On August 21, 2026, the Centers for Medicare & Medicaid Services (CMS) published a 60-day Paperwork Reduction Act (PRA) notice in the Federal Register (91 FR 54330–54331, Document No. 2026-17128). Among the information collections submitted for public review is a significant revision to CMS-10110, formally titled Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals (OMB Control No. 0938-0921).
Public comments on the proposed revision are due on or before October 20, 2026.
Under the July 2026 iteration described in the notice, CMS proposes to expand and retask the data collected through routine quarterly ASP submissions to support manufacturer effectuation of the Maximum Fair Price (MFP) for selected drugs payable under Medicare Part B.
For biopharma government-affairs leaders, gross-to-net pricing directors, and regulatory compliance counsel who just concluded the public comment cycle for the Medicare Negotiation Program proposed rule, the immediate operational dilemma is:
Did CMS reopen public comments on the Medicare Negotiation Program, is this the July 16 Part B effectuation draft guidance under another name, and what does CMS-10110 actually change for manufacturer quarterly ASP reporting?
The direct administrative answer is that CMS-10110 is neither a reopening of CMS-4215-P nor a duplicate of the July 16 guidance:
- CMS-4215-P Is Closed: The notice-and-comment rulemaking docket for the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program proposed rule (CMS-4215-P / 91 FR 36236) officially closed for public comment on August 17, 2026. CMS-10110 does not reopen that substantive policy docket.
- The July 16 Effectuation Draft Runs on a Separate Clock: CMS's draft guidance on Part B Maximum Fair Price Effectuation—published July 16, 2026—carries a public comment deadline of September 18, 2026.
- CMS-10110 Is the Operational Data Collection Engine: CMS-10110 is the Paperwork Reduction Act instrument that transforms the quarterly ASP file—originally created under Section 1847A to establish Part B provider payment limits—into a compliance and enforcement audit feed under Sections 1193 and 1196.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CMS-10110 ASP PRA REVISION: SUMMARY & REGULATORY SPECS │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Parameter │ Published Specification / Regulatory Citation │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Federal Register Notice │ FR Doc. 2026-17128; 91 FR 54330–54331 │
│ Document Identifier & OMB Number │ CMS-10110 / OMB Control No. 0938-0921 │
│ Formal Collection Title │ Manufacturer Submission of Average Sales Price (ASP) │
│ │ Data for Medicare Part B Drugs and Biologicals │
│ Publication Date │ August 21, 2026 │
│ Public Comment Deadline │ October 20, 2026 (60-day comment window) │
│ Primary Regulatory Purpose │ Revise CMS use of ASP data to support manufacturer │
│ │ effectuation of Part B Maximum Fair Price (MFP) │
│ Statutory Authorities Cited │ SSA § 1847A (ASP methodology; 42 CFR 414.800–806) │
│ │ SSA § 1193(a)(5) (Manufacturer agreement requirements) │
│ │ SSA § 1196(a)(1)–(3), (b) (Negotiation Program admin) │
│ Affected Public & Frequency │ Private Sector (500 manufacturers); Quarterly filings │
│ Estimated Annual Burden │ 4,500 responses; 49,500 total hours (~11 hrs/response) │
│ Agency Policy Contact │ Elisabeth Daniel (667-290-8793) │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
Below, we unpack the dual statutory hooks uniting ASP reporting with IRA enforcement, examine the mathematical and technical mechanics of quarterly submissions, untangle the four overlapping Medicare drug-pricing dockets active in late 2026, evaluate the operational compliance risks for manufacturer gross-to-net pricing teams, and provide a strategic blueprint for October 20 comment letters.
The Statutory Architecture: Bridging Section 1847A and Section 1193/1196
To grasp why CMS is revising CMS-10110, one must analyze the statutory evolution of Average Sales Price reporting under the Social Security Act (SSA).
The Traditional Role of ASP under SSA § 1847A
Enacted under the Medicare Modernization Act of 2003 (MMA) and codified at 42 CFR 414.800 through 414.806, section 1847A requires manufacturers of Medicare Part B-covered drugs and biologicals to submit quarterly pricing data to CMS within 30 days after the end of each calendar quarter. This includes:
- National Drug Code (NDC) level total gross sales revenue;
- Volume (total units sold in the commercial market);
- Price concessions, volume discounts, prompt-pay discounts, chargebacks, and commercial rebates;
- Wholesale Acquisition Cost (WAC) for newly launched or single-source products where ASP data is not yet established.
CMS uses these submissions to calculate quarterly Medicare Part B payment allowances, traditionally reimbursing administering physicians and hospital outpatient departments at ASP plus 6 percent (or ASP plus 8 percent for qualifying biosimilars during the statutory add-on window).
The IRA Expansion under SSA § 1193 and § 1196
The Inflation Reduction Act established the Medicare Drug Price Negotiation Program, adding Sections 1191 through 1198 to the Social Security Act. For Initial Price Applicability Year (IPAY) 2028 and subsequent years, selected drugs will include high-expenditure provider-administered drugs payable under Medicare Part B.
In FR Doc. 2026-17128, CMS explicitly connects ASP reporting to its Negotiation Program enforcement powers:
- Section 1193(a)(5): Under the statutory manufacturer agreement, a participating drug manufacturer must comply with requirements determined by the Secretary to be necessary for administering the program and facilitating MFP effectuation.
- Section 1196(a)(1)–(3) & (b): Authorizes the Secretary to establish administrative procedures, monitoring mechanisms, and civil monetary penalties to ensure that manufacturers make the Maximum Fair Price available to eligible Medicare Part B providers and beneficiaries.
By invoking these provisions, CMS is establishing that quarterly ASP filings are no longer merely a benchmark to calculate provider reimbursement limits. They will now serve as an active compliance audit feed to verify whether commercial sales, wholesaler chargebacks, and manufacturer price concessions properly effectuate the negotiated MFP across the supply chain.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CMS DUAL-USE MODEL FOR QUARTERLY ASP SUBMISSIONS │
├───────────────────────────────────┬──────────────────────────────────────────────────────────┤
│ Traditional Track (SSA § 1847A) │ • Calculates quarterly Medicare Part B payment limits. │
│ Payment Limit Formulation │ • Sets ASP + 6% physician / hospital reimbursement. │
│ │ • Governed by 42 CFR 414.800–806 methodology. │
├───────────────────────────────────┼──────────────────────────────────────────────────────────┤
│ New Enforcement Track (SSA § 1193)│ • Verifies that eligible Part B entities receive MFP. │
│ Negotiation Program Compliance │ • Audits manufacturer chargeback & effectuation feeds. │
│ │ • Triggers compliance inquiries and potential § 1196 │
│ │ civil monetary penalties for non-effectuation. │
└───────────────────────────────────┴──────────────────────────────────────────────────────────┘
Technical Mechanics: How Quarterly ASP Submissions Operate
Under 42 CFR 414.804(a)(1), ASP is manufacturer's U.S. sales for an 11-digit NDC, after excluding exempted sales and deducting price concessions, divided by units sold:
ASP = (Gross in-scope sales − price concessions) / in-scope units sold
Price concessions under 42 CFR 414.804(a)(2) include volume, prompt-pay, and cash discounts; contingent free goods; and chargebacks and rebates other than Medicaid rebates. Bona fide service fees are not price concessions.
Exclusions from the ASP calculation are strictly defined under SSA § 1847A(c)(2)(B):
- Sales exempt from Medicaid Best Price (e.g., nominal sales, federal depot pricing, 340B covered-entity purchases);
- Sales to the Department of Veterans Affairs (VA), Department of Defense (DoD), and Indian Health Service;
- Free goods and charitable patient assistance donations.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ QUARTERLY ASP REPORTING TIMELINE & CYCLE │
├──────────────────────┬──────────────────────┬────────────────────────────────────────────────┤
│ Calendar Quarter │ Manufacturer Data │ CMS Payment Allowance Effective Date │
│ (Sales Period) │ Submission Deadline │ │
├──────────────────────┼──────────────────────┼────────────────────────────────────────────────┤
│ Q1 (Jan 1 – Mar 31) │ April 30 (30 days) │ July 1 (Q3 ASP Payment Limit: ASP + 6%) │
│ Q2 (Apr 1 – Jun 30) │ July 30 (30 days) │ October 1 (Q4 ASP Payment Limit: ASP + 6%) │
│ Q3 (Jul 1 – Sep 30) │ October 30 (30 days) │ January 1 (Q1 ASP Payment Limit: ASP + 6%) │
│ Q4 (Oct 1 – Dec 31) │ January 30 (30 days) │ April 1 (Q2 ASP Payment Limit: ASP + 6%) │
└──────────────────────┴──────────────────────┴────────────────────────────────────────────────┘
Because of the 2-quarter lag between commercial sales transactions and the effective date of the published Medicare payment rate, using ASP filings to monitor real-time MFP compliance creates significant timing distortions that manufacturer revenue accounting teams must manage.
Part B vs. Part D MFP Effectuation: The Buy-and-Bill Divide
To understand why CMS-10110 is necessary for Medicare Part B, one must contrast the commercial distribution mechanics of pharmacy-dispensed (Part D) versus provider-administered (Part B) pharmaceuticals:
Part D Point-of-Sale Facilitation
In Medicare Part D, effectuation operates primarily through the Medicare Transaction Facilitator (MTF). When an eligible Part D beneficiary presents a prescription at a retail or mail-order pharmacy, the pharmacy benefits manager (PBM) adjudicates the claim in real-time. The MTF tracks the transaction so manufacturers can effectuate MFP for selected Part D drugs under the July 16, 2026 draft guidance. That facilitator architecture is a Part D construct; it is not the CMS-10110 ASP file.
Part B Buy-and-Bill Reality
In Medicare Part B, drugs are not dispensed through PBM pharmacy switches. Instead, physician practices, community oncology clinics, and hospital outpatient departments purchase drug inventory upfront from authorized specialty distributors (e.g., AmerisourceBergen/Cencora, Cardinal Health, McKesson) under the traditional buy-and-bill model.
When administering the drug to a Medicare Part B patient, the clinic bills Medicare via medical claims (using HCPCS J-codes and CPT administration codes). Because the distributor sells inventory at commercial acquisition prices, manufacturers must effectuate the MFP through one of two mechanisms:
- Prospective Wholesale Chargeback Model: The manufacturer authorizes distributors to sell product to eligible Part B providers at the MFP, with the distributor submitting a chargeback claim to the manufacturer for the difference between WAC and MFP.
- Retrospective Provider Rebate Model: The provider purchases at standard commercial price, administers the drug to an eligible Medicare patient, and submits proof-of-administration to a manufacturer effectuation portal to receive a retrospective rebate true-up to the MFP.
Because aggregate quarterly ASP filings summarize net sales across all commercial channels, CMS cannot easily distinguish between standard commercial discounts and targeted MFP effectuation payments without revising the data fields in CMS-10110.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ COMPARISON: MEDICARE PART D VS PART B MFP EFFECTUATION │
├────────────────────────────┬─────────────────────────────┬───────────────────────────────────┤
│ Operational Dimension │ Medicare Part D (Pharmacy) │ Medicare Part B (Buy-and-Bill) │
├────────────────────────────┼─────────────────────────────┼───────────────────────────────────┤
│ Dispensing Channel │ Retail, Mail, Long-Term Care│ Physician Offices, Infusion Suites│
├────────────────────────────┼─────────────────────────────┼───────────────────────────────────┤
│ Transaction Infrastructure │ PBM EDI Switches & MTF │ Specialty Distributors (Chargeback│
│ │ real-time data exchange │ or Retrospective Rebate Portal) │
├────────────────────────────┼─────────────────────────────┼───────────────────────────────────┤
│ Inventory Financing │ Pharmacy carries 15-30 days │ Practice finances high-cost vials │
│ │ inventory at retail cost │ on credit lines prior to billing │
├────────────────────────────┼─────────────────────────────┼───────────────────────────────────┤
│ CMS Verification Mechanism │ MTF claim adjudication logs │ Revised CMS-10110 ASP Submissions│
│ │ and PDE data feeds │ and Manufacturer Audit Trails │
└────────────────────────────┴─────────────────────────────┴───────────────────────────────────┘
The Late-2026 Regulatory Landscape: Four Distinct Clocks
Biopharma legal and pricing teams must navigate four parallel, highly technical Medicare policy dockets active in August through October 2026. Treating these as a single undifferentiated proceeding invites severe procedural errors:
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ THE FOUR MEDICARE PART B & IRA COMMENT CLOCKS (FALL 2026) │
├───────────────────┬───────────────────┬───────────────────┬──────────────────────────────────┤
│ Regulatory Docket │ Legal Instrument │ Comment Deadline │ Core Operational Scope │
├───────────────────┼───────────────────┼───────────────────┼──────────────────────────────────┤
│ CMS-4215-P │ Notice of Proposed│ **CLOSED** │ Comprehensive regulatory rules │
│ (Negotiation NPRM)│ Rulemaking (NPRM) │ (August 17, 2026) │ for Medicare drug negotiation, │
│ │ 91 FR 36236 │ │ selection, and manufacturer terms│
├───────────────────┼───────────────────┼───────────────────┼──────────────────────────────────┤
│ Part B MFP Draft │ Subregulatory │ **September 18,** │ Technical operational guidance on│
│ Effectuation │ Guidance Document │ **2026** │ retrospective vs prospective │
│ Guidance │ (CMS Program Hub) │ │ MFP effectuation models. │
├───────────────────┼───────────────────┼───────────────────┼──────────────────────────────────┤
│ CMS-1850-P │ Proposed Rule │ **August 31,** │ OPPS hospital payment: proposes │
│ (CY 2027 OPPS) │ (CMS-1850-P) │ **2026** │ ASP minus 33.4% for 340B drugs; │
│ │ 91 FR 41734 │ │ accelerated remedy clawback. │
├───────────────────┼───────────────────┼───────────────────┼──────────────────────────────────┤
│ CMS-10110 │ Paperwork │ **October 20,** │ Revisions to quarterly ASP data │
│ (ASP PRA Notice) │ Reduction Act ICR │ **2026** │ collection to monitor and police │
│ │ 91 FR 54330 │ │ Part B MFP compliance. │
└───────────────────┴───────────────────┴───────────────────┴──────────────────────────────────┘
For context on the closed proposed rule, see this site's CMS-4215-P comment recap. For the separate hospital reimbursement proceeding, see our analysis of the CY 2027 340B OPPS cut to ASP minus 33.4%. For broader commercial risk around Part B selected drugs, see IRA Part B buy-and-bill reimbursement risk and the Teva bona fide marketing ruling.
The CMS-2728 Do-Not-Confuse Warning
Practitioners reviewing Federal Register notice 2026-17128 will notice that Item 1 covers CMS-2728, the End Stage Renal Disease Medical Evidence Report (OMB 0938-0046, encompassing 7,478 respondents and 123,460 hours).
Item 1 proposes removing Social Determinants of Health (SDOH) questions from the initial ESRD registration form because the document is a one-time medical admission record rather than an ongoing clinical assessment.
This collection is completely unrelated to drug pricing, ASP, or the IRA. Comment letters addressing CMS-10110 should focus exclusively on Item 2.
Operational Compliance Risks for Manufacturer Pricing Teams
Retasking the quarterly ASP submission as an MFP compliance feed introduces substantial legal and operational friction for biopharma manufacturers:
1. Lagged Concessions and Restatement Noise
Under 42 CFR 414.804(a)(3), manufacturers must estimate lagged price concessions using a 12-month lookback percentage. 42 CFR 414.804(a)(6) is about calculating ASP from the labeled vial or container amount—not a 12-quarter restatement duty. (The familiar 12-quarter restatement window is a Medicaid AMP concept, not this ASP ICR.) Manufacturers still routinely revise prior ASP quarters when lagged chargebacks and rebates arrive. If CMS treats a first-cut quarterly ASP file as an MFP-effectuation audit snapshot, those later true-ups could look like non-compliance rather than ordinary lagged-data mechanics.
2. Reasonable Assumptions and Bundled Discounts
Effective January 1, 2026, 42 CFR 414.804(a)(5)(ii) requires manufacturers to submit reasonable assumptions for ASP calculations, including documentation of fair-market-value methodology. Bundled discounts are allocated under 42 CFR 414.804(a)(2)(iii)–(iv).
If CMS intends to cross-examine ASP line-item net prices against unit-level Maximum Fair Prices, comments should ask the agency to keep those documented assumptions from being treated as intentional failures to extend the MFP.
3. Interaction with 340B Non-Duplication Rules
Under SSA § 1193(d), manufacturers are protected against duplicate discounts, ensuring that a covered entity cannot claim both a 340B statutory ceiling price discount and an IRA Maximum Fair Price on the same unit of a selected drug.
Because 340B sales are excluded from ASP under 42 CFR 414.804(a)(4) (sales exempt from Medicaid best price and nominal sales), manufacturer revenue-management platforms must keep 340B identification aligned with any MFP audit file. Misclassification could distort ASP or create improper double-discount exposure.
Strategic Blueprint: What Manufacturers Should Put in October 20 Comments
Because CMS-10110 is a Paperwork Reduction Act proceeding, comments must be structured around the statutory criteria of the PRA rather than broad political critiques of the Inflation Reduction Act.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ STRATEGIC ROADMAP FOR OCTOBER 20 CMS-10110 COMMENTS │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Core PRA Evaluation Factor │ Recommended Manufacturer Comment Position │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ 1. Necessity & Practical Utility │ Challenge CMS to clarify how aggregate quarterly ASP │
│ (5 CFR 1320.5(d)(1)) │ data can accurately verify transaction-level MFP │
│ │ effectuation without misinterpreting lagged discounts. │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ 2. Accuracy of Burden Estimate │ Provide empirical data showing whether retasking │
│ (CMS: 11 hours per response) │ ASP systems for MFP audit trails exceeds CMS's │
│ │ 49,500-hour industry estimate. │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ 3. Protection of Confidential Data │ Demand explicit data firewalls ensuring that sensitive │
│ (Trade Secrets & Net Pricing) │ commercial ASP data submitted for Part B rate-setting │
│ │ is not shared across unauthorized compliance vendors. │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ 4. Restatement Safe Harbors │ Request that routine ASP true-ups driven by lagged │
│ (Lagged concession data) │ 42 CFR 414.804(a)(3) concessions not be treated as │
│ │ evidence of programmatic non-effectuation. │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
Compliance Checklist for Government Pricing Directors
Before submitting public comments on October 20, 2026, manufacturer pricing and compliance executives should complete the following internal evaluations:
- Quantify Enterprise Reporting Burden: Measure the internal hours required across government pricing, gross-to-net accounting, and IT data engineering teams to isolate MFP effectuation data in ASP reporting, contrasting real enterprise burden against CMS's 11-hour estimate.
- Review Lagged-Concession Restatement Logs: Audit how often lagged chargebacks and commercial rebate reconciliations force ASP true-ups under 42 CFR 414.804(a)(3).
- Examine 340B Carve-Out Algorithms: Verify that transaction-level 340B exclusions stay insulated from MFP effectuation feeds to prevent duplicate-discount exposure under SSA § 1193.
- Update Written Reasonable Assumptions: Confirm that assumptions submitted under 42 CFR 414.804(a)(5)(ii) describe how bundled discounts and prompt-pay concessions are allocated across selected and non-selected NDCs.
Frequently Asked Questions
When do public comments on CMS-10110 close?
Comments on the 60-day PRA notice published in Federal Register notice 2026-17128 must be received by CMS on or before October 20, 2026.
Is CMS-10110 the same as the CMS-4215-P proposed rule?
No. CMS-4215-P was the notice-and-comment proposed rule for the Medicare Drug Price Negotiation Program, which closed for public comment on August 17, 2026. CMS-10110 is an information collection request under the Paperwork Reduction Act focused specifically on the quarterly ASP reporting template and data utility.
Does using ASP for MFP effectuation change provider reimbursement for non-selected drugs?
No. Medicare Part B reimbursement for non-selected drugs and biologicals remains governed by SSA § 1847A, paying administering providers at ASP plus 6 percent (or ASP plus 8 percent for qualifying biosimilars during the statutory add-on window). CMS-10110 expands the regulatory use of the submitted data for selected drugs, but does not alter statutory payment formulas for non-selected products.
Who is the designated agency contact for CMS-10110?
In Federal Register notice 2026-17128, CMS designated Elisabeth Daniel at 667-290-8793 as the primary policy contact for inquiries regarding CMS-10110.
Sources
- Centers for Medicare & Medicaid Services (CMS). "Agency Information Collection Activities: Proposed Collection; Comment Request (CMS-10110 & CMS-2728)." Federal Register Notice 2026-17128 (91 FR 54330–54331), published August 21, 2026; comments due October 20, 2026. https://www.federalregister.gov/documents/2026/08/21/2026-17128/agency-information-collection-activities-proposed-collection-comment-request
- Centers for Medicare & Medicaid Services (CMS). "Paperwork Reduction Act (PRA) Listing and Supporting Statements." CMS Legislation & Guidance. https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing
- Centers for Medicare & Medicaid Services (CMS). "Medicare Drug Price Negotiation Program: Regulations, Guidance, and Policy Documents." CMS Prescription Drug Affordability Hub. https://www.cms.gov/initiatives/medicare-prescription-drug-affordability/overview/medicare-drug-price-negotiation-program/regulations-guidance-policy-documents
- Code of Federal Regulations. "Title 42, Public Health; Part 414, Subpart J—Submission of Manufacturer's Average Sales Price Data." 42 CFR 414.804 (lagged concessions at (a)(3); reasonable-assumptions submission at (a)(5)(ii); labeled-container amount at (a)(6)). https://www.ecfr.gov/current/title-42/section-414.804
- United States Code. "Social Security Act § 1847A (42 U.S.C. 1395w-3a) and Social Security Act §§ 1191–1198 (42 U.S.C. 1320f–1320f-7)." https://www.ssa.gov/OP_Home/ssact/title18/1847A.htm
