(i) Covered services, as specified in part 409 or part 410 of this chapter; or

(ii) Services excluded from coverage as custodial care or services not reasonable and necessary, but reimbursable in accordance with §§ 405.332 through 405.334 of this chapter, pertaining to limitation of liability.

(i) Basic rule. Except as provided in paragraph (a)(2)(ii) of this section, payment may not be made for inpatient hospital services or posthospital SNF care furnished after the day on which the hospital or SNF received the notice.

(ii) Exception. Payment may be made for 1 or 2 additional days if the QIO or UR committee approves them as necessary for planning for post-discharge care.

(i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a nurse practitioner in accordance with State law; and have a master's degree in nursing;

(ii) Be certified as a nurse practitioner by a professional association recognized by CMS that has, at a minimum, eligibility requirements that meet the standards in paragraph (e)(5)(i) of this section; or

(iii) Meet the requirements for a nurse practitioner set forth in paragraph (e)(5)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care.

(i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a clinical nurse specialist in accordance with State law; and have a master's degree in a defined clinical area of nursing;

(ii) Be certified as a clinical nurse specialist by a professional association recognized by CMS that has at a minimum, eligibility requirements that meet the standards in paragraph (e)(6)(i) of this section; or

(iii) Meet the requirements for a clinical nurse specialist set forth in paragraph (e)(6)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care.

(i) Continued hospitalization of the patient for medical treatment or medically required diagnostic study; or

(ii) Special or unusual services for cost outlier cases (under the prospective payment system set forth in subpart F of part 412 of this chapter).

(i) For treatment that could reasonably be expected to improve the patient's condition; or

(ii) For diagnostic study; and

(i) Intensive treatment services;

(ii) Admission and related services necessary for diagnostic study; or

(iii) Equivalent services.

(i) The individual needs or needed on a daily basis skilled nursing care (furnished directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in an SNF or a swing-bed hospital on an inpatient basis, and the SNF care is or was needed for a condition for which the individual received inpatient care in a participating hospital or a qualified hospital, as defined in § 409.3 of this chapter, or for a new condition that arose while the individual was receiving care in the SNF or swing-bed hospital for a condition for which he or she received inpatient care in a participating or qualified hospital; or

(ii) The individual has been correctly assigned one of the case-mix classifiers that CMS designates as representing the required level of care, as provided in § 409.30 of this chapter.

(i) Collaboration.

(ii) Types of employment relationships.

(i) The individual needs or needed intermittent skilled nursing care, or physical therapy or speech-language pathology services as defined in § 409.42(c) of this chapter. If a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient's care plan, the physician or allowed practitioner will include a brief narrative describing the clinical justification of this need. If the narrative is part of the certification form, then the narrative must be located immediately prior to the physician or allowed practitioner's signature signature. If the narrative exists as an addendum to the certification form, in addition to the physician or allowed practitioner's signature signature on the certification form, the physician or allowed practitioner must sign immediately following the narrative in the addendum.

(ii) Home health services are or were required because the individual is or was confined to the home, as defined in sections 1835(a) and 1814(a) of the Act, except when receiving outpatient services.

(iii) A plan for furnishing the services has been established and will be or was periodically reviewed by a physician or allowed practitioner and who is not precluded from performing this function under paragraph (d) of this section.

(iv) The services will be or were furnished while the individual was under the care of a physician or allowed practitioner.

(v) A face-to-face patient encounter, which is related to the primary reason the patient requires home health services, occurred no more than 90 days prior to the home health start of care date or within 30 days of the start of the home health care and was performed by physician or non-physician practitioner defined in paragraph (a)(1)(v)(A) of this section. The certifying physician or certifying allowed practitioner must also document the date of the encounter as part of the certification.

(i) Beneficiary elected transfer; or

(ii) Discharge with goals met and/or no expectation of a return to home health care.

(i) Need for occupational therapy may be the basis for continuing services that were initiated because the individual needed skilled nursing care or physical therapy or speech therapy.

(ii) If a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient's care plan, the physician or allowed practitioner must include a brief narrative describing the clinical justification of this need. If the narrative—

(i) The documentation from the HHA can be corroborated by other medical record entries in the certifying physician or allowed practitioner's medical record for the patient or the acute/post-acute care facility's medical record for the patient or both, thereby creating a clinically consistent picture that the patient is eligible for Medicare home health services.

(ii)

(i) The individual needs, or needed, physical therapy, occupational therapy, or speech-language pathology services.

(ii) The services were furnished while the individual was under the care of a physician, nurse practitioner, clinical nurse specialist, or physician assistant.

(iii) The services were furnished under a plan of treatment that meets the requirements of § 410.61 of this chapter.

(i) If the plan of treatment is established by a physician, nurse practitioner, clinical nurse specialist, or physician assistant, the certification must be signed by that physician or nonphysician practitioner.

(ii) If the plan of treatment is established by a physical therapist, occupational therapist, or speech-language pathologist, the certification must be signed by a physician or by a nurse practitioner, clinical nurse specialist, or physician assistant who has knowledge of the case, except as specified in paragraph (c)(5) of this section.

(i) Timing. Recertification is required at least every 90 days.

(ii) Content. When it is recertified, the plan or other documentation in the patient's record must indicate the continuing need for physical therapy, occupational therapy or speech-language pathology services.

(iii) Signature. The physician, nurse practitioner, clinical nurse specialist, or physician assistant who reviews the plan must recertify the plan by signing the medical record.

(i) The individual requires such services for a minimum of 9 hours per week.

(ii) The services are or were furnished while the individual was under the care of a physician.

(iii) The services were furnished under a written plan of treatment that meets the requirements of paragraph (d)(2) of this section.

(i) The plan is an individualized plan that is established and is periodically reviewed by a physician in consultation with appropriate staff participating in the program, and that sets forth—

(ii) The physician determines the frequency and duration of the services taking into account accepted norms of medical practice and a reasonable expectation of improvement in the patient's condition.

(i) Signature. The physician recertification must be signed by a physician who is treating the patient and has knowledge of the patient's response to treatment.

(ii) Timing. Recertifications are required at intervals established by the provider, but no less frequently than every 60 days.

(iii) Content. The recertification must specify that the patient continues to require at least 9 hours of intensive outpatient services and describe the following:

(i) The individual requires such services for a minimum of 20 hours per week and would require inpatient psychiatric care if the partial hospitalization services were not provided.

(ii) The services are or were furnished while the individual was under the care of a physician.

(iii) The services were furnished under a written plan of treatment that meets the requirements of paragraph (e)(2) of this section.

(i) The plan is an individualized plan that is established and is periodically reviewed by a physician in consultation with appropriate staff participating in the program, and that sets forth—

(ii) The physician determines the frequency and duration of the services taking into account accepted norms of medical practice and a reasonable expectation of improvement in the patient's condition.

(i) Signature. The physician recertification must be signed by a physician who is treating the patient and has knowledge of the patient's response to treatment.

(ii) Timing. The first recertification is required as of the 18th day of partial hospitalization services. Subsequent recertifications are required at intervals established by the provider, but no less frequently than every 30 days.

(iii) Content. The recertification must specify that the patient would otherwise require inpatient psychiatric care in the absence of continued stay in the partial hospitalization program and describe the following:

(i) The plan is being followed;

(ii) The patient is making progress in attaining the rehabilitation goals; and,

(iii) The treatment is not having any harmful effect on the patient.

(i) Claim means a transaction defined at 45 CFR 162.1101(a).

(ii) Electronic claim means a claim that is submitted via electronic media. A claim submitted via direct data entry is considered to be an electronic claim.

(iii) Direct data entry is defined at 45 CFR 162.103.

(iv) Electronic media is defined at 45 CFR 160.103.

(v) Initial Medicare claim means a claim submitted to Medicare for payment under Part A or Part B of the Medicare Program under title XVIII of the Act for initial processing, including claims sent to Medicare for the first time for secondary payment purposes. Initial Medicare claim excludes any adjustment or appeal of a previously submitted claim, and claims submitted for payment under Part C of the Medicare program under title XVIII of the Act.

(vi) Physician, practitioner, facility, or supplier is a Medicare provider or supplier other than a provider of services.

(vii) Provider of services means a provider of services as defined in section 1861(u) of the Act.

(viii) Small provider of services or small supplier means—

(i) There is no method available for the submission of an electronic claim. This exception includes claims submitted by Medicare beneficiaries and situations in which the standard adopted by the Secretary at 45 FR 162.1102 does not support all of the information necessary for payment of the claim. The Secretary may identify situations coming within this exception in guidance.

(ii) The entity submitting the claim is a small provider of services or small supplier.

(i) The submission of dental claims.

(ii) There is a service interruption in the mode of submitting the electronic claim that is outside the control of the entity submitting the claim, for the period of the interruption.

(iii) The entity submitting the claim submits fewer than 10 claims to Medicare per month, on average.

(iv) The entity submitting the claim only furnishes services outside of the U.S. territory.

(v) On demonstration, satisfactory to the Secretary, of other extraordinary circumstances precluding submission of electronic claims.

(i) The beneficiary;

(ii) The supplier or nonparticipating hospital that furnished the services; and

(iii) The physician who prescribed the services if they were furnished by a supplier other than the physician.

(i) None of the individuals listed in paragraph (b)(1), (2), (3), or (4) of this section was available or willing to sign the claim on behalf of the beneficiary at the time the service was provided;

(ii) The ambulance provider or supplier maintains in its files the following information and documentation for a period of at least four years from the date of service:

(i) By the hospital or SNF;

(ii) By physicians, if their services are billed by the hospital or SNF in its name; or

(iii) By physicians who bill separately, if the services were furnished in the hospital or SNF.

(i) By the provider or facility;

(ii) By physicians whose services are billed by the provider or facility in its name; or

(iii) By physicians who bill separately, if the services were furnished in the provider or facility.

(i) On or before December 31 of the following year for services that were furnished during the first 9 months of a calendar year; and

(ii) On or before December 31st of the second following year for services that were furnished during the last 3 months of the calendar year.

(i) At the time the service was furnished the beneficiary was not entitled to Medicare.

(ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.

(i) At the time the service was furnished the beneficiary was not entitled to Medicare.

(ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.

(iii) A State Medicaid agency recovered the Medicaid payment for the furnished service from a provider or supplier 6 months or more after the service was furnished.

(i) At the time the service was furnished the beneficiary was enrolled in a Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization.

(ii) The beneficiary was subsequently disenrolled from the Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization effective retroactively to or before the date of the furnished service.

(iii) The Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization recovered its payment for the furnished service from a provider or supplier 6 months or more after the service was furnished.

(i) If CMS or one of its contractors determines that a failure to meet the deadline specified in paragraph (a) of this section was caused by error or misrepresentation of an employee, Medicare contractor (including Medicare Administrative Contractor, intermediary, or carrier), or agent of HHS that was performing Medicare functions and acting within the scope of its authority, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which either the beneficiary or the provider or supplier received notification that the error or misrepresentation referenced in paragraph (b)(1) of this section was corrected. No extension of time will be granted for paragraph (b)(1) when the request for that exception is made to CMS or one of its contractors more than 4 years after the date of service.

(ii) If CMS or one of its contractors determines that both of the conditions are met in paragraph (b)(2) of this section but that all of the conditions in paragraph (b)(3) are not satisfied, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which either the beneficiary or the provider or supplier received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.

(iii) If CMS or one of its contractors determines that all of the conditions are met in paragraph (b)(3) of this section, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which the State Medicaid agency recovered the Medicaid payment for the furnished service from the provider or supplier.

(iv) If CMS or one of its contractors determines that all of the conditions are met in paragraph (b)(4) of this section, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which the Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization recovered its payment for the furnished service from the provider or supplier.

(i) To collect nothing for those services for which Medicare pays 100 percent of the Medicare approved amount.

(ii) To collect only the difference between the Medicare approved amount and the Medicare Part B payment (for example, the amount of any reduction in incurred expenses under § 410.155(c), any applicable deductible amount, and any applicable coinsurance amount) for services for which Medicare pays less than 100 percent of the approved amount.

(i) The beneficiary was without fault in the overpayment; and

(ii) The determination that the payment was incorrect was made by the carrier after the third year following the year in which the carrier sent notice to the beneficiary that it approved the payment.

(i) A Medicare-imposed revocation of any Medicare billing privileges.

(ii) Suspension or revocation of a license to provide health care by any State licensing authority.

(iii) Revocation for failure to meet DMEPOS quality standards.

(iv) A conviction of a Federal or State felony offense (as defined in § 424.535(a)(3)(i) within the last 10 years preceding enrollment, revalidation, or re-enrollment.

(v) An exclusion or debarment from participation in a Federal or State health care program.

(i) Federal regulatory requirements that specify requirements for the provision of DMEPOS and ensure accessibility for the disabled.

(ii) State licensure and regulatory requirements. If a State requires licensure to furnish certain items or services, a DMEPOS supplier—

(i) Must meet the following criteria:

(ii) May be the centralized location for all of the business records and the ordering and referring documentation of a multisite supplier.

(iii) May be a “closed door” business, such as a pharmacy or supplier providing services only to beneficiaries residing in a nursing home, that complies with all applicable Federal, State, and local laws and regulations. “Closed door” businesses must comply with all the requirements in this paragraph.

(i) Cellular phones, beepers, or pagers must not be used as the primary business telephone.

(ii) Calls must not be exclusively forwarded from the primary business telephone listed under the name of the business to a cellular phone, beeper, or pager.

(iii) Answering machines, answering services, facsimile machines or combination of these options must not be used exclusively as the primary business telephone during posted operating hours.

(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 § 424.502) must sign the liability insurance policy.

(i) The individual has given written permission to the supplier to contact them by telephone concerning the furnishing of a Medicare-covered item that is to be rented or purchased.

(ii) The supplier has furnished a Medicare-covered item to the individual and the supplier is contacting the individual to coordinate the delivery of the item.

(iii) If the contact concerns the furnishing of a Medicare-covered item other than a covered item already furnished to the individual, the supplier has furnished at least one covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact.

(i) The name, address, telephone number, and health insurance claim number of the beneficiary.

(ii) A summary of the complaint; the date it was received; the name of the person receiving the complaint, and a summary of actions taken to resolve the complaint.

(iii) If an investigation was not conducted, the name of the person making the decision and the reason for the decision.

(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.

(i) Except as specified in paragraph (c)(29)(ii) of this section, is prohibited from sharing a practice location with any other Medicare supplier or provider.

(ii) The prohibition specified in paragraph (c)(29)(i) of this section is not applicable at a practice location that meets one of the following:

(i) Except as specified in paragraph (c)(30)(ii) of this section, is open to the public a minimum of 30 hours per week.

(ii) The provision of paragraph (c)(30)(i) of this section is not applicable at a practice location where a—

(i) DMEPOS suppliers seeking enrollment or with a change in ownership. Except as provided in paragraph (d)(15) of this section, beginning May 4, 2009, DMEPOS suppliers seeking to enroll or to change the ownership of a supplier of DMEPOS must meet the requirements of paragraph (d) of this section for each assigned NPI for which the DMEPOS supplier is seeking to obtain Medicare billing privileges.

(ii) Existing DMEPOS suppliers. Except as provided in paragraph (d)(15) of this section, beginning October 2, 2009, each Medicare-enrolled DMEPOS supplier must meet the requirements of paragraph (d) of this section for each assigned NPI to which Medicare has granted billing privileges.

(i) A DMEPOS supplier enrolling in the Medicare program, making a change in ownership, or responding to a revalidation or reenrollment request must submit to the CMS contractor a surety bond from an authorized surety of $50,000 and, if required by the CMS contractor, an elevated bond amount as described in paragraph (d)(3) of this section with its paper or electronic Medicare enrollment application (CMS-855S, OMB number 0938-1056). The term of the initial surety bond must be effective on the date that the application is submitted to the CMS contractor.

(ii) A supplier that seeks to become an enrolled DMEPOS supplier through a purchase or transfer of assets or ownership interest must submit to the CMS contractor surety bond from an authorized surety of $50,000 and, if required by the CMS contractor, an elevated bond amount as described in paragraph (d)(3) of this section that is effective from the date of the purchase or transfer in order to exercise billing privileges as of that date. If the bond is effective at a later date, the effective date of the new DMEPOS supplier billing privileges is the effective date of the surety bond as validated by the CMS contractor.

(iii) A DMEPOS supplier enrolling a new practice location must submit to the CMS contractor a new surety bond from an authorized surety or an amendment or rider to the existing bond, showing that the new practice location is covered by an additional base surety bond of $50,000 or, as necessary, an elevated surety bond amount as described in paragraph (d)(3) of this section.

(i) If required, a DMEPOS supplier must obtain and maintain a base surety bond in the amount of $50,000 as specified in paragraph (d)(2) of this section and an elevated surety bond in the amount prescribed by the CMS contractor as described in paragraph (d)(3)(ii) of this section.

(ii) The CMS contractor prescribes an elevated surety bond amount of $50,000 per occurrence of an adverse legal action within the 10 years preceding enrollment, revalidation, or reenrollment, as defined in paragraph (a) of this section.

(i) Type of bond. A DMEPOS supplier must submit a bond that is continuous.

(ii) Minimum requirements of liability coverage.

(i) The bond must guarantee that the surety will, within 30 days of receiving written notice from CMS containing sufficient evidence to establish the surety's liability under the bond of unpaid claims, CMPs, or assessments, pay CMS a total of up to the full penal amount of the bond in the following amounts:

(ii) The bond must provide the following: The surety is liable for unpaid claims, CMPs, or assessments that occur during the term of the bond.

(iii) If the DMEPOS supplier fails to furnish a bond meeting the requirements of paragraph (d) of this section, fails to submit a rider when required, or if the DMEPOS supplier's billing privileges are revoked, the last bond or rider submitted by the DMEPOS supplier remains in effect until the last day of the surety bond coverage period and the surety remains liable for unpaid claims, CMPs, or assessments that—

(i) A DMEPOS supplier may cancel its surety bond and must provide written notice at least 30 days before the effective date of the cancellation to the CMS contractor and the surety.

(ii) Cancellation of a surety bond is grounds for revocation of the DMEPOS supplier's Medicare billing privileges unless the DMEPOS supplier provides a new bond before the effective date of the cancellation. The liability of the surety continues through the termination effective date.

(iii) If CMS receives notification of a lapse in bond coverage from the surety, the DMEPOS supplier's billing privileges are revoked. During this lapse, Medicare does not pay for items or services furnished during the gap in coverage, and the DMEPOS supplier is held liable for the items or services (that is, the DMEPOS supplier would not be permitted to charge the beneficiary for the items or services).

(iv) The surety must immediately notify the CMS contractor if there is a lapse in the surety's coverage of the DMEPOS supplier's coverage.

(i) CMS revokes the DMEPOS supplier's billing privileges if an enrolled DMEPOS supplier fails to obtain, file timely, or maintain a surety bond as specified in this subpart and CMS instructions. Notwithstanding paragraph (e) of this section, the revocation is effective the date the bond lapsed and any payments for items furnished on or after that date must be repaid to CMS by the DMEPOS supplier.

(ii) CMS denies billing privileges to a DMEPOS supplier if the supplier seeking to become an enrolled DMEPOS supplier fails to obtain and file timely a surety bond as specified with this subpart and CMS instructions.

(i) Qualifying entities and requirements.

(ii) Loss of a DMEPOS supplier exception. A DMEPOS supplier that no longer qualifies for an exception as described in paragraph (d)(15)(i) of this section must submit a surety bond to the CMS contractor in accordance with requirements of paragraph (d) of this section within 60 days after it knows or has reason to know that it no longer meets the criteria for an exception.

(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.

(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.

(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.

(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:

(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:

(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:

(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:

(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:

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

(xxi) An explanation of the following:

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

(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:

(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 § 424.502), managing employee (as defined in § 424.502), governing body member, W-2 or contracted surveyor, or W-2 or contracted health care or administrative or management services personnel thereof—

(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.

(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).

(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).

(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.

(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).

(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).

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

(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.

(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:

(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.

(i) Upon receipt of a 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.

(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).

(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)

(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:

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

(i) Except as otherwise directed or permitted in writing by CMS (for example, allowing sampling), the DMEPOS accrediting organization must—

(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 § 424.57(c).

(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—

(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—

(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.

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

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

(i)

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

(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:

(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.

(i) CMS may terminate a DMEPOS accrediting organization's approval for any of the following reasons:

(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.

(i) The reason for the termination.

(ii) The effective date of the termination.

(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 § 424.535.

(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:

(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.

(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) 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:

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

(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.

(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:

(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.

(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—

(ii)

(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 § 424.535(a).

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

(ii) If the suspension is lifted:

(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) 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—

(iii) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under § 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.

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

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

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

(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:

(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.

(i) A DMEPOS accrediting organization may request a reconsideration under part 498 of the following CMS initial determinations identified in § 498.3(b)(21) and (22):

(i)

(ii) A rebuttal submitted under this section must—

(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 § 498.3(b) of this chapter and therefore not appealable.

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

(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.

(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 § 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.

(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—

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

(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:

(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.

(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:

(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.

(i) The person found by SSA to be the surviving spouse, if he or she was either living in the same household with the deceased at the time of death, or was, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased beneficiary;

(ii) The child or children, who were, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one child, in equal parts to each child);

(iii) The parent or parents, who were, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one parent, in equal parts to each parent);

(iv) The person found by SSA to be the surviving spouse who was not living in the same household with the deceased at the time of death and was not, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased beneficiary;

(v) The child or children who were not entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one child, in equal parts to each child);

(vi) The parent or parents who were not entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one parent, in equal parts to each parent).

(i) Submit a claim on a CMS-prescribed form and an itemized bill in accordance with the requirements of this subpart. (See paragraph (g) of this section for an exception.)

(ii) Provide evidence that the services were furnished if the intermediary or carrier requests it.

(iii) Provide evidence of payment of the bill and of the identity of the person who paid it.

(i) Files a claim on a CMS-prescribed form in accordance with the applicable requirements of this subpart;

(ii) Upon request from the carrier, provides evidence that the services for which it claims payment were, in fact, furnished; and

(iii) Agrees in writing to accept the reasonable charge as the full charge for the services.

(i) A statement indicating that he or she has assumed legal obligation to pay for the services.

(ii) A claim on a CMS-prescribed form in accordance with the requirements of this subpart. (If a claim had been submitted by or on behalf of the beneficiary before he or she died, submission of another claim form is not required; a written request by the person seeking payment meets the requirement for a claim.)

(iii) An itemized bill that identifies the claimant as the person to whom the physician or other supplier holds responsible for payment. (If such an itemized bill had been submitted by or on behalf of the beneficiary before he or she died, submission of another itemized bill is not required.)

(iv) If the intermediary or carrier requests it, evidence that the services were actually furnished.

(i) Maintain and submit to CMS (via the applicable supplement or attachment) a list of all physicians, other eligible professionals, and pharmacists (regardless of whether the individual is a W-2 employee of the OTP) who are legally authorized to prescribe, order, or dispense controlled substances on behalf of the OTP. The list must include the physician's, other eligible professional's, or pharmacist's:

(ii) Certifying via the Form CMS-855A or Form CMS-855B (as applicable) and/or the applicable supplement or attachment thereto that the OTP meets and will continue to meet the specific requirements and standards for enrollment described in paragraphs (b) and (e) of this section.

(i) Except as stated in paragraph (b)(3)(ii) of this section, successfully complete the assigned categorical risk level screening required under, as applicable, § 424.518(b) and (c).

(ii) For currently enrolled OTPs that are changing their OTP enrollment from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, successfully complete the limited level of categorical screening under § 424.518(a) if the OTP has already completed, as applicable, the moderate or high level of categorical screening under § 424.518(b) or (c), respectively.

(i) Have a current, valid certification by SAMHSA for an opioid treatment program consistent with the provisions and requirements of § 8.11 of this title.

(ii) A provisional certification under § 8.11(e) of this title does not meet the requirements of paragraph (b)(4)(i) of this section.

(i) Medical director (as described in § 8.2 of this title).

(ii) Program sponsor (as described in § 8.2 of this title).

(i)