Title 42—Public Health--Volume 1
PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
§ 410.60   Outpatient physical therapy services: Conditions.
(a) Basic rule. Except as specified in paragraph (a)(3)(iii) of this section, Medicare Part B pays for outpatient physical therapy services only if they are furnished by an individual meeting the qualifications in part 484 of this chapter for a physical therapist or an appropriately supervised physical therapist assistant but only under the following conditions:
(1) They are furnished to a beneficiary while he or she is under the care of a physician who is a doctor of medicine, osteopathy, or podiatric medicine.
(2) They are furnished under a written plan of treatment that meets the requirements of § 410.61.
(3) They are furnished—
(i) By a provider as defined in § 489.2 of this chapter, or by others under arrangements with, and under the supervision of, a provider; or
(ii) By, or under the general supervision (or as specified otherwise) of, a physical therapist in private practice as described in paragraph (c) of this section; or
(iii) By, or incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform physical therapy services under State law. When a physical therapy service is provided incident to the service of a physician, physician's assistant, clinical nurse specialist, or nurse practitioner, by anyone other than a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to physical therapy and physical therapists, except that a license to practice physical therapy in the State is not required.
(4) Effective for dates of service on and after January 1, 2020, for physical therapy services described in paragraphs (a)(3)(i) or (ii) of this section, as applicable—
(i) Claims for services furnished in whole or in part by a physical therapist assistant must include the prescribed modifier; and
(ii) Effective for dates of service on or after January 1, 2022, claims for such services that include the modifier and for which payment is made under sections 1848 or 1834(k) of the Act are paid an amount equal to 85 percent of the amount of payment otherwise applicable for the service.
(iii) For purposes of this paragraph, “furnished in whole or in part” means when the physical therapist assistant either:
(A) Furnishes all the minutes of a service exclusive of the physical therapist; or
(B) Except as provided in paragraph (a)(4)(iv) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service separately from the part furnished by the physical therapist such that the minutes for that portion of a service (or unit of a service) furnished by the physical therapist assistant exceed 10 percent of the total minutes for that service (or unit of a service).
(iv) Paragraph (a)(4)(iii)(B) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day, when the physical therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant.
(v) Where there are two remaining 15-minute units to bill of the same service, and the physical therapist and physical therapist assistant each provided between 9 and 14 minutes of the service with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant and one unit is billed without the prescribed modifier for the service provided by the physical therapist.
(b) Condition for coverage of outpatient physical therapy services furnished to certain inpatients of a hospital or a CAH or SNF. Medicare Part B pays for outpatient physical therapy services furnished to an inpatient of a hospital, CAH, or SNF who requires them but who has exhausted or is otherwise + ineligible for benefit days under Medicare Part A.
(c) Special provisions for services furnished by physical therapists in private practice —(1) Basic qualifications. In order to qualify under Medicare as a supplier of outpatient physical therapy services, each individual physical therapist in private practice must meet the following requirements:
(i) Be legally authorized (if applicable, licensed, certified, or registered) to engage in the private practice of physical therapy by the State in which he or she practices, and practice only within the scope of his or her license, certification, or registration.
(ii) Engage in the private practice of physical therapy on a regular basis as an individual, in one of the following practice types: a solo practice, partnership, or group practice; or as an employee of one of these.
(iii) Bill Medicare only for services furnished in his or her private practice office space, or in the patient's home. A therapist's private practice office space refers to the location(s) where the practice is operated, in the State(s) where the therapist (and practice, if applicable) is legally authorized to furnish services, during the hours that the therapist engages in practice at that location. When services are furnished in private practice office space, that space must be owned, leased, or rented by the practice and used for the exclusive purpose of operating the practice. A patient's home does not include any institution that is a hospital, a CAH, or a SNF.
(iv) Treat individuals who are patients of the practice and for whom the practice collects fees for the services furnished.
(2) Supervision of physical therapy services. Except as otherwise provided in this paragraph (c)(2), physical therapy services are performed by, or under the general supervision of, a physical therapist in private practice. All services not performed personally by the therapist must be performed by employees of the practice, generally supervised by the therapist, and included in the fee for the therapist's services. Physical therapy services may be performed by a physical therapist assistant under the general supervision of the physical therapist in private practice; services performed by an unenrolled physical therapist must be under the direct supervision of the physical therapist.
(d) Excluded services. No service is included as an outpatient physical therapy service if it would not be included as an inpatient hospital service if furnished to a hospital or CAH inpatient.
(e) Annual limitation on incurred expenses —(1) Amount of limitation. (i) In 1999, 2000, and 2001, no more than $1,500 of allowable charges incurred in a calendar year for outpatient physical therapy services are recognized incurred expenses.
(ii) In 2002 and thereafter, the limitation shall be determined by increasing the limitation in effect in the previous calendar year by the increase in the Medicare Economic Index for the current year.
(iii) The limitation is not applied for services furnished from December 8, 2003 through December 31, 2005.
(iv) Outpatient physical therapy and speech-language pathology services furnished by a CAH directly or under arrangements must be counted towards the annual limitation on incurred expenses as if such services were paid under section 1834(k)(1)(b) of the Act.
(v) Beginning in 2018 and for each successive calendar year, the amount described in paragraph (e)(1)(ii) of this section is not applied as a limitation on incurred expenses for outpatient physical therapy and outpatient speech-language pathology services, but is instead applied as a threshold above which claims for physical therapy and speech-language pathology services must include the KX modifier (the KX modifier threshold) to indicate that the service is medically necessary and justified by appropriate documentation in the medical record; and claims for services above the KX modifier threshold that do not include the KX modifier are denied.
(2) For purposes of applying the KX modifier threshold, outpatient physical therapy includes:
(i) Outpatient physical therapy services furnished under this section;
(ii) Outpatient speech-language pathology services furnished under § 410.62;
(iii) Outpatient physical therapy and speech-language pathology services furnished by a comprehensive outpatient rehabilitation facility;
(iv) Outpatient physical therapy and speech-language pathology services furnished by a physician or incident to a physician's service;
(v) Outpatient physical therapy and speech-language pathology services furnished by a nurse practitioner, clinical nurse specialist, or physician assistant or incident to their services; and
(vi) Outpatient physical therapy and speech-language pathology services furnished by a CAH directly or under arrangements, included in the amount of annual incurred expenses as if such services were furnished and paid under section 1834(k)(1)(B) of the Act.
(3) A process for medical review of claims for physical therapy and speech-language pathology services applies as follows:
(i) For 2012 through 2017, medical review applies to claims for services at or in excess of $3,700 of recognized incurred expenses as described in paragraph (e)(1)(i) of this section.
(A) For 2012, 2013, and 2014 all claims at and above the $3,700 medical review threshold are subject to medical review; and
(B) For 2015, 2016, and 2017 claims at and above the $3,700 medical review threshold are subject to a targeted medical review process.
(ii) For 2018 and subsequent years, a targeted medical review process when the accrued annual incurred expenses reach the following medical review threshold amounts:
(A) Beginning with 2018 and before 2028, $3,000;
(B) For 2028 and each year thereafter, the applicable medical review threshold is determined by increasing the medical review threshold in effect for the previous year (starting with $3,000 for 2017) by the increase in the Medicare Economic Index for the current year.
§ 410.61   Plan of treatment requirements for outpatient rehabilitation services.
(a) Basic requirement. Outpatient rehabilitation services (including services furnished by a qualified physical or occupational therapist in private practice), must be furnished under a written plan of treatment that meets the requirements of paragraphs (b) through (e) of this section.
(b) Establishment of the plan. The plan is established before treatment is begun by one of the following:
(1) A physician.
(2) A physical therapist who furnishes the physical therapy services.
(3) A speech-language pathologist who furnishes the speech-language pathology services.
(4) An occupational therapist who furnishes the occupational therapy services.
(5) A nurse practitioner, a clinical nurse specialist, or a physician assistant.
(c) Content of the plan. The plan prescribes the type, amount, frequency, and duration of the physical therapy, occupational therapy, or speech-language pathology services to be furnished to the individual, and indicates the diagnosis and anticipated goals.
(d) Changes in the plan. Any changes in the plan—
(1) Are made in writing and signed by one of the following:
(i) The physician.
(ii) The physical therapist who furnishes the physical therapy services.
(iii) The occupational therapist that furnishes the occupational therapy services.
(iv) The speech-language pathologist who furnishes the speech-language pathology services.
(v) A registered professional nurse or a staff physician, in accordance with oral orders from the physician, physical therapist, occupational therapist, or speech-language pathologist who furnishes the services.
(vi) A nurse practitioner, a clinical nurse specialist, or a physician assistant.
(2) The changes are incorporated in the plan immediately.
§ 410.62   Outpatient speech-language pathology services: Conditions and exclusions.
(a) Basic rule. Except as specified in paragraph (a)(3)(ii) of this section, Medicare Part B pays for outpatient speech-language pathology services only if they are furnished by an individual who meets the qualifications for a speech-language pathologist in § 484.115 of this chapter and only under the following conditions:
(1) They are furnished to a beneficiary while he or she is under the care of a physician who is a doctor of medicine or osteopathy.
(2) They are furnished under a written plan of treatment that meets the requirements of § 410.61.
(3) They are furnished by one of the following:
(i) A provider as defined in § 489.2 of this chapter, or by others under arrangements with, and under the supervision of, a provider.
(ii) A speech-language pathologist in private practice as described in paragraph (c) of this section.
(iii) Incident to the service of, a physician, physician assistant, clinical nurse specialist, or nurse practitioner when those professionals may perform speech-language pathology services under State law. When a speech-language pathology service is provided incident to the services of a physician, physician assistant, clinical nurse specialist, or nurse practitioner, by anyone other than a physician, physician assistant, clinical nurse specialist, or nurse practitioner, the service and the person who furnishes the service must meet the standards and conditions that apply to speech-language pathology and speech-language pathologists, except that a license to practice speech-language pathology services in the State is not required.
(b) Condition for coverage of outpatient speech-language pathology services furnished to certain inpatients of a hospital or a CAH or SNF. Medicare Part B pays for outpatient speech-language pathology services furnished to an inpatient of a hospital, CAH, or SNF who requires the services but has exhausted or is otherwise ineligible for benefit days under Medicare Part A.
(c) Special provisions for services furnished by speech-language pathologists in private practice —(1) Basic qualifications. In order to qualify under Medicare as a supplier of outpatient speech-language pathology services, each individual speech-language pathologist in private practice must meet the following requirements:
(i) Be legally authorized (if applicable, licensed, certified, or registered) to engage in the private practice of speech-language pathology by the State in which he or she practices, and practice only within the scope of his or her license and/or certification.
(ii) Engage in the private practice of speech-language pathology on a regular basis as an individual, in one of the following practice types: a solo practice, partnership, or group practice; or as an employee of one of these.
(iii) Bill Medicare only for services furnished in one of the following:
(A) A speech-language pathologist's private practice office space that meets all of the following:
( 1 ) The location(s) where the practice is operated, in the State(s) where the therapist (and practice, if applicable) is legally authorized to furnish services and during the hours that the therapist engages in practice at that location.
( 2 ) The space must be owned, leased, or rented by the practice, and used for the exclusive purpose of operating the practice.
(B) A patient's home not including any institution that is a hospital, a CAH, or a SNF.
(iv) Treat individuals who are patients of the practice and for whom the practice collects fees for the services furnished.
(d) Excluded services. No service is included as an outpatient speech-language pathology service if it is not included as an inpatient hospital service if furnished to a hospital or CAH inpatient.
§ 410.63   Hepatitis B vaccine and blood clotting factors: Conditions.
Notwithstanding the exclusion from coverage of vaccines (see § 411.15 of this chapter) and self-administered drugs (see § 410.29), the following services are included as medical and other health services covered under § 410.10, subject to the specified conditions:
(a) Hepatitis B vaccine: Conditions. Effective January 1, 2025, hepatitis B vaccinations are reasonable and necessary for the prevention of illness for those individuals who are at high or intermediate risk of contracting hepatitis B as listed in paragraphs (a)(1) through (3) of this section:
(1) High risk groups. (i) End-Stage Renal Disease (ESRD) patients;
(ii) Hemophiliacs who receive Factor VIII or IX concentrates;
(iii) Clients of institutions for individuals with intellectual disabilities;
(iv) Persons who live in the same household as a hepatitis B carrier;
(v) Homosexual men;
(vi) Illicit injectable drug abusers;
(vii) Pacific Islanders (that is, those Medicare beneficiaries who reside on Pacific islands under U.S. jurisdiction, other than residents of Hawaii); and
(viii) Persons diagnosed with diabetes mellitus.
(2) Intermediate risk groups. (i) Staff in institutions for individuals with intellectual disabilities and classroom employees who work with individuals with intellectual disabilities;
(ii) Workers in health care professions who have frequent contact with blood or blood-derived body fluids during routine work (including workers who work outside of a hospital and have frequent contact with blood or other infectious secretions);
(iii) Heterosexually active persons with multiple sexual partners (that is, those Medicare beneficiaries who have had at least two documented episodes of sexually transmitted diseases within the preceding 5 years); and
(iv) Individuals who have not previously received a completed hepatitis B vaccination series or whose previous vaccination history is unknown.
(3) Exception. Individuals described in paragraphs (a) (1) and (2) of this section are not considered at high or intermediate risk of contracting hepatitis B if they have undergone a prevaccination screening and have been found to be currently positive for antibodies to hepatitis B.
(b) Blood clotting factors: Conditions. Effective July 18, 1984, blood clotting factors that are self-administered and control bleeding for hemophilia patients competent to use these factors without medical or other supervision, and items related to the administration of those factors. Therapies that enable the body to produce clotting factor and do not directly integrate into the coagulation cascade are not themselves clotting factors. The amount of clotting factors covered under this provision is determined by the carrier based on the historical utilization pattern or profile developed by the carrier for each patient, and based on consideration of the need for a reasonable reserve supply to be kept in the home in the event of emergency or unforeseen circumstance.
(c) Blood clotting factors: Furnishing Fee. (1) Effective January 1, 2005, a furnishing fee of $0.14 per unit of clotting factor is paid to entities that furnish blood clotting factors, as described in paragraph (b) of this section, unless the costs associated with furnishing the clotting factor are paid through another payment system, for example, hospitals that furnish clotting factor to patients during a Part A covered inpatient hospital stay, or practitioners that furnish clotting factor to patients in an outpatient setting and are paid for under the Physician Fee Schedule.
(2) The furnishing fee for blood clotting factors furnished in 2006 or a subsequent year is be equal to the furnishing fee paid the previous year increased by the percentage increase in the consumer price index for medical care for the 12-month period ending with June of the previous year.
§ 410.64   Additional preventive services.
(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of “preventive services” under § 410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following:
(1) Reasonable and necessary for the prevention or early detection of illness or disability.
(2) Recommended with a grade of A or B by the United States Preventive Services Task Force.
(3) Appropriate for individuals entitled to benefits under part A or enrolled under Part B.
(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.
§ 410.66   Emergency outpatient services furnished by a nonparticipating hospital and services furnished in a foreign country.
Conditions for payment of emergency inpatient services furnished by a nonparticipating U.S. hospital and for services furnished in a foreign country are set forth in subparts G and H of part 424 of this chapter.
§ 410.67   Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs.
(a) Basis and scope— (1) Basis. This section implements sections 1861(jjj), 1861(s)(2)(HH), 1833(a)(1)(CC) and 1834(w) of the Act which provide for coverage of opioid use disorder treatment services furnished by an opioid treatment program and the payment of a bundled payment under Part B to an opioid treatment program for opioid use disorder treatment services that are furnished to a beneficiary during an episode of care beginning on or after January 1, 2020.
(2) Scope. This section sets forth the criteria for an opioid treatment program, the scope of opioid use disorder treatment services, and the methodology for determining the bundled payments to opioid treatment programs for furnishing opioid use disorder treatment services.
(b) Definitions. For purposes of this section, the following definitions apply:
Episode of care means a one-week (contiguous 7-day) period.
Opioid treatment program means an entity that is an opioid treatment program (as defined in § 8.2 of this title, or any successor regulation) that meets the requirements described in paragraph (c) of this section.
Opioid use disorder treatment service means one of the following items or services for the treatment of opioid use disorder that is furnished by an opioid treatment program that meets the requirements described in paragraph (c) of this section.
(i) Opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal, Food, Drug, and Cosmetic Act for use in treatment of opioid use disorder.
(ii) Dispensing and administration of opioid agonist and antagonist treatment medications, if applicable.
(iii) Substance use counseling by a professional to the extent authorized under State law to furnish such services including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the counseling services may be furnished using audio-only telephone calls if all other applicable requirements are met.
(iv) Individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law), including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the therapy services may be furnished using audio-only telephone calls if all other applicable requirements are met.
(v) Toxicology testing.
(vi) Intake activities, including initial medical examination services required under § 8.12(f)(2) of this title and initial assessment services required under § 8.12(f)(4) of this title.
(A) For intake activities furnished via communications technology, the following flexibilities apply:
( 1 ) Services to initiate treatment with buprenorphine may be furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. In cases where audio-video communications technology is not available to the beneficiary, services to initiate treatment with buprenorphine may be furnished using audio-only telephone calls if all other applicable requirements are met.
( 2 ) Services to initiate treatment with methadone may be furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements, if the OTP practitioner determines that an adequate evaluation of the patient can be accomplished through audio-video communication technology.
(B) [Reserved]
(vii) Periodic assessment services required under § 8.12(f)(4) of this title, that are furnished during a face-to-face encounter, including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. In cases where a beneficiary does not have access to two-way audio-video communications technology, periodic assessments can be furnished using audio-only telephone calls if all other applicable requirements are met.
(viii) Opioid antagonist medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for the emergency treatment of known or suspected opioid overdose and overdose education furnished in conjunction with opioid antagonist medication.
(ix) Opioid treatment program (OTP) intensive outpatient services, which means one or more services specified in § 410.44(a)(4) when furnished by an OTP as part of a distinct and organized intensive ambulatory treatment program for the treatment of opioid use disorder (OUD) and that offers less than 24-hour daily care other than in an individual's home or in an inpatient or residential setting. OTP intensive outpatient services are reasonable and necessary for the diagnosis or active treatment of the individual's condition; are reasonably expected to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization; and are furnished in accordance with a physician or non-physician practitioner (as defined in section 1842(b)(18)(C) of the Act) certification and plan of care, as permitted by State law and scope of practice requirements, in which a physician or non-physician practitioner must certify that the individual has a need for a minimum of nine hours of services per week and requires a higher level of care intensity compared to other non-intensive outpatient OTP services. OTP intensive outpatient services do not include FDA-approved opioid agonist or antagonist medications for the treatment of OUD or opioid antagonist medications for the emergency treatment of known or suspected opioid overdose, or toxicology testing.
(x) Coordinated care and/or referral services, provided by an OTP to link a beneficiary with community resources to address unmet health-related social needs or the need and interest for harm reduction interventions and recovery support services that significantly limit the ability to diagnose or treat a patient's opioid use disorder.
(xi) Patient navigational services and/or peer recovery support services, when provided directly by an OTP or through referral, in order to assist patients with an OUD in navigating the health system and accessing supportive services, and/or to provide support in meeting patient-driven OUD treatment and recovery goals.
(c) Requirements for opioid treatment programs. To participate in the Medicare program and receive payment, an opioid treatment program must meet all of the following:
(1) Be enrolled in the Medicare program.
(2) Have in effect a certification by the Substance Abuse and Mental Health Services Administration (SAMHSA) for the opioid treatment program.
(3) Be accredited by an accrediting body approved by the SAMHSA.
(4) Have in effect a provider agreement under part 489 of this title.
(5) OTPs that provide OTP intensive outpatient services must meet the requirements set forth in § 424.24(d)(1) through (3) of this chapter related to content of certification, plan of treatment, and recertification for the purposes of furnishing OTP intensive outpatient services, except that the recertification required under § 424.24(d)(3)(ii) of this chapter may occur any time during an episode of care and any reference to a physician requirement in § 424.24(d)(1) through (3) may also be performed by a non-physician practitioner (as defined in section 1842(b)(18)(C) of the Act, as permitted by state law and scope of practice requirements.
(d) Bundled payments for opioid use disorder treatment services furnished by opioid treatment programs. (1) CMS will establish categories of bundled payments for opioid treatment programs for an episode of care as follows:
(i) Categories for each type of opioid agonist and antagonist treatment medication;
(ii) A category for medication not otherwise specified, which will be used for new FDA-approved opioid agonist or antagonist treatment medications for which CMS has not established a category; and
(iii) A category for episodes of care in which no medication is provided.
(2) The bundled payment for episodes of care in which a medication is provided consists of payment for a drug component, reflecting payment for the applicable FDA-approved opioid agonist or antagonist medication in the patient's treatment plan, and a non-drug component, reflecting payment for all other opioid use disorder treatment services reflected in the patient's treatment plan (including dispensing/administration of the medication, if applicable). The payments for the drug component and non-drug component are added together to create the bundled payment amount. The bundled payment for episodes of care in which no medication is provided consists of a single payment amount for all opioid use disorder treatment services reflected in the patient's treatment plan (excluding medication and dispensing/administration of medication).
(i) Drug component. The payment for the drug component for an episode of care will be determined as follows, using the most recent data available at time of ratesetting for the applicable calendar year:
(A) Implantable and injectable medications. For implantable and injectable medications, the payment is determined using the methodology set forth in section 1847A of the Act, except that the payment amount must be 100 percent of the ASP, if ASP is used; and the payment must be 100 percent of the wholesale acquisition cost (WAC), if WAC is used.
(B) For oral medications. ( 1 ) Except as provided under paragraph (d)(2)(i)(B)( 2 ) of this section, if ASP data are available, the payment amount is 100 percent of ASP, which will be determined based on ASP data that have been calculated consistent with the provisions in part 414, subpart J of this chapter and voluntarily submitted by drug manufacturers. If ASP data are not available, the payment amount for methadone will be based on the TRICARE rate and for buprenorphine will be calculated using the National Average Drug Acquisition Cost.
( 2 ) For CY 2022, the payment amount for methadone is the payment amount determined under paragraph (d)(2)(i)(B)( 1 ) of this section for methadone in CY 2021. For CY 2023 and subsequent years, the payment amount for methadone will be based on the payment amount determined under paragraph (d)(2)(i)(B)( 1 ) of this section for methadone in CY 2021 and updated by the PPI for Pharmaceuticals for Human Use (Prescription).
(C) Exception. For the drug component of bundled payments in the medication not otherwise specified category under paragraph (d)(1)(iii) of this section, the payment amount is be based on the applicable methodology under paragraphs (d)(2)(i)(A) and (B) of this section (applying the most recent available data for such new medication), or invoice pricing until the necessary data become available.
(ii) Non-drug component. The payment for CY 2020 for the non-drug component of the bundled payment for an episode of care is the sum of:
(A) The CY 2019 Medicare physician fee schedule non-facility rates for the following items and services:
( 1 ) Psychotherapy, 30 minutes with patient
( 2 ) Group psychotherapy
( 3 ) Alcohol and/or substance (other than tobacco) abuse structured assessment and brief intervention at the non-physician practitioner rate.
( 4 ) For administration of an injectable medication, if applicable, drug administration (Therapeutic, prophylactic).
( 5 ) For the insertion, removal, or insertion and removal of the implantable medication, if applicable, the applicable rate.
(B) For dispensing oral medication, if applicable, an approximation of the average dispensing fees under state Medicaid programs.
(C) One fourth of the sum of the CY 2019 Clinical Laboratory Fee Schedule rate for two drug tests, presumptive, capable of being read by direct optical observation only and for a drug test, definitive, 1-7 drug classes.
(iii) No medication provided episodes of care. The bundled payment amount for CY 2020 for an episode of care in which no medication is provided is based on the non-drug component rate for an episode of care in which a drug is dispensed or administered, not including any amounts reflecting the cost of dispensing or administration of a drug.
(iv) Increased level of psychotherapy. For CY 2023 and subsequent years, the payment for the non-drug component of the bundled payment for an episode of care under paragraph (d)(2) of this section is adjusted to reflect the CY 2019 Medicare physician fee schedule non-facility rate for psychotherapy, 45 minutes with patient.
(3) At least one OUD treatment service described in paragraphs (i) through (v) of the definition of opioid use disorder treatment service in paragraph (b) of this section must be furnished to bill for the bundled payment for an episode of care.
(4) Adjustments will be made to the bundled payment for the following:
(i) If the opioid treatment program furnishes:
(A) Counseling or therapy services in excess of the amount specified in the beneficiary's treatment plan and for which medical necessity is documented in the medical record, an adjustment will be made for each additional 30 minutes of counseling or individual therapy furnished during the episode of care.
(B) Intake activities described in paragraph (b)(6) of this section, an adjustment will be made when intake activities are furnished.
(C) Periodic assessments described in paragraph (b)(7) of this section, an adjustment will be made when this service is furnished.
(D) Additional take home supply of oral drugs of up to 21 days, in increments of 7 days, an adjustment will be made when oral medications are dispensed.
(E) Take-home supply of opioid antagonist medications that are approved by the Food and Drug Administration under section 505 of the Federal, Food, Drug and Cosmetic Act for the emergency treatment of known or suspected opioid overdose and overdose education furnished in conjunction with opioid antagonist medication, an adjustment will be made when these medications are dispensed. This adjustment will be limited to once every 30 days, except when a further take home supply of these medications is medically reasonable and necessary. The opioid treatment program must document in the medical record the reason(s) for the exception. The amount of the drug component of the adjustment will be determined using the methodology in paragraph (d)(2)(i) of this section. The amount of the non-drug component of the adjustment will be determined based on the CY 2020 Medicare payment rate for CPT code 96161.
(F) For OTP intensive outpatient services, an adjustment will be made when at least nine OTP intensive outpatient services described in paragraph (ix) of the definition of opioid use disorder treatment service in paragraph (b) of this section are furnished in a week. This adjustment will be based on the per diem payment rate for intensive outpatient services at hospital-based programs defined at § 410.44(c) and multiplied by a factor of three for a weekly payment adjustment.
(G) Coordinated care and/or referral services described in paragraph (x) of the definition of opioid use disorder treatment service in paragraph (b) of this section, an adjustment will be made when each additional 30 minutes of these services are furnished.
(H) Patient navigational services and/or peer recovery support services described in paragraph (xi) of the definition of opioid use disorder treatment service in paragraph (b) of this section, an adjustment will be made when each additional 30 minutes of these services are furnished.
(ii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, OTP intensive outpatient services, coordinated care and/or referral services, patient navigational services and/or peer recovery support services, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be geographically adjusted using the Geographic Adjustment Factor described in § 414.26 of this subchapter. For purposes of this adjustment, OUD treatment services that are furnished via an OTP mobile unit will be treated as if they were furnished at the physical location of the OTP registered with the Drug Enforcement Administration (DEA) and certified by SAMHSA.
(iii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, OTP intensive outpatient services, coordinated care and/or referral services, patient navigational services and/or peer recovery support services, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be updated annually using the Medicare Economic Index described in § 405.504(d) of this subchapter.
(5) Payment for medications delivered, administered or dispensed to a beneficiary as part of the bundled payment or an adjustment to the bundled payment under paragraph (d)(4)(i) of this section is considered a duplicative payment if a claim for delivery, administration or dispensing of the same medications for the same beneficiary on the same date of service was also separately paid under Medicare Part B or Part D. CMS will recoup the duplicative payment made to the opioid treatment program.
(6) For purposes of the adjustment to the bundled payment under paragraph (d)(4)(i)(A) of this section, after the end of the Public Health Emergency as defined in § 400.200 of this chapter, when services are furnished using audio-only technology the practitioner must certify, in a form and manner specified by CMS, that they had the capacity to furnish the services using two-way, audio/video communication technology, but used audio-only technology because audio/video communication technology was not available to the beneficiary.
(e) Beneficiary cost-sharing. A beneficiary copayment amount of zero will apply.
§ 410.68   Antigens: Scope and conditions.
Medicare Part B pays for—
(a) Antigens that are furnished as services incident to a physician's professional services; or
(b) A supply of antigen sufficient for not more than 12 months that is—
(1) Prepared for a patient by a doctor of medicine or osteopathy who has examined the patient and developed a plan of treatment including dosage levels; and
(2) Administered—
(i) In accord with the plan of treatment developed by the doctor of medicine or osteopathy who prepared the antigen; and
(ii) By a doctor of medicine or osteopathy or by a properly instructed person under the supervision of a doctor of medicine or osteopathy.
§ 410.69   Services of a certified registered nurse anesthetist or an anesthesiologist's assistant: Basic rule and definitions.
(a) Basic rule. Medicare Part B pays for anesthesia services and related care furnished by a certified registered nurse anesthetist or an anesthesiologist's assistant who is legally authorized to perform the services by the State in which the services are furnished.
(b) Definitions. For purposes of this part—
Anesthesia and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.
Anesthesiologist's assistant means a person who—
(1) Works under the direction of an anesthesiologist;
(2) Is in compliance with all applicable requirements of State law, including any licensure requirements the State imposes on nonphysician anesthetists; and
(3) Is a graduate of a medical school-based anesthesiologist's assistant educational program that—
(A) Is accredited by the Committee on Allied Health Education and Accreditation; and
(B) Includes approximately two years of specialized basic science and clinical education in anesthesia at a level that builds on a premedical undergraduate science background.
Anesthetist includes both an anesthesiologist's assistant and a certified registered nurse anesthetist.
Certified registered nurse anesthetist means a registered nurse who:
(1) Is licensed as a registered professional nurse by the State in which the nurse practices;
(2) Meets any licensure requirements the State imposes with respect to non-physician anesthetists;
(3) Has graduated from a nurse anesthesia educational program that meets the standards of the Council on Accreditation of Nurse Anesthesia Programs, or such other accreditation organization as may be designated by the Secretary; and
(4) Meets the following criteria:
(i) Has passed a certification examination of the Council on Certification of Nurse Anesthetists, the Council on Recertification of Nurse Anesthetists, or any other certification organization that may be designated by the Secretary; or
(ii) Is a graduate of a program described in paragraph (3) of this definition and within 24 months after that graduation meets the requirements of paragraph (4)(i) of this definition.
(5) For certified registered nurse anesthetist services, the certified registered nurse anesthetist may review and verify (sign and date), rather than re-document, notes in a patient's medical record made by physicians; residents; nurses; medical, physician assistant, and advanced practice registered nurse students; or other members of the medical team, including, as applicable, notes documenting the certified registered nurse anesthetist's presence and participation in the service.
§ 410.71   Clinical psychologist services and services and supplies incident to clinical psychologist services.
(a) Included services. (1) Medicare Part B covers services furnished by a clinical psychologist, who meets the requirements specified in paragraph (d) of this section, that are within the scope of his or her State license, if the services would be covered if furnished by a physician or as an incident to a physician's services.
(2) Medicare Part B covers services and supplies incident to the services of a clinical psychologist if the requirements of § 410.26 are met.
(b) Application of mental health treatment limitation. The treatment services of a clinical psychologist and services and supplies furnished as an incident to those services are subject to the limitation on payment for outpatient mental health treatment services set forth in § 410.155.
(c) Payment for consultations. A clinical psychologist or an attending or primary care physician may not bill Medicare or the beneficiary for the consultation that is required under paragraph (e) of this section.
(d) Qualifications. For purposes of this subpart, a clinical psychologist is an individual who—
(1) Holds a doctoral degree in psychology; and
(2) Is licensed or certified, on the basis of the doctoral degree in psychology, by the State in which he or she practices, at the independent practice level of psychology to furnish diagnostic, assessment, preventive, and therapeutic services directly to individuals.
(e) Agreement to consult. A clinical psychologist who bills Medicare Part B must agree to meet the requirements of paragraphs (e)(1) through (e)(3) of this section. The clinical psychologist's signature on a Medicare provider/supplier enrollment form indicates his or her agreement.
(1) Unless the beneficiary's primary care or attending physician has referred the beneficiary to the clinical psychologist, to inform the beneficiary that it is desirable for the clinical psychologist to consult with the beneficiary's attending or primary care physician (if the beneficiary has such a physician) to consider any conditions contributing to the beneficiary's symptoms.
(2) If the beneficiary assents to the consultation, in accordance with accepted professional ethical norms and taking into consideration patient confidentiality—
(i) To attempt, within a reasonable time after receiving the consent, to consult with the physician; and
(ii) If attempts to consult directly with the physician are not successful, to notify the physician, within a reasonable time, that he or she is furnishing services to the beneficiary.
(3) Unless the primary care or attending physician referred the beneficiary to the clinical psychologist, to document, in the beneficiary's medical record, the date the patient consented or declined consent to consultation, the date of consultation, or, if attempts to consult did not succeed, the date and manner of notification to the physician.
§ 410.72   Registered dietitians' and nutrition professionals' services.
(a) Definition: Registered dietitians and nutrition professionals. Meet the qualifications at § 410.134.
(b) Covered registered dietitian and nutrition professional services. Medicare Part B covers:
(1) Coverage condition. Medical nutrition therapy (MNT) services as defined at § 410.130 under the conditions of coverage at § 410.132.
(2) Other services. Registered dietitians and nutrition professionals may also provide diabetes self-management (DSMT) services if they are or represent an accredited DSMT entity and have an order from a physician or qualified nonphysician practitioner who is treating the patient's diabetic condition.
(3) Limits on MNT and DSMT. (i) DSMT and MNT cannot be furnished to a patient on the same date of service, and
(ii) MNT and DSMT services cannot be furnished incident to the professional services of a physician or nonphysician practitioner service.
(c) Limitations. The following services are not registered dietitian or nutrition professional services for purposes of billing Medicare Part B:
(1) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating hospital.
(2) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating SNF.
(3) Services furnished by a registered dietitian or nutrition professional to a patient in a Medicare-participating ESRD facility in accordance with the limitation on coverage of MNT service listed at § 410.132(b)(1).
(d) Professional services. Except for DSMT services furnished as, or on behalf of, an accredited DSMT entity, registered dietitians and nutrition professionals can be paid for their professional MNT services only when the services have been directly performed by them.
(e) Telehealth services. MNT and DSMT services may be provided as telehealth services (meeting the requirements in § 410.78) when registered dietitians or nutrition professionals act as distant site practitioners.
(f) Restrictions. The services of a registered dietitian or nutrition professional are provided on an assignment-related basis, and a registered dietitian or nutrition professional may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the registered dietitian or nutrition professional must refund the full amount of the impermissible charge to the beneficiary.
§ 410.73   Clinical social worker services.
(a) Definition: clinical social worker. For purposes of this part, a clinical social worker is defined as an individual who—
(1) Possesses a master's or doctor's degree in social work;
(2) After obtaining the degree, has performed at least 2 years of supervised clinical social work; and
(3) Either is licensed or certified as a clinical social worker by the State in which the services are performed or, in the case of an individual in a State that does not provide for licensure or certification as a clinical social worker—
(i) Is licensed or certified at the highest level of practice provided by the laws of the State in which the services are performed; and
(ii) Has completed at least 2 years or 3,000 hours of post master's degree supervised clinical social work practice under the supervision of a master's degree level social worker in an appropriate setting such as a hospital, SNF, or clinic.
(b) Covered clinical social worker services. Medicare Part B covers clinical social worker services.
(1) Definition. “Clinical social worker services” means, except as specified in paragraph (b)(2) of this section, the services of a clinical social worker furnished for the diagnosis and treatment of mental illness that the clinical social worker is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) of the State in which the services are performed. The services must be of a type that would be covered if they were furnished by a physician or as an incident to a physician's professional service and must meet the requirements of this section.
(2) Exception. The following services are not clinical social worker services for purposes of billing Medicare Part B:
(i) Services furnished by a clinical social worker to an inpatient of a Medicare-participating hospital.
(ii) Services furnished by a clinical social worker to an inpatient of a Medicare-participating SNF.
(iii) Services furnished by a clinical social worker to a patient in a Medicare-participating dialysis facility if the services are those required by the conditions for coverage for ESRD facilities under § 405.2163 of this chapter.
(c) Agreement to consult. A clinical social worker must comply with the consultation requirements set forth at § 410.71(f) (reading “clinical psychologist” as “clinical social worker”).
(d) Prohibited billing. (1) A clinical social worker may not bill Medicare for the services specified in paragraph (b)(2) of this section.
(2) A clinical social worker or an attending or primary care physician may not bill Medicare or the beneficiary for the consultation that is required under paragraph (c) of this section.
§ 410.74   Physician assistants' services.
(a) Basic rule. Medicare Part B covers physician assistants' services only if the following conditions are met:
(1) The services would be covered as physicians' services if furnished by a physician (a doctor of medicine or osteopathy, as set forth in section 1861(r)(1) of the Act).
(2) The physician assistant—
(i) Meets the qualifications set forth in paragraph (c) of this section;
(ii) Is legally authorized to perform the services in the State in which they are performed;
(iii) Performs services that are not otherwise precluded from coverage because of a statutory exclusion;
(iv) Performs the services in accordance with state law and state scope of practice rules for physician assistants in the state in which the physician assistant's professional services are furnished. Any state laws and scope of practice rules that describe the required practice relationship between physicians and physician assistants, including explicit supervisory or collaborative practice requirements, describe a form of supervision for purposes of section 1861(s)(2)(K)(i) of the Act. For states with no explicit state law and scope of practice rules regarding physician supervision of physician assistant's services, physician supervision is a process in which a physician assistant has a working relationship with one or more physicians to supervise the delivery of their health care services. Such physician supervision is evidenced by documenting at the practice level the physician assistant's scope of practice and the working relationships the physician assistant has with the supervising physician/s when furnishing professional services.
(v) Prior to January 1, 2022, furnishes services that are billed by the employer of a physician assistant; and
(vi) Performs the services—
(A) In all settings in either rural and urban areas; or
(B) As an assistant at surgery.
(b) Services and supplies furnished incident to a physician assistant's services. Medicare Part B covers services and supplies incident to the services of a physician assistant if the requirements of § 410.26 are met.
(c) Qualifications. For Medicare Part B coverage of his or her services, a physician assistant must meet all of the following conditions:
(1) Have graduated from a physician assistant educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; or
(2) Have passed the national certification examination that is administered by the National Commission on Certification of Physician Assistants; and
(3) Be licensed by the State to practice as a physician assistant.
(d) Professional services. Physician assistants can be paid for professional services only if the services have been professionally performed by them and no facility or other provider charges for the service or is paid any amount for the furnishing of those professional services.
(1) Supervision of other nonphysician staff by a physician assistant does not constitute personal performance of a professional service by the physician assistant.
(2) The services of a physician assistant are provided on an assignment-related basis, and the physician assistant may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the physician assistant must refund the full amount of the impermissible charge to the beneficiary.
(e) Medical record documentation. For physician assistants' services, the physician assistant may review and verify (sign and date), rather than re-document, notes in a patient's medical record made by physicians; residents; nurses; medical, physician assistant, and advanced practice registered nurse students; or other members of the medical team, including, as applicable, notes documenting the physician assistant's presence and participation in the service.
§ 410.75   Nurse practitioners' services.
(a) Definition. As used in this section, the term “physician” means a doctor of medicine or osteopathy, as set forth in section 1861(r)(1) of the Act.
(b) Qualifications. For Medicare Part B coverage of his or her services, a nurse practitioner must be a registered professional nurse who is authorized by the State in which the services are furnished to practice as a nurse practitioner in accordance with State law, and must meet one of the following:
(1) Obtained Medicare billing privileges as a nurse practitioner for the first time on or after January 1, 2003, and meets the following requirements:
(i) Be certified as a nurse practitioner by a recognized national certifying body that has established standards for nurse practitioners.
(ii) Possess a master's degree in nursing or a Doctor of Nursing Practice (DNP) doctoral degree.
(2) Obtained Medicare billing privileges as a nurse practitioner for the first time before January 1, 2003, and meets the standards in paragraph (b)(1)(i) of this section.
(3) Obtained Medicare billing privileges as a nurse practitioner for the first time before January 1, 2001.
(c) Services. Medicare Part B covers nurse practitioners' services in all settings in both rural and urban areas, only if the services would be covered if furnished by a physician and the nurse practitioner—
(1) Is legally authorized to perform them in the State in which they are performed;
(2) Is not performing services that are otherwise excluded from coverage because of one of the statutory exclusions; and
(3) Performs them while working in collaboration with a physician.
(i) Collaboration is a process in which a nurse practitioner works with one or more physicians to deliver health care services within the scope of the practitioner's expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanisms as provided by the law of the State in which the services are performed.
(ii) In the absence of State law governing collaboration, collaboration is a process in which a nurse practitioner has a relationship with one or more physicians to deliver health care services. Such collaboration is to be evidenced by nurse practitioners documenting the nurse practitioners' scope of practice and indicating the relationships that they have with physicians to deal with issues outside their scope of practice. Nurse practitioners must document this collaborative process with physicians.
(iii) The collaborating physician does not need to be present with the nurse practitioner when the services are furnished or to make an independent evaluation of each patient who is seen by the nurse practitioner.
(d) Services and supplies incident to a nurse practitioners' services. Medicare Part B covers services and supplies incident to the services of a nurse practitioner if the requirements of § 410.26 are met.
(e) Professional services. Nurse practitioners can be paid for professional services only when the services have been personally performed by them and no facility or other provider charges, or is paid, any amount for the furnishing of the professional services.
(1) Supervision of other nonphysician staff by a nurse practitioner does not constitute personal performance of a professional service by a nurse practitioner.
(2) The services of a nurse practitioner are provided on an assignment-related basis, and the nurse practitioner may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the nurse practitioner must refund the full amount of the impermissible charge to the beneficiary.
(f) Medical record documentation. For nurse practitioners' services, the nurse practitioner may review and verify (sign and date), rather than re-document, notes in a patient's medical record made by physicians; residents; nurses; medical, physician assistant, and advanced practice registered nurse students; or other members of the medical team, including, as applicable, notes documenting the nurse practitioner's presence and participation in the service.
§ 410.76   Clinical nurse specialists' services.
(a) Definition. As used in this section, the term “physician” means a doctor of medicine or osteopathy, as set forth in section 1861(r)(1) of the Act.
(b) Qualifications. For Medicare Part B coverage of his or her services, a clinical nurse specialist must—
(1) Be a registered nurse who is currently licensed to practice in the State where he or she practices and be authorized to perform the services of a clinical nurse specialist in accordance with State law;
(2) Have a master's degree in a defined clinical area of nursing from an accredited educational institution or a Doctor of Nursing Practice (DNP) doctoral degree; and
(3) Be certified as a clinical nurse specialist by a national certifying body that has established standards for clinical nurse specialists and that is approved by the Secretary.
(c) Services. Medicare Part B covers clinical nurse specialists' services in all settings in both rural and urban areas only if the services would be covered if furnished by a physician and the clinical nurse specialist—
(1) Is legally authorized to perform them in the State in which they are performed;
(2) Is not performing services that are otherwise excluded from coverage by one of the statutory exclusions; and
(3) Performs them while working in collaboration with a physician.
(i) Collaboration is a process in which a clinical nurse specialist works with one or more physicians to deliver health care services within the scope of the practitioner's expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanisms as provided by the law of the State in which the services are performed.
(ii) In the absence of State law governing collaboration, collaboration is a process in which a clinical nurse specialist has a relationship with one or more physicians to deliver health care services. Such collaboration is to be evidenced by clinical nurse specialists documenting the clinical nurse specialists' scope of practice and indicating the relationships that they have with physicians to deal with issues outside their scope of practice. Clinical nurse specialists must document this collaborative process with physicians.
(iii) The collaborating physician does not need to be present with the clinical nurse specialist when the services are furnished, or to make an independent evaluation of each patient who is seen by the clinical nurse specialist.
(d) Services and supplies furnished incident to clinical nurse specialists' services. Medicare Part B covers services and supplies incident to the services of a clinical nurse specialist if the requirements of § 410.26 are met.
(e) Professional services. Clinical nurse specialists can be paid for professional services only when the services have been personally performed by them and no facility or other provider charges, or is paid, any amount for the furnishing of the professional services.
(1) Supervision of other nonphysician staff by clinical nurse specialists does not constitute personal performance of a professional service by clinical nurse specialists.
(2) The services of a clinical nurse specialist are provided on an assignment-related basis, and the clinical nurse specialist may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the clinical nurse specialist must refund the full amount of the impermissible charge to the beneficiary.
(f) Medical record documentation. For clinical nurse specialists' services, the clinical nurse specialist may review and verify (sign and date), rather than re-document, notes in a patient's medical record made by physicians; residents; nurses; medical, physician assistant, and advanced practice registered nurse students; or other members of the medical team, including, as applicable, notes documenting the clinical nurse specialist's presence and participation in the service.
§ 410.77   Certified nurse-midwives' services: Qualifications and conditions.
(a) Qualifications. For Medicare coverage of his or her services, a certified nurse-midwife must:
(1) Be a registered nurse who is legally authorized to practice as a nurse-midwife in the State where services are performed;
(2) Have successfully completed a program of study and clinical experience for nurse-midwives that is accredited by an accrediting body approved by the U.S. Department of Education; and
(3) Be certified as a nurse-midwife by the American College of Nurse-Midwives or the American College of Nurse-Midwives Certification Council.
(b) Services. A certified nurse-midwife's services are services furnished by a certified nurse-midwife and services and supplies furnished as an incident to the certified nurse-midwife's services that—
(1) Are within the scope of practice authorized by the law of the State in which they are furnished and would otherwise be covered if furnished by a physician or as an incident to a physician's service; and
(2) Unless required by State law, are provided without regard to whether the certified nurse-midwife is under the supervision of, or associated with, a physician or other health care provider.
(c) Incident to services: Basic rule. Medicare Part B covers services and supplies incident to the services of a certified nurse-midwife if the requirements of § 410.26 are met.
(d) Professional services. A nurse-midwife can be paid for professional services only when the services have been performed personally by the nurse-midwife.
(1) Supervision of other nonphysician staff by a nurse-midwife does not constitute personal performance of a professional service by the nurse-midwife.
(2) The services of a certified nurse-midwife are provided on an assignment-related basis, and the certified nurse-midwife may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the certified nurse-midwife must refund the full amount of the impermissible charge to the beneficiary.
(3) A nurse-midwife may provide services that he or she is legally authorized to perform under State law as a nurse-midwife, if the services would otherwise be covered by the Medicare program when furnished by a physician or incident to a physicians' professional services.
(e) Medical record documentation. For certified nurse-midwives' services, the certified nurse-midwife may review and verify (sign and date), rather than re-document, notes in a patient's medical record made by physicians; residents; nurses; medical, physician assistant, and advanced practice registered nurse students; or other members of the medical team, including, as applicable, notes documenting the certified nurse-midwife's presence and participation in the service.
§ 410.78   Telehealth services.
(a) Definitions. For the purposes of this section the following definitions apply:
(1) Asynchronous store and forward technologies means the transmission of a patient's medical information from an originating site to the physician or practitioner at the distant site. The physician or practitioner at the distant site can review the medical case without the patient being present. An asynchronous telecommunications system in single media format does not include telephone calls, images transmitted via facsimile machines and text messages without visualization of the patient (electronic mail). Photographs visualized by a telecommunications system must be specific to the patient's medical condition and adequate for furnishing or confirming a diagnosis and or treatment plan. Dermatological photographs, for example, a photograph of a skin lesion, may be considered to meet the requirement of a single media format under this provision.
(2) Distant site means the site at which the physician or practitioner delivering the service is located at the time the service is provided via a telecommunications system.
(3) Interactive telecommunications system means, except as otherwise provided in this paragraph (a)(3), multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Interactive telecommunications system may also include two-way, real-time audio-only communication technology for any telehealth service furnished to a patient in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology. The following modifiers must be appended to a claim for telehealth services furnished using two-way, real-time audio-only communication technology to verify that the conditions set forth in the prior sentence have been met:
(i) Current Procedural Terminology (CPT) modifier “93”; and
(ii) For rural health clinics (RHCs) and federally qualified health centers (FQHCs), Medicare modifier “FQ”.
(4) Originating site means the location of an eligible Medicare beneficiary at the time the service being furnished via a telecommunications system occurs. For asynchronous store and forward telecommunications technologies, the only originating sites are Federal telemedicine demonstration programs conducted in Alaska or Hawaii.
(b) General rule. Medicare Part B pays for covered telehealth services included on the telehealth list when furnished by an interactive telecommunications system if the following conditions are met, except that for the duration of the Public Health Emergency as defined in § 400.200 of this chapter, Medicare Part B pays for office and other outpatient visits, professional consultation, psychiatric diagnostic interview examination, individual psychotherapy, pharmacologic management and end stage renal disease related services included in the monthly capitation payment furnished by an interactive telecommunications system if the following conditions are met:
(1) The physician or practitioner at the distant site must be licensed to furnish the service under State law. The physician or practitioner at the distant site who is licensed under State law to furnish a covered telehealth service described in this section may bill, and receive payment for, the service when it is delivered via a telecommunications system.
(2) The practitioner at the distant site is one of the following:
(i) A physician as described in § 410.20.
(ii) A physician assistant as described § 410.74.
(iii) A nurse practitioner as described in § 410.75.
(iv) A clinical nurse specialist as described in § 410.76.
(v) A nurse-midwife as described in § 410.77.
(vi) A clinical psychologist as described in § 410.71.
(vii) A clinical social worker as described in § 410.73.
(viii) A registered dietitian or nutrition professional as described in § 410.134.
(ix) A certified registered nurse anesthetist as described in § 410.69.
(x) Any distant site practitioner who can appropriately bill for diabetes self-management training services may do so on behalf of others who personally furnish the services as part of the DSMT entity.
(xi) A marriage and family therapist as described in 410.53.
(xii) A mental health counselor as described in 410.54.
(3) The services are furnished to a beneficiary at an originating site, which is one of the following:
(i) The office of a physician or practitioner.
(ii) A critical access hospital (as described in section 1861(mm)(1) of the Act).
(iii) A rural health clinic (as described in section 1861(aa)(2) of the Act).
(iv) A Federally qualified health center (as defined in section 1861(aa)(4) of the Act).
(v) A hospital (as defined in section 1861(e) of the Act).
(vi) A hospital-based or critical access hospital-based renal dialysis center (including satellites).
(vii) A skilled nursing facility (as defined in section 1819(a) of the Act).
(viii) A community mental health center (as defined in section 1861(ff)(3)(B) of the Act).
(ix) A renal dialysis facility (only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act);
(x) The home of an individual (only for purposes of the home dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act).
(xi) A mobile stroke unit (only for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke provided in accordance with section 1834(m)(6) of the Act).
(xii) The home of an individual (only for purposes of treatment of a substance use disorder or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a substance use disorder diagnosis.
(xiii) A rural emergency hospital (as defined in section 1861(kkk)(2) of the Act), for services furnished on or after January 1, 2023.
(xiv) The home of a beneficiary for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder for services that are furnished during the period beginning on the first day after the end of the emergency period as defined in our regulation at § 400.200 and ending on December 31, 2024 except as otherwise provided in this paragraph. Payment will not be made for a telehealth service furnished under this paragraph unless the following conditions are met:
(A) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service;
(B) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, at least once within 12 months of each subsequent telehealth service described in this paragraph, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens associated with an in-person service outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reason(s) for this decision in the patient's medical record.
(C) The requirements of paragraphs (b)(3)(xiv)(A) and (B) may be met by another physician or practitioner of the same specialty and subspecialty in the same group as the physician or practitioner who furnishes the telehealth service, if the physician or practitioner who furnishes the telehealth service described under this paragraph is not available.
(4) Except as provided in paragraph (b)(4)(iv) of this section, originating sites must be:
(i) Located in a health professional shortage area (as defined under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)) that is either outside of a Metropolitan Statistical Area (MSA) as of December 31st of the preceding calendar year or within a rural census tract of an MSA as determined by the Office of Rural Health Policy of the Health Resources and Services Administration as of December 31st of the preceding calendar year, or
(ii) Located in a county that is not included in a Metropolitan Statistical Area as defined in section 1886(d)(2)(D) of the Act as of December 31st of the preceding year, or
(iii) An entity participating in a Federal telemedicine demonstration project that has been approved by, or receive funding from, the Secretary as of December 31, 2000, regardless of its geographic location.
(iv) The geographic requirements specified in paragraph (b)(4) of this section do not apply to the following telehealth services:
(A) Home dialysis monthly ESRD-related clinical assessment services furnished on or after January 1, 2019, at an originating site described in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance with section 1881(b)(3)(B) of the Act; and
(B) Services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke.
(C) Services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis, for purposes of treatment of a substance use disorder or a co-occurring mental health disorder.
(D) Services furnished on or after January 1, 2025 for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder. Payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service and within 6 months of any subsequent telehealth service.
(5) The medical examination of the patient is under the control of the physician or practitioner at the distant site.
(c) Telepresenter not required. A telepresenter is not required as a condition of payment unless a telepresenter is medically necessary as determined by the physician or practitioner at the distant site.
(d) Exception to the interactive telecommunications system requirement. For Federal telemedicine demonstration programs conducted in Alaska or Hawaii only, Medicare payment is permitted for telehealth when asynchronous store and forward technologies, in single or multimedia formats, are used as a substitute for an interactive telecommunications system.
(e) Limitations. (1) A clinical psychologist and a clinical social worker, a marriage and family therapist (MFT), and a mental health counselor (MHC) may bill and receive payment for individual psychotherapy via a telecommunications system, but may not seek payment for medical evaluation and management services.
(2) The physician visits required under § 483.40(c) of this title may not be furnished as telehealth services.
(3) The distant site practitioner who reports the DSMT services may bill and receive payment when a professional furnishes injection training for an insulin-dependent patient using interactive telecommunications technology when such training is included as part of the DSMT plan of care referenced at § 410.141(b)(2).
(f) Process for adding or deleting services. Except as otherwise provided in this paragraph (f), changes to the list of Medicare telehealth services are made through the annual physician fee schedule rulemaking process. During the Public Health Emergency, as defined in § 400.200 of this chapter, we will use a subregulatory process to modify the services included on the Medicare telehealth list during the Public Health Emergency, taking into consideration infection control, patient safety, and other public health concerns resulting from the emergency. CMS maintains the list of services that are Medicare telehealth services under this section, including the current HCPCS codes that describe the services on the CMS website.
§ 410.79   Medicare Diabetes Prevention Program expanded model: Conditions of coverage.
(a) Medicare Diabetes Prevention Program (MDPP) services will be available beginning on April 1, 2018.
(b) Definitions. For purposes of this section, the following definitions apply:
Baseline weight means the MDPP beneficiary's body weight recorded during that beneficiary's first core session.
CDC-approved DPP curriculum refers to the content of the core sessions, core maintenance sessions, and ongoing maintenance sessions. The curriculum may be either the CDC-preferred curriculum as designated by the CDC DPRP Standards or an alternative curriculum approved for use in DPP by the CDC.
Combination with an online component refers to sessions that are delivered as a combination of online (non-live) with in-person or distance learning.
Core maintenance session means an MDPP service that—
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during a core maintenance session interval;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for maintenance sessions.
Core session means an MDPP service that—
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during months 1 through 6 of the MDPP services period;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for core sessions.
Diabetes Prevention Recognition Program (DPRP) refers to a program administered by the Centers for Disease Control and Prevention (CDC) that recognizes organizations that are able to furnish diabetes prevention program (DPP) services, follow a CDC-approved DPP curriculum, and meet CDC's performance standards and reporting requirements.
Distance learning refers to an MDPP session that is delivered by trained Coaches via remote classroom and is furnished in a manner consistent with the DPRP Standards for distance learning sessions. The Coach provides live (synchronous) delivery of session content in one location and participants call-in or video-conference from another location.
Extended flexibilities refer to the flexibilities as described in paragraphs (e)(3)(iii) and (iv) of this section.
Extended flexibilities period refers to the 4-year period (January 1, 2024 to December 31, 2027) for the Extended flexibilities to apply.
Full CDC DPRP recognition refers to the designation from the CDC that an organization has consistently furnished CDC-approved DPP sessions, met CDC-performance standards and met CDC reporting requirements for at least 24-36 months following the organization's application to participate in the DPRP.
Full-Plus CDC DPRP recognition refers to organizations that have met the Full CDC DPRP recognition, and at the time full recognition is achieved, has met the following retention criterion: Eligible participants in the evaluation cohort must have been retained at the following percentages: A minimum of 50 percent at the beginning of the fourth month since the cohorts held their first sessions; A minimum of 40 percent at the beginning of the seventh month since the cohorts held their first sessions; and A minimum of 30 percent at the beginning of the tenth month since the cohorts held their first sessions.
In-person with a distance learning component refers to DPP sessions that are delivered in person by trained Coaches where participants have the option of attending sessions via MDPP distance learning.
Make-up session means a core session or a core maintenance session furnished to an MDPP beneficiary when the MDPP beneficiary misses a regularly scheduled core session or core maintenance session.
MDPP beneficiary means a Medicare beneficiary who meets the criteria specified in paragraph (c)(1)(i) of this section, who has initiated the MDPP services period by attending the first core session, and for whom the MDPP services period has not ended as specified in paragraph (c)(3) of this section.
MDPP services means structured health behavior change sessions that are furnished under the MDPP expanded model with the goal of preventing diabetes among Medicare beneficiaries with prediabetes, and that follow a CDC-approved curriculum. The sessions provide practical training in long-term dietary change, increased physical activity, and problem-solving strategies for overcoming challenges to maintaining weight loss and a healthy lifestyle.
MDPP services period means the time period, beginning on the date an MDPP beneficiary attends his or her first core session, over which the Set of MDPP services is furnished to the MDPP beneficiary, to include the core services period described in paragraph (c)(2)(i) and, subject to paragraph (c)(3) of this section.
MDPP session means a core session or a core maintenance session.
MDPP supplier means an entity that is enrolled in Medicare to furnish MDPP services as provided in § 424.205 of this chapter.
Medicare Diabetes Prevention Program (MDPP) refers to a model test expanded under section 1115A(c) of the Act that makes MDPP services available to MDPP beneficiaries.
National Diabetes Prevention Program (National DPP) refers to an evidence-based intervention targeted to individuals with pre-diabetes that is furnished in community and health care settings and administered by the Centers for Disease Control and Prevention (CDC).
Ongoing maintenance session interval means one of the up to four consecutive 3-month time periods during the ongoing services period described in paragraph (c)(2)(ii) of this section, during which an MDPP supplier offers at least one ongoing maintenance session to an MDPP beneficiary per month.
Online means sessions that are delivered 100 percent through the internet via phone, tablet, or laptop in an asynchronous (non-live) classroom where participants are experiencing the content on their own time without a live (including non-artificial intelligence (AI)) Coach teaching the content. These sessions must be furnished in a manner consistent with the DPRP Standards for online sessions. Live Coach interaction must be offered to each participant during weeks when the participant has engaged with content. Emails and text messages can count toward the requirement for live Coach interaction if there is bi-directional communication between the Coach and participant. Chat bots and AI forums do not count as live Coach interaction.
Required minimum weight loss refers to the percentage by which the beneficiary's updated weight is less than the baseline weight. The required minimum weight loss percentage is 5 percent.
Set of MDPP services means the series of MDPP sessions, composed of core sessions and core maintenance sessions, and subject to paragraph (c)(3) of this section offered over the course of the MDPP services period.
Virtual make-up session means a make-up session that is not furnished in person and that is furnished in a manner consistent with the DPRP standards for virtual sessions.
Virtual session refers to an MDPP session that is not furnished in person and that is furnished in a manner consistent with the DPRP standards for distance learning sessions.
(c) Coverage for MDPP services —(1) Beneficiary eligibility. (i) A Medicare beneficiary is eligible for MDPP services offered during the core services period described in paragraph (c)(2)(i) of this section if the beneficiary meets all of the following criteria:
(A) Is enrolled under Medicare Part B;
(B) Attended the first core session within the most recent 12-month time period and, prior to attending this first core session, had not previously received the set of MDPP services in his or her lifetime;
(C) Has, on the date of attendance at the first core session, a body mass index (BMI) of at least 25 if not self-identified as Asian or a BMI of at least 23 if self-identified as Asian;
(D) Has received, within the 12-month time period prior to the date of attendance at the first core session, a hemoglobin A1c test with a value of between 5.7 and 6.4 percent, a fasting plasma glucose test with a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose test (oral glucose tolerance test) with a value of between 140 and 199 mg/dL;
(E) Has, as of the date of attendance at the first core session, no previous diagnosis of diabetes, other than gestational diabetes; and
(F) Does not have end-stage renal disease (ESRD).
(ii) Weight measurements used to determine the achievement or maintenance of the required minimum weight loss must be taken in person by an MDPP supplier during an MDPP session.
(2) MDPP services period. An MDPP beneficiary's MDPP services period is composed of the following periods and intervals:
(i) The core services period, which is the first 12 months of the MDPP services period, and consists of:
(A) Up to 16 core sessions offered at least 1 week apart during months 1 through 6 of the MDPP services period; and
(B) Up to 6 core maintenance sessions offered at least 1 month apart during months 7 through 12 of the MDPP services period.
(ii) [Reserved]
(3) Limitations on the MDPP services period.
(i) The MDPP services period ends upon completion of the core services period described in paragraph (c)(2)(i) of this section.
(ii) [Reserved]
(d) Make-up sessions. (1) An MDPP supplier may offer a make-up session to an MDPP beneficiary who missed a regularly scheduled session. MDPP make-up sessions may only use in-person or distance learning delivery. If an MDPP supplier offers one or more make-up sessions to an MDPP beneficiary, each such session must be furnished in accordance with the following requirements:
(i) The curriculum furnished during the make-up session must address the same CDC-approved DPP curriculum topic as the regularly scheduled session that the beneficiary missed;
(ii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session on the same day as a regularly scheduled session; and
(iii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session per week.
(2) An MDPP supplier may offer virtual make-up sessions only if consistent with the requirements in paragraph (d)(1) of this section. Virtual make-up sessions are also subject to the following requirements:
(i) Virtual make-up sessions must be furnished in a manner consistent with the DPRP standards for virtual sessions;
(ii) An MDPP supplier may only offer virtual make-up sessions based on an individual MDPP beneficiary's request; and
(iii) An MDPP supplier may offer to an MDPP beneficiary:
(A) No more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions are core maintenance sessions; and
(B) [Reserved]
(3) Make-up sessions furnished in accordance with paragraph (d)(1) of this section that an MDPP beneficiary attends in person are counted toward meeting the attendance requirements described in paragraph (c)(1) of this section and toward achieving the performance goals described in § 414.84(b) of this chapter as if the MDPP beneficiary attended a regularly scheduled session. Virtual make-up sessions furnished in accordance with paragraph (d)(2) of this section are also counted toward such attendance requirements and performance goals, subject to the following limitations:
(i) The MDPP beneficiary receives no more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions may be core maintenance sessions; and
(ii) [Reserved]
(e) MDPP expanded model emergency policy. (1) Notwithstanding paragraphs (a) through (d) of this section, the policies described in this paragraph (e) apply during the Public Health Emergency (PHE) as defined in § 400.200 of this chapter and during any future 1135 waiver event that CMS determines may disrupts in-person MDPP services (an “applicable 1135 waiver event”). For purposes of this paragraph (e), “1135 waiver event” means an emergency period and emergency area, as such terms are defined in section 1135(g) of the Act, for which the Secretary has authorized one or more waivers under section 1135 of the Act.
(2)(i) CMS determines that an 1135 waiver event may disrupt in-person MDPP services if MDPP suppliers would likely be unable to conduct classes in-person, or MDPP beneficiaries would likely be unable to attend in-person classes, for reasons related to health, safety, or site availability or suitability. Health and safety reasons may include, but are not limited to, the avoidance of transmission of contagious diseases, compliance with laws and regulations during an 1135 waiver event, or the physical safety of MDPP beneficiaries and MDPP coaches, as defined in § 424.205(a) of this chapter, during an 1135 waiver event.
(ii) If CMS determines that an 1135 waiver event may disrupt in-person MDPP services, CMS will communicate such determination for purposes of the policies described in this paragraph (e), to all affected MDPP suppliers.
(3) The following changes apply under this paragraph (e), when CMS has determined that an 1135 waiver event may disrupt in-person MDPP services:
(i) The in-person attendance requirements of paragraphs (c)(1)(ii)(A) and (c)(1)(iii)(A) of this section do not apply.
(ii) MDPP suppliers may start new cohorts during the PHE as defined in § 400.200 of this chapter or an applicable 1135 waiver event only if a baseline weight measurement can be obtained as described in paragraph (e)(3)(iii) of this section.
(iii) MDPP suppliers can obtain weight measurements for MDPP beneficiaries for the baseline weight and any weight loss based performance achievement goals in the following manner:
(A) In-person, when the weight measurement can be obtained safely and in compliance with all applicable laws and regulations;
(B) Via digital technology, such as scales that transmit weights securely via wireless or cellular transmission; or
(C) Self-reported weight measurements from the at-home digital scale of the MDPP beneficiary. Self-reported weights must be obtained during live, synchronous online video technology, such as video chatting or video conferencing, where in the MDPP Coach observes the beneficiary weighing themselves and views the weight indicated on the at-home digital scale, or the MDPP supplier receives one (1) or two (2) date-stamped photo(s) or a video recording of the beneficiary's weight, with the beneficiary visible on the scale, submitted by the MDPP beneficiary to the MDPP supplier. Photo or video must clearly document the weight of the MDPP beneficiary as it appears on their digital scale on the date associated with the billable MDPP session. If choosing to submit one photo, this photo must show the beneficiary's weight on the scale with the beneficiary visible in their home. If choosing to submit 2 photos, one photo must show the beneficiary's weight on the digital scale, and a second photo must show the beneficiary visible in their home. All photos must be date-stamped.
(iv) The virtual session limits described in paragraphs (d)(2) and (d)(3)(i) and (ii) of this section do not apply, and MDPP suppliers may provide all MDPP sessions virtually, through distance learning or a combination of in-person or distance learning, during the PHE as defined in § 400.200 of this chapter or applicable 1135 waiver event. If the beneficiary began the MDPP services period virtually, or changed from in-person to virtual services during the Extended flexibilities period, a PHE as defined in § 400.200 of this chapter or applicable 1135 waiver event, he/she may continue to receive the Set of MDPP services virtually even after the PHE or 1135 waiver event has concluded, until the end of the beneficiary's MDPP services period, so long as the provision of virtual services complies with all of the following requirements:
(A) The curriculum furnished during the virtual session addresses the same CDC-approved DPP curriculum topic as the regularly scheduled session.
(B) The MDPP supplier furnishes to the MDPP beneficiary a maximum of one virtual make-up session on the same day as a regularly scheduled session.
(C) The MDPP supplier furnishes to the MDPP beneficiary a maximum of one virtual make-up session per week.
(D) Virtual sessions are furnished in a manner consistent with the DPRP standards for distance learning sessions.
(E) The MDPP supplier offers virtual sessions only upon an individual MDPP beneficiary's request or agreement to receive services virtually.
(F) The MDPP supplier offers to an MDPP beneficiary:
( 1 ) Up to 16 virtual sessions offered weekly during the core session period, months 1 through 6 of the MDPP services period;
( 2 ) Up to 6 virtual sessions offered monthly during the core maintenance session interval periods, months 7 through 12 of the MDPP services period.
( 3 ) No more than 12 virtual sessions offered monthly during the ongoing maintenance session intervals, months 13 through 24 for beneficiaries enrolled before January 1, 2022.
(v) MDPP suppliers may suspend the in-person delivery of the set of MDPP services, when necessary due to the applicable 1135 waiver event, and subsequently resume in-person services either upon the end date of the 1135 waiver event emergency period or an effective date specified by CMS. Upon resumption of the set of MDPP services on an in-person basis, the following paragraphs apply:
(A) Beneficiaries who were receiving MDPP services as of March 31, 2020 whose in-person sessions are suspended due to the PHE as defined in § 400.200 of this chapter may elect to restart the set of MDPP services at the beginning or resume with the most recent attendance session of record.
(B) Beneficiaries who begin the set of MDPP services on or after January 1, 2021 who are in the first 12 months of the set of MDPP services as of the start of an applicable 1135 waiver event, whose in-person sessions are suspended due to the applicable 1135 waiver event, and who elect not to continue with MDPP services virtually, may elect to restart the set of MDPP services at the beginning or may resume with the most recent attendance session of record.
(C) Beneficiaries who began the set of MDPP services between January 1, 2021 and December 31, 2021 and who are in the second year of the set of MDPP services as of the start of an applicable 1135 waiver event, whose in-person sessions are suspended due to the applicable 1135 waiver event, and who elect not to continue with MDPP services virtually can elect to attend ongoing maintenance sessions; and may restart the ongoing maintenance session interval in which they were participating at the start of the applicable 1135 waiver event or may resume with the most recent attendance session of record.
(D) Beneficiaries whose in-person sessions are suspended due to the applicable 1135 waiver event who elect to continue with MDPP services virtually, as described in paragraph (e)(2)(i) of this section, are not eligible to restart the set of MDPP services at a later date, but may elect to suspend the virtual set of MDPP services and resume the set of in-person MDPP services with the most recent attendance session of record.
(E) Beneficiaries may make an election as described in paragraph (e)(3)(v)(A), (B), (C), or (D) of this section, as applicable, only one time per applicable1135 waiver event.
(F) Beneficiary eligibility, as described in paragraph (c)(1)(i) of this section, will not be impacted by any changes to the beneficiary's body mass index (BMI) or reduction in hemoglobin A1c, fasting plasma glucose, or 2-hour plasma glucose test values achieved during the set of MDPP services or any intervening time in which a beneficiary has suspended the set of MDPP services. MDPP suppliers will utilize the following weight measurements as the baseline weight for purposes of determining all weight-loss achievements:
( 1 ) For an MDPP beneficiary who began receiving the set of MDPP services before March 31, 2020, has suspended services during an applicable 1135 waiver event, and then elects to restart the set of MDPP services at the first core session, the MDPP supplier must record a new baseline weight on the date of first core session that restarts the set of MDPP services.
( 2 ) For an MDPP beneficiary who began receiving the Set of MDPP services on or after January 1, 2021, has suspended services during an applicable 1135 waiver event, the MDPP supplier must use the baseline weight recorded at the beneficiary's first core session.
(vi) The minimum weight loss requirements for beneficiary eligibility in the ongoing maintenance session intervals described in paragraphs (c)(1)(ii)(B) and (c)(1)(iii)(B) of this section are waived only for MDPP beneficiaries who were receiving the MDPP set of services prior to January 1, 2021.
§ 410.80   Applicable rules.
Home health services furnished under Medicare Part B are subject to the rules set forth in subpart E of part 409 of this chapter.
§ 410.100   Included services.
Subject to the conditions and limitations set forth in §§ 410.102 and 410.105, CORF services means the following services furnished to an outpatient of the CORF by personnel that meet the qualifications set forth in § 485.70 of this chapter. Payment for CORF services are made in accordance with § 414.1105.
(a) Physician's services. CORF facility physician services are administrative in nature and include consultation with and medical supervision of nonphysician staff, participation in plan of treatment reviews and patient care review conferences, and other medical and facility administration activities. Diagnostic and therapeutic services furnished to an individual CORF patient by a physician in a CORF facility are not CORF physician services. These services, if covered, are physician services under § 410.20 with payment for these services made to the physician in accordance with part 414 subpart B.
(b) Physical therapy services. (1) These services include—
(i) Testing and measurement of the function or dysfunction of the neuromuscular, musculoskeletal, cardiovascular and respiratory systems; and.
(ii) Assessment and treatment related to dysfunction caused by illness or injury, and aimed at preventing or reducing disability or pain and restoring lost function.
(2) The establishment of a maintenance therapy program for an individual whose restoration potential has been reached is a physical therapy service; however, maintenance therapy itself is not covered as part of these services.
(c) Occupational therapy services. These services include—
(1) Teaching of compensatory techniques to permit an individual with a physical impairment or limitation to engage in daily activities.
(2) Evaluation of an individual's level of independent functioning.
(3) Selection and teaching of task-oriented therapeutic activities to restore sensory-integrative function; and
(4) Assessment of an individual's vocational potential, except when the assessment is related solely to vocational rehabilitation.
(d) Speech-language pathology services. These are services for the diagnosis and treatment of speech and language disorders that create difficulties in communication.
(e) Respiratory therapy services. (1) Respiratory therapy services are for the assessment, treatment, and monitoring of patients with deficiencies or abnormalities of cardiopulmonary function.
(2) Respiratory therapy services include the following:
(i) Application of techniques for support of oxygenation and ventilation of the patient.
(ii) Therapeutic use and monitoring of gases, mists, and aerosols and related equipment.
(iii) Bronchial hygiene therapy.
(iv) Pulmonary rehabilitation techniques to develop strength and endurance of respiratory muscles and other techniques to increase respiratory function, such as graded activity services; these services include physiologic monitoring and patient education.
(f) Prosthetic device services. These services include—
(1) Prosthetic devices (excluding dental devices and renal dialysis machines), that replace all or part of an internal body organ or external body member (including contiguous tissue) or replace all or part of the function of a permanently inoperative or malfunctioning external body member or internal body organ; and
(2) Services necessary to design the device, select materials and components, measure, fit, and align the device, and instruct the patient in its use.
(g) Orthotic device services. These services include—
(1) Orthopedic devices that support or align movable parts of the body, prevent or correct deformities, or improve functioning; and
(2) Services necessary to design the device, select the materials and components, measure, fit, and align the device, and instruct the patient in its use.
(h) Social and psychological services. Social and psychological services include the assessment and treatment of an individual's mental and emotional functioning and the response to and rate of progress as it relates to the individual's rehabilitation plan of treatment, including physical therapy services, occupational therapy services, speech-language pathology services and respiratory therapy services.
(i) Nursing care services. Nursing care services include nursing services provided by a registered nurse that are prescribed by a physician and are specified in or directly related to the rehabilitation treatment plan and necessary for the attainment of the rehabilitation goals of the physical therapy, occupational therapy, speech-language pathology, or respiratory therapy plan of treatment.
(j) Drugs and biologicals. These are drugs and biologicals that are the following:
(1) Prescribed by a physician and administered by or under the supervision of a physician or by a registered professional nurse; and
(2) Not excluded from Medicare Part B payment for reasons specified in § 410.29.
(k) Supplies and durable medical equipment. Supplies and durable medical equipment include the following:
(1) Disposable supplies.
(2) Durable medical equipment of the type specified in § 410.38 (except for renal dialysis systems) for a patient's use outside the CORF, whether purchased or rented.
(l) Home environment evaluation. A home environment evaluation—
(1) Is a single home visit to evaluate the potential impact of the home situation on the patient's rehabilitation goals.
(2) Requires the presence of the patient and the physical therapist, occupational therapist, or speech-language pathologist, as appropriate.
§ 410.102   Excluded services.
None of the services specified in § 410.100 is covered as a CORF service if the service—
(a) Would not be covered as an inpatient hospital service if furnished to a hospital inpatient;
(b) Is not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. An example would be services furnished as part of a maintenance program involving repetitive activities that do not require the skilled services of nurses or therapists.
§ 410.105   Requirements for coverage of CORF services.
Services specified in § 410.100 and not excluded under § 410.102 are covered as CORF services if they are furnished by a participating CORF (that is, a CORF that meets the conditions of subpart B of part 485 of this chapter, and has in effect a provider agreement under part 489 of this chapter) and if the following requirements are met:
(a) Referral and medical history. The services must be furnished to an individual who is referred by a physician who certifies that the individual needs skilled rehabilitation services, and makes the following information available to the CORF before or at the time treatment is begun:
(1) The individual's significant medical history.
(2) Current medical findings.
(3) Diagnosis(es) and contraindications to any treatment modality.
(4) Rehabilitation goals, if determined.
(b) When and where services are furnished. (1) All services must be furnished while the individual is under the care of a physician.
(2) Except as provided in paragraph (b)(3) of this section, the services must be furnished on the premises of the CORF.
(3) Exceptions. (i) Physical therapy, occupational therapy, and speech-language pathology services may be furnished away from the premises of the CORF including the individual's home when payment is not otherwise made under Title XVIII of the Act.
(ii) The single home environment evaluation visit specified in § 410.100(m) is also covered.
(c) Plan of treatment. (1) The service must be furnished under a written plan of treatment that—
(i) Is established and signed by a physician before treatment is begun; and
(ii) Prescribes the type, amount, frequency, and duration of the services to be furnished, and indicates the diagnosis and anticipated rehabilitation goals.
(2) The plan must be reviewed at least every 60 days for respiratory therapy services and every 90 days for physical therapy, occupational therapy and speech-language pathology services by a facility physician or the referring physician who, when appropriate, consults with the professional personnel providing the services.
(3) The reviewing physician must certify or recertify that the plan is being followed, the patient is making progress in attaining the rehabilitation goals, and the treatment is having no harmful effects on the patient.
(d) Claims. Effective for dates of service on and after January 1, 2020 physical therapy or occupational therapy services covered as part of a rehabilitation plan of treatment described in paragraph (c) of this section, as applicable—
(1) Claims for such services furnished in whole or in part by a physical therapist assistant or an occupational therapy assistant must be identified with the inclusion of the respective prescribed modifier; and
(2) Effective for dates of service on and after January 1, 2022, such claims are paid an amount equal to 85 percent of the amount of payment otherwise applicable for the service as defined at section 1834(k) of the Act.
(3) For purposes of this paragraph, “furnished in whole or in part” means when the physical therapist assistant or occupational therapy assistant either—
(i) Furnishes all the minutes of a service exclusive of the respective physical therapist or occupational therapist; or
(ii) Except as provided in paragraph (d)(3)(iii) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service, separately from the part furnished by the physical or occupational therapist such that the minutes for that portion of a service (or unit of a service) exceed 10 percent of the total time for that service (or unit of a service).
(iii) Paragraph (d)(3)(ii) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day when the physical or occupational therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant or occupational therapy assistant.
(iv) Where there are two remaining 15-minute units to bill of the same service and the physical therapist and the physical therapist assistant or the occupational therapist and the occupational therapy assistant, as applicable, each provided between 9 and 14 minutes, with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant or occupational therapy assistant and one unit is billed without the prescribed modifier for the service provided by the physical therapist or occupational therapist.
§ 410.110   Requirements for coverage of partial hospitalization services by CMHCs.
Medicare part B covers partial hospitalization services furnished by or under arrangements made by a CMHC if they are provided by a CMHC as defined in § 410.2 that has in effect a provider agreement under part 489 of this chapter and if the services are—
(a) Prescribed by a physician and furnished under the general supervision of a physician;
(b) Subject to certification by a physician in accordance with § 424.24(e)(1) of this subchapter; and
(c) Furnished under a plan of treatment that meets the requirements of § 424.24(e)(2) of this subchapter.
§ 410.111   Requirements for coverage of intensive outpatient services in CMHCs.
Medicare part B covers intensive outpatient services furnished by or under arrangements made by a CMHC if they are provided by a CMHC as defined in § 410.2 that has in effect a provider agreement under part 489 of this chapter and if the services are—
(a) Prescribed by a physician and furnished under the general supervision of a physician;
(b) Subject to certification by a physician in accordance with § 424.24(d)(1) of this chapter; and
(c) Furnished under a plan of treatment that meets the requirements of § 424.24(d)(2) of this chapter.
§ 410.130   Definitions.
For the purposes of this subpart, the following definitions apply:
Chronic renal insufficiency means the stage of renal disease associated with a reduction in renal function not severe enough to require dialysis or transplantation (glomerular filtration rate [GFR] 15-59 ml/min/1.73m 2 ).
Diabetes means diabetes mellitus, a condition of abnormal glucose metabolism .
Episode of care means services covered in a 12-month time period when coordinated with initial diabetes self-management training (DSMT) and one calendar year for each year thereafter, starting with the assessment and including all covered interventions based on referral(s) from a physician as specified in § 410.132(c). The time period covered for gestational diabetes extends only until the pregnancy ends.
Medical nutrition therapy services means nutritional diagnostic, therapeutic, and counseling services provided by a registered dietitian or nutrition professional for the purpose of managing diabetes or a renal disease.
Physician means a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she performs such function or action (including a physician within the meaning of section of 1101(a)(7) of the Act).
Renal disease means chronic renal insufficiency, end-stage renal disease when dialysis is not received, or the medical condition of a beneficiary for 36 months after kidney transplant.
§ 410.132   Medical nutrition therapy.
(a) Conditions for coverage of MNT services. Medicare Part B pays for MNT services provided by a registered dietitian or nutrition professional as defined in § 410.134 when the beneficiary is referred for the service by a physician.
(b) Limitations on coverage of MNT services. (1) MNT services based on a diagnosis of renal disease as described in this subpart are not covered for beneficiaries receiving maintenance dialysis for which payment is made under section 1881 of the Act.
(2) A beneficiary may only receive the maximum number of hours covered under the DSMT benefit for both DSMT and MNT during the initial DSMT training period unless additional hours are determined to be medically necessary under the national coverage determination process.
(3) In years when the beneficiary is eligible for MNT and follow-up DSMT, the beneficiary may only receive the maximum number of hours covered under MNT unless additional hours are determined to be medically necessary under the national coverage determination process.
(4) If a beneficiary has both diabetes and renal disease, the beneficiary may only receive the maximum number of hours covered under the renal MNT benefit in one episode of care unless he or she is receiving initial DSMT services, in which case the beneficiary would receive whichever is greater.
(5) An exception to the maximum number of hours in paragraphs (b)(2), (3), and (4) of this section may be made when a physician determines that there is a change of diagnosis, medical condition, or treatment regimen related to diabetes or renal disease that requires a change in MNT during an episode of care.
(c) Referrals . Referral may only be made by a physician when the beneficiary has been diagnosed with diabetes or renal disease as defined in this subpart with documentation noted by a referring physician in the beneficiary's medical record.
§ 410.134   Provider qualifications.
For Medicare Part B coverage of MNT, only a registered dietitian or nutrition professional may provide the services. “Registered dietitian or nutrition professional” means an individual who, on or after December 22, 2000:
(a) Holds a bachelor's or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics accredited by an appropriate national accreditation organization recognized for this purpose.
(b) Has completed at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional.
(c) Is licensed or certified as a dietitian or nutrition professional by the State in which the services are performed. In a State that does not provide for licensure or certification, the individual will be deemed to have met this requirement if he or she is recognized as a “registered dietitian” by the Commission on Dietetic Registration or its successor organization, or meets the requirements of paragraphs (a) and (b) of this section.
(d) Exceptions. (i) A dietitian or nutritionist licensed or certified in a State as of December 21, 2000 is not required to meet the requirements of (a) and (b) of this section.
(ii) A “registered dietitian” in good standing, as recognized by the Commission of Dietetic Registration or its successor organization, is deemed to have met the requirements of (a) and (b) of this section.
§ 410.140   Definitions.
For purposes of this subpart, the following definitions apply:
ADA stands for the American Diabetes Association.
Approved entity means an individual, physician, or entity accredited by an approved organization as meeting one of the sets of quality standards described in § 410.144 and approved by CMS under § 410.141(e) to furnish training.
Deemed entity means an individual, physician, or entity accredited by an approved organization, but that has not yet been approved by CMS under § 410.145(b) to furnish training.
Diabetes means diabetes mellitus, a condition of abnormal glucose metabolism.
NSDSMEP stands for the National Standards for Diabetes Self Management Education Programs.
Organization means a national accreditation organization.
Rural means an area that meets one of the following conditions:
(1) Is not urbanized (as defined by the Bureau of the Census) and that is designated by the chief executive officer of the State, and certified by the Secretary, as an area with a shortage of personal health services.
(2) Is designated by the Secretary either as an area with a shortage of personal health services or as a health professional shortage area.
(3) Is designated by the Indian Health Service as a health service delivery area as defined in § 36.15 of this title.
Training means outpatient diabetes self-management training.
§ 410.141   Outpatient diabetes self-management training.
(a) General rule. Medicare Part B covers training defined in § 410.140 if all of the conditions and requirements of this subpart are met.
(b) Conditions for coverage. The training must meet the following conditions:
(1) Training orders. Following an evaluation of the beneficiary's need for the training, the training is ordered by the physician (or qualified nonphysician practitioner) (as defined in § 410.32(a)(2)) treating the beneficiary's diabetes.
(2) Plan of care. It is included in a comprehensive plan of care established by the physician (or qualified nonphysician practitioner) treating the beneficiary for diabetes that meets the following requirements:
(i) Describes the content, number of sessions, frequency, and duration of the training as written by the physician (or qualified nonphysician practitioner) treating the beneficiary.
(ii) Contains a statement specified by CMS and signed by the physician (or qualified nonphysician practitioner) managing the beneficiary's diabetic condition. By signing this statement, the physician (or qualified nonphysician practitioner) certifies that he or she is managing the beneficiary's diabetic condition and the training described in the plan of care is needed to ensure therapy compliance or to provide the beneficiary with the skills and knowledge to help manage the beneficiary's diabetes. The physician's (or qualified nonphysician practitioner's) statement must identify the beneficiary's specific medical conditions (described in paragraph (d) of this section) that the training will address.
(iii) Provides that any changes to the plan of care are signed by the physician (or qualified nonphysician practitioner) treating the beneficiary.
(iv) Is incorporated into the approved entity's medical record for the beneficiary and is made available, upon request, to CMS.
(3) Reasonable and necessary. It is reasonable and necessary for treating or monitoring the condition of a beneficiary who meets the conditions described in paragraph (d) of this section.
(c) Types and frequency of training—(1) Initial training—
General rule. (i) Medicare Part B covers initial training that meets the following conditions:
(A) Is furnished to a beneficiary who has not previously received initial training under this benefit.
(B) Is furnished within a continuous 12-month period.
(C) Does not exceed a total of 10 hours.
(D) Except as permitted under paragraph (c)(1)(ii) of this section, 9 hours of the training are furnished in a group setting consisting of 2 to 20 individuals who need not all be Medicare beneficiaries.
(E) Is furnished in increments of no less than one-half hour.
(F) May include 1 hour of individual training for an assessment of the beneficiary's training needs.
(ii) Exception. Medicare covers training on an individual basis for a Medicare beneficiary who meets any of the following conditions:
(A) No group session is available within 2 months of the date the training is ordered.
(B) The beneficiary's physician (or qualified nonphysician practitioner) documents in the beneficiary's medical record that the beneficiary has special needs resulting from conditions, such as severe vision, hearing, or language limitations that will hinder effective participation in a group training session.
(2) Follow-up training. After receiving the initial training described in paragraph (c)(1) of this section, Medicare covers follow-up training that meets the following conditions:
(i) Consists of no more than 2 hours individual or group training for a beneficiary each year.
(ii) Group training consists of 2 to 20 individuals who need not all be Medicare beneficiaries.
(iii) Is furnished any time in a calendar year following the year in which the beneficiary completes the initial training.
(iv) Is furnished in increments of no less than one-half hour.
(v) The physician (or qualified nonphysician practitioner) treating the beneficiary must document, in the referral for training and the beneficiary's medical record, the specific medical condition (described in paragraph (d) of this section) that the follow-up training must address.
(d) Beneficiaries who may be covered. Medicare Part B covers outpatient diabetes self-management training for a beneficiary who has been diagnosed with diabetes.
(e) Who may furnish services. Training may be furnished by a physician, individual, or entity that meets the following conditions:
(1) Furnishes other services for which direct Medicare payment may be made.
(2) May properly receive Medicare payment under § 424.73 or § 424.80 of this chapter, which set forth prohibitions on assignment and reassignment of benefits.
(3) Submits necessary documentation to, and is accredited by, an accreditation organization approved by CMS under § 410.142 to meet one of the sets of quality standards described in § 410.144.
(4) Provides documentation to CMS, as requested, including diabetes outcome measurements set forth at § 410.146.
§ 410.142   CMS process for approving national accreditation organizations.
(a) General rule. CMS may approve and recognize a nonprofit or not-for-profit organization with demonstrated experience in representing the interest of individuals with diabetes to accredit entities to furnish training.
(b) Required information and materials. An organization requesting CMS's approval and recognition of its accreditation program must furnish to CMS the following information and materials:
(1) The requirements and quality standards that the organization uses to accredit entities to furnish training.
(2) If an organization does not use the CMS quality standards or the NSDSMEP quality standards described in § 410.144(a) or (b), a detailed comparison including a crosswalk between the organization's standards and the CMS quality standards described in § 410.144(a).
(3) Detailed information about the organization's accreditation process, including all of the following information:
(i) Frequency of accreditation.
(ii) Copies of accreditation forms, guidelines, and instructions to evaluators.
(iii) Descriptions of the following:
(A) The accreditation review process and the accreditation status decision making process.
(B) The procedures used to notify a deemed entity of deficiencies in its outpatient diabetes self-management training program and procedures to monitor the correction of those deficiencies.
(C) The procedures used to enforce compliance with the accreditation requirements and standards.
(4) Detailed information about the individuals who perform evaluations for the organization, including all of the following information:
(i) The education and experience requirements for the individuals who perform evaluations.
(ii) The content and frequency of continuing education furnished to the individuals who perform evaluations.
(iii) The process used to monitor the performance of individuals who perform evaluations.
(iv) The organization's policies and practices for participation in the accreditation process by an individual who is professionally or financially affiliated with the entity being evaluated.
(5) A description of the organization's data management and analysis system for its accreditation activities and decisions, including the kinds of reports, tables, and other displays generated by that system.
(6) A description of the organization's procedures for responding to and investigating complaints against an approved entity, including policies and procedures regarding coordination of these activities with appropriate licensing bodies, ombudsmen programs, and CMS.
(7) A description of the organization's policies and procedures for withholding or removing a certificate of accreditation for failure to meet the organization's standards or requirements, and other actions the organization takes in response to noncompliance with its standards and requirements.
(8) A description of all types (for example, full or partial) and categories (for example, provisional, conditional, or temporary) of accreditation offered by the organization, the duration of each type and category of accreditation, and a statement identifying the types and categories that will serve as a basis for accreditation if CMS approves the organization.
(9) A list of all of the approved entities currently accredited to furnish training and the type, category, and expiration date of the accreditation held by each of them.
(10) The name and address of each person with an ownership or control interest in the organization.
(11) Documentation that demonstrates its ability to furnish CMS with electronic data in CMS-compatible format.
(12) A resource analysis that demonstrates that its staffing, funding, and other resources are adequate to perform the required accreditation activities.
(13) A statement acknowledging that, as a condition for approval and recognition by CMS of its accreditation program, it agrees to comply with the requirements set forth in §§ 410.142 through 410.146.
(14) Additional information CMS requests to enable it to respond to the organization's request for CMS approval and recognition of its accreditation program to accredit entities to furnish training.
(c) Onsite visit. CMS may visit the prospective organization's offices to verify information in the organization's application, including, but not limited to, review of documents, and interviews with the organization's staff.
(d) Notice and comment —(1) Proposed notice. CMS publishes a proposed notice in the Federal Register announcing its intention to approve an organization's request for CMS approval and recognition of its accreditation program and the standards it uses to accredit entities to furnish training. The notice includes the following information:
(i) The basis for approving the organization.
(ii) A description of how the organization's accreditation program applies and enforces quality standards that have been determined by CMS to meet or exceed the CMS quality standards described in § 410.144(a) or how the organization would use the NSDSMEP quality standards described in § 410.144(b).
(iii) An opportunity for public comment.
(2) Final notice. (i) After considering public comments CMS receives on the proposed notice, it publishes a final notice in the Federal Register indicating whether it has approved an organization's request for CMS approval and recognition of its accreditation program and the standards it uses to accredit entities to furnish training.
(ii) If CMS approves the request, the final notice specifies the effective date and the term of the approval, which may not exceed 6 years.
(e) Criteria CMS uses to approve national accreditation organizations. In deciding to approve and recognize an organization's accreditation program to accredit entities to furnish training, CMS considers the following criteria:
(1) The organization uses and enforces quality standards that CMS has determined meet or exceed the CMS quality standards described in § 410.144(a), or uses the NSDSMEP quality standards described in § 410.144(b).
(2) The organization meets the requirements for approved organizations in § 410.143.
(3) The organization is not owned or controlled by the entities it accredits, as defined in § 413.17(b)(2) or (b)(3), respectively, of this chapter.
(4) The organization does not accredit any entity it owns or controls.
(f) Notice of CMS's decision. CMS notifies the prospective organization in writing of its decision. The notice includes the following information:
(1) Statement of approval or denial.
(2) If approved, the expiration date of CMS's approval and recognition of the accreditation program.
(3) If denied, the rationale for the denial and the reconsideration and reapplication procedures.
(g) Reconsideration of adverse decision. An organization that has received CMS's notice of denial of its request for CMS approval and recognition of its accreditation program to accredit entities to furnish training may request reconsideration of CMS's decision in accordance with part 488 subpart D of this chapter.
(h) Request for approval following denial. (1) Except as provided in paragraph (h)(2) of this section, an organization that has received CMS's notice of denial of its request for CMS approval and recognition of its accreditation program to accredit entities to furnish training may submit a new request to CMS if it meets the following conditions:
(i) Has revised its accreditation program to correct the deficiencies CMS noted in its denial notice.
(ii) Demonstrates, through documentation, the use of one of the sets of quality standards described in § 410.144.
(iii) Resubmits the application in its entirety.
(2) For an organization that has requested reconsideration of CMS's denial of its request for CMS approval and recognition of its accreditation program to accredit entities to furnish training, CMS will not consider the organization's new request until all administrative proceedings on the previous request have been completed.
(i) Withdrawal. An organization requesting CMS approval and recognition of its accreditation program to accredit entities may withdraw its application at any time.
(j) Applying for continued CMS approval. At least 6 months before the expiration of CMS's approval and recognition of the organization's program, an organization must request from CMS continued approval and recognition.
(k) Change of ownership. An accreditation organization whose accreditation program(s) is (are) approved and recognized by CMS that wishes to undergo a change of ownership is subject to the requirements set out at § 488.5(f) of this chapter.
§ 410.143   Requirements for approved accreditation organizations.
(a) Ongoing responsibilities of an approved accreditation organization. An organization approved and recognized by CMS must undertake the following activities on an ongoing basis:
(1) Provide to CMS in writing, on a monthly basis, all of the following:
(i) Copies of all accreditation decisions and any accreditation-related information that CMS may require (including corrective action plans and summaries of unmet quality standards described in § 410.144).
(ii) Notice of all complaints related to approved entities.
(iii) Within 30 days of taking remedial or adverse action (including revocation, withdrawal, or revision of an approved entity's deemed status) against an approved entity, information describing the remedial or adverse action and the circumstances that led to taking the action.
(iv) Notice of any proposed changes in its accreditation standards and requirements or evaluation process. If an organization implements changes without CMS approval (other than changes to the NSDSMEP quality standards described in § 410.144(b)), CMS may withdraw its approval and recognition of the organization's accreditation program.
(2) If an organization does not use the NSDSMEP quality standards described in § 410.144(b), and wishes to change its quality standards that CMS previously approved, the organization must submit its plan to alter its quality standards and include a crosswalk between the set of quality standards described in § 410.144 and the organization's revised standards. If an organization implements changes in its quality standards without CMS approval, CMS may withdraw its approval and recognition of the organization's accreditation program.
(3) If CMS notifies an organization that uses the CMS quality standards described in § 410.144(a) that it has changed the CMS quality standards, the organization must meet the following requirements:
(i) Submit to CMS, within 30 days of CMS's notification of a change in the quality standards, its organization's plan to alter its quality standards to conform to the revised quality standards described in § 410.144(a).
(ii) Implement the changes to its accreditation program by the implementation date specified in CMS's notification of the changes in the quality standards.
(b) CMS oversight of approved national accreditation organizations. CMS, or its agent, performs oversight activities to ensure that an approved organization and the entities the organization accredits continue to meet a set of quality standards described in § 410.144. CMS (or its agent) uses the following procedures:
(1) Equivalency review. CMS compares the organization's standards and its application and enforcement of its standards to a set of quality standards (described in § 410.144) and processes when any of the following conditions exist:
(i) CMS imposes new requirements or changes its process for approving and recognizing an organization.
(ii) Except for an organization that uses the NSDSMEP quality standards, the organization proposes to adopt new standards or changes its accreditation process.
(iii) The organization reapplies to CMS for continuation of its approval and recognition by CMS of its program to accredit entities to furnish training.
(2) Validation reviews. CMS validates an organization's accreditation process by conducting evaluations of approved entities accredited by the organization and comparing its results to the results of the organization's evaluation of the approved entities.
(3) Onsite inspections. CMS may conduct an onsite inspection of the organization's operations and offices to verify information and assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, reviewing documents, auditing documentation of meetings concerning the accreditation process, evaluating accreditation results or the accreditation status decision making process, and interviewing the organization's staff.
(4) Withdrawal of CMS approval and recognition. (i) CMS gives an organization written notice of CMS's intent to withdraw its approval and recognition of the organization's program to accredit entities if CMS determines through an equivalency review, validation review, onsite inspection, or CMS's daily experience with the organization that any of the following conditions exist:
(A) Except for those accrediting organizations using quality standards in § 410.144(b), the quality standards that the organization applies and enforces do not meet or exceed the CMS quality standards described in § 410.144(a).
(B) The organization has failed to meet the requirements for accreditation in §§ 410.142 through 410.144.
(ii) Request for reconsideration. An organization may request a reconsideration of CMS's decision to withdraw its approval and recognition of the organization in accordance with part 488, subpart D of this chapter.
§ 410.144   Quality standards for deemed entities.
An organization approved and recognized by CMS may accredit an entity to meet one of the following sets of quality standards:
(a) CMS quality standards. Standards prescribed by CMS, which include the following:
(1) Organizational structure. (i) Provides the educational resources to support the programs offered and the beneficiaries served, including adequate space, personnel, budget, instructional materials, confidentiality, privacy, and operational support.
(ii) Defines clearly and documents the organizational relationships, lines of authority, staffing, job descriptions, and operational policies.
(iii) Maintains a written policy that affirms education as an integral component of diabetes care.
(iv) Includes in its operational policies, specific standards and procedures identifying the amount of collaborative, interactive, skill-based training methods and didactic training methods furnished to the beneficiary.
(v) Assesses the service area to define the target population in order to appropriately allocate personnel and resources.
(vi) Identifies in its operational policies, the minimal amount that each team member must be involved in the following:
(A) Development of training materials.
(B) Instruction of beneficiaries.
(2) Environment. Maintains a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of all patients and that meets all applicable fire protection and life safety codes.
(3) Program staff. (i) Requires a program coordinator who is responsible for program planning, implementation, and evaluation.
(ii) Requires nonphysician professional staff to obtain 12 hours of continuing diabetes education concerning educational principles and behavior change strategies every 2 years.
(4) Team approach. (i) Except as provided in paragraph (a)(4)(ii) of this section for a rural area, furnishes services using a multidisciplinary instructional team that meets the following requirements:
(A) The team includes at least a registered dietitian, as recognized under State law, and a certified diabetes educator (CDE), certified by a qualified organization that has registered with CMS, who have didactic experience and knowledge of diabetes clinical and educational issues. (If the team includes a registered nurse, an approved entity may delay implementation of the requirement for a CDE until February 27, 2004.)
(B) The team is qualified to teach the training content areas required in paragraph (a)(5) of this section.
(C) All appropriate team members must be present during the portion of the training for which they are responsible and must directly furnish the training within the scope of their practices.
(ii) In a rural area, an individual who is qualified as a registered dietitian and as a CDE that is currently certified by an organization approved by CMS (or until February 27, 2004 an individual who is qualified as a registered dietitian and as a registered nurse) may furnish training and is deemed to meet the multidisciplinary team requirement in paragraph (a)(4)(i) of this section.
(5) Training content. Offers training and is capable of meeting the needs of its patients on the following subjects:
(i) Diabetes overview/pathophysiology of diabetes.
(ii) Nutrition.
(iii) Exercise and activity.
(iv) Diabetes medications (including skills related to the self-administration of injectable drugs).
(v) Self-monitoring and use of the results.
(vi) Prevention, detection, and treatment of acute complications.
(vii) Prevention, detection, and treatment of chronic complications.
(viii) Foot, skin, and dental care.
(ix) Behavior change strategies, goal setting, risk factor reduction, and problem solving.
(x) Preconception care, pregnancy, and gestational diabetes.
(xi) Relationships among nutrition, exercise, medication, and blood glucose levels.
(xii) Stress and psychosocial adjustment.
(xiii) Family involvement and social support.
(xiv) Benefits, risks, and management options for improving glucose control.
(xv) Use of health care systems and community resources.
(6) Training methods. (i) Offers individual and group instruction for effective training.
(ii) Uses instructional methods and materials that are appropriate for the target population, and participants being served.
(iii) Uses primarily interactive, collaborative, skill-based training methods and maximizes the use of interactive training methods.
(7) Review of plan of care and goals. (i) Reviews each beneficiary's plan of care.
(ii) Develops and updates an individual assessment, in collaboration with each beneficiary, that includes relevant medical history, present health status, health service or resource utilization, risk factors, diabetes knowledge and skills, cultural influences, health beliefs and attitudes, health behaviors and goals, support systems, barriers to learning, and socioeconomic factors.
(iii) Based on the assessment, develops, in collaboration with each beneficiary, an individual education plan. Includes in the education plan, the goals for education, the periodic updates, the specific amount of interactive, collaborative, skill-based training methods and didactic training methods that have been and will be furnished.
(iv) Documents the results, including assessment, intervention, evaluation and follow-up in the beneficiary's medical record.
(v) Forwards a copy of the documentation in paragraph (a)(7)(ii) through (iv) of this section to the referring physician (or qualified nonphysician practitioner).
(vi) Periodically updates the beneficiary's referring physician (or qualified nonphysician practitioner) about the beneficiary's educational status.
(8) Educational intervention. Offers appropriate and timely educational intervention based on referral from the beneficiary's physician (or qualified nonphysician practitioner) and based on periodic reassessments of health status, knowledge, skills, attitudes, goals, and self-care behaviors.
(9) Performance measurement and quality improvement. Establishes and maintains an effective internal performance measurement and quality improvement program that focuses on maximizing outcomes by improving patient safety and quality of care. The program must meet the following requirements:
(i) Stresses health outcomes (for example, improved beneficiary diabetes control, beneficiary understanding, or beneficiary compliance) and provides for the collection, analysis, and reporting of data that permits measurement of performance outcomes, or other quality indicators.
(ii) Requires an entity to take the following actions:
(A) Evaluate itself on an annual basis as to its effectiveness in using performance measures.
(B) Improve its performance on at least one outcome or quality indicator each year.
(10) Quality improvement. Has an agreement with a QIO to participate in quality improvement projects defined by the QIO, or if a program elects not to participate in a QIO project, it must be able to demonstrate a level of achievement through a project of its own design that is comparable to or better than the achievement to be expected from participation in the QIO quality improvement project.
(b) The National Standards for Diabetes Self-Management Education Programs. The set of quality standards contained in the NSDSMEP or any NSDSMEP standards subsequently revised.
(c) Standards of a national accreditation organization that represents individuals with diabetes. Standards that meet or exceed the CMS quality standards described in paragraph (a) of this section that have been developed by a national organization (and approved by CMS) that is either a nonprofit or not-for-profit organization with demonstrated experience in representing the interest of individuals, including health care professionals and Medicare beneficiaries, with diabetes.
§ 410.145   Requirements for entities.
(a) Deemed entities. (1) Except as permitted in paragraph (a)(2) of this section, an entity may be deemed to meet a set of quality standards described in § 410.144 if the following conditions are met:
(i) The entity has submitted necessary documentation and is fully accredited (and periodically reaccredited) by an organization approved by CMS under § 410.142.
(ii) The entity is not accredited by an organization that owns or controls the entity.
(2) Before August 27, 2002 CMS may deem an entity to meet the NSDSMEP quality standards described in § 410.144(b), if the entity provides the Medicare contractor that will process its claims with a copy of a current certificate the entity received from the ADA that verifies the training program it furnishes meets the NSDSMEP quality standards described in § 410.144(b).
(b) Approved entities. An entity may be approved to furnish training if the entity meets the following conditions:
(1) Before submitting a claim for Medicare payment, forwards a copy of its certificate or proof of accreditation from an organization approved by CMS under § 410.142 indicating that the entity meets a set of quality standards described in § 410.144, or before August 27, 2002, submits documentation of its current ADA recognition status.
(2) Agrees to submit to evaluation (including onsite inspections) by CMS (or its agent) to validate its approved organization's accreditation process.
(3) Authorizes its approved organization to release to CMS a copy of its most recent accreditation evaluation, and any accreditation-related information that CMS may require.
(4) At a minimum, allows the QIO (under a contract with CMS) access to beneficiary or group training records.
(c) Effective dates —(1) Deemed to meet quality standards. Except as permitted in paragraph (c)(2) of this section, the date on which an entity is deemed to meet a set of quality standards described in § 410.144 is the later of one of the following dates:
(i) The date CMS approves and recognizes the accreditation organization to accredit entities to furnish training.
(ii) The date an organization accredits the entity to meet a set of quality standards described in § 410.144.
(2) Approved to furnish training. CMS covers the training furnished by an entity beginning on the later of one of the following dates:
(i) The date CMS approves the deemed entity as meeting the conditions for coverage in § 410.141(e).
(ii) The date the entity is deemed to meet a set of quality standards described in § 410.144.
(d) Removal of approved status —(1) General rule. CMS removes an entity's approved status for any of the following reasons:
(i) CMS determines, on the basis of its own evaluation or the results of the accreditation evaluation, that the entity does not meet a set of quality standards described in § 410.144.
(ii) CMS withdraws its approval of the organization that deemed the entity to meet a set of quality standards described in § 410.144.
(iii) The entity fails to meet the requirements of paragraphs (a) and (b) of this section.
(2) Effective date. The effective date of CMS's removal of an entity's approved status is 60 days after the date of CMS's notice to the entity.
§ 410.146   Diabetes outcome measurements.
(a) Information collection. An approved entity must collect and record in an organized systematic manner the following patient assessment information at least on a quarterly basis for a beneficiary who receives training under § 410.141:
(1) Medical information that includes the following:
(i) Duration of the diabetic condition.
(ii) Use of insulin or oral agents.
(iii) Height and weight by date.
(iv) Results and date of last lipid test.
(v) Results and date of last HbA1C.
(vi) Information on self-monitoring (frequency and results).
(vii) Blood pressure with the corresponding dates.
(viii) Date of the last eye exam.
(2) Other information that includes the following:
(i) Educational goals.
(ii) Assessment of educational needs.
(iii) Training goals.
(iv) Plan for a follow-up assessment of achievement of training goals between 6 months and 1 year after the beneficiary completes the training.
(v) Documentation of the training goals assessment.
(b) Follow-up assessment information. An approved entity may obtain information from the beneficiary's survey, primary care physician contact, and follow-up visits.
§ 410.150   To whom payment is made.
(a) General rules. (1) Any SMI enrollee is, subject to the conditions, limitations, and exclusions set forth in this part and in parts 405, 416 and 424 of this chapter, entitled to have payment made as specified in paragraph (b) of this section.
(2) The services specified in paragraphs (b)(5) through (b)(14) of this section must be furnished by a facility that has in effect a provider agreement or other appropriate agreement to participate in Medicare.
(b) Specific rules. Subject to the conditions set forth in paragraph (a) of this section, Medicare Part B pays as follows:
(1) To the individual, or to a physician or other supplier on the individual's behalf, for medical and other health services furnished by the physician or other supplier.
(2) To a nonparticipating hospital on the individual's behalf for emergency outpatient services furnished by the hospital, in accordance with subpart G of part 424 of this chapter.
(3) To the individual, for emergency outpatient services furnished by a nonparticipating hospital, in accordance with § 424.53 of this chapter.
(4) To the individual, for physicians' services and ambulance services furnished outside the United States in accordance with § 424.53 of this chapter.
(5) To a provider on the individual's behalf for medical and other health services furnished by the provider (or by others under arrangements made with them by the provider).
(6) To a home health agency on the individual's behalf for home health services furnished by the home health agency.
(7) To a clinic, rehabilitation agency, or public health agency on the individual's behalf for outpatient physical therapy or speech pathology services furnished by the clinic or agency (or by others under arrangements made with them by the clinic or agency).
(8) To a rural health clinic or Federally qualified health center on the individual's behalf for rural health clinic or Federally qualified health center services furnished by the rural health clinic or Federally qualified health center, respectively.
(9) To an ambulatory surgical center (ASC) on the individual's behalf for covered ambulatory surgical center facility services that are furnished in connection with surgical procedures performed in an ASC, as provided in part 416 of this chapter.
(10) To a comprehensive outpatient rehabilitation facility (CORF) on the individual's behalf for comprehensive outpatient rehabilitation facility services furnished by the CORF.
(11) To a renal dialysis facility, on the individual's behalf, for institutional or home dialysis services, supplies, and equipment furnished by the facility.
(12) To a critical access hospital (CAH) on the individual's behalf for outpatient CAH services furnished by the CAH.
(13) To a community mental health center (CMHC) on the individual's behalf, for partial hospitalization services or intensive outpatient services furnished by the CMHC (or by others under arrangements made with them by the CMHC).
(14) To an SNF for services (other than those described in § 411.15(p)(2) of this chapter) that it furnishes to a resident (as defined in § 411.15(p)(3) of this chapter) of the SNF who is not in a covered Part A stay.
(15)(i) Prior to January 1, 2022, to the qualified employer of a physician assistant for professional services furnished by the physician assistant and for services and supplies provided incident to his or her services. Payment is made to the employer of a physician assistant regardless of whether the physician assistant furnishes services under a W-2, employer-employee employment relationship, or whether the physician assistant is an independent contractor who receives a 1099 reflecting the relationship. Both types of relationships must conform to the appropriate guidelines provided by the Internal Revenue Service. A qualified employer is not a group of physician assistants that incorporate to bill for their services. Payment is made only if no facility or other provider charges or is paid any amount for services furnished by a physician assistant.
(ii) Effective on or after January 1, 2022, payment is made to a physician assistant for professional services furnished by a physician assistant in all settings in both rural and nonrural areas and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges, or is paid, any amount for the furnishing of professional services of the physician assistant.
(16) To a nurse practitioner or clinical nurse specialist for professional services furnished by a nurse practitioner or clinical nurse specialist in all settings in both rural and nonrural areas and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges, or is paid, any amount for the furnishing of the professional services of the nurse practitioner or clinical nurse specialist.
(17) To a clinical psychologist on the individual's behalf for clinical psychologist services and for services and supplies furnished as an incident to his or her services.
(18) To a clinical social worker on the individual's behalf for clinical social worker services.
(19) To a participating HHA, for home health services (including medical supplies described in section 1861(m)(5) of the Act, but excluding durable medical equipment to the extent provided for in such section) furnished to an individual who at the time the item or service is furnished is under a plan of care of an HHA (without regard to whether the item or service is furnished by the HHA directly, under arrangement with the HHA, or under any other contracting or consulting arrangement).
(20) To a certified nurse-midwife for professional services furnished by the certified nurse-midwife in all settings and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges or is paid any amount for the furnishing of the professional services of the certified nurse-midwife.
(21) To a marriage and family therapist on the individual's behalf for marriage and family therapist services.
(22) To a mental health counselor on the individual's behalf for mental health counseling services.
§ 410.152   Amounts of payment.
(a) General provisions —(1) Exclusion from incurred expenses. As used in this section, “incurred expenses” are expenses incurred by an individual, during his or her coverage period, for covered Part B services, excluding the following:
(i) Expenses incurred for services for which the beneficiary is entitled to have payment made under Medicare Part A or would be so entitled except for the application of the Part A deductible and coinsurance requirements.
(ii) Expenses incurred in meeting the Part B blood deductible (§ 410.161).
(iii) In the case of services payable under a formula that takes into account reasonable charges, reasonable costs, customary charges, customary (insofar as reasonable) charges, charges related to reasonable costs, fair compensation, a pre-treatment prospective payment rate, or a standard overhead amount, or any combination of two or more of these factors, expenses in excess of any factor taken into account under that formula.
(iv) Expenses in excess of the outpatient mental health treatment limitation described in § 410.155.
(v) In the case of expenses incurred for outpatient physical therapy services including speech-language pathology services, the expenses excluded are from the incurred expenses under § 410.60(e). In the case of expenses incurred for outpatient occupational therapy including speech-language pathology services, the expenses excluded are from the incurred expenses under § 410.59(e).
(2) Other applicable provisions. Medicare Part B pays for incurred expenses the amounts specified in paragraphs (b) through (k) of this section, subject to the following:
(i) The principles and procedures for determining reasonable costs and reasonable charges and the conditions for Medicare payment, as set forth in parts 405 (subparts E and X), 413, and 424 of this chapter.
(ii) The Part B annual deductible (§ 410.160).
(iii) The special rules for payment to health maintenance organizations (HMOs), health care prepayment plans (HCPPs), and competitive medical plans (CMPs) that are set forth in part 417 of this chapter. (A prepayment organization that does not qualify as an HMO, CMP, or HCPP is paid in accordance with paragraph (b)(4) of this section.)
(b) Basic rules for payment. Except as specified in paragraphs (c) through (h) and (m) and (n) of this section, Medicare Part B pays the following amounts:
(1) For services furnished by, or under arrangements made by, a provider other than a nominal charge provider, whichever of the following is less:
(i) 80 percent of the reasonable cost of the services.
(ii) The reasonable cost of, or the customary charges for, the services, whichever is less, minus 20 percent of the customary (insofar as reasonable) charges for the services.
(2) For services furnished by, or under arrangements made by, a nominal charge provider, 80 percent of fair compensation.
(3) For emergency outpatient hospital services furnished by a nonparticipating hospital that is eligible to receive payment for those services under subpart G of part 424 of this chapter, the amount specified in paragraph (b)(1) of this section.
(4) For services furnished by a person or an entity other than those specified in paragraphs (b)(1) through (b)(3) of this section, 80 percent of the reasonable charges or 80 percent of the payment amount computed on any other payment basis for the services.
(c) Amount of payment: Home health services other than durable medical equipment (DME). For home health services other than DME furnished by, or under arrangements made by, a participating HHA, Medicare Part B pays the following amounts:
(1) For services furnished by an HHA that is a nominal charge provider, 100 percent of fair compensation.
(2) For services furnished by an HHA that is not a nominal charge provider, the lesser of the reasonable cost of the services and the customary charges for the services.
(d) Amount of payment: DME furnished as a home health service —(1) Basic rule. Except as specified in paragraph (d)(2) of this section—
(i) For DME furnished by an HHA that is a nominal charge provider, Medicare Part B pays 80 percent of fair compensation.
(ii) For DME furnished by an HHA that is not a nominal charge provider, Medicare Part B pays the lesser of the following:
(A) 80 percent of the reasonable cost of the service.
(B) The reasonable cost of, or the customary charge for, the service, whichever is less, minus 20 percent of the customary (insofar as reasonable) charge for the service.
(2) Exception. If the DME is used DME purchased by or on behalf of the beneficiary at a price at least 25 percent less than the reasonable charge for new equipment—
(i) For used DME furnished by an HHA that is a nominal charge provider, Medicare Part B pays 100 percent of fair compensation.
(ii) For used DME furnished by an HHA that is not a nominal charge provider, Medicare Part B pays 100 percent of the reasonable cost of, or the customary charge for, the services, whichever is less.
(e) Amount of payment: Renal dialysis services, supplies, and equipment. Effective for services furnished on or after August 1, 1983, Medicare Part B pays for the institutional dialysis services specified in § 409.250 and the home dialysis services, supplies, and equipment specified in § 409.252, as follows:
(1) Except as provided in paragraph (d)(2) of this section, 80 percent of the per treatment prospective reimbursement rate established under § 413.170 of this chapter, for outpatient maintenance dialysis furnished by ESRD facilities approved in accordance with part 494 of this chapter.
(2) Exception. If a home dialysis patient elects to obtain home dialysis supplies or equipment (or both) from a party other than an approved ESRD facility, payment is in accordance with paragraph (b)(4) of this section.
(f) Amount of payment: Rural health clinic (RHC) and Federally qualified health center (FQHC) services. Medicare Part B pays, for services by a participating RHC or FQHC that is authorized to bill under the reasonable cost system, 80 percent of the costs determined under subpart X of part 405 of this chapter, to the extent those costs are reasonable and related to the cost of furnishing RHC or FQHC services or reasonable on the basis of other tests specified by CMS.
(g) Amount of payment: Used durable medical equipment furnished by otherthan an HHA. Medicare Part B pays the following amounts for used DME purchased by or on behalf of the beneficiary at a price at least 25 percent less than the reasonable charge for comparable new equipment:
(1) For used DME furnished by, or under arrangements made by, a nominal charge provider, 100 percent of fair compensation.
(2) For used DME furnished by or under arrangements made by a provider that is not a nominal charge provider, 100 percent of the reasonable cost of the service or the customary charge for the service, whichever is less.
(3) For used DME furnished by other than a provider, 100 percent of the reasonable charge.
(h) Amount of payment: Preventive vaccine administration. For the administration of the preventive vaccines described in paragraph (l)(1) of this section, as furnished by providers described in §§ 409.100 and 410.150 of this subchapter, Medicare Part B pays the following amounts, except as otherwise provided under this subchapter:
(1) Effective January 1, 2022, for administration of an influenza, hepatitis B or pneumococcal vaccine, $30 per dose.
(2) For the administration of a COVID-19 vaccine:
(i) Effective January 1, 2022, for administration of a COVID-19 vaccine, $40 per dose.
(ii) For services furnished on or after January 1 of the year following the year in which the Secretary ends the March 27, 2020 Emergency Use Authorization declaration for drugs and biologicals (issued at 85 FR 18250) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), for administration of a COVID-19 vaccine, an amount equal to the amount that would be paid for the administration of a preventive vaccine described in paragraph (h)(1) of this section.
(3) Subject to conditions specified in this paragraph, in addition to the payment described in paragraph (h)(1) or (2) of this section, an additional payment for preventive vaccine administration in the patient's home:
(i) Effective January 1, 2022 for administration of a COVID-19 vaccine in the home, an additional payment of $35.50.
(ii) Effective January 1, 2024, for the administration of one or more of the preventive vaccines described in paragraphs (h)(1) and (2) of this section in the home, a payment equal to that of the payment in paragraph (h)(3)(i) of this section.
(iii) An additional payment for preventive vaccine administration in the home can be made if:
(A) The patient has difficulty leaving the home, or faces barriers to getting a vaccine in settings other than their home.
(B) The sole purpose of the visit is to administer one or more preventive vaccines.
(C) The home is not an institution that meets the requirements of sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, or §§ 409.42(a) of this subchapter.
(4) The payment amount for the administration of a preventive vaccine described in paragraphs (h)(1) and (2) of this section, and the additional payment for the administration of a preventive vaccine in the home as described in paragraph (h)(3) of this section, is adjusted to reflect geographic cost variations:
(i) For services furnished before January 1, 2023, using the Geographic Practice Cost Indices (GPCIs) established for the year, as described in section 1848(e)(1) of the Act and §§ 414.2 and 414.26 of this subchapter.
(ii) For services furnished on or after January 1, 2023, using the Geographic Adjustment Factor (GAF) established for the year as described in section 1848(e)(2) of the Act and §§ 414.2 and 414.26 of this subchapter.
(5) For services furnished on or after January 1, 2023, the payment amount for administration of a preventive vaccine described in paragraphs (h)(1) and (2) of this section, and the additional payment for the administration of a preventive vaccine in the home as described in paragraph (h)(3) of this section, is updated annually using the percentage change in the Medicare Economic Index (MEI), as described in section 1842(i)(3) of the Act and § 405.504(d) of this subchapter.
(i) Amount of payment: ASC facility services. (1) For ASC facility services furnished on or after July 1, 1987 and before January 1, 2008, in connection with the surgical procedures specified in part 416 of this chapter, Medicare Part B pays 80 percent of a standard overhead amount as specified in § 416.120(c) of this chapter, except that, for screening flexible sigmoidoscopies and screening colonoscopies, Part B coinsurance is 25 percent of the standard overhead amount and Medicare Part B pays 75 percent of the standard overhead amount.
(2) For ASC services furnished on or after January 1, 2008, in connection with the covered surgical procedures specified in § 416.166 of this subchapter, except as provided in paragraphs (i)(2)(i), (i)(2)(ii), and (l) of this section, Medicare Part B pays the lesser of 80 percent of the actual charge or 80 percent of the prospective payment amount, geographically adjusted, if applicable, as determined under Subpart F of Part 416 of this subchapter. Part B coinsurance is 20 percent of the actual charge or 20 percent of the prospective payment amount, geographically adjusted, if applicable
(i) If the limitation described in § 416.167(b)(3) of this subchapter applies, Medicare pays 80 percent of the amount determined under Subpart B of Part 414 of this subchapter and Part B coinsurance is 20 percent of the applicable payment amount, except as provided in paragraph (l) of this section.
(ii) Between January 1, 2008 and December 31, 2010, Medicare Part B pays 75 percent of the applicable payment amount for screening flexible sigmoidoscopies and screening colonoscopies, and Part B coinsurance is 25 percent of the applicable payment amount.
(j) Amount of payment: services of Federally funded health facilities prior to October 1, 1991. Medicare Part B pays 80 percent of charges related to the reasonable costs that a Federally funded health facility incurs in furnishing the services. See § 411.8(b)(6) of this chapter.
(k) Amount of payment: Outpatient CAH services. (1) Payment for CAH outpatient services is the reasonable cost of the CAH in providing these services, as determined in accordance with section 1861(v)(1)(A) of the Act, with § 413.70(b) and (c) of this chapter, and with the applicable principles of cost reimbursement in part 413 and in part 415 of this chapter.
(2) Payment for CAH outpatient services is subject to the applicable Medicare Part B deductible and coinsurance amounts, except as described in § 413.70(b)(2)(iii) of this chapter, with Part B coinsurance being calculated as 20 percent of the customary (insofar as reasonable) charges of the CAH for the services.
(l) Amount of payment : Preventive services. Except as provided otherwise in this paragraph, Medicare Part B pays 100 percent of the Medicare payment amount established under the applicable payment methodology for the service furnished by a provider or supplier for the following preventive services:
(1) Pneumococcal, influenza, hepatitis B, and COVID-19 vaccine and administration.
(2) Screening mammography.
(3) Screening pap tests and screening pelvic exam.
(4) Prostate cancer screening tests (excluding digital rectal examinations).
(5) Colorectal cancer screening tests (excluding barium enemas).
(i) For the colorectal cancer screening tests described in § 410.37(j), Medicare Part B pays at the specified percentage as follows:
(A) 80 percent for CY 2022.
(B) 85 percent for CY 2023 through 2026.
(C) 90 percent for 2027 through 2029.
(D) 100 percent beginning January 1, 2030.
(ii) [Reserved]
(6) Bone mass measurement.
(7) Medical nutrition therapy (MNT) services.
(8) Cardiovascular screening blood tests.
(9) Diabetes screening tests.
(10) Ultrasound screening for abdominal aortic aneurysm (AAA).
(11) Additional preventive services identified for coverage through the national coverage determination (NCD) process.
(12) Initial Preventive Physical Examination (IPPE).
(13) Annual Wellness Visit (AWV), providing Personalized Prevention Plan Services (PPPS).
(m) Amount of payment: Rebatable drugs. In the case of a rebatable drug (as defined in section 1847A(i)(2)(A) of the Act), including a selected drug (as defined in section 1192(c) of the Act), furnished by providers on or after April 1, 2023, in a calendar quarter during which the payment amount for such drug as specified in section 1847A(i)(3)(A)(ii)(I)(aa) or (bb), as applicable, exceeds the inflation-adjusted amount (as defined in section 1847A(i)(3)(C) of the Act) for such drug, Medicare Part B pays, subject to the deductible, the difference between the allowed payment amount determined under section 1847A of the Act and 20 percent of the inflation-adjusted amount, which is applied as a percent to the payment amount for such calendar quarter.
(n) Amount of payment: Insulin furnished through an item of durable medical equipment. For insulin furnished on or after July 1, 2023 through an item of durable medical equipment (as defined in § 414.202), Medicare Part B pays the difference between the applicable payment amount for such insulin and the coinsurance amount, with the coinsurance amount not to exceed $35 for a month's supply.
(o) Amount of payment: Drugs covered as additional preventive services (DCAPS). For a drug covered as an additional preventive service, as defined at § 410.64, payment must be made as follows:
(1) Payment for a drug covered as an additional preventive service, per section 1861(a)(1)(W)(ii) of the Act and paragraphs (l)(11) of this section and § 410.160(b)(13), is 100 percent of the lesser of—
(i) The actual charge on the claim for program benefits; or
(ii) The amount determined under the fee schedule as described in paragraph (o)(3) of this section.
(2) Payment for the supplying or administration of a drug covered as an additional preventive service per section 1861(a)(1)(W)(ii) of the Act and paragraphs (l)(11) of this section and § 410.160(b)(13), is 100 percent of the lesser of—
(i) The actual charge on the claim for program benefits; or
(ii) The amount determined under the fee schedule as described in paragraph (o)(4) of this section.
(3) The payment limit for a drug covered as an additional preventive service, as defined at § 410.64, appears on the DCAPS fee schedule and is determined as follows:
(i) If Average Sales Price (ASP) data is available for the drug, consistent with part 414, subpart J, of this chapter, then the payment limit is determined using the methodology set forth in section 1847A of the Act and according to the provisions in part 414, subpart K, of this chapter.
(ii) If ASP data is not available, then the payment limit is determined according to the most recently published National Average Drug Acquisition Cost (NADAC) prices for the drug and is the lesser of the median NADAC price of all generic forms of the drug or the lowest NADAC price brand name product.
(iii) If ASP data and NADAC prices are not available, then the payment limit is determined according to the most recently published pharmaceutical pricing data for the drug as included in the Federal Supply Schedule (FSS), as managed by the Department of Veterans Affairs per 48 CFR part 38, and is the lesser of the median FSS price of all generic forms of the drug or the lowest FSS price brand name product.
(iv) If ASP data, NADAC prices, and FSS pharmaceutical prices are not available, then the payment limit is the invoice price determined by the MAC.
(4) The payment limits for supplying and administering a drug covered as an additional preventive service, as defined at § 410.64, appear on the DCAPS fee schedule and are determined as follows:
(i) For a drug that is supplied by a pharmacy, the payment limit for a supplying fee is as follows:
(A) For the first prescription that the pharmacy provides to a beneficiary in a 30-day period for a drug covered as an additional preventive service, $24.
(B) For all subsequent prescriptions that the pharmacy provides to a beneficiary in a 30-day period for a drug covered as an additional preventive service, $16.
(ii) For a drug that is administered by a physician or a non-physician practitioner, the payment limit for administration is set in accordance with part 414, subpart B, of this chapter. This fee is not subject to the Part B deductible, per § 410.160(b)(13). This fee is equal to 100 percent of the Medicare payment amount established under the applicable payment methodology, per paragraph (l)(11) of this section.
§ 410.155   Outpatient mental health treatment limitation.
(a) Limitation. For services subject to the limitation as specified in paragraph (b) of this section, the percentage of the expenses incurred for such services during a calendar year that is considered incurred expenses under Medicare Part B when determining the amount of payment and deductible under § 410.152 and § 410.160 of this part, respectively, is as follows:
(1) For expenses incurred in years before 2010, 62 1/2 percent.
(2) For expenses incurred in 2010 and 2011, 68 3/4 percent.
(3) For expenses incurred in 2012, 75 percent.
(4) For expenses incurred in 2013, 81 1/4 percent.
(5) For expenses incurred in CY 2014 and subsequent years, 100 percent.
(b) Application of the limitation —(1) Services subject to the limitation. Except as specified in paragraph (b)(2) of this section, services furnished by physicians and other practitioners, whether furnished directly or incident to those practitioners' services, are subject to the limitation if they are furnished in connection with the treatment of a mental, psychoneurotic, or personality disorder (that is, any condition identified by a diagnosis code within the range of 290 through 319) and are furnished to an individual who is not an inpatient of a hospital:
(i) Services furnished by physicians and other practitioners, whether furnished directly or as an incident to those practitioners' services.
(ii) Services provided by a CORF.
(2) Services not subject to the limitation. Services not subject to the limitation include the following:
(i) Services furnished to a hospital inpatient.
(ii) Brief office visits for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental, psychoneurotic, or personality disorders billed under HCPCS code M0064 (or its successor).
(iii) Partial hospitalization services or intensive outpatient services not directly provided by a physician.
(iv) Psychiatric diagnostic services billed under CPT codes 90801 and 90802 (or successor codes) and diagnostic psychological and neuropsychological tests billed under CPT code range 96101 through 96125 (or successor codes) that are performed to establish a diagnosis.
(v) Medical management such as that furnished under CPT code 90862 (or its successor code), as opposed to psychotherapy, furnished to a patient diagnosed with Alzheimer's disease or a related disorder.
(3) Payment amounts. The Medicare payment amount and the patient liability amounts for outpatient mental health services subject to the limitation for each year during which the limitation is phased out are as follows:
(c) General formula. A general formula for calculating the amount of Medicare payment and the patient liability for outpatient mental health services subject to the limitation is as follows:
(1) Multiply the Medicare approved amount by the percentage of incurred expenses that is recognized as incurred expenses for Medicare payment purposes for the year involved;
(2) Subtract from this amount the amount of any remaining Part B deductible for the patient and year involved; and,
(3) Multiply this amount by 0.80 (80 percent) to obtain the Medicare payment amount.
(4) Subtract the Medicare payment amount from the Medicare-approved amount to obtain the patient liability amount.
§ 410.160   Part B annual deductible.
(a) Basic rule. Except as provided in paragraph (b) of this section, incurred expenses (as defined in § 410.152) are subject to, and count toward meeting the annual deductible.
(b) Exceptions. Expenses incurred for the following services are not subject to the Part B annual deductible and do not count toward meeting that deductible:
(1) Home health services.
(2) Pneumococcal, influenza, and hepatitis b, and COVID-19 vaccines and their administration.
(3) Federally qualified health center services.
(4) ASC facility services furnished before July 1987 and physician services furnished before April 1988 that met the requirements for payment of 100 percent of the reasonable charges.
(5) Screening mammography services as described in § 410.34 (c) and (d).
(6) Screening pelvic examinations as described in § 410.56.
(7) Beginning January 1, 2007, colorectal cancer screening tests as described in § 410.37.
(8) Beginning January 1, 2011, for a surgical service, and beginning January 1, 2015, for an anesthesia service, furnished in connection with, as a result of, and in the same clinical encounter as a planned colorectal cancer screening test. A surgical or anesthesia service furnished in connection with, as a result of, and in the same clinical encounter as a colorectal cancer screening test means—a surgical or anesthesia service furnished on the same date as a planned colorectal cancer screening test as described in § 410.37.
(9) Beginning January 1, 2009, initial preventive physical examinations as described in § 410.16.
(10) Bone mass measurement.
(11) Medical nutrition therapy (MNT) services.
(12) Annual Wellness Visit (AWV), providing Personalized Prevention Plan Services (PPPS).
(13) Additional preventive services identified for coverage through the national coverage determination (NCD) process.
(c) Application of the Part B annual deductible. (1) Before payment is made under § 410.152, an individual's incurred expenses for the calendar year are reduced by the Part B annual deductible.
(2) The Part B annual deductible is applied to incurred expenses in the order in which claims for those expenses are processed by the Medicare program.
(3) Only one Part B annual deductible may be imposed for any calendar year and it may be met by any combination of expenses incurred in that year.
(d) Special rule for services reimbursable on a formula basis. (1) In applying the formula that takes into account reasonable costs, customary charges, and customary (insofar as reasonable) charges, and is used to determine payment for services furnished by a provider that is not a nominal charge provider, the Medicare intermediary takes the following steps:
(i) Reduces the customary charges for the services by an amount equal to any unmet portion of the deductible for the calendar year, in accordance with paragraph (b) of this section. (The amount of this reduction is considered to be the amount of the deductible that is met on the basis of the services to which it is applied.)
(ii) Determines 20 percent of any remaining portion of the customary (insofar as reasonable) charge.
(iii) Determines the lesser of the reasonable cost of the services and the customary charges for the services.
(iv) Reduces the amount determined under paragraph (c)(1)(iii) of this section by the sum of the reduction made under paragraph (c)(1)(i) of this section and the amount determined under parargaph (c)(1)(ii) of this section.
(v) Reduces the reasonable cost of the services by the amount of the reduction made under paragraph (c)(1)(i) of this section and multiplies the result by 80 percent.
(2) In accordance with § 410.152(b)(1), the amount payable is the amount determined under paragraph (c)(1)(iv) of this section, or the amount determined under paragraph (c)(1)(v) of this section, whichever is less.
(e) Special rule for services of an independent rural health clinic. Application of the Part B annual deductible to rural health clinic services is in accordance with § 405.2425(b)(2) of this chapter.
(f) Amount of the Part B annual deductible. (1) Beginning with expenses for services furnished during calendar year 2006, and for all succeeding years, the annual deductible is the previous year's deductible plus the annual percentage increase in the monthly actuarial rate for Medicare enrollees age 65 and over, rounded to the nearest dollar.
(2) For 2005, the deductible is $110.
(3) From 1991 through 2004, the deductible was $100.
(4) From 1982 through 1990, the deductible was $75.
(5) From 1973 through 1981, the deductible was $60.
(6) From 1966 through 1972, the deductible was $50.
(g) Carryover of Part B annual deductible. For calendar years before 1982, the Part B annual deductible was reduced by the amount of expenses incurred during the last quarter of the preceding year that was applied to meet the deductible for that preceding year. Example: If $20 of expenses incurred in November 1980 was used to meet the 1980 deductible, the 1981 deductible was reduced to $40 ($60-$20).
(h) Examples of application of the annual deductible. (1) Mr. A submitted claims for the following expenses incurred during 1982: $20 for services furnished in March by physician X; $30 for services furnished in April by physician Y; $50 for services furnished in June by physician Z, for a total of $100. The carrier determined that the charges as submitted were the reasonable charges. The first $75 of expenses for which claims were processed is applied to meet the $75 deductible for that year. Medicare Part B pays 80 percent of the remaining $25, or $20.
(2) Mr. B submitted a claim that included a $25 charge by a doctor for an examination to prescribe a hearing aid and an $80 charge for office surgery. This was the first claim relating to Mr. B's medical expenses processed in the calendar year. The carrier disallowed the $25 charge because the type of examination is not covered by Medicare. The carrier reduced the $80 surgery charge to a reasonable charge of $40. Only the $40 reasonable charge for covered services will count toward meeting Mr. B's deductible. Since the remainder of the surgery charge constitutes and excess over the reasonable charge, it cannot be applied to satisfy Mr. B's deductible.
(3) Mr. C became entitled to Medicare Part B benefits on July 1, 1982. He incurred expenses of $200 in July, August, and September. The carrier determined that the changes as submitted were reasonable. Even though Mr. C was entitled to benefits for only half the year, he must meet the full $75 deductible. Thus, $75 of this expense constitutes Mr. C's deductible. Medicare would pay $100, which is 80 percent of the remaining $125.
§ 410.161   Part B blood deductible.
(a) General rules. (1) As used in this section, packed red cells means the red blood cells that remain after plasma is separated from whole blood.
(2) A unit of packed red cells is treated as the equivalent of a pint of whole blood, which in this section is referred to as a unit of whole blood.
(3) Medicare does not pay for the first 3 units of whole blood or units of packed red cells that are furnished under Part A or Part B in a calendar year. The Part B blood deductible is reduced to the extent that a blood deductible has been applied under Part A.
(4) The blood deductible does not apply to other blood components such as platelets, fibrinogen, plasma, gamma globulin and serum albumin, or to the costs of processing, storing, and administering blood.
(5) The blood deductible is in addition to the Part B annual deductible specified in § 410.160.
(b) Beneficiary's responsibility for the first 3 units of blood. (1) The beneficiary is responsible for the first three units of whole blood or packed red cells received during a calendar year.
(2) If the blood is furnished by a hospital or CAH, the rules set forth in § 409.87 (b), (c), and (d) of this chapter apply.
(3) If the blood is furnished by a physician, clinic, or other supplier that has accepted assignment of Medicare benefits, or claims payment under § 424.64 of this chapter because the beneficiary died without assigning benefits, the supplier may charge the beneficiary the reasonable charge for the first 3 units, to the extent that those units are not replaced.
§ 410.163   Payment for services furnished to kidney donors.
Notwithstanding any other provisions of this chapter, there are no deductible or coinsurance requirements with respect to services furnished to an individual who donates a kidney for transplant surgery.
§ 410.165   Payment for rural health clinic services and ambulatory surgical center services: Conditions.
(a) Medicare Part B pays for covered rural health clinic and Federally qualified health center services if—
(1) The services are furnished in accordance with the requirements of subpart X of part 405 of this chapter and subpart A of part 491 of this chapter; and
(2) The clinic or center files a written request for payment on the form and in the manner prescribed by CMS.
(b) Medicare Part B pays for covered ambulatory surgical center (ASC) services if—
(1) The services are furnished in accordance with the requirements of part 416 of this chapter; and
(2) The ASC files a written request for payment on the form and in the manner prescribed by CMS.
§ 410.170   Payment for home health services, for medical and other health services furnished by a provider or an approved ESRD facility, and for comprehensive outpatient rehabilitation facility (CORF) services: Conditions.
Payment under Medicare Part B, for home health services, for medical and other health services, or for CORF services, may be made to the provider or facility only if the following conditions are met:
(a) Request for payment. A written request for payment is filed by or on behalf of the individual to whom the services were furnished.
(b) Physician or allowed practitioner certification. For home health services, a physician or allowed practitioner provides certification and recertification in accordance with § 424.22 of this chapter.
(c) In the case of home dialysis support services described in § 410.52, the services are furnished in accordance with a written plan prepared and periodically reviewed by a team that includes the patient's physician and other professionals familiar with the patient's condition as required by § 494.90 of this chapter.
§ 410.172   Payment for partial hospitalization services in CMHCs: Conditions.
Medicare Part B pays for partial hospitalization services furnished in a CMHC on behalf of an individual only if the following conditions are met:
(a) The CMHC files a written request for payment on the CMS form 1450 and in the manner prescribed by CMS; and
(b) The services are furnished in accordance with the requirements described in § 410.110.
§ 410.173   Payment for intensive outpatient services in CMHCs: Conditions.
Medicare Part B pays for intensive outpatient services furnished in a CMHC on behalf of an individual only if the following conditions are met:
(a) The CMHC files a written request for payment on the CMS form 1450 and in the manner prescribed by CMS; and
(b) The services are furnished in accordance with the requirements described in § 410.111.
§ 410.175   Alien absent from the United States.
(a) Medicare does not pay Part B benefits for services furnished to an individual who is not a citizen or a national of the United States if those services are furnished in any month for which the individual is not paid monthly social security cash benefits (or would not be paid if he or she were entitled to those benefits) because he or she has been outside the United States continuously for 6 full calendar months.
(b) Payment of benefits resumes with services furnished during the first full calendar month the alien is back in the United States.