42 C.F.R. Subpart X—Rural Health Clinic and Federally Qualified Health Center Services
Title 42 - Public Health
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Source: 43 FR 8261, Mar. 1, 1978, unless otherwise noted.
Subpart X is based on the provisions of the following sections of the Act: Section 1833 sets forth the amounts of payment for supplementary medical insurance services. Section 1861(aa) sets forth the rural health clinic services and Federally qualified health center services covered by the Medicare program. [60 FR 63176, Dec. 8, 1995] (a) Scope. This subpart establishes the requirements for coverage and reimbursement of rural health clinic and Federally qualified health center services under Medicare. (b) Definitions. As used in this subpart, unless the context indicates otherwise: Act means the Social Security Act. Allowable costs means costs that are incurred by a clinic or center and are reasonable in amount and proper and necessary for the efficient delivery of rural health clinic and Federally qualified health center services. Beneficiary means an individual enrolled in the Supplementary Medical Insurance program for the Aged and Disabled (part of title XVIII of the Act). Coinsurance means that portion of the clinic's charge for covered services for which the beneficiary is liable in addition to the deductible. Carrier means an organization that has a contract with the Secretary to administer the benefits covered by this subpart. Covered services means items or services for which the beneficiary is entitled to have payment made on his or her behalf under this subpart. Deductible means: (1) The first $100 of expenses incurred by the beneficiary during any calendar year for items and services covered under Part B of title XVIII; and (2) The expenses incurred for the first 3 pints of blood or 3 units of packed red blood cells furnished to a beneficiary during any calendar year. (See §§410.160 and 410.161 of this chapter for greater detail.) Federally qualified health center (FQHC) means an entity that has entered into an agreement with CMS to meet Medicare program requirements under §§405.2434 and— (1) Is receiving a grant under section 329, 330, or 340 of the Public Health Service Act, or is receiving funding from such a grant under a contract with the recipient of such a grant and meets the requirements to receive a grant under section 329, 330 or 340 of the Public Health Service Act; (2) Based on the recommendation of the PHS, is determined by CMS to meet the requirements for receiving such a grant; (3) Was treated by CMS, for purposes of part B, as a comprehensive federally funded health center (FFHC) as of January 1, 1990; or (4) Is an outpatient health program or facility operated by a tribe or tribal organizations under the Indian Self-Determination Act or by an Urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act. CMS stands for Centers for Medicare & Medicaid Services. Intermittent nursing care means a medically predictable need for nursing care from time to time, but usually not less frequently than once every 60 days. Nurse-midwife means a registered professional nurse who meets the following requirements: (1) Is currently licensed to practice in the State as a registered professional nurse. (2) Is legally authorized under State law or regulations to practice as a nurse-midwife. (3) Except as provided in paragraph (b)(10)(iv) of this section, has completed a program of study and clinical experience for nurse-midwives, as specified by the State. (4) If the State does not specify a program of study and clinical experience that nurse-midwives must complete to practice in that State, meets one of the following conditions: (i) Is currently certified as a nurse-midwife by the American College of Nurse-Midwives. (ii) Has satisfactorily completed a formal education program (of at least one academic year) that, upon completion, qualifies the nurse to take the certification examination offered by the American College of Nurse-Midwives. (iii) Has successfully completed a formal educational program for preparing registered nurses to furnish gynecological and obstetrical care to women during pregnancy, delivery, and the postpartum period, and care to normal newborns, and was practicing as a nurse-midwife for a total of 12 months during any 18-month period from August 8, 1976 to July 16, 1982. Nurse practitioner and physician assistant means individuals who meet the applicable education, training experience and other requirements of §491.2 of this chapter. Part-time nursing care means nursing care that is required on less than a full-time basis, that is, less than 8 hours a day or 40 hours a week. Physician means the following: (1) A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which the function is performed. (2) Within limitations as to the specific services furnished, a doctor of dentistry or dental or oral surgery, a doctor of optometry, a doctor of podiatry or surgical chiropody or a chiropractor. (See section 1861(r) of the Act for specific limitations.) (3) A resident (including residents as defined in §415.152 of this chapter who meet the requirements in §415.206(b) of this chapter for payment under the physician fee schedule). Reporting period means a period of 12 consecutive months specified by the intermediary as the period for which a clinic or center must report its costs and utilization. The first and last reporting periods may be less than 12 months. Rural health clinic (RHC) means an entity that: (1) Meets the requirements of section 1861(aa)(2) of the Act and part 491 of this chapter concerning RHC services and conditions for approval. (2) Has filed an agreement with CMS that meets the basic requirements described in §405.2402 to provide RHC services under Medicare. (3) Does not share space, staff, supplies, records, and other resources during RHC hours of operation with a private Medicare or Medicaid practice operated by the same physicians and nonphysician practitioners working for the RHC. Operation of a multipurpose clinic with other types of health providers or suppliers is permissible subject to the provisions in paragraph (4) of this definition. (4) Appropriately allocates and excludes from the RHC cost report the net non-RHC costs if it operates at a multipurpose location that involves the sharing of common space, medical support staff, or other physical resources with other health care providers or suppliers. Secretary means the Secretary of Health and Human Services or his delegate. Visiting nurse services means part-time or intermittent nursing care and related medical supplies (other than drugs or biologicals) furnished by a registered nurse or licensed practical nurse to a homebound patient. (Secs. 1102, 1833, 1861(aa), 1871, 1902(a)(13), Social Security Act; 49 Stat. 647, 79 Stat. 302, 322, and 331, 91 Stat. 1485 (42 U.S.C. 1302, 1395l, 1395hh, 1395x(aa), and 1396(a)(13)) [43 FR 8261, Mar. 1, 1978, as amended at 43 FR 30526, July 14, 1978; 47 FR 21049, May 17, 1982; 47 FR 23448, May 28, 1982; 51 FR 41351, Nov. 14, 1986; 57 FR 24975, June 12, 1992; 59 FR 26958, May 25, 1994; 60 FR 63176, Dec. 8, 1995; 61 FR 14657, Apr. 3, 1996; 69 FR 74815, Dec. 24, 2003] (a) Certification by the State survey agency. The rural health clinic must be certified in accordance with part 491 of this chapter. (b) Acceptance of the clinic as qualified to furnish rural health clinic services. If the Secretary, after reviewing the survey agency recommendation and other evidence relating to the qualifications of the rural health clinic, determines that it meets the requirements of this subpart and of part 491 of this chapter, he will send the clinic: (1) Written notice of the determination; and (2) Two copies of the agreement to be filed as required by section 1861(aa)(1) of the Act. (c) Filing of agreement by the rural health clinic. If the rural health clinic wishes to participate in the program, it must: (1) Have both copies of the agreement signed by an authorized representative; and (2) File them with the Secretary. (d) Acceptance by the Secretary. If the Secretary accepts the agreement filed by the rural health clinic, he will return to the clinic one copy of the agreement, with a notice of acceptance specifying the effective date. (e) Duration of agreement. The agreement shall be for a term of one year and may be renewed annually by mutual consent of the Secretary and the rural health clinic. (f) Appeal rights. If the Secretary does not certify a rural health clinic, or refuses to enter into or renew an agreement, the facility is entitled to a hearing in accordance with part 498 of this chapter. [43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987] (a) Under the agreement, the rural health clinic agrees to the following: (1) Maintaining compliance with conditions. The clinic agrees to maintain compliance with the conditions set forth in part 491 of this chapter and to report promptly to CMS any failure to do so. (2) Charges to beneficiaries. The clinic agrees not to charge the beneficiary or any other person for items and services for which the beneficiary is entitled to have payment made under the provisions of this part (or for which the beneficiary would have been entitled if the rural health clinic had filed a request for payment in accordance with §410.165 of this chapter), except for any deductible or coinsurance amounts for which the beneficiary is liable under §405.2410. (3) Refunds to beneficiaries. (i) The clinic agrees to refund as promptly as possible any money incorrectly collected from beneficiaries or from someone on their behalf. (ii) As used in this section, money incorrectly collected means sums collected in excess of the amount for which the beneficiary was liable under §405.2410. It includes amounts collected at a time when the beneficiary was believed not to be entitled to Medicare benefits but: (A) The beneficiary is later determined to have been entitled to Medicare benefits; and (B) The beneficiary's entitlement period falls within the time the rural health clinic's agreement with the Secretary is in effect. (4) Beneficiary treatment. (i) The clinic agrees to accept beneficiaries for care and treatment; and (ii) The clinic agrees not to impose any limitations on the acceptance of beneficiaries for care and treatment that it does not impose on all other persons. (b) Additional provisions. The agreement may contain any additional provisions that the Secretary finds necessary or desirable for the efficient and effective administration of the Medicare program. [43 FR 8261, Mar. 1, 1978, as amended at 51 FR 41351, Nov. 14, 1986] (a) Termination by rural health clinic—(1) Notice to Secretary. If the clinic wishes to terminate its agreement it shall file with the Secretary a written notice stating the intended effective date of termination. (2) Action by the Secretary. (i) The Secretary may approve the date proposed by the clinic, or set a different date no later than 6 months after the date of the clinic's notice. (ii) The Secretary may approve a date which is less than 6 months after the date of notice if he determines that termination on that date would not: (A) Unduly disrupt the furnishing of services to the community serviced by the clinic; or (B) Otherwise interfere with the effective and efficient administration of the Medicare program. (3) Cessation of business. If a clinic ceases to furnish services to the community, that shall be deemed to be a voluntary termination of the agreement by the clinic, effective on the last day of business. (b) Termination by the Secretary—(1) Cause for termination. The Secretary may terminate an agreement if he determines that the rural health clinic: (i) No longer meets the conditions for certification under part 491 of this chapter; or (ii) Is not in substantial compliance with the provisions of the agreement, the requirements of this subpart, any other applicable regulations of this part, or any applicable provisions of title XVIII of the Act; or (iii) Has undergone a change of ownership. (2) Notice of termination. The Secretary will give notice of termination to the rural health clinic at least 15 days before the effective date stated in the notice. (3) Appeal by the rural health clinic. A rural health clinic may appeal the termination of its agreement in accordance with the provisions set forth in part 498 of this chapter. (c) Effect of termination. Payment will not be available for rural health clinic services furnished on or after the effective date of termination. (d) Notice to the public. Prompt notice of the date and effect of termination shall be given to the public, through publication in local newspapers: (1) By the clinic, after the Secretary has approved or set a termination date; or (2) By the Secretary, when he has terminated the agreement. (e) Conditions for reinstatement after termination of agreement by the Secretary. When an agreement with a rural health clinic is terminated by the Secretary, the rural health clinic may not file another agreement to participate in the Medicare program unless the Secretary: (1) Finds that the reason for the termination of the prior agreement has been removed; and (2) Is assured that the reason for the termination will not recur. [43 FR 8261, Mar. 1, 1978, as amended at 52 FR 22454, June 12, 1987] (a) Application of deductible. (1) Medicare payment for RHC services begins only after the beneficiary has incurred the deductible. Medicare applies the Medicare Part B deductible as follows: (i) If the deductible is fully met by the beneficiary before the RHC visit, Medicare pays 80 percent of the all-inclusive rate. (ii) If the deductible is not fully met by the beneficiary before the visit and the amount of the RHC's reasonable customary charge for the service that is applied to the deductible is— (A) Less than the all-inclusive rate, the amount applied to the deductible is subtracted from the all-inclusive rate and 80 percent of the remainder, if any, is paid to the RHC; or (B) Equal to or exceeds the all-inclusive rate, no payment is made to the RHC. (2) Medicare payment for FQHC services is not subject to the usual Part B deductible. (b) Application of coinsurance. (1) The beneficiary is responsible for the coinsurance amount that cannot exceed 20 percent of the clinic's reasonable customary charge for the covered service. (2) The beneficiary's deductible and coinsurance liability for any one service furnished by the RHC may not exceed a reasonable amount customarily charged by the RHC for that particular service. (3) For any one service furnished by an FQHC, the coinsurance liability may not exceed 20 percent of reasonable amount customarily charged by the FQHC for that particular service. [69 FR 74815, Dec. 24, 2003] (a) Rural health clinic services reimbursable under this subpart are: (1) The physicians' services specified in §405.2412; (2) Services and supplies furnished as an incident to a physician's professional service; (3) The nurse practitioner or physician assistant services specified in §405.2414; (4) Services and supplies furnished as an incident to a nurse practitioner's or physician assistant's services; and (5) Visiting nurse services. (b) Rural health clinic services are reimbursable when furnished to a patient at the clinic, at a hospital or other medical facility, or at the patient's place of residence. (a) Physicians' services are professional services that are performed by a physician at the clinic or are performed away from the clinic by a physician whose agreement with the clinic provides that he or she will be paid by the clinic for such services. (a) Services and supplies incident to a physician's professional service are reimbursable under this subpart if the service or supply is: (1) Of a type commonly furnished in physicians' offices; (2) Of a type commonly rendered either without charge or included in the rural health clinic's bill; (3) Furnished as an incidental, although integral, part of a physician's professional services; (4) Furnished under the direct, personal supervision of a physician; and (5) In the case of a service, furnished by a member of the clinic's health care staff who is an employee of the clinic. (b) Only drugs and biologicals which cannot be self-administered are included within the scope of this benefit. (a) Professional services are reimbursable under this subpart if: (1) Furnished by a nurse practitioner, physician assistant, nurse midwife, or specialized nurse practitioner who is employed by, or receives compensation from, the rural health clinic; (2) Furnished under the medical supervision of a physician; (3) Furnished in accordance with any medical orders for the care and treatment of a patient prepared by a physician; (4) They are of a type which the nurse practitioner, physician assistant, nurse midwife or specialized nurse practitioner who furnished the service is legally permitted to perform by the State in which the service is rendered; and (5) They would be covered if furnished by a physician. (b) The physician supervision requirement is met if the conditions specified in §491.8(b) of this chapter and any pertinent requirements of State law are satisfied. (c) The services of nurse practitioners, physician assistants, nurse midwives or specialized nurse practitioners are not covered if State law or regulations require that the services be performed under a physician's order and no such order was prepared. (a) Services and supplies incident to a nurse practitioner's or physician assistant's services are reimbursable under this subpart if the service or supply is: (1) Of a type commonly furnished in physicians' offices; (2) Of a type commonly rendered either without charge or included in the rural health clinic's bill; (3) Furnished as an incidental, although integral part of professional services furnished by a nurse practitioner, physician assistant, nurse midwife, or specialized nurse practitioner; (4) Furnished under the direct, personal supervision of a nurse practitioner, physician assistant, nurse midwife, specialized nurse practitioner or a physician; and (5) In the case of a service, furnished by a member of the clinic's health care staff who is an employee of the clinic. (b) The direct personal supervision requirement is met in the case of a nurse practitioner, physician assistant, nurse midwife, or specialized nurse practitioner only if such a person is permitted to supervise such services under the written policies governing the rural health clinic. (c) Only drugs and biologicals which cannot be self-administered are included within the scope of this benefit. (a) Visiting nurse services are covered if: (1) The rural health clinic is located in an area in which the Secretary has determined that there is a shortage of home health agencies; (2) The services are rendered to a homebound individual; (3) The services are furnished by a registered nurse, licensed practical nurse, or licensed vocational nurse who is employed by, or receives compensation for the services from the clinic; and (4) The services are furnished under a written plan of treatment that is: (i) Established and reviewed at least every 60 days by a supervising physician of the rural health clinic or established by a nurse practitioner, physician assistant, nurse midwife, or specialized nurse practitioner and reviewed at least every 60 days by a supervising physician; and (ii) Signed by the nurse practitioner, physician assistant, nurse midwife, specialized nurse practitioner, or the supervising physician of the clinic. (b) The nursing care covered by this section includes: (1) Services that must be performed by a registered nurse, licensed practical nurse, or licensed vocational nurse if the safety of the patient is to be assured and the medically desired results achieved; and (2) Personal care services, to the extent covered under Medicare as home health services. These services include helping the patient to bathe, to get in and out of bed, to exercise and to take medications. (c) This benefit does not cover household and housekeeping services or other services that would constitute custodial care. (d)Forpurposesofthissection, homebound means an individual who is permanently or temporarily confined to his or her place of residence because of a medical or health condition. The individual may be considered homebound if he or she leaves the place of residence infrequently. For this purpose, “place of residence” does not include a hospital or long term care facility. A shortage of home health agencies exists if the Secretary determines that the rural health clinic: (a) Is located in a county, parish, or similar geographic area in which there is no participating home health agency or adequate home health services are not available to patients of the rural health clinic; (b) Has (or expects to have) patients whose permanent residences are not within the area serviced by a participating home health agency; or (c) Has (or expects to have) patients whose permanent residences are not within a reasonable traveling distance, based on climate and terrain, of a participating home health agency. Source: 57 FR 24978, June 12, 1992, unless otherwise noted.
(a) Filing procedures. (1) In response to a request from an entity that wishes to participate in the Medicare program, CMS enters into an agreement with an entity when— (i) PHS recommends that the entity qualifies as a Federally qualified health center; (ii) The Federally qualified health center assures CMS that it meets the Federally qualified health center requirements specified in this subpart and part 491, as described in §405.2434(a); and (iii) The FQHC terminates other provider agreements, unless the FQHC assures CMS that it is not using the same space, staff and resources simultaneously as a physician's office or another type of provider or supplier. A corporate entity may own other provider types as long as the provider types are distinct from the FQHC. (2) CMS sends the entity a written notice of the disposition of the request. (3) When the requirement of paragraph (a)(1) of this section is satisfied, CMS sends the entity two copies of the agreement. The entity must sign and return both copies of the agreement to CMS. (4) If CMS accepts the agreement filed by the Federally qualified health center, CMS returns to the center one copy of the agreement with the notice of acceptance specifying the effective date (see §489.11), as determined under §405.2434. (b) Recommendations by PHS about Federally qualified health centers. (1) An entity must— (i) Meet the applicable requirements of the PHS Act, as specified in §405.2401(b); and (ii) Be recommended by PHS to CMS as a Federally qualified health center. (2) The PHS notifies CMS of entities that meet the requirements specified in §405.2401(b). (c) Provider-based and freestanding Federally qualified health centers. The requirements and benefits under Medicare for provider-based or freestanding Federally qualified health centers are the same, except that payment methodologies differ, as described in §405.2462. (d) Appeals. An entity is entitled to a hearing in accordance with part 498 of this chapter when CMS fails to enter into an agreement with the entity. [57 FR 24978, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996] Under the agreement, the Federally qualified health center must agree to the following: (a) Maintain compliance with the requirements. (1) The Federally qualified health center must agree to maintain compliance with the Federally qualified health center requirements set forth in this subpart and part 491, except that the provisions of §491.3 do not apply. (2) Centers must promptly report to CMS any changes that result in noncompliance with any of these requirements. (b) Effective date of agreement. (1) Except as specified in paragraph (b)(2) of this section, the effective date of the agreement is the date CMS accepts the signed agreement, which assures that all Federal requirements are met. (2) For facilities that met all requirements on October 1, 1991, the effective date of the agreement can be October 1, 1991. (c) Charges to beneficiaries. (1) The beneficiary is responsible for payment of a coinsurance amount which is 20 percent of the amount of Part B payment made to the Federally qualified health center for the covered services. There is no coinsurance for a second or third opinion obtained in accordance with section 1164 of the Act or for pneumococcal vaccine and its administration. (2) The beneficiary is responsible for blood deductible expenses, as specified in §410.161. (3) The Federally qualified health center agrees not to charge the beneficiary (or any other person acting on behalf of a beneficiary) for any Federally qualified health center services for which the beneficiary is entitled to have payment made on his or her behalf by the Medicare program (or for which the beneficiary would have been entitled if the Federally qualified health center had filed a request for payment in accordance with §410.165 of this chapter), except for coinsurance amounts. (4) The Federally qualified health center may charge the beneficiary for items and services that are not Federally qualified health center services. However, if the item or service is covered under Part B of Medicare, and the Federally qualified health center agrees to receive Part B payment under the assignment method, the Federally qualified health center may not charge the beneficiary more than 20 percent of the Part B payment. (d) Refunds to beneficiaries. (1) The Federally qualified health center must agree to refund as promptly as possible any money incorrectly collected from Medicare beneficiaries or from someone on their behalf. (2) As used in this section, “money incorrectly collected” means any amount for covered services that is greater than the amount for which the beneficiary was liable because of the coinsurance requirements specified in part 410, subpart E. (3) Amounts also are considered incorrectly collected if the Federally qualified health center believed the beneficiary was not entitled to Medicare benefits but— (i) The beneficiary was later determined to have been so entitled; (ii) The beneficiary's entitlement period fell within the time the Federally qualified health center's agreement with CMS was in effect; and (iii) The amounts exceed the beneficiary's coinsurance liability. (e) Treatment of beneficiaries. (1) The Federally qualified health center must agree to accept Medicare beneficiaries for care and treatment. (2) The Federally qualified health center may not impose any limitations with respect to care and treatment of Medicare beneficiaries that it does not also impose upon all other persons seeking care and treatment from the Federally qualified health center. Failure to comply with this requirement is a cause for termination of the Federally qualified health center's agreement with CMS in accordance with §405.2436(d). (3) If the Federally qualified health center does not furnish treatment for certain illnesses and conditions to patients who are not Medicare beneficiaries, it need not furnish such treatment to Medicare beneficiaries. (a) Termination by Federally qualified health center. The Federally qualified health center may terminate its agreement by— (1) Filing with CMS a written notice stating its intention to terminate the agreement; and (2) Notifying CMS of the date on which the Federally qualified health center requests that the termination take effect. (b) Effective date. (1) Upon receiving a Federally qualified health center's notice of intention to terminate the agreement, CMS will set a date upon which the termination takes effect. This effective date may be— (i) The date proposed by the Federally qualified health center in its notice of intention to terminate, if that date is acceptable to CMS; or (ii) Except as specified in paragraph (2) of this section, a date set by CMS, which is no later than 6 months after the date CMS receives the Federally qualified health center's notice of intention to terminate. (2) The effective date of termination may be less than 6 months following CMS's receipt of the Federally qualified health center's notice of intention to terminate if CMS determines that termination on such a date would not— (i) Unduly disrupt the furnishing of Federally qualified health center services to the community; or (ii) Otherwise interfere with the effective and efficient administration of the Medicare program. (3) The termination is effective at the end of the last day of business as a Federally qualified health center. (c) Termination by CMS. (1) CMS may terminate an agreement with a Federally qualified health center if it finds that the Federally qualified health center— (i) No longer meets the requirements specified in this subpart; or (ii) Is not in substantial compliance with— (A) The provisions of the agreement; or (B) The requirements of this subpart, any other applicable regulations of this part, or any applicable provisions of title XVIII of the Act. (2) Notice by CMS. CMS will notify the Federally qualified health center in writing of its intention to terminate an agreement at least 15 days before the effective date stated in the written notice. (3) Appeal. A Federally qualified health center may appeal CMS's decision to terminate the agreement in accordance with part 498 of this chapter. (d) Effect of termination. When a Federally qualified health center's agreement is terminated whether by the Federally qualified health center or CMS, payment will not be available for Federally qualified health center services furnished on or after the effective date of termination. When CMS has terminated an agreement with a Federally qualified health center, CMS will not enter into another agreement with the Federally qualified health center to participate in the Medicare program unless CMS— (a) Finds that the reason for the termination no longer exists; and (b) Is assured that the reason for the termination of the prior agreement will not recur. (a) When the Federally qualified health center voluntarily terminates the agreement and an effective date is set for the termination, the Federally qualified health center must notify the public prior to a prospective effective date or on the actual day that business ceases, if no prospective date of termination has been set, through publication in at least one newspaper in general circulation in the area serviced by the Federally qualified health center of the— (1) Effective date of termination of the provision of services; and (2) Effect of termination of the agreement. (b) When CMS terminates the agreement, CMS will notify the public through publication in at least one newspaper in general circulation in the Federally qualified health center's service area. (a) What constitutes change of ownership—(1) Incorporation. The incorporation of an unincorporated FQHC constitutes change of ownership. (2) Merger. The merger of the center corporation into another corporation, or the consolidation of two or more corporations, one of which is the center corporation, resulting in the creation of a new corporation, constitutes a change of ownership. (The merger of another corporation into the center corporation does not constitute change of ownership.) (3) Leasing. The lease of all or part of an entity constitutes a change of ownership of the leased portion. (b) Notice to CMS. A center which is contemplating or negotiating change of ownership must notify CMS. (c) Assignment of agreement. When there is a change of ownership as specified in paragraph (a) of this section, the agreement with the existing center is automatically assigned to the new owner if it continues to meet the conditions to be a Federally qualified health center. (d) Conditions that apply to assigned agreements. An assigned agreement is subject to all applicable statutes and regulations and to the terms and conditions under which it was originally issued including, but not limited to, the following: (1) Compliance with applicable health and safety standards. (2) Compliance with the ownership and financial interest disclosure requirements of part 420, subpart C of this subchapter. (a) For purposes of this section, the terms rural health clinic and clinic when they appear in the cross references in paragraph (b) of this section also mean Federally qualified health centers. (b) FQHC services that are paid for under this subpart are outpatient services that include the following: (1) Physician services specified in §405.2412. (2) Services and supplies furnished as an incident to a physician's professional services, as specified in §405.2413. (3) Nurse practitioner or physician assistant services specified in §405.2414. (4) Services and supplies furnished as an incident to a nurse practitioner or physician assistant services, as specified in §405.2415. (5) Clinical psychologist and clinical social worker services specified in §405.2450. (6) Services and supplies furnished as an incident to a clinical psychologist or clinical social worker services, as specified in §405.2452. (7) Visiting nurse services specified in §405.2416. (8) Nurse-midwife services specified in §405.2401. (9) Preventive primary services specified in §405.2448 of this subpart. (c) Federally qualified health center services are covered when provided in outpatient settings only, including a patient's place of residence, which may be a skilled nursing facility or a nursing facility or other institution used as a patient's home. (d) Federally qualified health center services are not covered in a hospital, as defined in section 1861(e)(1) of the Act. [57 FR 24979, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996] (a) Preventive primary services are those health services that— (1) A center is required to provide as preventive primary health services under section 329, 330, and 340 of the Public Health Service Act; (2) Are furnished by or under the direct supervision of a nurse practitioner, physician assistant, nurse midwife, specialized nurse practitioner, clinical psychologist, clinical social worker, or a physician; (3) In the case of a service, are furnished by a member of the center's health care staff who is an employee of the center or by a physician under arrangements with the center; and (4) Except as specifically provided in section 1861(s) of the Act, include only drugs and biologicals that cannot be self-administered. (b) Preventive primary services which may be paid for when provided by Federally qualified health centers are the following: (1) Medical social services. (2) Nutritional assessment and referral. (3) Preventive health education. (4) Children's eye and ear examinations. (5) Prenatal and post-partum care. (6) Perinatal services. (7) Well child care, including periodic screening. (8) Immunizations, including tetanus-diptheria booster and influenza vaccine. (9) Voluntary family planning services. (10) Taking patient history. (11) Blood pressure measurement. (12) Weight. (13) Physical examination targeted to risk. (14) Visual acuity screening. (15) Hearing screening. (16) Cholesterol screening. (17) Stool testing for occult blood. (18) Dipstick urinalysis. (19) Risk assessment and initial counseling regarding risks. (20) Tuberculosis testing for high risk patients. (21) For women only. (i) Clinical breast exam. (ii) Referral for mammography; and (iii) Thyroid function test. (c) Preventive primary services do not include group or mass information programs, health education classes, or group education activities, including media productions and publications. (d) Screening mammography is not considered a Federally qualified health center service, but may be provided at a Federally qualified health center if the center meets the requirements applicable to that service specified in §410.34 of this subchapter. Payment is made under applicable Medicare requirements. (e) Preventive primary services do not include eyeglasses, hearing aids, or preventive dental services. [57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996] (a) For clinical psychologist or clinical social worker professional services to be payable under this subpart, the services must be— (1) Furnished by an individual who owns, is employed by, or furnishes services under contract to the FQHC; (2) Of a type that the clinical psychologist or clinical social worker who furnishes the services is legally permitted to perform by the State in which the service is furnished; (3) Performed by a clinical social worker or clinical psychologist who is legally authorized to perform such services under State law or the State regulatory mechanism provided by the law of the State in which such services are performed; and (4) Covered if furnished by a physician. (b) If State law prescribes a physician supervision requirement, it is met if the conditions specified in §491.8(b) of this chapter and any pertinent requirements of State law are satisfied. (c) The services of clinical psychologists or clinical social workers are not covered if State law or regulations require that the services be performed under a physician's order and no such order was prepared. [57 FR 24980, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996] (a) Services and supplies incident to a clinical psychologist's or clinical social worker's services are reimbursable under this subpart if the service or supply is— (1) Of a type commonly furnished in a physician's office; (2) Of a type commonly furnished either without charge or included in the Federally qualified health center's bill; (3) Furnished as an incidental, although integral part of professional services furnished by a clinical psychologist or clinical social worker; (4) Furnished under the direct, personal supervision of a clinical psychologist, clinical social worker or physician; and (5) In the case of a service, furnished by a member of the center's health care staff who is an employee of the center. (b) The direct personal supervision requirement in paragraph (a)(4) of this section is met only if the clinical psychologist or clinical social worker is permitted to supervise such services under the written policies governing the Federally qualified health center.
Title 42: Public Health
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart X—Rural Health Clinic and Federally Qualified Health Center Services
§ 405.2400 Basis.
§ 405.2401 Scope and definitions.
§ 405.2402 Basic requirements.
§ 405.2403 Content and terms of the agreement with the Secretary.
§ 405.2404 Terminations of agreements.
§ 405.2410 Application of Part B deductible and coinsurance.
§ 405.2411 Scope of benefits.
§ 405.2412 Physicians' services.
§ 405.2413 Services and supplies incident to a physician's services.
§ 405.2414 Nurse practitioner and physician assistant services.
§ 405.2415 Services and supplies incident to nurse practitioner and physician assistant services.
§ 405.2416 Visiting nurse services.
§ 405.2417 Visiting nurse services: Determination of shortage of agencies.
Federally Qualified Health Center Services
§ 405.2430 Basic requirements.
§ 405.2434 Content and terms of the agreement.
§ 405.2436 Termination of agreement.
§ 405.2440 Conditions for reinstatement after termination by CMS.
§ 405.2442 Notice to the public.
§ 405.2444 Change of ownership.
§ 405.2446 Scope of services.
§ 405.2448 Preventive primary services.
§ 405.2450 Clinical psychologist and clinical social worker services.
§ 405.2452 Services and supplies incident to clinical psychologist and clinical social worker services.
Payment for Rural Health Clinic and Federally Qualified Health Center Services
Source: 57 FR 24976, 24977, June 12, 1992, unless otherwise noted.
§ 405.2460 Applicability of general payment exclusions.
The payment conditions, limitations, and exclusions set out in subpart C of this part, part 410 and part 411 of this chapter are applicable to payment for services provided by rural health clinics and Federally qualified health centers, except that preventive primary services, as defined in §405.2448, are covered in Federally qualified health centers and not excluded by the provisions of section 1862(a) of the Act.
§ 405.2462 Payment for rural health clinic services and Federally qualified health clinic services.
(a) General rules. (1) RHCs and FQHCs are paid on the basis of 80 percent of an all-inclusive rate per visit determined by the fiscal intermediary for each beneficiary visit for covered services, subject to an annual payment limit.
(2) The fiscal intermediary determines the all-inclusive rate in accordance with this subpart and instructions issued by CMS.
(3) If an RHC is an integral and subordinate part of a hospital, it can receive an exception to the per-visit payment limit if the hospital has fewer than 50 beds as determined by using one of the following methods:
(i) The determination of the number of beds at §412.105(b) of this chapter.
(ii) The hospital's average daily patient census count of those beds described in §412.105(b) of this chapter, and the hospital meets all of the following conditions:
(A) It is a sole community hospital as determined in accordance with §412.92 or 412.109(a) of this chapter.
(B) It is located in a level 8 or level 9 nonmetropolitan county using urban influence codes as defined by the U.S. Department of Agriculture.
(C) It has an average daily patient census that does not exceed 40.
(b) Payment procedures. To receive payment, an RHC or FQHC must follow the payment procedures specified in §410.165 of this chapter.
(c) Mental health limitation. Payment for the outpatient treatment of mental, psychoneurotic, or personality disorders is subject to the limitations on payment in §410.155(c) of this chapter.
[69 FR 74816, Dec. 24, 2003]
§ 405.2463 What constitutes a visit.
(a) Visit. (1) A visit is a face-to-face encounter between a clinic or center patient and a physician, physician assistant, nurse practitioner, nurse-midwife, or visiting nurse.
(2) For FQHCs, a visit also means a face-to-face encounter between a patient and a qualified clinical psychologist or clinical social worker.
(3) Encounters with more than one health professional and multiple encounters with the same health professional that take place on the same day and at a single location constitute a single visit, except when one of the following conditions exist:
(i) After the first encounter, the patient suffers illness or injury requiring additional diagnosis or treatment.
(ii) For FQHCs, the patient has a medical visit and an other health visit, as defined in paragraphs (b) and (c) of this section.
(4) Payment. (i) Medicare pays for two visits per day when the conditions in paragraph (a)(3) of this section are met.
(ii) In all other cases, payment is limited to one visit per day.
(b) Medical visit. For purposes of paragraph (a)(3) of this section, a medical visit is a face-to-face encounter between an FQHC patient and a physician, physician assistant, nurse practitioner, nurse-midwife, or visiting nurse.
(c) Other health visit. For purposes of paragraph (a)(3) of this section, an other health visit is a face-to-face encounter between an FQHC patient and a clinical psychologist, clinical social worker, or other health professional for mental health services.
[61 FR 14657, Apr. 3, 1996]
§ 405.2464 All-inclusive rate.
(a) Determination of rate. (1) An all-inclusive rate is determined by the intermediary at the beginning of the reporting period.
(2) The rate is determined by dividing the estimated total allowable costs by estimated total visits for rural health clinic or Federally qualified health center services.
(3) The rate determination is subject to any tests of reasonableness that may be established in accordance with this subpart.
(b) Adjustment of rate. (1) The intermediary, during each reporting period, periodically reviews the rate to assure that payments approximate actual allowable costs and visits for rural health clinic or Federally qualified health center services and adjusts the rate if:
(i) There is a significant change in the utilization of clinic or center services;
(ii) Actual allowable costs vary materially from the clinic or center's allowable costs; or
(iii) Other circumstances arise which warrant an adjustment.
(2) The clinic or center may request the intermediary to review the rate to determine whether adjustment is required.
§ 405.2466 Annual reconciliation.
(a) General. Payments made to a rural health clinic or a Federally qualified health center during a reporting period are subject to reconciliation to assure that those payments do not exceed or fall short of the allowable costs attributable to covered services furnished to Medicare beneficiaries during that period.
(b) Calculation of reconciliation. (1) The total reimbursement amount due the clinic or center for covered services furnished to Medicare beneficiaries is based on the report specified in §405.2470(c)(2) and is calculated by the intermediary as follows:
(i) The average cost per visit is calculated by dividing the total allowable cost incurred for the reporting period by total visits for rural health clinic or Federally qualified health center services furnished during the period. The average cost per visit is subject to tests of reasonableness which may be established in accordance with this subpart.
(ii) The total cost of rural health clinic or Federally qualified health center services furnished to Medicare beneficiaries is calculated by multiplying the average cost per visit by the number of visits for covered rural health clinic or Federally qualified health center services by beneficiaries.
(iii) For rural health clinics, the total reimbursement due the clinic is 80 percent of the amount calculated by subtracting the amount of deductible incurred by beneficiaries that is attributable to rural health clinic services from the cost of these services. The reimbursement computation for Federally qualified health centers does not include a reduction related to the deductible because Federally qualified health center services are not subject to a deductible.
(iv) For rural health clinics and FQHCs, payment for pneumococcal and influenza vaccine and their administration is 100 percent of Medicare reasonable cost.
(2) The total reimbursement amount due is compared with total payments made to the clinic or center for the reporting period, and the difference constitutes the amount of the reconciliation.
(c) Notice of program reimbursement. The intermediary sends written notice to the clinic or center:
(1) Setting forth its determination of the total reimbursement amount due the clinic or center for the reporting period and the amount, if any, of the reconciliation; and
(2) Informing the clinic or center of its right to have the determination reviewed at a hearing under the procedures set forth in subpart R of this part.
(d) Payment of reconciliation amount—(1) Underpayments. If the total reimbursement due the clinic or center exceeds the payments made for the reporting period, the intermediary makes a lump-sum payment to the clinic or center to bring total payments into agreement with total reimbursement due the clinic or center.
(2) Overpayments. If the total payments made to a clinic or center for the reporting period exceed the total reimbursement due the clinic or center for the period, the intermediary arranges with the clinic or center for repayment through a lump-sum refund, or, if that poses a hardship for the clinic or center, through offset against subsequent payments or a combination of offset and refund. The repayment must be completed as quickly as possible, generally within 12 months from the date of the notice of program reimbursement. A longer repayment period may be agreed to by the intermediary if the intermediary is satisfied that unusual circumstances exist which warrant a longer period.
[57 FR 24976, June 12, 1992, as amended at 61 FR 14657, Apr. 3, 1996]
§ 405.2468 Allowable costs.
(a) Applicability of general Medicare principles. In determining whether and to what extent a specific type or item of cost is allowable, such as interest, depreciation, bad debts and owner compensation, the intermediary applies the principles for reimbursement of provider costs, as set forth in part 413 of this subchapter.
(b) Typical rural health clinic and Federally qualified health center costs. The following types and items of cost are included in allowable costs to the extent that they are covered and reasonable:
(1) Compensation for the services of a physician, physician assistant, nurse practitioner, nurse-midwife, visiting nurse, qualified clinical psychologist, and clinical social worker who owns, is employed by, or furnishes services under contract to an FQHC. (RHCs are not paid for services furnished by contracted individuals other than physicians.)
(2) Compensation for the duties that a supervising physician is required to perform under the agreement specified in §491.8 of this chapter.
(3) Costs of services and supplies incident to the services of a physician, physician assistant, nurse practitioner, nurse-midwife, qualified clinical psychologist, or clinical social worker.
(4) Overhead costs, including clinic or center administration, costs applicable to use and maintenance of the entity, and depreciation costs.
(5) Costs of services purchased by the clinic or center.
(c) Tests of reasonableness for rural health clinic cost and utilization. Tests of reasonableness authorized by sections 1833(a) and 1861(v)(1)(A) of the Act may be established by CMS or the carrier with respect to direct or indirect overall costs, costs of specific items and services, or costs of groups of items and services. Those tests include, but are not limited to, screening guidelines and payment limitations.
(d) Screening guidelines. (1) Costs in excess of amounts established by the guidelines are not included unless the clinic or center provides reasonable justification satisfactory to the intermediary.
(2) Screening guidelines are used to assess the costs of services, including the following:
(i) Compensation for the professional and supervisory services of physicians and for the services of physician assistants, nurse practitioners, and nurse-midwives.
(ii) Services of physicians, physician assistants, nurse practitioners, nurse-midwives, visiting nurses, qualified clinical psychologists, and clinical social workers.
(iii) The level of administrative and general expenses.
(iv) Staffing (for example, the ratio of other clinic or center personnel to physicians, physician assistants, and nurse practitioners).
(v) The reasonableness of payments for services purchased by the clinic or center, subject to the limitation that the costs of physician services purchased by the clinic or center may not exceed amounts determined under the applicable provisions of subpart E of part 405 or part 415 of this chapter.
(e) Payment limitations. Limits on payments may be set by CMS, on the basis of costs estimated to be reasonable for the provision of such services.
(f) Graduate medical education. (1) Effective for that portion of cost reporting periods occurring on or after January 1, 1999, if an RHC or an FQHC incurs “all or substantially all” of the costs for the training program in the nonhospital setting as defined in §413.75(b) of this chapter, the RHC or FQHC may receive direct graduate medical education payment for those residents.
(2) Direct graduate medical education costs are not included as allowable cost under §405.2466(b)(1)(i); and therefore, are not subject to the limit on the all-inclusive rate for allowable costs.
(3) Allowable graduate medical education costs must be reported on the RHC's or the FQHC's cost report under a separate cost center.
(4) Allowable graduate medical education costs are non-reimbursable if payment for these costs are received from a hospital or a Medicare+Choice organization.
(5) Allowable direct graduate medical education costs under paragraphs (f)(6) and (f)(7)(i) of this section, are subject to reasonable cost principles under part 413 and the reasonable compensation equivalency limits in §§415.60 and 415.70 of this chapter.
(6) The allowable direct graduate medical education costs are those costs incurred by the nonhospital site for the educational activities associated with patient care services of an approved program, subject to the redistribution and community support principles in §413.85(c).
(i) The following costs are allowable direct graduate medical education costs to the extent that they are reasonable—
(A) The costs of the residents' salaries and fringe benefits (including travel and lodging expenses where applicable).
(B) The portion of teaching physicians' salaries and fringe benefits that are related to the time spent teaching and supervising residents.
(C) Facility overhead costs that are allocated to direct graduate medical education.
(ii) The following costs are not allowable graduate medical education costs—
(A) Costs associated with training, but not related to patient care services.
(B) Normal operating and capital-related costs.
(C) The marginal increase in patient care costs that the RHC or FQHC experiences as a result of having an approved program.
(D) The costs associated with activities described in §413.85(h) of this chapter.
(7) Payment is equal to the product of—
(i) The RHC's or the FQHC's allowable direct graduate medical education costs; and
(ii) Medicare's share, which is equal to the ratio of Medicare visits to the total number of visits (as defined in §405.2463).
(8) Direct graduate medical education payments to RHCs and FQHCs made under this section are made from the Federal Supplementary Medical Insurance Trust Fund.
[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24977, June 12, 1992; 60 FR 63176, Dec. 8, 1995; 61 FR 14658, Apr. 3, 1996; 63 FR 41002, July 31, 1998; 66 FR 39932, Aug. 1, 2001; 70 FR 47484, Aug. 12, 2005]
§ 405.2469 Federally Qualified Health Centers supplemental payments.
Federally Qualified Health Centers under contract (directly or indirectly) with Medicare Advantage organizations are eligible for supplemental payments for covered Federally Qualified Health Center services furnished to enrollees in Medicare Advantage plans offered by the Medicare Advantage organization to cover the difference, if any, between their payments from the Medicare Advantage plan and what they would receive under the cost-based Federally Qualified Health Center payment system.
(a) Calculation of supplemental payment. (1) The supplemental payment for Federally Qualified Health Center covered services provided to Medicare patients enrolled in Medicare Advantage plans is based on the difference between—
(i) Payments received by the center from the Medicare Advantage plan as determined on a per visit basis; and
(ii) The Federally Qualified Health Center's all-inclusive cost-based per visit rate as set forth in this subpart, less any amount the FQHC may charge as described in section 1857(e)(3)(B) of the Act.
(2) Any financial incentives provided to Federally Qualified Health Centers under their Medicare Advantage contracts, such as risk pool payments, bonuses, or withholds, are prohibited from being included in the calculation of supplemental payments due to the Federally Qualified Health Center.
(b) Per visit supplemental payment. A supplemental payment required under this section is made to the Federally Qualified Health Center when a covered face-to-face encounter occurs between a Medicare Advantage enrollee and a practitioner as set forth in §405.2463.
[70 FR 70329, Nov. 21, 2005, as amended at 71 FR 9460, Feb. 24, 2006]
§ 405.2470 Reports and maintenance of records.
(a) Maintenance and availability of records. The rural health clinic or Federally qualified health center must:
(1) Maintain adequate financial and statistical records, in the form and containing the data required by CMS, to allow the intermediary to determine payment for covered services furnished to Medicare beneficiaries in accordance with this subpart;
(2) Make the records available for verification and audit by HHS or the General Accounting Office;
(3) Maintain financial data on an accrual basis, unless it is part of a governmental institution that uses a cash basis of accounting. In the latter case, appropriate depreciation on capital assets is allowable rather than the expenditure for the capital asset.
(b) Adequacy of records. (1) The intermediary may suspend reimbursement if it determines that the clinic or center does not maintain records that provide an adequate basis to determine payments under Medicare.
(2) The suspension continues until the clinic or center demonstrates to the intermediary's satisfaction that it does, and will continue to, maintain adequate records.
(c) Reporting requirements—(1) Initial report. At the beginning of its initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for rural health clinic or Federally qualified health center services for the reporting period, in the form and detail required by CMS, and such other information as CMS may require to establish the payment rate.
(2) Annual reports. Within 90 days after the end of its reporting period, the clinic or center must submit, in such form and detail as may be required by CMS, a report of:
(i) Its operations, including the allowable costs actually incurred for the period and the actual number of visits for rural health clinic or Federally qualified health center services furnished during the period; and
(ii) The estimated costs and visits for rural health clinic services or Federally qualified health center services for the succeeding reporting period and such other information as CMS may require to establish the payment rate.
(3) Late reports. If the clinic or center does not submit an adequate annual report on time, the intermediary may reduce or suspend payments to preclude excess payment to the clinic or center.
(4) Inadequate reports. If the clinic or center does not furnish a report or furnishes a report that is inadequate for the intermediary to make a determination of program payment, CMS may deem all payments for the reporting period to be overpayments.
(5) Postponement of due date. For good cause shown by the clinic or center, the intermediary may, with CMS's approval, grant a 30-day postponement of the due date for the annual report.
(6) Reports following termination of agreement or change of ownership. The report from a clinic or center which voluntarily or involuntarily ceases to participate in the Medicare program or experiences a change in ownership (see §§405.2436–405.2438) is due no later than 45 days following the effective date of the termination of agreement or change of ownership.
§ 405.2472 Beneficiary appeals.
A beneficiary may request a hearing by an intermediary (subject to the limitations and conditions set forth in subpart H of this part) if:
(a) The beneficiary is dissatisfied with an intermediary's determination denying a request for payment made on his or her behalf by a rural health clinic or Federally qualified health center; or
(b) The beneficiary is dissatisfied with the amount of payment; or
(c) The beneficiary believes the request for payment is not being acted upon with reasonable promptness.
[43 FR 8261, Mar. 1, 1978. Redesignated and amended at 57 FR 24978, June 12, 1992]
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