comments Regarding Proposed Rule to Codify the Medicare Prescription Drug Price Negotiation Program (CMS-4215-P). August 17, 2026. Available at: citizen.org/article/public-citizen-comments-regarding-proposed-rule-to-codify-the-medicare-prescription-drug-price-negotiation-program-cms-4215-p.
7. HIV+Hepatitis Policy Institute — Comments to CMS Administrator on Medicare Price Negotiation and Rx Programs (Docket CMS-2026-2080). August 17, 2026. Available at: hivhep.org/testimony-comments-letters/comments-to-cms-administrator-on-medicare-price-negotiation-and-rx-programs.
8. Patients Rising — We Just Told CMS: A Lower Price Only Counts If It Reaches the Patient. Advocacy Statement, August 17, 2026. Available at: patientsrising.org/advocacy-updates/cms-medicare-negotiation-2029-rule-comment-2026.
9. Politico — Prescription Pulse: Industry Previews Next Medicare Drug Price Battles. August 18, 2026. Available at: politico.com/newsletters/prescription-pulse/2026/08/18/industry-previews-next-medicare-drug-price-battles-01039384.