Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies

42 CFR Part 405

Administrative practice and procedure, Diseases, Health facilities, Health professions, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 414

Administrative practice and procedure, Biologics, Diseases, Drugs, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 424

Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 455

Fraud, Grant programs--health, Health facilities, Health professions, Investigations, Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 484

Health facilities, Health professions, Medicare, and Reporting and recordkeeping requirements.

42 CFR Part 498

Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as follows:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0 1. The authority for part 405 continues to read as follows:

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

0 2. Section 405.800 is amended by revising paragraph (b)(2) to read as follows:

Sec. 405.800 Appeals of CMS or a CMS contractor.

* * * * *

(b) * * *

(2) Effective date of revocation. The effective date of a revocation is as specified in Sec. 424.535 of this chapter. * * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0 3. The authority for part 414 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0 4. Section 414.234 is amended by revising paragraph (c)(1) introductory text and adding paragraphs (c)(1)(ii)(A) and (B) to read as follows:

Sec. 414.234 Prior authorization for items frequently subject to unnecessary utilization.

* * * * *

(c) * * *

(1) Items requiring prior authorization. CMS publishes in the Federal Register and posts on the CMS Prior Authorization website a list of items, the Required Prior Authorization List, that require prior authorization as a condition of payment, unless otherwise exempt under paragraph (c)(1)(ii) of this section. * * * * *

(ii) * * *

(A) An exemption is provided for a supplier that achieves a rate of payable claims submitted, based on Medicare's billing, coding or payment requirements, of at least 90 percent during an initial or periodic review and remains in effect until CMS withdraws the exemption. An exemption of a supplier is withdrawn if the rate of non- payable claims submitted, based on Medicare's billing, coding or payment requirements, becomes higher than 10 percent, based upon a periodic assessment.

(B) CMS provides a notice of an exemption or withdrawal of an exemption to the supplier at least 60 days before the effective date. * * * * *

0 5. Section 414.402 is amended by-- 0 a. Adding the definitions of “Adjusted fee schedule amount” and “Competition” in alphabetical order; 0 b. Removing the phrase “Competitive bidding program” in the definition of “Competitive bidding program” and adding in its place “Competitive bidding program (CBP)”; 0 c. Adding paragraph (6) to the definition of “Item”; and 0 d. Adding the definitions of “Remote item delivery competitive bidding program”, “Remote item delivery item”, and “Unadjusted fee schedule amount” in alphabetical order.

The additions read as follows:

Sec. 414.402 Definitions.

* * * * *

Adjusted fee schedule amount means the payment amount established for the item under one of the following:

(1) Subpart C of this part, with the application of Sec. 414.105.

(2) Subpart D of this part, with the application of Sec. 414.210(g).

(3) Subpart Q of this part, with the application of Sec. 414.1690. * * * * *

Competition means a competitive bidding area and product category combination for which a bidding entity submits a bid and for which a supplier enters into a DMEPOS CBP supplier contract to furnish items and services within the product category to beneficiaries residing within the competitive bidding area. * * * * *

Item * * *

(6) Other medical equipment described in section 1861(m)(5) of the Act, including supplies related to ostomy care and urological supplies. * * * * *

Remote item delivery competitive bidding program means a competitive bidding program wherein contract suppliers are responsible for furnishing remote item delivery items under a product category to all Medicare beneficiaries regardless of where they live in the CBA. The CBA could be one nationwide CBA that includes all areas (all States, territories, and the District of Columbia) or a CBA covering a specific region of the country.

Remote item delivery item means an item falling under a remote item delivery competitive bidding program that may be shipped or delivered to a beneficiary's home, regardless of the method of delivery, or picked up at a local pharmacy or supplier storefront if the beneficiary or caregiver for the beneficiary chooses to pick the item up in person. * * * * *

Unadjusted fee schedule amount means the payment amount established for the item under one of the following:

(1) Subpart C of this part, without the application of Sec. 414.105.

(2) Subpart D of this part, without the application of Sec. 414.210(g).

(3) Subpart Q of this part, without the application of Sec. 414.1690. * * * * *

0 6. Section 414.408 is amended by-- 0 a. Revising paragraph (b); and 0 b. Adding paragraphs (e)(2)(v), (g)(6), and (m).

The revision and additions read as follows:

Sec. 414.408 Payment rules.

* * * * *

(b) Changes to the single payment amount. (1) For the second year (12-month period) of a DMEPOS CBP supplier contract period, the single payment amount for each item under each competitive bidding program is updated based on the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) for the 12-month period ending 6 months prior to the start of the second year of the applicable DMEPOS CBP supplier contract period.

(2) For the third year (12-month period) of a DMEPOS CBP supplier contract period, if applicable, the single payment amount for each item under each competitive bidding program is updated based on the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) for the 12-month period ending 6 months prior to the start of the third year of the applicable DMEPOS CBP supplier contract period.

(3) In no case can the updated single payment amount for an item in the applicable CBA be greater than the unadjusted fee schedule amount for the item in such area or 110 percent of the adjusted fee schedule amount for the item in such area. * * * * *

(e) * * *

(2) * * *

(v) A Medicare enrolled provider or supplier, as the terms are defined under Sec. 400.202 of this chapter, that is operated by the Indian Health Service (IHS) or a Tribe or Tribal organization in accordance with the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5301, et seq.) may furnish an item to an AI/AN Medicare beneficiary who is eligible for services from the IHS. * * * * *

(g) * * *

(6) Other medical equipment described in section 1861(m)(5) of the Act, including supplies related to ostomy care and urological supplies. * * * * *

(m) Special temporary transition rules for payment for supplies and accessories necessary for the effective use of beneficiary-owned continuous glucose monitors and insulin infusion pumps. CMS continues, as applicable, to make separate payments under the DMEPOS competitive bidding program for supplies and accessories for class II continuous glucose monitors or insulin infusion pumps owned by the beneficiary at the time a competitive bidding program is phased in for class II continuous glucose monitors or insulin infusion pumps for the first time in a CBA where the beneficiary resides until coverage for the beneficiary-owned equipment ends, the equipment is no longer used, or at any point when the equipment has been replaced with rented equipment under the DMEPOS CBP.

0 7. Section 414.412 is amended by-- 0 a. Revising paragraph (b)(2); 0 b. Redesignating paragraphs (b)(3) through (5) as paragraphs (b)(6) through (8); 0 c. Adding new paragraphs (b)(3) through (5); 0 d. Adding paragraphs (b)(9) through (12); 0 e. Revising paragraphs (g)(1) and (g)(3)(ii); and 0 f. Adding paragraph (g)(5).

The revisions and additions read as follows:

Sec. 414.412 Submission of bids under a competitive bidding program.

* * * * *

(b) * * *

(2) The bid amount for each lead item in a product category included under the DMEPOS CBP for the first time must not exceed the unadjusted fee schedule amount for the lead item.

(3) The bid amount for each lead item in a product category included in a prior competition, if it has been 1 year or less since a SPA was paid for the item in the prior competition, must not exceed, for the same CBA, the lesser of--

(i) The most recent SPA for the item plus 10 percent; or

(ii) The unadjusted fee schedule amount for the item.

(4) The bid amount for each lead item in a product category included in a prior competition, if it has been more than 1 year since a SPA was paid for the item in the prior competition, must not exceed the lesser of the--

(i) Most recent SPA made for the item, as adjusted by the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) from the mid-point of the most recent 12-month period the SPA was in effect to the date that is 6 months prior to the date CMS announces the dates suppliers may register and submit bids under the current round of competition, plus 10 percent; or

(ii) The unadjusted fee schedule amount for the item.

(5) The bid amount for each lead item in a product category included in a prior competition but made under a bid for a new CBA, must not exceed the lesser of the--

(i) Adjusted fee schedule amount for the item plus 10 percent; or

(ii) Unadjusted fee schedule amount for the item. * * * * *

(9) The bid amount submitted for rental of class II continuous glucose monitors included as a lead item in a product category in a remote item delivery competitive bidding program for the first time must not exceed the payment amount that would otherwise apply to the monthly fee schedule amount for the supplies for the class II continuous glucose monitor under subpart D of this part plus the average of the purchase fee schedule amounts that would otherwise apply to the class II continuous glucose monitor for the areas included in the remote item delivery competitive bidding program divided by 60.

(10) The bids amount submitted for rental of insulin infusion pumps included as a lead item in a product category in a remote item delivery competitive bidding program for the first time must not exceed the nonrural payment amount that would otherwise apply to the supplies and accessories for the insulin infusion pump under subpart D of this part, with the application of Sec. 414.210(g), for a 1-month period plus the total nonrural rental fee schedule amounts that would otherwise apply to rental of the insulin pump for 13 months of continuous use under subpart D of this part, with the application of Sec. 414.210(g), divided by 60.

(11) The bid amounts submitted for an OTS back brace or OTS knee brace included as a lead item in a product category in a remote item delivery competitive bidding program for the first time cannot exceed the average nonrural payment amount that would otherwise apply to the item under subpart D of this part, with the application of Sec. 414.210(g), for the areas included in the remote item delivery competitive bidding program.

(12) Notwithstanding paragraphs (b)(9) through (11) of this section, the bid amount for each lead item in a product category in a remote item delivery competitive bidding program for the first time must not exceed the average payment amount that would otherwise apply to the item under subpart C, D, or Q of this part for the areas included in the remote item delivery competitive bidding program. * * * * *

(g) * * *

(1) Bidding requirements. A bidding entity may not submit a bid(s) and be awarded a contract for a competition unless it obtains a bid surety bond for the CBA from an authorized surety on the Department of the Treasury's Listing of Certified Companies and provides proof of having obtained the bond by submitting a copy to CMS by the deadline for bid submission. * * * * *

(3) * * *

(ii) Where the bid(s) does not meet the specified forfeiture conditions in paragraph (g)(3)(i) of this section, the bid surety bond liability will be returned within 90 days of the public announcement of contract suppliers for the CBA. CMS will notify the bidding entity that it did not meet the specified forfeiture requirements and the bid surety bond will not be collected by CMS. * * * * *

(5) Bid surety bond riders. (i) Bid surety bonds submitted prior to the deadline for bid submission are reviewed to determine if they contain any deficiencies that would make the applicable bid(s) ineligible to receive a DMEPOS CBP supplier contract offer. If any deficiency is found that can be rectified under paragraph (g)(5)(ii) of this section, CMS will notify the bidder of the deficiency(ies) and allow the bidder to submit a bid surety bond rider to rectify the deficiency(ies).

(ii) Bidding entities can submit a bid surety bond rider to correct the identified deficiency(ies) applicable to any of the bid surety bond requirements outlined in paragraphs (g)(2)(i) and (ii) of this section. No other deficiency(ies) can be rectified by a bid surety bond rider.

(iii) Bidding entities notified of a bid surety bond deficiency have 10-business days after the date of the notice to submit a bid surety bond rider. The bidder must receive the bid surety bond rider from the authorized surety that issued the original bid surety bond.

0 8. Section 414.414 is amended by revising paragraphs (d), (e), (f), and (h) to read as follows:

Sec. 414.414 Conditions for awarding contracts.

* * * * *

(d) Financial standards--(1) Financial document requirements. (i) By the close of the bid window, the bidding entity must, in accordance with paragraph (d)(2) of this section, submit a business credit report with a numerical credit score or rating, unless the bidding entity is unable to generate a business credit report with a numerical credit score or rating because the bidding entity has not been in operation long enough to generate a numerical score or rating.

(ii) By the close of the bid window, a bidding entity that is unable to generate a business credit report with a numerical credit score or rating is required to submit both a business credit report showing no data or insufficient information to generate a credit score and a personal credit report with a numerical credit score or rating from the bidding entity's Authorized Official or Delegated Official listed in CMS' PECOS.

(iii) The bidding entity must submit the documentation described in paragraphs (d)(1)(i) and (ii) of this section containing the approved crediting agency, an approved numerical credit score or rating, the name of the bidding entity or authorized official or delegated official, as applicable, and the date that the credit report was prepared, which must be generated within the 90 calendar days prior to the opening of the bid window in a form and manner specified by CMS. If the numerical credit score or rating is generated separately from the credit report, the bidding entity's name and the date it was prepared must be shown on the credit report and included with the numerical credit score or rating.

(iv) The bidding entity must attest in the bidding system that it is submitting one bid that includes all commonly owned or commonly controlled locations, and that it will furnish the lead item and all non-lead items in the same competition.

(2) Financial scoring methodology. A credit report scoring list is published before the opening of the bid window in the round specific Request for Bids Instructions or a fact sheet or both which includes all of the following:

(i) The approved credit agencies from which a bidding entity must obtain business and personal credit reports as applicable with a numerical credit score or rating. Bidding entities that must obtain both a business and personal credit report with a numerical credit score or rating do not have to utilize the same approved credit agency for both.

(ii) The approved business and personal credit reports as applicable and associated numerical credit scores or ratings that must be submitted.

(iii) The scoring system that will be utilized to determine if a bidding entity meets the financial sustainability threshold.

(e) Evaluation of bids. CMS evaluates composite bids submitted for a lead item within a product category by doing all of the following:

(1) Calculating the number of suppliers selected to furnish the items and services in the competition in accordance with paragraph (h) of this section.

(2) Arraying the composite bids from the lowest composite bid price to the highest composite bid price.

(3) Selecting the number of suppliers and networks calculated under paragraph (e)(1) of this section that meet the requirements in paragraphs (b) through (d) of this section with the lowest composite bids.

(f) Expected savings. A DMEPOS CBP supplier contract is not awarded for a competition under this subpart unless CMS determines that the SPA to be paid to contract suppliers for the lead item would be no greater than the lesser of--

(1) 110 percent of the adjusted fee schedule amount for the item, if applicable; or

(2) The unadjusted fee schedule amount for the item. * * * * *

(h) Sufficient number of contract suppliers. (1) Notwithstanding paragraph (h)(1)(ii) of this section, for competitions included in the DMEPOS CBP in 2018 or 2023, the first time a competition is recompeted after 2023, the number of contract suppliers selected to furnish items and services in the competition is double the number of contract suppliers that furnished at least 5 percent of total allowed services for the lead item furnished by contract suppliers to the applicable beneficiary population during 2018 or 2023, adjusted up or down based on the percentage change in Part B enrollment in the CBA since 2018 or 2023, and rounded to the nearest whole number.

(i) CMS adjusts the number of contract suppliers selected in accordance with paragraph (h)(1) of this section for a competition to ensure the number selected is--

(A) Not less than 50 percent of the total number of contract suppliers that furnished the lead item in 2018 or 2023 rounded up to the nearest whole number;

(B) Not more than 75 percent of the total number of contract suppliers that furnished the lead in 2018 or 2023 rounded down to the nearest whole number; and

(C) At least 2.

(ii) [Reserved]

(2) For competitions included in the DMEPOS CBP in 2018 or 2023, the first time a competition is recompeted after 2023 in accordance with paragraph (h)(1) of this section, the number of contract suppliers selected to furnish items and services in the competition is equal to the number of contract suppliers CMS selected the first time the competition was recompeted after 2023 in accordance with paragraph (h)(1) of this section, trended up or down based on the percentage change in Part B enrollment in the CBA since the first year (12-month period) of the most recent DMEPOS CBP supplier contract period, and rounded to the nearest whole number.

(3) For competitions not included in the DMEPOS CBP in 2018 or 2023--

(i) The first time a competition is conducted after 2023, the number of contract suppliers selected to furnish items and services is 125 percent of the number of suppliers that furnished at least 3 percent of total utilization for the lead item in the product category and CBA during the most recent calendar year, and rounded to the nearest whole number, unless there would be less than 2 contract suppliers, in which case the number of contract suppliers will be 2.

(ii) For all subsequent recompetes for the competition, the number of suppliers selected to furnish items and services is equal to the number of contract suppliers selected in the prior competition or recompete, as applicable, trended up or down based on the percentage change in Part B enrollment in the CBA since the first year (12-month period) of the most recent DMEPOS CBP supplier contract period, and rounded to the nearest whole number. * * * * *

0 9. Section 414.416 is amended by revising paragraph (b) to read as follows:

Sec. 414.416 Determination of competitive bidding payment amounts.

* * * * *

(b) Methodology for setting payment amount. (1) Notwithstanding paragraphs (b)(2) and (3) of this section, a single payment amount for a lead item furnished under a competitive bidding program is equal to the 75th percentile of bid amounts submitted for that item by suppliers whose composite bids for the product category that includes the item are equal to or below the pivotal bid for that product category. If the 75th percentile of bid amounts falls between 2 bidding entities, the SPA is determined by using the amount that is 75 percent between the two bid amounts, rounded to the nearest cent.

(2) The single payment amount for an item in a product category furnished under a competitive bidding program that is not a lead item for that product category (non-lead item) is equal to the single payment amount for the lead item in the same product category multiplied by the ratio of the 2015 fee schedule amount for the non- lead item for the applicable area to which the fee schedule amount applies (State, District of Columbia, Puerto Rico, or United States Virgin Islands) to the 2015 fee schedule amount for the lead item for the same area.

(3) The single payment amount for an item included in a product category in a remote item delivery competitive bidding program furnished under a competitive bidding program that is not a lead item for that product category (non-lead item) is equal to the single payment amount for the lead item in the same product category multiplied by the ratio of the average 2015 fee schedule amount for the non-lead item for the applicable area to which the fee schedule amount applies (State, District of Columbia, Puerto Rico, or United States Virgin Islands, a combination thereof, or nationwide) to the average 2015 fee schedule amount for the lead item for the same area.

(i)(A) The 2015 fee schedule amounts for a continuous glucose monitor and supplies are calculated using the 2025 fee schedule amounts and removing the covered items update factors for years 2016 through 2025 specified under section 1834(a)(14) of the Act.

(B) The 2015 fee schedule amounts for the bundled monthly rental of a continuous glucose monitor are calculated by adding the 2015 fee schedule amount for the supplies to the average of the 2015 fee schedule amounts for the purchase of a new continuous glucose monitor divided by 60 for the areas included in the remote item delivery CBP.

(ii) The 2015 fee schedule amount for the monthly supplies for a continuous glucose monitor owned by a beneficiary is calculated using the 2025 fee schedule amount and removing the covered item update factors for years 2016 through 2025 specified under section 1834(a)(14) of the Act.

(iii) The 2015 fee schedule amounts for the bundled monthly rental of an insulin infusion pump and supplies and accessories are calculated using the average 2015 fee schedule amounts for the insulin infusion pump multiplied by 10.5 and divided by 60 for the nonrural areas included in the remote item delivery CBP, and then adding the average 2015 fee schedule amounts for the sterile syringe type cartridge for the insulin infusion pump multiplied by 9 for the nonrural areas included in the remote item delivery CBP plus the average 2015 fee schedule amounts for the weekly insulin pump supplies multiplied by 4 for the areas included in the remote item delivery CBP.

(iv) The 2015 fee schedule amounts for the monthly supplies and accessories for an insulin infusion pump owned by a beneficiary is calculated using the average 2015 fee schedule amounts for the sterile syringe type cartridge for the insulin infusion pump multiplied by 9 for the areas

included in the remote item delivery CBP plus the average 2015 fee schedule amounts for the weekly insulin pump supplies multiplied by 4 for the areas included in the remote item delivery CBP.

0 10. Section 414.422 is amended by adding paragraph (h) to read as follows:

Sec. 414.422 Terms of contracts.

* * * * *

(h) Contract termination during a public health emergency (PHE) under section 319 of the Public Health Service Act. (1) If CMS determines in accordance with paragraph (h)(2) of this section, that due to a public health emergency (PHE) declared by the Secretary under section 319 of the Public Health Services Act, contract suppliers are unable to furnish certain items and services to beneficiaries in certain areas impacted by a PHE (PHE-impacted area) as required under their respective DMEPOS CBP supplier contracts, CMS may unilaterally terminate or modify each applicable DMEPOS CBP supplier contract to allow any Medicare enrolled DMEPOS supplier to furnish the applicable items and services to Medicare beneficiaries in the PHE-impacted area. Depending on the geographic extent of the PHE, a PHE-impacted area may refer to entire CBA(s) or only certain areas within a CBA.

(i) If the items and services in the PHE-impacted area identified in accordance with paragraph (h)(2) of this section encompass all competitions referenced in a DMEPOS CBP supplier contract, CMS will unilaterally terminate the DMEPOS CBP supplier contract.

(ii) If the items and services in the PHE-impacted area identified in accordance with paragraph (h)(2) of this section encompass only a portion of the competitions referenced in a DMEPOS CBP supplier contract, CMS will unilaterally modify the DMEPOS CBP supplier contract to remove the contract supplier's obligation to furnish specified items and services in the PHE- impacted area, as well as CMS's obligation to pay for those items and services under the DMEPOS CBP supplier contract.

(iii) After termination or modification of all applicable DMEPOS CBP supplier contracts, CMS reverts back to the general fee-for-service program requirements set forth in subpart D of this part for the applicable competition(s) or defined area(s) within a CBA.

(2) CMS may remove items and services furnished in a PHE-impacted area from the DMEPOS CBP when all of the following qualifying criteria are met:

(i) The Secretary declares a PHE under section 319 of the Public Health Services Act.

(ii) CMS determines that verifiable evidence exists of a DMEPOS access problem for beneficiaries for a certain competition or defined area(s) within the competition's CBA.

(iii) CMS determines that awarding additional DMEPOS CBP supplier contracts, per Sec. 414.414(i), would not address the access concerns.

(iv) CMS determines terminating or modifying each impacted DMEPOS CBP supplier contract to exclude certain competition(s) or defined area(s) within the competition's CBA from the DMEPOS CBP would alleviate access concerns.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0 11. The authority for part 424 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 12. Section 424.22 is amended by: 0 a. Revising paragraph (a)(1)(v)(A); and 0 b. Removing paragraph (a)(1)(v)(C).

The revision reads as follows:

Sec. 424.22 Requirements for home health services.

* * * * *

(a) * * *

(1) * * *

(v) * * *

(A) The face-to-face encounter must be performed by one of the following:

(1) A physician (as defined at Sec. 484.2 of this chapter).

(2) A nurse practitioner (as defined at Sec. 484.2 of this chapter).

(3) A clinical nurse specialist (as defined at Sec. 484.2 of this chapter).

(4) A physician assistant (as defined at Sec. 484.2 of this chapter).

(5) A certified nurse-midwife (as defined in section 1861(gg) of the Act) as authorized by State law. * * * * *

0 13. Section 424.57 is amended by-- 0 a. Revising paragraphs (c)(10), (22), (23), and (24) and (e)(1); and 0 b. Adding paragraph (h).

The revisions and addition read as follows:

Sec. 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges.

* * * * *

(c) * * *

(10) Has a comprehensive liability insurance policy in the amount of at least $300,000 that covers both the supplier's place of business and all customers and employees of the supplier.

(i) In the case of a supplier that manufactures its own items, this insurance must also cover product liability and completed operations.

(ii) Failure to maintain required insurance at all times results in revocation of the supplier's billing privileges retroactive to the date the insurance lapsed.

(iii) An authorized official of the supplier (as that term is defined in Sec. 424.502) must sign the liability insurance policy. * * * * *

(22)(i) All suppliers of DMEPOS and other items and services, and all of their locations whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare.

(ii) The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the supplier to receive payment for those specific products and services.

(iii) An accredited DMEPOS supplier may be denied enrollment, or its enrollment may be revoked, if CMS determines that it is not compliant with the DMEPOS quality standards.

(23) All DMEPOS suppliers must notify their DMEPOS accrediting organization when a new DMEPOS location is opened.

(24) All accredited DMEPOS suppliers must be surveyed and reaccredited at least once every 12 months. * * * * *

(e) * * *

(1) Revocation. CMS revokes a supplier's billing privileges if it is found not to meet the conditions or standards in paragraphs (b) and (c) of this section. Except as otherwise provided in this section, the revocation effective date is as specified in Sec. 424.535. * * * * *

(h) Change in majority ownership. A supplier must comply with the provisions of Sec. 424.551 if it undergoes a change in majority ownership.

0 14. Section 424.58 is amended by revising paragraphs (b) through (e) and adding paragraphs (f) through (o) to read as follows:

Sec. 424.58 Accreditation.

* * * * *

(b) Definitions. The following definitions apply to the provisions in this section:

Complaint means an allegation from any party and via any format that one of the DMEPOS accrediting organization's accredited DMEPOS suppliers may be non-compliant with

one or more DMEPOS quality standards or other applicable CMS requirement. The complaint need not involve actual or potential beneficiary harm.

Immediate family member means any person with whom the accrediting organization owner(s), surveyors or employees have a lineal or immediate familial or marital relationship, including all of the following:

(i) A husband or wife.

(ii) Birth or adoptive parent, child, or sibling.

(iii) Stepparent, stepchild, stepbrother, or stepsister.

(iv) Father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law.

(v) Grandparent or grandchild.

(vi) Spouse of a grandparent or grandchild.

Immediate jeopardy means a situation in which the DMEPOS supplier's non-compliance with one or more DMEPOS quality standards or other applicable CMS requirement has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient or to the health and safety of the general public.

Reasonable assurance means that a DMEPOS accrediting organization has demonstrated to CMS' satisfaction all of the following:

(i) Its DMEPOS accreditation program requirements meet or exceed the Medicare program requirements.

(ii) The DMEPOS suppliers that the DMEPOS accrediting organization accredits meet or exceed Medicare program requirements.

(iii) The DMEPOS accrediting organization is compliant with all provisions of this section.

Unannounced survey means both of the following:

(i) A survey that is conducted without any prior notice of any type (through any means of communication or forum) to the DMEPOS supplier to be surveyed such that the supplier does not expect the survey until the surveyors arrive.

(ii) The DMEPOS accrediting organization schedules its surveys so that DMEPOS suppliers cannot predict when they will be performed.

(c) Initial application procedures--(1) Required information. An independent DMEPOS accrediting organization applying for initial approval of its DMEPOS accreditation program is required to furnish CMS with all the following information and materials to demonstrate that the DMEPOS accrediting organization provides reasonable assurance (as defined in paragraph (b) of this section) regarding its program.

(i) A list of the types of DMEPOS supplies, products, and services for which the organization is requesting approval.

(ii) A detailed comparison of the organization's accreditation requirements and standards with the applicable DMEPOS quality standards, such as a crosswalk.

(iii) A detailed description of the organization's operational, survey, and other accreditation processes to confirm that the DMEPOS suppliers it accredits meet or exceed the DMEPOS quality standards and Medicare program requirements. This must include all of the following:

(A) Procedures for performing unannounced surveys.

(B) Frequency of the surveys performed.

(C) Copies of the organization's survey forms.

(D) Guidelines and instructions to surveyors.

(E) Quality review processes for deficiencies identified with accreditation requirements.

(F) Dispute resolution processes and policies when there is a negative survey finding or decision.

(G) If the DMEPOS accrediting organization has the discretion to perform a survey in certain instances, how it determines whether to perform one. This must include a suggested methodology for sampling locations for surveys under a single tax identification number or organization.

(iv) Procedures used to notify DMEPOS suppliers of compliance or noncompliance with the accreditation requirements.

(v) Procedures used to monitor the correction of deficiencies found during an accreditation survey.

(vi) Procedures for coordinating surveys with another DMEPOS accrediting organization if the organization does not accredit all supplies, products, and services the DMEPOS supplier provides.

(vii) Detailed professional information about the individuals who perform surveys for the DMEPOS accrediting organization, including the size and composition of accreditation survey teams for each type of DMEPOS supplier accredited, and the education and experience requirements that surveyors must meet. The information must also include the following:

(A) The content and frequency of the continuing education training provided to survey personnel.

(B) The evaluation systems used to monitor the performance of individual surveyors and survey teams.

(C) Policies and procedures for a surveyor or institutional affiliate of the DMEPOS accrediting organization that participates in a survey or accreditation decision regarding a DMEPOS supplier with which that individual or institution is professionally or financially affiliated.

(D) The organization's policies and procedures to avoid conflicts of interest and the appearance thereof involving individuals who conduct surveys or participate in accreditation decisions. This must include the organization's policies and procedures for all of the following:

(1) The separation of its consulting services from its accreditation services.

(2) Protecting the integrity of the DMEPOS accrediting organization's accreditation program (including the requirements of paragraphs (m) and (n) of this section).

(3) The prevention and handling of potential or actual conflicts of interest that could arise from situations in which a DMEPOS accrediting organization owner, surveyor, or employee has an interest in, or relationship with, a DMEPOS supplier to which the accrediting organization provides accreditation services. Such interests or relationships include, but are not limited to the following:

(i) Being employed as a DMEPOS accrediting organization surveyor.

(ii) Being employed by a DMEPOS supplier that is accredited by the DMEPOS accrediting organization.

(iii) Having an ownership, financial, or investment interest in a DMEPOS supplier that is accredited by the DMEPOS accrediting organization.

(iv) Serving as a director of or trustee for a DMEPOS supplier that is accredited by the DMEPOS accrediting organization.

(v) Serving on a utilization review committee of a DMEPOS supplier that is accredited by the DMEPOS accrediting organization.

(vi) Accepting fees or payments from a DMEPOS supplier or group of DMEPOS suppliers that is/are accredited by the DMEPOS accrediting organization.

(vii) Accepting fees for personal services, contract services, referral services, or for furnishing supplies to a DMEPOS supplier that is accredited by the DMEPOS accrediting organization.

(viii) Providing consulting services to a DMEPOS supplier that the DMEPOS accrediting organization accredits.

(ix) Having any immediate family member (as defined in paragraph (b) of this section) engaged in any of the activities described in paragraphs (c)(1)(vii)(D)(3)(i) through (viii) of this section.

(x) Engaging in any activities during the course of the survey of the facility

that would be or cause a conflict of interest.

(4) For notifying CMS when a conflict of interest is discovered.

(5) For the purposes of this section, a conflict of interest exists when a DMEPOS accrediting organization, the DMEPOS accrediting organization's successors, transferees, or assigns, the DMEPOS accrediting organization owner(s), surveyors, or employees, or the immediate family members of the DMEPOS accrediting organization owners(s), surveyors and other employees have an employment, business, financial or other type of interest in or relationship with a DMEPOS supplier that the DMEPOS accrediting organization accredits.

(E) The organization's policies and procedures for ensuring it has an adequate number of surveyors at all times.

(viii) Its processes for identifying and correcting deficiencies within its DMEPOS accreditation program.

(ix) A description of the organization's data management, analysis and reporting system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system. This must also include a detailed description of how the organization uses its data to ensure the compliance of its DMEPOS accreditation program with Medicare program requirements.

(x) Procedures for responding to, investigating, and (as applicable) closing out complaints against accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies, ombudsman programs, the applicable National Provider Enrollment contractor, and CMS. This must also include a detailed outline of all of the following:

(A) The steps and research the DMEPOS accrediting organization will undertake in its initial review of the complaint as described in paragraph (e)(3) of this section.

(B) How the DMEPOS accrediting organization determines whether, in accordance with a complaint, non-compliance with a DMEPOS quality standard or other applicable CMS requirement exists, including the information it considers in its review and when and how it would take action against the DMEPOS supplier.

(xi) The organization's policies and procedures for notifying CMS of DMEPOS suppliers that fail to meet the DMEPOS accrediting organization's requirements.

(xii) A description of all types, categories, and durations of accreditations offered by the organization.

(xiii) A list of the following:

(A) All currently accredited DMEPOS suppliers.

(B) The types, categories, and product codes of accreditation currently held by each DMEPOS supplier.

(C) The effective and expiration dates of each DMEPOS supplier's current accreditation.

(D) The upcoming survey cycles for all DMEPOS suppliers' accreditation surveys scheduled to be performed by the organization.

(xiv) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data in ASCII comparable code.

(xv) A resource analysis that demonstrates that the organization's staffing, funding, and other resources are adequate to perform fully the required surveys and related activities.

(xvi) Information that demonstrates the DMEPOS accrediting organization's knowledge, expertise, and experience in DMEPOS.

(xvii) Information about the DMEPOS accrediting organization's ability to conduct timely reviews of DMEPOS supplier accreditation applications.

(xviii) A description of the organization's accreditation decision- making process. This includes its policies and procedures for approving, denying, or terminating accreditation status for DMEPOS suppliers that fail to meet the DMEPOS accrediting organization's standards or requirements. This must include an explanation of the reasons for which it will deny or terminate a supplier's accreditation.

(xix) Policies and procedures for both of the following:

(A) Determining whether and when a survey is performed (for example, the DMEPOS supplier is providing a new item type). This includes the circumstances under which the DMEPOS accrediting organization will impose a corrective action plan (CAP) in lieu of performing a follow-up survey for an identified DMEPOS supplier deficiency.

(B) Ensuring that all onsite surveys are unannounced, including procedures that protect against unannounced surveys becoming known to the DMEPOS supplier before the visit.

(xx) Policies and procedures regarding when the DMEPOS accrediting organization will apply a CAP to a DMEPOS supplier. This must include the following:

(A) The specific circumstances under which the DMEPOS accrediting organization will apply a CAP as opposed to, as applicable, denying or terminating accreditation and the rationale for why the accrediting organization believes a CAP in these situations is more appropriate.

(B) How a CAP is developed, implemented, and enforced, including the following:

(1) How the DMEPOS accrediting organization determines whether a CAP is acceptable.

(2) The requirements of (and the timeframe and deadline for) the DMEPOS supplier's resumption of compliance.

(3) How the DMEPOS accrediting organization determines whether the DMEPOS supplier has resumed compliance and maintains compliance.

(4) The circumstances under which the DMEPOS accrediting organization will impose a CAP in lieu of performing a follow-up survey for an identified DMEPOS supplier deficiency.

(xxi) An explanation of the following:

(A) What the DMEPOS accrediting organization considers to be a DMEPOS supplier deficiency and how it defines the term deficiency.

(B) Whether the DMEPOS accrediting organization has different levels of DMEPOS supplier deficiencies.

(xxii) In performing the functions described in this section, its processes for both of the following:

(A) Detecting and addressing potential fraud, waste, and abuse by DMEPOS suppliers (including identifying the accrediting organization's definitions of the terms fraud, waste, and abuse).

(B) Reporting this activity to CMS and, as applicable, law enforcement.

(xxiii) A statement on the DMEPOS accrediting organization's letterhead that is signed and dated by the accrediting organization's chief executive officer (or similar official with authority to commit the organization to adhere to Medicare laws and regulations) acknowledging that, as a condition for CMS approval or continued approval of a DMEPOS accrediting organization's accreditation program, the organization agrees to all of the following:

(A) Provide CMS, within 3 business days of CMS's request, both of the following:

(1) Any of the information described in paragraph (e)(1)(i) of this section.

(2) Any other information CMS deems necessary to facilitate its oversight of the DMEPOS accrediting organization's accreditation program.

(B) Provide CMS written notification when an accreditation survey or

complaint investigation identifies an immediate jeopardy situation (as that term is defined in paragraph (b) of this section). Consistent with paragraph (e)(1)(iii) of this section, this notice must be provided within 2 business days of the finding.

(C) Provide written notification to CMS of any proposed changes to the DMEPOS accrediting organization's accreditation program and that it will not implement the proposed changes without prior written notice of continued program approval from CMS consistent with paragraph (e)(2) of this section.

(D) Notify CMS in writing of any decision to terminate, revoke, withdraw, or amend the accreditation status of a specific DMEPOS supplier within 3 business days of the date the organization took such action.

(E) Notify CMS of any decision to apply a CAP to a specific DMEPOS supplier within 10 calendar days of the decision. This notification must include the following:

(1) The reason for the decision.

(2) A detailed explanation and justification as to why the DMEPOS accrediting organization applied a CAP instead of, as applicable, denying or terminating the DMEPOS supplier's accreditation.

(3) The details of the DMEPOS supplier's CAP.

(F) Submit timely, accurate, and complete data to support CMS's evaluation of the DMEPOS accrediting organization's performance.

(1) Data to be submitted includes, but is not limited to, DMEPOS supplier identifying information, survey schedules, survey findings, and notices of accreditation decisions.

(2) The organization must submit necessary data according to the instructions and timeframes CMS specifies.

(G) In response to a written notice from CMS to the organization of a change in the CMS quality standards, survey process, or other requirement, provide CMS with proposed corresponding changes in the organization's requirements for its DMEPOS accreditation program to ensure continued comparability with the CMS quality standards, survey process, and requirements. This includes compliance with the following requirements:

(1) Submission of the data required in paragraph (e)(7) of this section.

(2) The proposed changes must be submitted to CMS within 30 calendar days of the date of the written CMS notice to the organization.

(3) The organization must not implement its proposed corresponding changes without prior CMS approval.

(H) Apply and adhere to in its accreditation activities any CMS- established--

(1) Definition(s) of deficiency; and

(2) Deficiency levels and categories.

(I) The DMEPOS accrediting organization will permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.

(J) If CMS permits the DMEPOS accrediting organization to perform surveys via a sampling process, the accrediting organization:

(1) Will submit to CMS its planned sampling methodology in detail; and

(2) Will not undertake sampling until CMS has approved the accrediting organization's submitted methodology.

(K) Will not include the following as patient medical records in its DMEPOS supplier surveys:

(1) Mock files.

(2) Fictional patient records.

(3) Simulated documentation.

(4) Templates.

(5) Duplicate patient records.

(L) Have a binding written agreement with each DMEPOS supplier the DMEPOS accrediting organization accredits regarding whether the accrediting organization, the supplier in question, or both will assume the costs of a survey that CMS directs the accrediting organization to perform in accordance with paragraph (e)(8)(ii) of this section.

(M) Submit all required information to CMS both before and after approval of its DMEPOS accreditation program in a truthful, accurate, and complete manner.

(N) Adhere to all of the requirements of this section at all times, including the policies, procedures, practices, and agreements it outlined in paragraph (c) of this section as part of its initial or reapproval application and any CMS-approved changes thereto under paragraph (e)(2) or (7) of this section.

(2) Additional information needed. If CMS determines that additional information is necessary to make a determination for approval or denial of the organization's initial application, CMS notifies the organization and affords it an opportunity to provide the additional information.

(3) Withdrawing an application. A DMEPOS accrediting organization may withdraw its initial application for CMS' approval of its DMEPOS accreditation program at any time before CMS posts the notice described in paragraph (c)(6) of this section.

(4) Reasons for denial. CMS may deny a DMEPOS accrediting organization's application for any of the following reasons:

(i) The DMEPOS accrediting organization has failed to comply with all application, data, and agreement submission requirements outlined in this paragraph (c).

(ii) The DMEPOS accrediting organization has failed to provide reasonable assurance (as defined in paragraph (b) of this section).

(iii) The current number of CMS-approved DMEPOS accreditation programs is sufficient to ensure the continued administration of CMS' DMEPOS accreditation program.

(iv) The DMEPOS accrediting organization's DMEPOS accreditation program was previously terminated, suspended, or placed on probation by CMS under, respectively, paragraph (h), (i), or (j) of this section.

(v) The DMEPOS accrediting organization, or any owner (as defined in Sec. 424.502), managing employee (as defined in Sec. 424.502), governing body member, W-2 or contracted surveyor, or W-2 or contracted health care or administrative or management services personnel thereof--

(A) Is excluded by the Office of Inspector General (OIG) from Medicare, Medicaid, and any other Federal health care program;

(B) Is debarred, suspended, or otherwise excluded from participating in any Federal procurement or non-procurement activity in accordance with section 2455 of the Federal Acquisition Streamlining Act (FASA);

(C) Within the preceding 10 years--

(1) Was convicted of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries;

(2) Has had a Medicare enrollment revoked under Sec. 424.535;

(3) Has had a license to provide health care suspended or revoked by any State licensing authority; or

(4) Has been suspended or terminated from participating in a Federal or State health care program.

(vi) The DMEPOS accrediting organization has submitted false or misleading information on its application in order to gain CMS approval or reapproval as a DMEPOS accrediting organization.

(vii) The AO is non-compliant with any provision in this section.

(viii) CMS otherwise determines that approval of the applicant as a DMEPOS AO would not be in the best interests of the Medicare program and its beneficiaries.

(5) Notice of approval or denial of application. CMS sends to the DMEPOS accrediting organization a notice of its

decision to approve or deny the application within 210 calendar days from the date CMS determines the accrediting organization's application is complete. The final notice specifies the following:

(i) The basis for the decision.

(ii) If applicable, the effective date of approval.

(iii) If applicable, the term of the approval (not to exceed 6 years).

(6) Decision announcement. CMS announces on its website its decision to approve or deny the DMEPOS accrediting organization's application.

(i) This announcement is posted within 210 calendar days from the date that CMS determines that the DMEPOS accrediting organization's application was complete.

(ii) If the application is approved, the posting states the approval's effective date (no later than the announcement's posting date) and length (6 years or less).

(7) Term of approval. CMS may approve a DMEPOS accreditation organization for any period up to a maximum of 6 years.

(d) Reapproval process--(1) General requirement--(i) Timeline for submission. Except as stated in paragraph (d)(1)(ii) of this section, an approved DMEPOS accrediting organization that seeks to continue as such must apply for reapproval of accreditation no later than 9 months before the expiration of its current term of approval. If the organization fails to do so, CMS, at its discretion, may provide the organization an additional 30 days to reapply.

(ii) Discretion to request reapproval applications. CMS may require DMEPOS accrediting organizations to submit reapproval applications under this paragraph (d) any time after January 1, 2026. An application must be submitted within 60 calendar days of CMS' submission request. Failure to submit the application results in the termination of the DMEPOS accrediting organization's approval.

(2) Submission of information and statements. As part of its reapproval application, the DMEPOS accrediting organization must submit all information and statements identified in paragraph (c)(1) of this section. CMS may also request information under paragraph (c)(2) of this section.

(3) Withdrawing an application. A DMEPOS accrediting organization may withdraw its reapproval application for CMS' approval of its DMEPOS accreditation program at any time before CMS posts the notice described in paragraph (d)(6) of this section.

(4) Denial reasons. CMS may deny a DMEPOS accrediting organization's reapproval application for any of the reasons described in paragraph (c)(4) of this section.

(5) Notice of approval or denial of application. CMS sends a notice of its decision to approve or deny the DMEPOS accrediting organization's reapproval application within 210 calendar days from the date CMS determines the accrediting organization's reapproval application is complete. The final notice specifies the following:

(i) The basis for the decision.

(ii) If applicable, the effective date of reapproval.

(iii) If applicable, the term of the reapproval (not to exceed 6 years).

(6) Decision announcement. CMS announces on its website its decision to reapprove or deny the DMEPOS accrediting organization's reapproval application.

(i) This announcement is posted within 210 calendar days from the date that CMS determines that the DMEPOS accrediting organization's reapproval application was complete.

(ii) If the reapproval application is approved, the posting states the reapproval's effective date (no later than the announcement's posting date) and length (6 years or less).

(7) Term of approval. CMS may reapprove a DMEPOS accreditation organization for any period up to a maximum of 6 years.

(e) Ongoing responsibilities of a CMS-approved DMEPOS accrediting organization. A DMEPOS accrediting organization approved by CMS must undertake the following activities on an ongoing basis:

(1) Submission of information. (i) On a monthly basis, provide to CMS all the following in written format (either electronic or hard copy):

(A) Copies of all accreditation survey results and reports, together with any survey related information that CMS may require. This includes both of the following:

(1) CAPs and summaries of findings with respect to unmet CMS requirements.

(2) The instances where the DMEPOS accrediting organization had the discretion to perform a survey (for example, sampling) but decided not to, including the reason(s) for the organization's decision.

(B) Notice of all accreditation decisions.

(C) Notice of all resolved deficiencies.

(D) Information about any supplier of DMEPOS and other items and services against which the CMS-approved DMEPOS accrediting organization has taken remedial or adverse action, including termination of the supplier's accreditation.

(ii) CMS may at any time request the DMEPOS accrediting organization to submit any of the information described in paragraph (e)(1)(i) of this section or any other data CMS deems necessary to facilitate its oversight of the accrediting organization's DMEPOS accreditation program. This information must be furnished to CMS within 3 business days of the request.

(iii) Within 2 business days of identifying an immediate jeopardy deficiency of a DMEPOS supplier, provide CMS with written notice of the deficiency and any adverse action implemented by the DMEPOS accrediting organization.

(2) Standard or requirement changes. Provide written notice of any proposed changes to its accreditation standards, requirements, or survey process. This includes the addition, modification, or removal of a new DMEPOS product service category to the list of categories for which the organization accredits DMEPOS suppliers.

(i) The notice must be submitted to CMS no less than 60 calendar days before the proposal's planned effective date. It must include the following:

(A) A detailed description of the changes and the rationale for them.

(B) A detailed crosswalk (in table format) that states the exact language of the organization's revised accreditation requirements and the applicable Medicare requirements for each.

(ii) CMS communicates to the DMEPOS accrediting organization in writing its approval or disapproval of the proposal within 30 calendar days of the proposed change's effective date.

(iii) CMS approval is required before the DMEPOS accrediting organization can implement the change. If the organization implements the changes before or without CMS' approval, CMS may terminate its approval of the accrediting organization.

(3) Addressing complaints. (i) Upon receipt of a complaint--

(A) Notify CMS in writing of the complaint no later than 5 calendar days after receipt;

(B) Using the DMEPOS accrediting organization's policies and procedures described in paragraph (c)(1)(x) of this section, perform an initial review of the complaint to determine whether, based on the complaint and any other information, the DMEPOS supplier may be non- compliant with one or more DMEPOS quality standards or other applicable CMS requirement; and

(C) Perform a survey of the DMEPOS supplier if the DMEPOS accrediting organization's initial review concludes that such non- compliance may exist. This survey must be performed no later than 21 calendar days after the accrediting organization received the initial complaint.

(ii) No later than 10 calendar days after completing the action in, as applicable, paragraph (e)(3)(i)(B) or (C) of this section, notify CMS in writing of the result of the initial review or, as applicable, the survey. The notice must include information regarding any action the DMEPOS accrediting organization took or plans to take with respect to the DMEPOS supplier, such as a termination of accreditation or a CAP.

(4) CAPs. Notify CMS in writing of any decision to apply a CAP to a specific DMEPOS supplier within 10 calendar days of the decision. This notification must include all of the following:

(i) The reason for the decision.

(ii) A detailed explanation and justification as to why the DMEPOS accrediting organization applied a CAP instead of, as applicable, denying or terminating the DMEPOS supplier's accreditation.

(iii) The details of the DMEPOS supplier's CAP (for example, deadline for compliance, the DMEPOS accrediting organization's plans for enforcement and ensuring compliance).

(5) Denials and terminations. (i) Notify CMS in writing of any decision to deny accreditation to (or terminate, revoke, withdraw, or amend the accreditation of) a DMEPOS supplier within 5 calendar days of the decision. This notification must include the reason for the denial or termination.

(ii)(A) Notwithstanding any other provision in this section, the DMEPOS accrediting organization must deny accreditation to (or terminate the accreditation of) a DMEPOS supplier if--

(1) The supplier does not meet the licensure requirements in Sec. 424.57(c)(1)(ii);

(2) The supplier is not operational (as that term is defined in Sec. 424.502);

(3) The supplier's location does not meet the accessibility requirements in Sec. 424.57(c)(7)(i)(B);

(4) The supplier's Medicare enrollment is revoked due to non- compliance with one or more DMEPOS quality standards and the reenrollment bar under Sec. 424.535(c) has not expired; or

(5) Directed by CMS.

(B) If paragraph (e)(5)(ii)(A)(5) of this section applies, the DMEPOS accrediting organization must do the following:

(1) Deny or terminate the DMEPOS supplier's accreditation no later than 3 business days after receiving written notice from CMS to do so.

(2) Notify CMS in writing that it has taken this action within 5 business days of receiving the written notice from CMS.

(6) Provide an annual summary of data related to accreditation. Provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends.

(7) Notification of change from CMS. (i) Within 30 calendar days of receipt of a written notice from CMS to the organization of a change in the quality standards, survey process, or other requirement, provide CMS with proposed corresponding changes to the organization's requirements for its CMS-approved DMEPOS accreditation program to ensure continued comparability with the CMS quality standards, survey process, or other requirements. This includes all of the following:

(A) An acknowledgment of CMS's notification of the change.

(B) A revised cross walk reflecting the new requirements.

(C) An explanation of how the DMEPOS accrediting organization plans to alter its standards to conform to CMS's new requirements, within the timeframes specified in the notification it received from CMS.

(ii) The DMEPOS accrediting organization must not implement its proposed corresponding changes without prior CMS approval.

(8) Performance of surveys. (i) Except as otherwise directed or permitted in writing by CMS (for example, allowing sampling), the DMEPOS accrediting organization must--

(A) Perform a survey of all DMEPOS supplier locations for which the supplier seeks accreditation or reaccreditation with the DMEPOS accrediting organization. This includes, but is not limited to, accreditations for a new item type the supplier has not previously furnished or as required under Sec. 424.551;

(B) Perform all surveys as unannounced surveys; and

(C) Not accredit the DMEPOS supplier before the survey is performed and the DMEPOS accrediting organization determines that the supplier is compliant with the quality standards.

(ii) CMS may, at any time, direct the DMEPOS accrediting organization to perform a survey of an accredited DMEPOS supplier or a group thereof. Existence of an actual or suspected supplier deficiency is not a requirement for CMS to direct the performance of a survey of a supplier.

(iii) When performing a survey, the DMEPOS accrediting organization must also confirm that the DMEPOS supplier meets the licensure requirements in Sec. 424.57(c).

(9) Surveyor witnesses. Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.

(10) Data entry. If directed by CMS, enter accreditation, survey, product code, and other data into a CMS-designated system.

(11) Relationships. The DMEPOS accrediting organization, or any owner (as defined in Sec. 424.502), managing employee (as defined in Sec. 424.502), governing body member, or any W-2 or contracted surveyor, health care, administrative. or management personnel thereof, must not have any of the following:

(i) A current exclusion by the OIG from Medicare, Medicaid, and any other Federal health care program.

(ii) A current debarment, suspension, or exclusion from participating in any other Federal procurement or non-procurement activity in accordance with section 2455 of the Federal Acquisition Streamlining Act (FASA).

(iii) Within the preceding 10 years--

(A) A conviction of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries;

(B) A Medicare enrollment revocation under Sec. 424.535;

(C) A suspension or revocation of a license to provide health care by any State licensing authority; or

(D) A suspension or termination from participating in a Federal or State health care program.

(f) Continuing federal oversight of approved DMEPOS accrediting organizations. CMS evaluates the performance of each CMS-approved DMEPOS accreditation program on an ongoing basis. Means of monitoring include, but are not limited to, the reviews identified in this paragraph (f).

(1) Equivalency review. CMS may, at any time, compare the DMEPOS accrediting organization's standards and its application and enforcement of those standards to the comparable CMS requirements and processes.

(2) Validation survey of DMEPOS supplier--(i) Survey scope. CMS may survey suppliers of DMEPOS and other items and services accredited under this section in order to validate the DMEPOS accrediting organization's survey process. Surveys can be comprehensive

or focus on certain standards or requirements.

(ii) Authorization. A DMEPOS supplier selected for a validation survey must--

(A) Authorize the validation survey to take place; and

(B) Permit the CMS survey team to monitor the correction of any deficiencies found during the validation survey.

(iii) Failure to authorize. If a DMEPOS supplier selected for a validation survey fails to comply with the requirements of paragraph (f)(2)(ii) of this section, it is deemed to no longer meet the DMEPOS supplier quality standards and may have its enrollment revoked.

(iv) Non-compliance. If a validation survey results in a finding that the DMEPOS supplier is not in compliance with one or more DMEPOS supplier quality standards, the supplier no longer meets the DMEPOS quality standards and may have its enrollment revoked.

(3) Deficiencies. (i) With respect to DMEPOS supplier compliance with the quality standards, CMS has the discretion to do all of the following:

(A) Define the term deficiency.

(B) Establish levels and categories of deficiencies.

(C) Revise the quality standards.

(ii) In its DMEPOS accreditation activities, the DMEPOS accrediting organization must apply and adhere to all of the following:

(A) Any CMS-established definition of deficiency.

(B) All CMS-established levels and categories of deficiencies.

(C) All CMS-established quality standards.

(4) Review of DMEPOS accrediting organization. (i)(A) CMS may at any time and for any reason conduct a review of the DMEPOS accrediting organization's processes or performance to:

(1) Verify the organization's representations to CMS; or

(2) Assess the organization's compliance with its own policies and procedures, the provisions of this section, and all other CMS requirements.

(B) The scope, length, and timing of the review are within CMS' discretion. Evidence of the DMEPOS accrediting organization's potential non-compliance with any element addressed in paragraph (f)(4)(i)(A) of this section is not a prerequisite for performing a review.

(ii) Types of CMS reviews include, but are not limited, the following, and may be performed collectively or individually:

(A) Equivalency reviews under paragraph (f)(1) of this section.

(B) Conducting surveys of accredited DMEPOS suppliers under paragraph (f)(2) of this section.

(C) Examining the results of a DMEPOS accrediting organization's surveys of DMEPOS suppliers.

(D) Observing a DMEPOS accrediting organization's onsite surveys and other audits of DMEPOS suppliers.

(E) Conducting onsite inspections of the DMEPOS accrediting organization's operations and offices.

(F) Requesting and reviewing documents.

(G) Interviewing DMEPOS accrediting organization staff.

(H) Observing an accreditation organization's internal meetings concerning the accreditation process.

(g) Voluntary termination of CMS-approved DMEPOS accreditation program--(1) Timing. A DMEPOS accrediting organization may voluntarily terminate its CMS-approved accreditation program at any time. In doing so, the accrediting organization must do all of the following:

(i) Notify CMS of its decision to voluntarily terminate its approved DMEPOS accreditation program at least 120 calendar days in advance of the effective date of the termination.

(ii) Provide written notice at least 90 days in advance of the effective date of the termination to each of its accredited DMEPOS suppliers but not before notifying CMS of its decision in accordance with paragraph (g)(1)(i) of this section. The notice to each supplier must do the following:

(A) Describe the provisions in paragraph (g)(2) of this section regarding the expiration dates of the DMEPOS supplier's accreditation with the terminating DMEPOS accrediting organization.

(B) Inform the DMEPOS supplier that any lapse in its accreditation (including between the date its existing accreditation with the terminating DMEPOS accrediting organization expires and the effective date of its accreditation with a different accrediting organization) may result in the revocation of its enrollment under Sec. 424.535.

(2) Supplier continuation of accreditation. Unless the DMEPOS supplier is otherwise determined to be non-compliant with the quality standards or other requirement for accreditation, the supplier's accreditation with the terminating DMEPOS accrediting organization remains in effect until the earlier of the following:

(i) The expiration of its current term of accreditation with the terminating DMEPOS accrediting organization.

(ii) The effective date of its accreditation with a different CMS- approved DMEPOS accrediting organization.

(h) Involuntary termination--(1) Reasons for termination. (i) CMS may terminate a DMEPOS accrediting organization's approval for any of the following reasons:

(A) CMS determines that the DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section).

(B) CMS determines that the continued approval of a CMS-approved DMEPOS accreditation program of any DMEPOS accrediting organization poses an immediate jeopardy to the patients of the entities accredited under that program, or the continued approval otherwise constitutes a hazard to the public health.

(C) CMS determines that the DMEPOS accrediting organization is non- compliant with any provision of this section. This includes, but is not limited to, situations where the accrediting organization has failed to do either of the following:

(1) Comply with a term or condition of a statement or agreement in paragraph (c)(1)(xxiii) of this section.

(2) Adhere to a policy, procedure, or practice it outlined under paragraph (c) of this section as part of its initial application or reapproval application or a CMS-approved change thereto under paragraph (e)(2) or (7) of this section.

(D) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under Sec. 424.535(a) for failing to comply with the quality standards.

(ii) CMS may terminate the DMEPOS accrediting organization's DMEPOS accreditation program effective the date of the letter described in paragraph (h)(2) of this section or any date thereafter.

(2) Notification to DMEPOS accrediting organization. CMS notifies the DMEPOS accrediting organization in writing of its decision to terminate the organization's accreditation approval. The notice must include all of the following:

(i) The reason for the termination.

(ii) The effective date of the termination.

(3) Announcement. CMS announces its termination decision (and the effective date thereof) on its website.

(4) Notification to DMEPOS suppliers. A DMEPOS accrediting organization whose CMS approval of its DMEPOS accreditation program has been terminated must notify, in writing, each of its accredited DMEPOS suppliers of the termination of CMS approval and its

implications no later than 30 calendar days after the CMS website announcement described in paragraph (h)(3) of this section. The notice to each DMEPOS supplier must do all of the following:

(i) Describe the provisions in paragraph (h)(6) of this section regarding the expiration dates of the DMEPOS supplier's accreditation with the terminated DMEPOS accrediting organization.

(ii) Inform the DMEPOS supplier that any lapse in its accreditation (including between the date its existing accreditation with the terminated DMEPOS accrediting organization expires and the effective date of its accreditation with a different DMEPOS accrediting organization) results in the revocation of its enrollment under Sec. 424.535.

(5) Collaboration. If CMS terminates a DMEPOS accrediting organization's approved status, the DMEPOS accrediting organization must work collaboratively with CMS to direct its accredited DMEPOS suppliers to the remaining CMS-approved DMEPOS accrediting organizations within a reasonable period of time.

(6) Continued accreditation. (i) Unless the DMEPOS supplier is otherwise determined to be non-compliant with the quality standards or other requirement for accreditation, the supplier's accreditation with the terminated DMEPOS accrediting organization remains in effect until the earliest of one of the following:

(A) The expiration of its current term of accreditation with the terminated DMEPOS accrediting organization.

(B) The effective date of its accreditation with a different CMS- approved DMEPOS accrediting organization.

(C) A date specified by CMS based on the circumstances of the termination of the DMEPOS accrediting organization's approval.

(ii) In the event paragraph (h)(6)(i)(C) of this section is applicable, CMS notifies the affected DMEPOS supplier in writing of the deadline by which the supplier must be reaccredited.

(7) Refunds. If CMS terminates a DMEPOS accrediting organization's approved status, the terminated organization must refund to a DMEPOS supplier all payments the supplier made to the organization--

(i) As part of the DMEPOS supplier's request for accreditation or reaccreditation; and

(ii) Prior to the organization's notification to the DMEPOS supplier of its final decision regarding the supplier's request.

(i) Suspension--(1) Reasons for suspension. CMS may suspend a DMEPOS accrediting organization's approval for any of the following reasons:

(i) CMS determines that the DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section).

(ii) CMS determines that the DMEPOS accrediting organization is non-compliant with any provision of this section. This can include, but is not limited to, situations where the DMEPOS accrediting organization has failed to do either of the following:

(A) Comply with a term or condition of a statement or agreement in paragraph (c)(1)(xxiii) of this section.

(B) Adhere to a policy, procedure, or practice it outlined under paragraph (c) of this section as part of its initial application or reapproval application or a CMS-approved change thereto under paragraph (e)(2) or (7) of this section.

(iii) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under Sec. 424.535 for failing to comply with the DMEPOS quality standards.

(2) Components of a suspension. (i) Except as otherwise specified or permitted by CMS, a DMEPOS accrediting organization may not perform any Medicare DMEPOS accreditation activities while suspended.

(ii) CMS determines the length of the suspension, which lasts no longer than 1 year. Upon the expiration of the suspension period, CMS either lifts the suspension or terminates the organization's approval in accordance with paragraph (h) of this section.

(iii) CMS may suspend the DMEPOS accrediting organization's DMEPOS accreditation program effective the date of the letter described in paragraph (i)(3) of this section or any date thereafter.

(3) Notification to DMEPOS accrediting organization. (i) CMS notifies the DMEPOS accrediting organization in writing of its decision to suspend the organization's accreditation approval. The notice must include the following:

(A) The reason(s) for the suspension.

(B) The effective date and length of the suspension.

(C) The terms of the suspension.

(D) The steps the DMEPOS accrediting organization must take to have the suspension lifted.

(ii) No later than 3 calendar days after the date it receives the notice of suspension, the DMEPOS accrediting organization must notify CMS in writing its acknowledgment of receipt of such notice.

(iii) No later than 3 calendar days after receipt of such acknowledgment, CMS publishes on its website a notice of its decision to suspend its approval of the organization's DMEPOS accreditation program.

(4) Status of DMEPOS suppliers. (i) The accreditation status of DMEPOS suppliers currently accredited by the suspended DMEPOS accrediting organization remains in effect through the length of the suspension unless--

(A) The DMEPOS supplier's current term of accreditation with the suspended DMEPOS accrediting organization expires during the suspension;

(B) The DMEPOS supplier is otherwise determined to be non-compliant with the quality standards or other requirement for accreditation; or

(C) CMS specifies a different accreditation termination date based on the circumstances of the suspension of the DMEPOS accrediting organization's DMEPOS accreditation program.

(ii)(A) If paragraph (i)(4)(i)(A) of this section applies, the DMEPOS supplier must be reaccredited by--

(1) Its current DMEPOS accrediting organization if the suspension has been lifted; or

(2) A different CMS-approved DMEPOS accrediting organization.

(B) If paragraph (i)(4)(i)(C) of this section applies, CMS notifies the affected DMEPOS supplier in writing of the deadline by which the supplier must be reaccredited.

(iii) Any lapse in the DMEPOS supplier's accreditation (including between the date its existing accreditation with the suspended DMEPOS accrediting organization expires and the effective date of its accreditation with a different accrediting organization) may result in the revocation of its enrollment under Sec. 424.535(a).

(5) Lifting of suspension. (i) CMS lifts a DMEPOS accrediting organization's suspension if it determines all of the following:

(A) The reasons for the suspension no longer exist.

(B) The DMEPOS accrediting organization demonstrates reasonable assurance (as defined in paragraph (b) of this section).

(C) The DMEPOS accrediting organization is in compliance with all provisions of this section.

(ii) If the suspension is lifted:

(A) CMS notifies the DMEPOS accrediting organization thereof in writing.

(B) No later than 3 calendar days after the date it receives the notice described

in paragraph (i)(5)(i)(A) of this section, the DMEPOS accrediting organization must notify CMS in writing its acknowledgment of receipt of such notice.

(C) No later than 3 calendar days after receipt of such acknowledgment, CMS publishes on its website a notice of the lifting of the suspension.

(6) Refunds. If CMS suspends a DMEPOS accrediting organization's DMEPOS accreditation program, the accrediting organization must refund to a DMEPOS supplier all payments the supplier made to the organization--

(i) As part of the DMEPOS supplier's request for accreditation or reaccreditation; and

(ii) Prior to the organization's notification to the DMEPOS supplier of its final decision regarding the supplier's request.

(7) Multiple suspensions. Nothing in this paragraph (i) prohibits CMS from suspending the organization's DMEPOS accreditation program more than once.

(j) Probation--(1) Placement on probation. CMS may place a DMEPOS accrediting organization's DMEPOS accreditation program on probation and require the organization's successful completion of a corrective action plan (CAP) if CMS determines any of the following:

(i) The DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section).

(ii) The DMEPOS accrediting organization is non-compliant with any provision of this section. This can include, but is not limited to, situations where the accrediting organization has failed to--

(A) Comply with a term or condition of a statement or agreement in paragraph (c)(1)(xxiii) of this section; or

(B) Adhere to a policy, procedure, or practice it outlined under paragraph (c) of this section as part of its--

(1) Initial or reapproval application; or

(2) A CMS-approved change thereto under paragraph (e)(2) or (7) of this section.

(iii) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under Sec. 424.535(a) for failing to comply with the quality standards.

(iv) The DMEPOS organization's period of suspension under paragraph (i) of this section has expired and CMS determines that a subsequent probationary period and CAP are warranted.

(2) Notification to accrediting organization. (i) CMS notifies the DMEPOS accrediting organization in writing of the probation. The notice must include the following:

(A) The reason(s) for CMS' decision.

(B) The length of the probationary period, which must not exceed 1 year.

(C) The terms of the CAP.

(D) The requirements and deadline for achieving compliance.

(E) A description of how CMS will monitor the DMEPOS accrediting organization's efforts to resume compliance (for example, requests for information, surveys).

(ii) Except as otherwise prescribed in the CAP, the DMEPOS accrediting organization may continue its accreditation activities as normal.

(3) Conclusion of period. (i) At the conclusion of the probationary period, CMS notifies the DMEPOS accrediting organization in writing of the following:

(A) Whether the DMEPOS accrediting organization is compliant with all requirements of this section.

(B) The reason for the determination in paragraph (j)(3)(i)(A) of this section.

(C) The consequences of the determination (for example, termination or suspension of accreditation, successful completion of and cessation of the probationary period and CAP).

(ii) If CMS determines that the DMEPOS accrediting organization has resumed compliance with all requirements of this section, CMS may do all of the following:

(A) Send the notice described in paragraph (j)(3)(i) of this section.

(B) Terminate the probationary period.

(C) End the CAP before the conclusion of the assigned probationary period.

(k) Noncompliance actions. (1) CMS may impose a certain action in paragraph (h), (i), or (j) of this section in lieu of another such action specified in paragraph (h), (i), or (j) of this section if the same ground(s) for the action exists.

(2) CMS may terminate--

(i) A probation period (either before or in accordance with the probationary period's original expiration date) and impose a suspension or termination if grounds for either action exist.

(ii) A suspension (either before or in accordance with the suspension's original expiration date) and impose a termination if a basis for doing so exists.

(l) Reconsiderations and rebuttals--(1) Reconsiderations. (i) A DMEPOS accrediting organization may request a reconsideration under part 498 of the following CMS initial determinations identified in Sec. 498.3(b)(21) and (22):

(A) Denial of the DMEPOS accrediting organization's application for initial approval of its DMEPOS accreditation program under paragraph (c)(4) of this section.

(B) Denial of the DMEPOS accrediting organization's application for reapproval of its DMEPOS accreditation program under paragraph (d)(4) of this section.

(C) Termination of the DMEPOS accrediting organization's approval of its DMEPOS accreditation program under paragraph (h)(1) of this section.

(2) Rebuttals. (i)(A) If a DMEPOS accrediting organization receives notice from CMS that its DMEPOS accreditation program has been suspended or placed on probation in accordance with paragraph (i) or (j) of this section, the DMEPOS accrediting organization has 15 calendar days from the date of the written notice of the suspension or probation to submit a rebuttal to CMS.

(B) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (l)(2)(i)(A) of this section.

(ii) A rebuttal submitted under this section must--

(A) Be in writing;

(B) Specify the facts or issues about which the DMEPOS accrediting organization disagrees with CMS' determination, as well as the reasons for disagreement;

(C) Submit all documentation the DMEPOS accrediting organization wants CMS to consider in its review of its determination; and

(D) Be submitted in the form of a letter that is signed and dated by the DMEPOS accrediting organization's CEO (or similar official with authority to commit the organization to adhere to Medicare laws and regulations) or a legal representative (as defined in Sec. 498.10 of this chapter).

(1) If the legal representative is an attorney, the attorney must include a statement that he or she has the authority to represent the accrediting organization; this statement would be sufficient to constitute notice of such authority.

(2) If the legal representative is not an attorney, the accrediting organization must file with CMS written notice of the appointment of a representative; this notice of appointment must be signed and dated by, as applicable, the accrediting organization's CEO (or similar official with authority to commit the organization to adhere to Medicare laws and regulations) or a legal representative.

(iii) The DMEPOS accrediting organization's failure to submit a rebuttal that is both timely under paragraph (l)(2)(i) of this section and fully compliant with all of the requirements of paragraph (l)(2)(ii) of this section constitutes a waiver of all rebuttal rights under this section.

(iv) Upon receipt of a timely and compliant rebuttal, CMS reviews the rebuttal to determine whether the imposition of the suspension or probation is correct.

(v) CMS is not required to delay the imposition of the suspension or probation pending the completion of the CMS review described in paragraph (l)(2)(iv) of this section.

(vi) A determination made under paragraph (i) or (j) of this section is not an initial determination under Sec. 498.3(b) of this chapter and therefore not appealable.

(m) Restrictions on consulting--(1) Definition. For purposes of this paragraph (m) only, the terms consulting and consulting services mean those services provided by a DMEPOS accrediting organization (or its consulting division or separate business entity (such as a company or corporation) that provides such services) for the review of a DMEPOS supplier's standards, processes, policies, and functions for compliance with the accrediting organization's standards, the DMEPOS quality standards, or other Medicare requirements through simulation of a real survey, such as a mock survey, with comprehensive written reports of findings and early intervention and action to correct deficiencies prior to an actual accreditation survey.

(2) Prohibitions. Except as provided in paragraph (m)(3) of this section, an accrediting organization or its consulting division or separate business entity (such as a company or corporation that provides consulting) may not provide consulting services in the following instances:

(i) To any new DMEPOS supplier before the initial accreditation survey has been completed.

(A) For purposes of this paragraph (m)(2)(i), the term initial survey means the first accreditation survey performed of a supplier by a DMEPOS accrediting organization that has not previously received accreditation services from that accrediting organization.

(B) If a supplier is voluntarily or involuntarily terminated from the services of a DMEPOS accrediting organization and later retains the services of the same or a new DMEPOS accrediting organization, the first accreditation survey performed by the same or new DMEPOS accrediting organization of that supplier would be considered an initial accreditation survey.

(ii) To a DMEPOS supplier that the DMEPOS accrediting organization accredits within 6 months prior to the next scheduled re-accreditation survey of that supplier. For purposes of this paragraph (m)(2)(ii), the term re-accreditation survey means any subsequent accreditation survey performed by the accrediting organization following the initial survey.

(iii) To a DMEPOS supplier to which the DMEPOS accrediting organization provides accreditation services, in response to a complaint received by the accrediting organization regarding that supplier.

(3) Circumstances permitting consulting. A DMEPOS accrediting organization, its consulting division, or separate business entity, such as a company or corporation that provides consulting, may provide consulting to the DMEPOS suppliers it accredits only under the following circumstances:

(i) During the 6-month period after an initial or re-accreditation survey is performed.

(ii) To address complaints received and investigated by CMS or its contractor regarding a DMEPOS accrediting organization's accredited DMEPOS supplier in which one or more immediate jeopardy deficiencies or grounds for revocation of enrollment under Sec. 424.535 are identified. Such consulting by an accrediting organization may occur only after CMS or the CMS contractor investigation is completed and must only address those issues identified in the investigation.

(iii) Consulting services provided to DMEPOS suppliers that the DMEPOS accrediting organization does not accredit at the time the consulting services are furnished.

(iv) General education provided by the DMEPOS accrediting organization about its DMEPOS accreditation program.

(4) Submission of report. The DMEPOS accrediting organization must provide to CMS upon CMS' request and with each initial and reapproval application under paragraphs (c) and (d) of this section a report containing the following information:

(i) Whether the DMEPOS accrediting organization or an associated consulting division or company established by the accrediting organization provides consulting services.

(ii) The names, National Provider Identifiers, and addresses of all DMEPOS suppliers to which the DMEPOS accrediting organization or its associated consulting division or company has provided consulting services during the previous 6-month period.

(iii) The dates the consulting services were provided to each DMEPOS supplier.

(iv) Whether the DMEPOS accrediting organization has ever provided, or is currently providing, accreditation services to any DMEPOS supplier listed in this report.

(v) For each DMEPOS supplier listed in this report, the date--

(A) Of the most recent accreditation survey performed; and

(B) That the next re-accreditation survey is due to be performed.

(vi) A description of the consulting services provided to each DMEPOS supplier listed in this report.

(5) Consulting firewall policies and procedures. (i) A DMEPOS accrediting organization, its consulting division, or separate business entity (such as a company or corporation that provides consulting services to the DMEPOS suppliers the accrediting organization accredits) must have and adhere to written consulting policies and procedures, which, at a minimum, must include the following:

(A) The DMEPOS accrediting organization's consulting services must be provided by a separate division of the accrediting organization or separate business entity, such as a company or corporation, that is separate from the accrediting organization's accreditation division.

(B) A DMEPOS accrediting organization's consulting division or separate business entity must maintain separate staff from that of the accrediting organization's accreditation divisions to ensure that the consulting division staff do not perform the accrediting organization's accreditation division functions and that the accrediting organization's accreditation division staff do not perform consulting division functions.

(C) A DMEPOS accrediting organization's accreditation staff and surveyors are prohibited from marketing the accrediting organization's consulting services to the accrediting organization's accreditation clients.

(ii) A DMEPOS accrediting organization that provides consulting services must submit its written consulting firewall policies and procedures to CMS by a date specified by CMS and with each application submitted seeking initial CMS approval or reapproval of their DMEPOS accreditation programs.

(n) Conflicts of interest--(1) General prohibition regarding relationships. (i) If a DMEPOS accrediting organization owner, surveyor, or employee (currently or within the previous 2 years) has or had an interest in or relationship (as described in paragraph (c)(1)(vii)(D) of this section) with a DMEPOS supplier that is accredited by the DMEPOS

accrediting organization, the accrediting organization owner, surveyor, or employee is not permitted to do any of the following:

(A) Participate in the survey of that DMEPOS supplier.

(B) Have input into the results of the survey and accreditation for that DMEPOS supplier.

(C) Have involvement with the pre-or post-survey activities for that DMEPOS supplier.

(D) Have contact with or access to the records for the survey and accreditation of that DMEPOS supplier.

(ii) For purposes of this paragraph (n)(1), the term immediate family member has the same meaning as that term is defined in paragraph (b) of this section.

(iii) CMS may request at any time outside of the initial approval and reapproval processes that the DMEPOS accrediting organization furnish any and all information required under paragraph (c)(1)(vii)(D) of this section.

(2) CMS Contractor. An entity may not serve as a CMS-approved DMEPOS accrediting organization if it is currently a CMS contractor (or an owner or subsidiary thereof (regardless of the ownership percentage involved)) with any oversight responsibility of DMEPOS suppliers.

(o) Change of ownership. A DMEPOS accrediting organization that wishes to undergo a change of ownership is subject to the requirements of Sec. 488.5(f).

Sec. 424.205 [Amended]

0 15. Section 424.205 is amended by-- 0 a. In paragraph (a), in the definition of “Coach eligibility end date”, removing the phrase “paragraph (d)(5)” and adding in its place the phrase “paragraph (c)(5)”. 0 b. In paragraph (b)(4), removing the phrase “paragraph (d)(5)” and adding in its place the phrase “paragraph (c)(5)”. 0 c. In paragraph (b)(6), removing the phrase “paragraph (d)” and adding in its place the phrase “paragraph (c)”; 0 d. In paragraph (c)(3): 0 i. Removing the phrase “paragraph (d)(5)” and adding in its place the phrase “paragraph (c)(5)”; and 0 ii. Removing the phrase “paragraph (e)(1)” and adding in its place the phrase “paragraph (d)(1)”; 0 e. In paragraph (c)(6), removing the phrase “paragraph (d)(4)” and adding in its place the phrase “paragraph (c)(4)”; 0 f. In paragraph (c)(8), removing the phrase “paragraph (d)(8)(i)” and adding in its place the phrase “paragraph (c)(8)(i)”; 0 g. In paragraph (c)(8)(ii): 0 i. Removing the phrase “paragraphs (d)(8)(i)(B)” and adding in its place the phrase “paragraphs (c)(8)(i)(B)”; and 0 ii. Removing the phrase “paragraph (d)(8)(i)(C)” and adding in its place the phrase “paragraph (c)(8)(i)(C)”; 0 h. In paragraph (c)(10), removing the phrase “paragraph (d)(8)” and adding in its place the phrase “paragraph (c)(8)”; 0 i. In paragraph (c)(11)(iii), removing the phrase “paragraph (d)” and adding in its place the phrase “paragraph (c)”; 0 j. In paragraph (c)(12), removing the phrase “paragraph (g)” and adding in its place the phrase “paragraph (f)”; 0 k. In paragraph (c)(15), removing the phrase “paragraph (g)” and adding in its place the phrase “paragraph (f)”; 0 l. In paragraph (d)(2): 0 i. Removing the phrase “paragraph (d)(5)” and adding in its place the phrase “paragraph (c)(5)”; and 0 ii. Removing the phrase “paragraph (e)(1)” and adding in its place the phrase “paragraph (d)(1)”; 0 m. In paragraph (g)(1): 0 i. Removing the phrase “Sec. 424.530(a)(1)” and adding in its place adding “Sec. 424.530(a)(1) or (18)” each time it appears; and 0 ii. Removing the phrase “Sec. 424.535(a)(1)” and adding in its place adding “Sec. 424.535(a)(1) or (23)” each time it appears; 0 n. In paragraph (g)(1)(i), removing the phrase “paragraph (h)(1)(i)” and adding in its place the phrase “paragraph (g)(1)(i)” each time it appears; 0 o. In paragraph (g)(1)(ii): 0 i. Removing the phrase “paragraph (d)” and adding in its place the phrase “paragraph (c)”; and 0 ii. Removing the phrase “paragraph (h)(1)(ii)” and adding in its place the phrase “paragraph (g)(1)(ii)” each time it appears; 0 p. In paragraph (g)(1)(v)(A), removing the reference “Sec. 424.205(d)(3)” and adding in its place the reference “Sec. 424.205(c)(3)”; and 0 q. In paragraph (g)(1)(v)(B), removing the phrase “paragraph (h)(1)(v)” and adding in its place the phrase “paragraph (g)(1)(v)” each time it appears.

0 16. Section 424.502 is amended by revising the definition of “Deactivate” to read as follows:

Sec. 424.502 Definitions.

* * * * *

Deactivate means, except in the situations described in Sec. 424.547, that the provider or supplier's billing privileges were stopped, but can be restored upon the submission of updated information. * * * * *

0 17. Section 424.510 is amended by-- 0 a. In paragraph (d)(2)(iii) introductory text, removing the phrase “including--” and adding in its place the phrase “including the following:”; 0 b. In paragraph (d)(2)(iii)(A), removing the phrase “; and” and adding a period in its place; and 0 c. Adding paragraphs (d)(2)(iii)(C) and (d)(10).

The additions read as follows:

Sec. 424.510 Requirements for enrolling in the Medicare program.

* * * * *

(d) * * *

(2) * * *

(iii) * * *

(C) Any other documentation needed to verify and confirm the information furnished on the enrollment application. This includes, but is not limited to, documentation regarding the provider's or supplier's ownership or management. * * * * *

(10) Legal responsibility. All providers and suppliers are legally responsible for the accuracy, completeness, and truthfulness of all information they provide on or with their applications, regardless of whether another party completed the application. * * * * *

0 18. Section 424.516 is amended by revising paragraph (e)(1) to read as follows:

Sec. 424.516 Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program.

* * * * *

(e) * * *

(1) Within 30 days for a change of ownership or control (including changes in authorized official(s) or delegated official(s)), an adverse legal action, or a change, addition, or deletion of a practice location. * * * * *

0 19. Section 424.522 is amended by revising paragraph (a) to read as follows:

Sec. 424.522 Additional effective dates.

(a) Reassignments. (1) The effective date of a reassignment of benefits under Sec. 424.80 is the later of the dates identified in Sec. 424.520(d)(1)(i) and (ii).

(2) Retrospective billing in accordance with a reassignment of benefits and as described in Sec. 424.521(a)(1) is permissible if the circumstances in Sec. 424.521(a)(1) are applicable. * * * * *

Sec. 424.530 [Amended]

0 20. Section 424.530 is amended by-- 0 a. In paragraph (a)(11)(ii), removing the word “drugs” and adding in its place the phrase “one or more drugs”; and

0 b. In paragraph (a)(18)(v), removing the phrase “or (d)” and adding in its place the phrase “or (c)”.

0 21. Section 424.535 is amended by-- 0 a. Adding paragraphs (a)(8)(i)(D) and (a)(8)(iii); 0 b. In paragraph (a)(13)(ii), removing the word “drugs” and adding in its place the phrase “one or more drugs”; 0 c. In paragraph (a)(14) introductory text, removing the phrase “Part B or D drugs” and adding in its place the phrase “Medicare-covered drugs”; 0 d. In paragraph (a)(23)(v), removing the phrase “or (d)” and adding in its place the phrase “or (c)”; 0 e. Revising paragraph (g)(1); 0 f. Redesignating paragraph (g)(2)(viii) as paragraph (g)(2)(xv); 0 g. Adding a new paragraph (g)(2)(viii) and paragraphs (g)(2)(ix) through (xiv); and 0 h. Revising newly redesignated paragraph (g)(2)(xv)(D).

The revisions and additions read as follows:

Sec. 424.535 Revocation of enrollment in the Medicare program.

(a) * * *

(8) * * *

(i) * * *

(D) The beneficiary attests that the item(s) or service(s) identified on the provider's or supplier's claim or claims was not or were not rendered or furnished. * * * * *

(iii) The effective date of a revocation under this paragraph (a)(8) is--

(A) For revocations under paragraph (a)(8)(i) of this section, the earliest date of service on the claim or claims that is or are triggering the revocation; and

(B) For revocations under paragraph (a)(8)(ii), the last date of service on the claims in question. * * * * *

(g) * * *

(1) Except as described in paragraphs (a)(8)(iii) and (g)(2) and (3) of this section, a revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier.

(2) * * *

(viii) For revocations based on a lapse in the IDTF's comprehensive liability insurance under Sec. 410.33(g)(6) of this chapter, the date the insurance lapsed.

(ix) For revocations based on the provider's or supplier's submission of false or misleading information on the enrollment application, the date the application's certification statement was signed.

(x) For revocations based on the provider's or supplier's failure to timely report a change of ownership or adverse legal action, or a change, addition, or deletion of a practice location, the day after the date by which the provider or supplier was required to report the change, addition, or deletion.

(xi) For revocations based on the surrender of the provider's or supplier's provider's Drug Enforcement Administration certificate of registration in response to a show cause order, the date the certificate was surrendered.

(xii) For revocations based on a State's suspension or revocation of the physician's or practitioner's ability to prescribe one or more drugs, the date of the suspension or revocation.

(xiii) For revocations of any of the provider's or supplier's other enrollments under paragraph (i) of this section, the effective date of the revocation that triggered the revocation(s) of the other enrollment(s).

(xiv) For revocations based on a DMEPOS supplier's non-compliance with a condition or standard in Sec. 424.57(b) or (c), respectively, the date on which the non-compliance began.

(xv) * * *

(D) For all standard violations not addressed in this paragraph (g)(2), the effective date in paragraph (g)(1) of this section applies if the effective date in paragraph (g)(3) of this section does not. * * * * *

Sec. 424.540 [Amended]

0 22. Section 424.540 is amended in paragraph (a)(8) by removing the phrase “HHA change” and adding in its place the phrase “HHA, hospice, or DMEPOS supplier change”.

0 23. Section 424.541 is amended by-- 0 a. Revising paragraphs (a)(1)(i), (a)(2)(ii)(B)(2), and (a)(3); and 0 b. In paragraph (a)(5), removing the phrases “Title 42” and “60-day stay period” and adding in their places the phrases “this title” and “CMS-assigned stay period”, respectively.

The revisions read as follows:

Sec. 424.541 Stay of enrollment.

(a) * * *

(1) * * *

(i) Is non-compliant with at least one enrollment requirement in this title. (This includes situations where its change of information or revalidation application was rejected under Sec. 424.525(a)(1) or (2).) * * * * *

(2) * * *

(ii) * * *

(B) * * *

(2) The stay ends (as described in paragraph (a)(5) of this section) on or before the expiration of the originally designated stay period.

(3)(i) The effective date of a stay of enrollment is, as applicable--

(A) The date on which the provider's or supplier's non-compliance began; or

(B) The date on which the provider's or supplier's change of information or revalidation application was rejected under Sec. 424.525.

(ii) CMS may establish a stay of enrollment for any period up to a maximum of 60 days. * * * * *

0 24. Adding Sec. 424.547 to read as follows:

Sec. 424.547 Deactivation based on ordering, certifying, or referring services and items.

(a)(1) CMS may deactivate a physician's or practitioner's ability to order, certify, or refer the Medicare services and items identified in Sec. 424.507(a) and (b) if the individual:

(i) Is enrolled via the Form CMS-855O application solely to order, certify, or refer Medicare services or items; and

(ii) Has not been listed as the ordering, certifying, or referring individual on a Medicare Part A or B claim received in the previous 12 consecutive months.

(2) For purposes of this section only, the term deactivate means that the physician's or practitioner's ability to order, certify, or refer Medicare services or items has been stopped but can be restored upon the submission of updated information.

(b)(1) For a deactivated physician or practitioner to reactivate an ability to order, certify, or refer Medicare services and items, the individual must recertify that the enrollment information currently on file with Medicare is correct, furnish any missing information as appropriate, and be in compliance with all applicable enrollment requirements in this title.

(2) Notwithstanding paragraph (b)(1) of this section, CMS may, for any reason, require a deactivated physician or practitioner to, as a prerequisite for reactivating the ability to order, certify, or refer, submit a complete Form CMS-855O application.

(c) The effective date of a reactivation of an ability to order, certify, or refer Medicare services and items under this section is the date on which the Medicare contractor received the individual's reactivation submission that was processed to approval.

(d) A physician or practitioner may not order, certify, or refer the Medicare services or items described in Sec. 424.507(a) and (b) while deactivated under this section.

0 25. Adding Sec. 424.551 to read as follows:

Sec. 424.551 DMEPOS supplier changes in majority ownership.

(a) Definition. For purposes of this section only, a change in majority ownership occurs when an individual or organization acquires more than a 50 percent direct ownership interest in a DMEPOS supplier during the 36 months following the DMEPOS supplier's initial enrollment into the Medicare program or the 36 months following the DMEPOS supplier's most recent change in majority ownership (including asset sale, stock transfer, merger, and consolidation). This includes an individual or organization that acquires majority ownership in a DMEPOS supplier through the cumulative effect of asset sales, stock transfers, consolidations, or mergers during the 36-month period after Medicare billing privileges are conveyed or the 36-month period following the DMEPOS supplier's most recent change in majority ownership.

(b) General principle. Unless an exception in paragraph (c) of this section applies, if there is a change in majority ownership of a DMEPOS supplier by sale (including asset sales, stock transfers, mergers, and consolidations) within 36 months after the effective date of the DMEPOS supplier's initial enrollment in Medicare or within 36 months after the DMEPOS supplier's most recent change in majority ownership, the Medicare billing privileges do not convey to the new owner. The prospective owner of the DMEPOS supplier must instead do both of the following:

(1) Enroll in the Medicare program as a new DMEPOS supplier under the provisions of Sec. 424.510.

(2) Undergo a survey by, and obtain a new accreditation from, a CMS-approved DMEPOS accrediting organization in accordance with Sec. Sec. 424.57 and 424.58.

(c) Exceptions. The following situations are exceptions to the requirements of paragraph (b) of this section:

(1) A DMEPOS supplier's parent company is undergoing an internal corporate restructuring, such as a merger or consolidation.

(2) The owners of the existing DMEPOS supplier are changing the DMEPOS supplier's current business structure (for example, from a corporation to a partnership (general or limited); from a limited liability company (LLC) to a corporation; or from a general or limited to an LLC) and the owners remain the same.

(3) An individual owner of the DMEPOS supplier dies.

PART 455--PROGRAM INTEGRITY: MEDICAID

0 26. The authority citation for part 455 continues to read as follows:

Authority: 42 U.S.C. 1302.

Sec. 455.416 [Amended]

0 27. Section 455.416 is amended in paragraph (c) by removing the phrase “of the Act and under the” and adding in its place the phrase “of the Act or under the”.

PART 484--HOME HEALTH SERVICES

0 28. The authority citation for part 484 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

Sec. 484.45 [Amended]

0 29. Section 484.45 is amended in paragraph (a) by removing the word “beneficiary” and adding in its place the word “patient” each time it appears.

0 30. Section 484.55 is amended by revising paragraph (d)(1)(i) to read as follows:

Sec. 484.55 Condition of participation: Comprehensive assessment of patients.

* * * * *

(d) * * *

(1) * * *

(i) Elected transfer; * * * * *

0 31. Section 484.245 is amended by revising paragraph (d)(4) and adding paragraphs (d)(5) and (6) to read as follows:

Sec. 484.245 Requirements under the Home Health Quality Reporting Program (HH QRP).

* * * * *

(d) * * *

(4)(i) CMS notifies the HHA, in writing, of its final decision regarding any reconsideration request through at least one of the following methods:

(A) CMS designated data submission system.

(B) The United States Postal Service.

(C) Email from the CMS Medicare Administrative Contractor (MAC).

(ii) CMS grants a timely request for reconsideration, and reverses an initial finding of non-compliance, only if CMS determines that the HHA was in full compliance with the HH QRP requirements for the applicable program year.

(5)(i) An HHA may request, and CMS may grant, an extension to file a reconsideration request if, during the period to request a reconsideration as set forth in paragraph (d)(2) of this section, the HHA was affected by an extraordinary circumstance beyond the control of the HHA (for example, a natural or man-made disaster).

(ii) HHAs must submit the reconsideration extension request no later than 30 calendar days from the date of the written notification of noncompliance.

(iii) The reconsideration extension request must--

(A) Be submitted to CMS via email to CMS HHAPU reconsiderations at [email protected]; and

(B) Contain all the following information:

(1) The CCN for the HHA.

(2) The business name of the HHA.

(3) The business address of the HHA.

(4) Contact information for the HHA's chief executive officer or designated personnel, including the name, telephone number, title, email address, and physical mailing address, which may not be a post office box.

(5) A statement of the reason for the request for the extension.

(6) Evidence of the impact of extraordinary circumstances, including, for example, photographs, newspaper articles, and other media.

(6) CMS notifies the HHA in writing of its final decision regarding the HHA's request for an extension to file a reconsideration of noncompliance request via an email from CMS. * * * * *

0 32. Section 484.358 is amended by adding paragraph (i) to read as follows:

Sec. 484.358 HHVBP Measure removal factors.

* * * * *

(i) It is not feasible to implement the measure specifications.

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE MEDICAID PROGRAM

0 33. The authority for part 498 continues to read as follows:

Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.

0 34. Section 498.3 is amended by adding paragraphs (b)(21) and (22) to read as follows:

Sec. 498.3 Scope and applicability.

* * * * *

(b) * * *

(21) A denial of a DMEPOS accrediting organization's approval or re-approval under Sec. 424.58(c)(4) or (d)(4) of this chapter, respectively.

(22) An involuntary termination of a DMEPOS accrediting organization's approved DMEPOS accreditation program under Sec. 424.58(h)(1) of this chapter. * * * * *

Robert F. Kennedy, Jr., Secretary, Department of Health and Human Services. [FR Doc. 2025-21767 Filed 11-28-25; 4:15 pm]

BILLING CODE 4120-01-P