Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies.

The Medicare proposed rules address payment under the physician fee schedule (“PFS”)¹ and hospital outpatient prospective payment system (“OPPS”) and ambulatory surgical center (“ASC”) payment system² for calendar year 2026 (“CY 2026”) (collectively, the “Proposed Rules”). The various changes proposed include changes in the following areas that are likely to interest life sciences companies:

• Drug price reporting and reimbursement
• Cell and gene therapy
• Diagnostic radiopharmaceuticals
• Skin substitutes
• Software as a service
• Non-opioid pain relief
• Digital mental health treatment devices used to support behavioral health services

CMS has invited comments on the Proposed Rules through September 12 (for the PFS) and September 15 (for the OPPS/ASC).

Drug Pricing and Reimbursement

Bona Fide Service Fees (“BFSFs”)

CMS proposes to revise the longstanding definition of BFSFs used for purposes of calculating Medicare average sales price (“ASP”) and to introduce stricter requirements for fair market value (“FMV”) determinations and documentation.

BFSFs, which are excluded from the ASP calculation, are currently defined under Medicare regulations as fees paid by a manufacturer to an entity that (1) represent FMV, (2) for a bona fide, itemized service actually performed on behalf of the manufacturer, (3) that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement, and (4) are not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug.³ A fee must meet all four conditions of the definition to be considered a BFSF rather than a price concession to be deducted from ASP.

CMS’s proposed changes would alter: (1) what represents FMV, and (2) what evidence is required to show that a fee is not passed on to an affiliate, client, or customer.

(1) FMV Determination Proposal

• For fees paid by a manufacturer to an entity that do not vary directly with the amount of drug sold or price of a manufacturer’s drug, FMV would need to be determined either based on: (i) comparable market transactions that generally reflect current market conditions, or (ii) the cost of the service plus a reasonable markup to the total cost.
• For fees paid by a manufacturer to an entity that do vary directly with the amount of drug sold or price of a manufacturer’s drug, FMV would need to be determined by an independent third-party valuator, using the cost of the service and adding a reasonable markup to the total cost. If any material portion of cost data would not be available, manufacturers would need to follow a market-based approach based on verifiable market data until such time as sufficient cost data would become available.
• Moreover, fees that vary directly with the amount or price of a manufacturer’s drugs would be presumed to be price concessions deducted from the calculation of the manufacturer’s ASP unless the manufacturer determined the fees were FMV using a cost-based approach, which could be further validated with market-based data.
• CMS proposes to require manufacturers to conduct FMV analyses at least as frequently as the renewal frequency of the underlying agreement.

(2) Supporting Documentation

• Starting January 1, 2026, manufacturers would need to submit certification letters from BFSF recipients confirming that such fees are not passed on to affiliates, clients, or customers (regardless of whether the entity takes title to the drug). If it implemented this proposal, CMS would seemingly contravene, for purposes of Medicare ASP, longstanding Medicaid guidance dating back to 2007 that manufacturers could presume, in the absence of any evidence or notice to the contrary, that a fee paid is not passed on to a client or customer of any entity.
• CMS also proposes to revise data submission requirements⁴ and require manufacturers to quarterly submit the following documentation to CMS: (1) the methodology used to determine FMV and periodic reviews of FMV, (2) certification letters from BFSF recipients that fees are not passed on, and (3) reasonable assumptions for calculating ASP.

These proposals, if finalized, would be effective for sales occurring as of January 1, 2026 (i.e., they would take effect as of manufacturers’ first quarter 2026 ASP reporting).

CMS also shares its views regarding certain fees that would not qualify as BFSFs: (1) payments by drug manufacturers to drug distributors that lower the price that distributors and purchasing physicians pay and/or that appear to exceed FMV; (2) payment by a manufacturer of credit card processing fees; (3) payment by a manufacturer of certain cell and gene therapies for tissue procurement, as CMS considers these services integral to the product’s manufacture; and (4) certain data sharing services fees where the data is required for legal compliance and audit purposes.

Bundled Sales Arrangements

There is currently no regulatory definition of “bundled sale” for purposes of calculating Medicare ASP, and CMS has instructed manufacturers to make reasonable assumptions in the absence of specific guidance. Some manufacturers have adopted the Medicaid “bundled sale” arrangement for purposes of ASP calculations, but there is no prior requirement to do so. In the CY 2026 PFS Proposed Rule, CMS proposes to define a “bundled arrangement” in a manner generally consistent with the definition under Medicaid as:

“Bundled Arrangement[”] means an arrangement regardless of physical packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or another product or some other performance requirement (for example, the achievement of market share, inclusion or tier placement on a formulary, purchasing patterns, prior purchases), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs or biologicals been purchased separately or outside the bundled arrangement.⁵

This proposed definition would require manufacturers to allocate discounts proportionally across all products in a bundled sales arrangement.⁶ In adopting a definition largely the same as the Medicaid definition, the agency noted its “intent for consistency with policies for [Average Manufacturer Price].”⁷ CMS declined, however, to adopt the Medicaid portion of the bundled sales definition that addresses value-based purchasing arrangements.

Maximum Fair Price (“MFP”) in the ASP Calculation

Under the Inflation Reduction Act (“IRA”) Medicare Drug Price Negotiation Price Program, CMS negotiates an MFP for certain high-expenditure, single-source drugs payable under Medicare Part B and covered under Part D (i.e., selected drugs).⁸ The IRA does not expressly address whether units of a drug sold at MFP are to be included in Medicare ASP reporting.

Effective January 1, 2026, CMS clarifies its view that manufacturers must include units of selected drugs sold at the MFP in their ASP calculations, given that such drug sales are included in Medicaid best price.⁹ The agency further clarified its position that its published payment limit for an IRA-negotiated drug would be a payment limit based on MFP.¹⁰

Excluding 340B Units from IRA Medicare Part D Inflation Rebates

CMS proposes to implement a claims-based methodology to remove 340B units from Medicare Part D drug inflation rebate calculations.¹¹ CMS would do so by evaluating whether a Medicare Part D prescription drug event (“PDE”) record is potentially 340B-eligible, based on examining the affiliation of the National Provider Identifier of the prescriber associated with the PDE record, the designation of the dispensing pharmacy associated with the PDE, and 340B data available from the Health Resources and Services Administration. CMS seeks comment on this methodology and potential alternative methodologies.

Additionally, CMS proposes to establish a voluntary 340B repository where covered entities can submit data on Medicare Part D 340B claims to allow CMS to assess such data for use in identifying units of Medicare Part D rebatable drugs for which a manufacturer provides a discount under the 340B Program in a future applicable period. For context, in its initial Medicare Part D Drug Inflation Rebate Guidance, CMS had solicited comments on the best mechanism to identify 340B units dispensed under Medicare Part D.¹² Commenters suggested a mechanism through which covered entities would retrospectively submit data to CMS. Beginning in 2026, covered entities (or a vendor on their behalf) would optionally begin submitting information to the repository for Medicare Part D 340B claims with dates of service on or after January 1, 2026. CMS is issuing a parallel information collection request to assess burdens associated with collection of data for such a 340B repository.

Drug Acquisition Cost Survey

In its CY 2026 OPPS/ASC Proposed Rule, CMS proposes to conduct a nationwide survey of hospital outpatient drug acquisition costs for each separately payable drug. The submission window would open by early CY 2026, and CMS would intend to complete the survey in time for results to inform CY 2027 OPPS/ASC payment policies. The agency solicits comments on “whether [CMS] should make responding to the survey a mandatory requirement of all hospitals paid under the OPPS” and how to interpret non-responses to the survey.¹³

In a press release on the CY 2026 OPPS/ASC Proposed Rule, CMS states that this survey would be taken to lower the cost of prescription drugs,¹⁴ consistent with the Executive Order (“E.O.”) 14273, “Lowering Drug Prices by Once Again Putting Americans First,” signed by President Trump on April 15, 2025.¹⁵ The E.O. directs the Secretary of Health and Human Services (“HHS”), within 180 days, to publish a plan to conduct a survey under section 1833(t)(14)(D)(ii) of the Social Security Act¹⁶ to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments. Although the E.O. did not expressly reference the 340B Program, action by the previous Trump administration suggests that the acquisition cost survey could presage reductions in Medicare reimbursement for drugs. In 2018, President Trump had reduced Medicare payments to hospitals by 28.5% for drugs purchased at 340B prices, after which litigation ensued.¹⁷ In 2022, the Supreme Court unanimously decided in American Hospital Association v. Becerra that the Secretary of HHS lacked discretion to cut Medicare’s reimbursement for selected hospitals without first conducting a drug acquisition cost survey.¹⁸

Cell and Gene Therapy Payment

Medicare Part B covers many cellular immunotherapies and gene therapies that are approved by the U.S. Food & Drug Administration (“FDA”) under a biologics license application as so-called “incident to” drugs and biologicals,¹⁹ typically paid at ASP plus 6%.²⁰ Cell-based autologous therapies require cells to be collected from the patient, altered to create the intended therapy, and then administered to the same patient for treatment. These manufacturing steps tend to have a very high cost of labor, which results in a high final cost of the therapy.

Noting the desire for consistent payment policies, as well as to curb spending, in the CY 2026 PFS Proposed Rule, CMS proposes to eliminate separate payment for manufacturing steps for autologous cell-based immunotherapies and gene therapies, and instead treat those costs as paid in a product’s ASP, effective January 1, 2026. And, as noted above, payments made by the manufacturer to an entity for tissue procurement would not qualify as BFSFs, and, therefore, would be part of the total price.

CMS appears to remain focused on reforms to address payer costs for cell and gene therapies, spanning across administrations. Previously, in February 2023, the Biden administration announced the Cell and Gene Therapy Access Model, under CMS’s Innovation Center, to increase access to cell and gene therapies, improve outcomes, and lower costs. In January 2024, the Biden administration announced that sickle cell disease would be the model’s first focus, set to begin in 2025 and possibly expand to other types of cell and gene therapies.²¹ Although the Trump administration announced changes to the Innovation Center to end certain models by December 31, 2025 as part of its initiative to lower costs and improve quality of care,²² the Cell and Gene Therapy Access Model continues to receive support. On July 15, 2025, CMS announced that 33 states, plus the District of Columbia and Puerto Rico, will participate in the first-of-its-kind model.²³ The Cell and Gene Therapy Access Model will allow the federal government to negotiate outcomes-based agreements with cell and gene therapy manufacturers on behalf of state Medicaid agencies. Under the model, participating states will receive guaranteed discounts and rebates from participating cell and gene therapy manufacturers if the therapies fail to deliver their promised therapeutic benefits.

Diagnostic Radiopharmaceuticals

Historically, under the OPPS, the costs associated with diagnostic radiopharmaceuticals have been packaged into the payment for the nuclear medicine tests with which they are used.²⁴ In CY 2025, CMS finalized a change in its payment policy for diagnostic radiopharmaceuticals, offering separate payment for any diagnostic radiopharmaceutical with an average per-day cost (calculated based on the product’s arithmetic mean unit cost) greater than $630, and removing the costs of radiopharmaceuticals from payments for nuclear medicine tests.²⁵

In the CY 2026 OPPS/ASC Proposed Rule, CMS proposes to update the $630 cost-per-day threshold to $655 so that, starting in 2026, radiopharmaceuticals costing over $655 per day would be paid separately from the service in which they are used, whereas radiopharmaceuticals with a per-day cost below $655 would remain packaged with the services in which they are used. Additionally, the diagnostic radiopharmaceuticals that exceed $655 per day would be assigned to an ambulatory payment classification, making them specified covered outpatient drugs.

CMS also encourages manufacturers to submit ASP information for diagnostic pharmaceuticals, if possible, although ASP reporting is voluntary for diagnostic radiopharmaceuticals paid under the OPPS for CY 2026.²⁶ Although not proposing a change in the payment methodology, CMS expresses its view that the use of ASP for radiopharmaceutical OPPS payment could “improve payment accuracy for separately payable diagnostic radiopharmaceuticals by applying an established methodology that has already been successfully implemented under the OPPS for other separately payable drugs and biologicals, as well as therapeutic radiopharmaceuticals.”²⁷ The agency seeks comments on how it can ensure more consistent, validated, and universal reporting to support ASP as a viable payment methodology for diagnostic radiopharmaceuticals in future rulemaking.

Skin Substitutes

CMS has historically reimbursed skin substitutes primarily as biologicals, using an ASP-based methodology.²⁸ When a procedure using a skin substitute product is performed, providers bill one or more Healthcare Common Procedure Coding System (“HCPCS”) codes to describe the preparation of the wound, the use of at least one skin substitute product, and application of the skin substitute product through suturing or various other techniques.

In recent years, CMS has raised concerns about the cost efficacy of skin substitutes, specifically the sustainability of existing payment models and provider confusion due to its perceived coding inconsistencies and setting-based payment discrepancies. Moreover, CMS has expressed concern regarding the scientific evidence supporting the therapeutic benefit of skin substitutes generally.²⁹ CMS notes that the recent proliferation of new products—particularly minimally manipulated tissues—with rising launch prices and utilization has led to significant spending.

Under the Proposed Rules, CMS proposes to separately pay for skin substitutes when furnished as incident-to supplies in conjunction with a covered procedure in a non-facility or hospital outpatient department (“HOPD”) setting—a notable departure from the current bundled payment approach. In a press release, CMS indicates this change would reduce spending by 90%, incentivize the use of products with the most clinical evidence of success, and not come at a cost to patient access and quality of care.³⁰

Additionally, CMS proposes to classify and reimburse skin substitutes in line with their FDA regulatory status into one of three categories: (1) 361 Human Cells, Tissues, and Cellular and Tissue-Based Products; (2) pre-market approval devices; and (3) 510(k) devices. For CY 2026, CMS proposes a single blended rate of $125.38/cm² for these products, based on the volume-weighted average payment amounts for 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (which has the highest volume-weighted average payment amounts from the three categories), using hospital outpatient utilization to weight each category. In the future, CMS plans to differentiate reimbursement by regulatory category, and seeks comments on the proposed initial payment rates.

CMS has also issued guidance that would limit coverage to those skin substitutes supported by published clinical trials with a sufficiently sized, well-defined patient population and robust study design.³¹ Initially set to be implemented on February 12, 2025, but delayed to January 1, 2026, the guidance currently would limit coverage to just 17 approved products.³²

CMS seeks comment on approaches to coverage and rate-setting, including setting separate rates for each category, using pooled averages, and creating additional subgroups.

Software as a Service

Software as a service (“SaaS”) in the hospital outpatient setting (i.e., clinical decision software and algorithm-driven services that assist practitioners in making clinical assessments) is a small part of hospital outpatient care for fee-for-service Medicare beneficiaries, but its use in HOPDs is growing.³³ Prior to CY 2018, CMS considered SaaS procedures to be supportive or ancillary services, such that payments were packaged into the payment for the underlying clinical service. In recent years, CMS has paid separately for SaaS through New Technology Ambulatory Payment Classifications. As these technologies evolve, some parties have stated that the lack of a consistent payment policy can impede patient access.

In its CY 2026 OPPS/ASC Proposed Rule, CMS seeks comments on how the value of SaaS may be adequately weighed and recognized in a payment policy. Specifically, CMS requests information on lessons learned from risk-bearing payment arrangements and input on how to incorporate the underlying value of SaaS within medical practice into a payment policy.

Non-Opioid Treatments for Pain Relief

The so-called “NOPAIN Act” provides for temporary additional payments for non-opioid treatments for pain relief furnished as a covered outpatient department service on or after January 1, 2025, and before January 1, 2028, that meet specific statutory requirements.³⁴

CMS proposes to extend temporary additional payments for certain non-opioid treatments through December 31, 2027. Starting in CY 2026, CMS proposes five drugs and six devices to qualify for separate payments as non-opioid treatments in HOPD and ASC settings. CMS solicits comments on additional drugs or devices that may qualify for separate payment.

Coverage Opportunities for Behavioral Health and Chronic Illness

In the CY 2025 PFS Final Rule, CMS established Medicare payments to billing practitioners for digital mental health treatment (“DMHT”) devices furnished incident to professional behavioral health services used in conjunction with ongoing behavioral health care treatment. DMHT devices refer to software devices cleared, approved, or granted de novo authorization by the FDA that are intended to treat a mental health condition, in conjunction with ongoing behavioral health care treatment, by generating and delivering a mental health treatment intervention with a demonstrable positive therapeutic impact. Effective January 1, 2025, CMS finalized three HCPCS G-codes for DMHT devices, to be billed by physicians and practitioners who are authorized to furnish services for the diagnosis and treatment of mental illness.

In the CY 2026 PFS Proposed Rule, CMS clarifies that, for coverage, the patient must have a mental health condition diagnosis, but the billing practitioner does not need to be the practitioner who made the diagnosis. With this clarification, CMS stresses its ongoing vigilance for fraud, waste, and abuse in the DMHT device space. CMS also proposes three new G-codes to integrate behavioral health services into advanced primary care management (“APCM”) when the APCM base code is reported by the same practitioner in the same month, so as to not require time-based documentation.

Additionally, CMS proposes to expand coverage to include FDA-classified attention-deficit/hyperactivity disorder digital therapy devices, provided they are adjuncts to clinician-supervised care and meet special control requirements.

CMS notes that while coverage is currently limited to DMHT devices that treat insomnia, substance use disorders, depression, and anxiety, future use cases may expand coverage.²⁵ CMS anticipates that updating payment policies will be an iterative process relating first to behavioral health treatment and by extension to chronic conditions.

CMS solicits comments on how digital therapeutic devices may offer innovative means to access certain behavioral health services. CMS also solicits comments on the possibility of establishing additional separate coding and payment for a broader set of services using digital tools as part of mental health treatment plans of care.³⁶

1. Press Release, Ctrs. for Medicare & Medicaid Servs., Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule (CMS-1832-P) (July 14, 2025), https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2026-medicare-physician-fee-schedule-pfs-proposed-rule-cms-1832-p; 90 Fed. Reg. 32,352 (July 16, 2025) (to be codified at 42 C.F.R. pts. 405, 410, 414, 424, 425, 427, 428, 495 & 512).
2. Press Release, Ctrs. for Medicare & Medicaid Servs., Calendar Year 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Proposed Rule (CMS-1834-P) (July 15, 2025), https://www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-and-ambulatory-surgical; 90 Fed. Reg. 33,476 (July 17, 2025) (to be codified at 42 C.F.R. pts. 410, 412, 413, 415, 416 & 419).
3. See 42 C.F.R. § 414.802. The current Medicare definition is consistent with the definition under the Medicaid drug rebate program regulations. See id. § 447.502.
4. Id. § 414.802(a)(5).
5. 90 Fed. Reg. at 32,542.
6. See 42 C.F.R. § 414.802.
7. 90 Fed. Reg. at 32,543.
8. See 42 U.S.C. § 1320f(c)(3).
9. See id. § 1396r-8(c)(1)(C), (D).
10. See id. § 1320f(c)(3).
11. See 42 C.F.R. § 428.203(b)(2).
12. Medicare Part D Drug Inflation Rebates Paid by Manufacturers: Initial Memorandum, Implementation of Section 1860D-14B of Social Security Act, and Solicitation of Comments, Dr. Meena Seshamani, Deputy Adm’r & Dir. of Ctr. for Medicare, to Pharm. Mfrs. of Part D Rebatable Drugs and Other Interested Parties (Feb. 9, 2023), https://www.cms.gov/files/document/medicare-part-d-inflation-rebate-program-initial-guidance.pdf.
13. 90 Fed. Reg. at 33,654.
14. Press Release, Ctrs. for Medicare & Medicaid Servs., Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey (last updated July 17, 2025), https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient-pps/outpatient-prospective-payment-system-opps-drug-acquisition-cost-survey.
15. 90 Fed. Reg. 16,441 (Apr. 15, 2025).
16. Section 1833(t)(14)(D)(ii) of the Social Security Act requires the Secretary of HHS to periodically conduct surveys of hospital acquisition costs for each specified covered outpatient drug for use in setting the payment rates for such drugs. Following the conclusion of this survey, the Secretary must consider and propose any appropriate adjustments that would align Medicare payments with acquisition costs, consistent with the budget neutrality requirement in section 1833(t)(9)(B) of the Social Security Act and other legal requirements. See 42 U.S.C. § 1395l(r)(14)(D)(ii).
17. See Press Release, Ctrs. for Medicare & Medicaid Servs., Fact Sheet, Hospital Outpatient Prospective Payment System (OPPS): Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Final Rule (CMS 1793-F) (Nov 02, 2023), https://www.cms.gov/newsroom/fact-sheets/hospital-outpatient-prospective-payment-system-opps-remedy-340b-acquired-drug-payment-policy.
18. See 596 U.S. 724 (2022).
19. 42 U.S.C. § 1395x.
20. Id. § 1395w-3a.
21. Press Release, Ctrs. for Medicare & Medicaid Servs., Biden-Harris Administration Announces Action to Increase Access to Sickle Cell Disease Treatments (Jan. 30, 2024), https://www.cms.gov/newsroom/press-releases/biden-harris-administration-announces-action-increase-access-sickle-cell-disease-treatments.
22. Press Release, Ctrs. for Medicare & Medicaid Servs., Fact Sheet: CMS Innovation Center Announces Model Portfolio Changes to Better Protect Taxpayers and Help Americans Live Healthier Lives (Mar. 12, 2025), https://www.cms.gov/newsroom/fact-sheets/cms-innovation-center-announces-model-portfolio-changes-better-protect-taxpayers-and-help-americans.
23. Press Release, U.S. Dep’t of Health & Hum. Servs., CMS Expands Access to Lifesaving Gene Therapies Through Innovative State Agreements (July 15, 2025), https://www.hhs.gov/press-room/cms-announces-participation-in-cell-and-gene-therapy-access-model.html.
24. 42 C.F.R. § 419.2(b)(15).
25. 89 Fed. Reg. 93,912 (Nov. 27, 2024).
26. 90 Fed. Reg. at 33,504.
27. Id. at 33,505.
28. See 42 U.S.C. § 1395w-32.
29. Ctrs. for Medicare & Medicaid Servs., L35041: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (last updated Nov. 8, 2024), https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35041.
30. Press Release, Ctrs. for Medicare & Medicaid Servs., CMS Proposes Physician Payment Rule to Significantly Cut Spending Waste, Enhance Quality Measures, and Improve Chronic Disease Management for People with Medicare (July 14, 2025), https://www.cms.gov/newsroom/press-releases/cms-proposes-physician-payment-rule-significantly-cut-spending-waste-enhance-quality-measures-and.
31. Ctrs. for Medicare & Medicaid Servs., L35041: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (last updated Nov. 8, 2024), https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35041.
32. Id.
33. MEDPAC, Report to the Congress: Medicare and the Health Care Delivery System 151 (2024), https://www.medpac.gov/wp-content/uploads/2024/06/Jun24_Ch4_MedPAC_Report_To_Congress_SEC.pdf.
34. Section 4135(a) and (b) of the Consolidated Appropriations Act, “Access to Non-Opioid Treatments for Pain Relief,” provides for temporary additional payments for non-opioid treatments for pain relief, as that term is defined in section 1833(t)(16)(G)(i) of the Social Security Act. 42 U.S.C. § 1395l(t)(16)(G)(i).
35. 90 Fed. Reg. at 32,503.
36. Id. at 32,504.