)5.618-405.621, of any amounts inectly collected from an individual, or any other person on his behalf. 5.608 Allowable charges; deductible, coinsurance and copayment.

) Subject to the provisions of parahs (b) and (c) of this section, a cipating provider of services may ge an individual, or other person: > The amount of the inpatient hosdeductible or if less, the actual ges for such services (see § 405.113) he amount of inpatient hospital co'ance for each day the individual is shed inpatient hospital services dur

spell of illness after the 60th day before the 91st day or the 151st day, plicable (see § 405.115);

With respect to outpatient hosdiagnostic services furnished on or e March 31, 1968, the outpatient tal diagnostic services deductible for iduals covered only under the hosinsurance program, and 20 percent e reasonable charges for outpatient tal diagnostic services during a distic study period for which payment ade under the hospital insurance

The posthospital extended care ces coinsurance amount;

The $50 supplementary medical ince deductible;

Twenty percent of the reasonable es in excess of the $50 deductible for and services covered under the ementary medical insurance plan. After March 31, 1968, where a hosrendering outpatient services to a iciary enrolled under part B is unto determine the individual's deole status (for example, where the dual does not furnish the hospital official information as to his deole status such as his Explanation

efits or Utilization Notice) the hosmay, notwithstanding the limitaof 405.608(a) (4) and (5), charge eneficiary its full customary charges ch services, but only if such charges uch services do not exceed $50. e the beneficiary furnishes the hoswith official information as to his tible status, the hospital may e the beneficiary only the unmet n of his deductible and the 20 percoinsurance amount. In either case ospital is required to file with the nediary information as to the serv

(a) Hospital insurance program; allowable charges. A provider of services may charge an individual or other person for any of the first 3 pints of whole blood furnished the individual on or before December 31, 1967, as an inpatient during a spell of illness. With respect to blood furnished an individual on or after January 1, 1968, under the hospital insurance program, a provider may in accordance with its customary practice also appropriately charge the individual or other person for any of the first 3 pints of whole blood or equivalent quantities of packed red blood cells furnished in a spell of illness. Charges to the individual are subject to the following conditions:

(1) A provider may not charge an individual for whole blood (or packed red blood cells) furnished such individual more than the amount customarily charged by it for such items.

(2) No charge may be made for any of such first 3 pints of whole blood (or packed red blood cells) which have been replaced pint for pint by, or on behalf of the individual, or for which arrangements have been made for replacement on his behalf.

(b) Supplementary medical insurance program; allowable charges. A provider of services may charge an individual or other person for any of the first 3 pints of whole blood or equivalent quantities of packed red blood cells (see however, § 405.231 regarding drugs and biologicals which cannot be self-administered) furnished an individual in a calendar year beginning on or after January 1, 1968. Charges made to the individual or other person are subject to the conditions described in subparagraphs (1) and (2) of paragraph (a) of this section.

(c) Excess charges. Any excess of such charge over the cost incurred by the pro

vider for such whole blood (or packed red blood cells) shall be deducted from any payment to such provider under this Part 405.

[33 F.R. 20038, Dec. 31, 1968]

§ 405.610

Allowable charges; items or services more expensive than, or in excess of, those for which payment may be made.

Where items or services furnished by a provider of services at the request of an individual are more expensive than, or in excess of, items and services for which an individual is entitled to have payment made under the provisions described in Subpart A and B of this Part 405, a provider of services may charge such individual an amount equal to the difference between that amount which the provider of services customarily charges for such items or services and the amount customarily charged by it for the items or services with respect to which payment can be made under title XVIII of the Act. To avoid misunderstanding and disputes the provider should inform the individual who requests a service for which a charge will be made, that there will be a charge of specified amount for the service.

§ 405.612 Compliance with procedural and other requirements; individual's refusal to execute request for pay

ment.

(a) For purposes of § 405.607(a) (2), compliance with procedural and other requirements means that the provider of services:

(1) Has secured, from the individual or a proper person acting on his behalf, a written request for payment to be made to the provider, and the provider has properly filed such request; and

(2) Has in its files the required certification and recertification by a physician relating to the services furnished to the individual (see §§ 405.1625405.1634); and

(3) Has furnished to the Secretary such information as the Secretary has found necessary in order to determine the amount due the provider on behalf of the individual for the period with respect to which payment is to be made or any prior period; and

(4) Has complied with the provisions requiring timely utilization review of long stay cases so that a limitation on days of service has not been imposed under section 1866(d) of the Act (see § 405.617).

(b) Failure on the part of the provider to be in compliance with each of the procedural and other requirements prescribed in paragraph (a) of this section prevents the provider from charging the individual, or any other person, for items and services for which the individual is entitled to have payment made under the the provisions described in the regulations in this Part 405, except that, the provisions of paragraph (a) of this section will not be applicable when the individual refuses to execute a written request for payment to be made on his behalf to the provider. In such cases, the provider may charge the individual, subject to the provisions of § 405.618, for all items and services furnished.

§ 405.613 Termination by provider of

services.

(a) A provider may terminate a section 1866 agreement by filing with the Secretary a written notice of its intention to terminate such agreement. The notice of intent to terminate should state the date for the termination of the agreement (the date must be the first day of a month). The Secretary may accept the termination date stated in the notice or he may set a different date. If the notice of termination does not specify the date for the termination of the agreement, the date is to be set by the Secretary. However, if the termination date is set by the Secretary, such date shall not be more than 6 months from the date the notice is filed. In addition to giving notice to the Secretary, the provider should also give at least 15 days notice to the public by publishing in one or more local newspaper a statement of the date of termination of the provider agreement with the Secretary The notice also should inform the public of the applicability of termination (see § 405.615) as it relates to the services of the provider.

(b) The Secretary may accept a notice of termination which is filed by a provider less than 6 months before the termination date, if the Secretary determines that to do so would not unduly disrupt the furnishing of services to the community serviced by the provider or otherwise interfere with the effective and efficient administration of the health insurance benefits program provided by title XVIII of the Act. If the notice of termination is accepted by the Secretary. the provider should also give notice to the

public in accordance with the provisions of paragraph (a) of this section.

(c) Notwithstanding the provisions of paragraphs (a) and (b) of this section, a cessation of business (e.g., the permanent or temporary cessation of the furnishing of services to the community by the provider) is deemed to be a voluntary termination of the agreement by the provider effective with the date of cessation of business.

§ 405.614 Termination by the Secretary.

(a) Cause for termination. The Secretary may terminate an agreement if the Secretary determines that the provider of services:

(1) Is not complying substantially with the provisions of title XVIII and this Part 405, or with the provisions of the agreement entered into pursuant to 405.606; or

(2) No longer meets the appropriate conditions of participation necessary to qualify as a hospital (see Subpart J of this part), extended care facility (see Subpart K of this part), or home health agency (see Subpart L of this part), as the case may be; or

(3) Fails to furnish information as the Secretary finds to be necessary for a determination as to whether payments are due or were due under this Part 405 and the amounts thereof; or

(4) Refuses to permit examination of its fiscal or other records by, or on behalf of, the Secretary as may be necessary for verification of information furnished as as for payment under the health inbenefits program.

tice of termination. The Secre1 give notice of termination to der of services at least 15 days he effective date of termination Her's agreement. In addition

ce to the provider, the Secso give notice of such tere public. The notice of tere Secretary shall state the of the termination of the nent and the applicability

(see § 405.615), as it rervices of the provider. by agency or institution. dissatisfied with a deterninating the section 1866 ith such provider, shall be hearing with respect to such n (see Subpart O of this

§ 405.615

Applicability of termination.

A termination of an agreement under the conditions described in § 405.613 or § 405.614, shall be applicable:

(a) In the case of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services), or posthospital extended care services, furnished to any individual who is admitted to the hospital or extended care facility furnishing such services on or after the effective day of the termination;

(b) In the case of home health services furnished to an individual under a plan therefor established on or after the effective date of such termination or, if a plan is established before such effective date, with respect to such services furnished to such individual after the calendar year in which such termination is effective; and

(c) In the case of items and services (other than those described in paragraphs (a) and (b) of this section) furnished on or after the effective date of such termination.

§ 405.616 Reinstatement of provider as participant after termination.

Where an agreement between a provider of services and the Secretary is terminated by the Secretary, such institution or agency may not file another agreement to participate in the health insurance benefits program unless the Secretary finds that the reason for the termination of the prior agreement has been removed and that there is reasonable assurance that it will not recur. § 405.617 Limitation; failure to make timely utilization review.

(a) If it is found that there is a substantial failure to make timely utilization review of long-stay cases in a hospital or extended care facility the Secretary may determine that no payment shall be made for inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or for posthospital extended care services furnished an individual after the 20th day of a continuing period of such services.

(b) Before making any such determination to withhold payment as described in paragraph (a) of this section, notice shall be given to the provider of the intention to make such determination and will afford the institution or agency an opportunity for a hearing.

(c) The limitation described in paragraph (a) of this section, shall become effective as of the date specified in the determination and shall be applicable to services furnished to individuals admitted after such date. The limitation shall remain in effect until such date as the Secretary finds that:

(1) The reason for such limitation has been removed; and

(2) There is reasonable assurance that it will not recur.

§ 405.618 Disposition of incorrect collections.

Under the terms of the agreement between a provider and the Secretary (see § 405.607), a provider must make adequate provision for the return (or other disposition) of any moneys incorrectly collected from an individual or any other person on his behalf. The term "moneys incorrectly collected" means amounts (other than those paid in accordance with the provisions of § 405.608(b)) in excess of the deductible or coinsurance, paid to a provider of services by an individual (or other person on his behalf) for items and services for which the individual is entitled to have payment made under the health insurance program. For purposes of this section, a payment by an individual to a provider which was proper when made, will be deemed to be an "incorrect collection," for which refund or other disposition must be made where the individual is retroactively entitled to hospital insurance benefits. § 405.619

Notice of charges and collections by a provider of services. Where a provider of services collects moneys from a beneficiary or any other person on his behalf, for items and services furnished to the beneficiary, such provider shall inform the intermediary of such collection (see § 405.621). § 405.620 Return or other disposition of moneys incorrectly collected.

(a) General. A provider of services in possession of an incorrect collection (see § 405.618) is required to refund or set aside the money. Until such time as the provider returns or sets aside the incorrectly collected funds, on amount equal to such incorrect collections may be offset against the amounts otherwise due the provider.

(b) Refund. Refund is to be made by the provider to the beneficiary, or any other person from whom the provider

collected the moneys. If the individual to whom refund is to be made cannot be located, or is determined to have died, the provider is to make disposition of the moneys in accordance with the applicable State law.

(c) Moneys set aside. Where it appears that refund will be delayed indefinitely, the provider of services will so notify the intermediary and will then set an amount equal to the amount incorrectly collected aside in a separate account identified as to the individual to whom the payment is due. This amount incorrectly collected will be carried on the provider's records in this manner until final disposition is made in accordance with the applicable State law.

(d) Applicable State law. The applicable State law means the law which would be applied by the courts of the State in which the hospital, extended care facility, or home health agency is located.

§ 405.621 Appropriate time limits within

which provider action must be taken.

The incorrect collection should be refunded as promptly as possible. If refund cannot be made within 60 days after the date of notice to the provider that an incorrect collection was made, an amount of money equal to the amount incorrectly collected must be set aside as described in § 405.620 (c).

§ 405.625 Transfer of provider ownership; general.

(a) A transfer of ownership of a provider of services participating in the health insurance program under an agreement with the Secretary will, under the conditions discussed in § 405.626, render such agreement invalid as between the Secretary and the transferee. In order for the new entity to participate in the program, it must be established that it meets the conditions for participation appropriate to the hospital, extended care facility or home health agency, or rehabilitation agency or clinic, as the case may be (see Subparts J, K, and L of this Part 405) and that it meets the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252; P.L. 88-352).

(b) A participating provider contemplating or negotiating a change of ownership must advise the Secretary of such a contingency to assure, if the successor owner desires to participate in the program, continued payment to the hospital,

extended care facility or home health agency, rehabilitation agency, or clinic on behalf of individuals entited under title XVIII of the Act.

§ 405.626 Change of ownership; participating in the health insurance pro

gram.

(a) Partnership. In the case of a partnership which is a party to an agreeEment with the Secretary, the removal,

addition, or the substitution of an individual for a partner in the association E generally, in the absence of an express statement to the contrary, dissolves the old partnership and creates a new partnership which is not a party to the previously executed provider agreement. I Thus, for the purpose of section 1866 of the Act, a change of ownership has occurred, the section 1866 agreement with the prior partnership is dissolved, the new entity must meet the applicable title XVIII conditions of participation set forth in Subparts J, K, and L of this Part 405 and title VI of the Civil Rights Act of 1964 (78 Stat. 252; P.L. 88-352); and an agreement must be executed and filed with the Secretary in order to establish the title XVIII obligations of the new partnership.

a

(b) Sole proprietorship. Where #participating provider of services consists of a sole proprietorship not incorporated under applicable State law, a transfer of title and property to another party, constitutes a change of ownership for the purpose of section 1866 of the Act. The I successor must establish that the apEplicable title XVIII conditions of participation and title VI of the Civil Rights Act of 1964 are met and an agreement must be filed with the Secretary by the E successor owner.

(c) Corporation. If the provider is a corporate body, a transfer of corporate Estock would not, in itself, constitute a change of ownership for the purpose of Esection 1866 of the Act. Similarly, a merger of one or more corporations with the participating provider corporation surviving would not generally require a new ; certification or the execution of a new provider agreement with the surviving entity. A consolidation of two or more corporations resulting in the creation of a new corporate entity would constitute a change of ownership, however, requir=ing a certification by the State agency and the filing of a provider agreement with the Secretary by the new corporation.

(d) Leasing. When a facility which has achieved participating provider status is leased in whole, or in part, the lessee does not assume provider status under title XVIII of the Act.

(1) If the entire provider facility is leased, the section 1866 provider agreement with the former operator of the facility terminates. If only part of the provider facility is leased, the provider agreement remains in effect with respect to the unleased portion, but a survey must be conducted to determine whether the unleased portion continues to be in compliance with the conditions for participation in the program.

(2) If the lessee of the facility requests approval as a provider of services for the purpose of participating in the program, it must be established that the leased portion of the facility meets the conditions for participation, requirements of Title VI of the Civil Rights Act of 1964, and an agreement must be filed with the Secretary by the lessee. § 405.651

or

Nomination of agency organization as "intermediary"; contractual undertakings with intermediaries.

(a) Under section 1816 of the Act, groups of providers, or associations of providers, may nominate on behalf of the members of such group or association, a national, State, or other public or private agency or organization for the purpose of entering into an agreement with the Secretary providing for the determination of amounts payable under title XVIII, and the making of such payments, by such agency or organization to providers of services. A member of a group or association may, however, deal directly with the Secretary rather than through an intermediary. The nomination of an agency or organization by a group or association of providers of services (see § 405.653) shall not be binding on any member of such group or association if such member notifies the Secretary of its desire not to be bound by such nomination.

(b) In order to accomplish the objectives of the supplementary medical insurance benefits provisions described in Subpart B of this part, with maximum efficiency and convenience to both the enrollees and providers of services furnishing medical and other health services to them and, at the same time, to coordinate the implementation of hospital insurance benefits provisions (see