Title 42—Public Health--Volume 1
PART 486—CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS
§ 486.1   Basis and scope.
(a) Statutory basis. This part is based on the following sections of the Act:
1102 and 1138(b), 1871 of the Social Security Act, section 371(b) of the Public Health Service Act—for coverage of organ procurement services.
1861(p)—for coverage of outpatient physical therapy services furnished by physical therapists in independent practice.
1861(s) (3), (15), and (17)—for coverage of portable X-ray services.
(b) Scope. (1) This part sets forth the conditions for coverage of certain specialized services that are furnished by suppliers and that are not specified in other portions of this chapter.
(2) The conditions for coverage of other specialized services furnished by suppliers are set forth in the following regulations which, unless otherwise indicated, are part of this chapter:
(i) Ambulatory surgical center (ASC) services—Part 416.
(ii) Ambulance services—Part 410, subpart B.
(iii) ESRD services—Part 405, subpart U.
(iv) Laboratory services—Part 493.
(v) Mammography services—Part 410, subpart B (§ 410.34) and 21 CFR part 900, subpart B, of the Food and Drug Administration regulations.
(vi) Rural health clinic and Federally qualified health center services—Part 491, subpart A.
§ 486.100   Condition for coverage: Compliance with Federal, State, and local laws and regulations.
The supplier of portable X-ray services is in conformity with all applicable Federal, State, and local laws and regulations.
(a) Standard—licensure or registration of supplier. In any State in which State or applicable local law provides for the licensure or registration of suppliers of X-ray services, the supplier is (1) licensed or registered pursuant to such law, or (2) approved by the agency of the State or locality responsible for licensure or registration as meeting the standards established for such licensure or registration.
(b) Standard—licensure or registration of personnel. All personnel engaged in operating portable X-ray equipment are currently licensed or registered in accordance with all applicable State and local laws.
(c) Standard—licensure or registration of equipment. All portable X-ray equipment used in providing portable X-ray services is licensed or registered in accordance with all applicable State and local laws.
(d) Standard—conformity with other Federal, State, and local laws and regulations. The supplier of portable X-ray services agrees to render such services in conformity with Federal, State, and local laws relating to safety standards.
§ 486.102   Condition for coverage: Supervision by a qualified physician.
Portable X-ray services are provided under the supervision of a qualified physician.
(a) Standard—physician supervision. The performance of the roentgenologic procedures is subject to the supervision of a physician who meets the requirements of paragraph (b) of this section and one of the following requirements is met:
(1) The supervising physician owns the equipment and it is operated only by his employees, or
(2) The supervising physician certifies annually that he periodically checks the procedural manuals and observes the operators' performance, that he has verified that equipment and personnel meet applicable Federal, State, and local licensure and registration requirements and that safe operating procedures are used.
(b) Standard—qualifications of the physician supervisor. Portable X-ray services are provided under the supervision of a licensed doctor of medicine or licensed doctor of osteopathy who is qualified by advanced training and experience in the use of X-rays for diagnostic purposes, i.e., he (1) is certified in radiology by the American Board of Radiology or by the American Osteopathic Board of Radiology or possesses qualifications which are equivalent to those required for such certification, or (2) is certified or meets the requirements for certification in a medical specialty in which he has become qualified by experience and training in the use of X-rays for diagnostic purposes, or (3) specializes in radiology and is recognized by the medical community as a specialist in radiology.
§ 486.104   Condition for coverage: Qualifications, orientation and health of technical personnel.
Portable X-ray services are provided by qualified technologists.
(a) Standard: Qualifications of technologists. All operators of the portable X-ray equipment meet the requirements of paragraph (a)(1) or (2) of this section.
(1) Successful completion of a program of formal training in X-ray technology at which the operator received appropriate training and demonstrated competence in the use of equipment and administration of portable x-ray procedures; or
(2) Successful completion of 24 full months of training and experience under the direct supervision of a physician who is certified in radiology or who possesses qualifications which are equivalent to those required for such certification.
(b) Standard—personnel orientation. The supplier of portable X-ray services has an orientation program for personnel, based on a procedural manual which is: Available to all members of the staff, incorporates relevant portions of professionally recognized documents, and includes instruction in all of the following:
(1) Precautions to be followed to protect the patient from unnecessary exposure to radiation;
(2) Precautions to be followed to protect an individual supporting the patient during X-ray procedures from unnecessary exposure to radiation;
(3) Precautions to be followed to protect other individuals in the surrounding environment from exposure to radiation;
(4) Precautions to be followed to protect the operator of portable X-ray equipment from unnecessary exposure to radiation;
(5) Considerations in determining the area which will receive the primary beam;
(6) Determination of the time interval at which to check personnel radiation monitors;
(7) Use of the personnel radiation monitor in providing an additional check on safety of equipment;
(8) Proper use and maintenance of equipment;
(9) Proper maintenance of records;
(10) Technical problems which may arise and methods of solution;
(11) Protection against electrical hazards;
(12) Hazards of excessive exposure to radiation.
(c) Standard: Employee records. Records are maintained and include evidence that—
(1) Each employee is qualified for his or her position by means of training and experience; and
(2) Employees receive adequate health supervision.
§ 486.106   Condition for coverage: Referral for service and preservation of records.
All portable X-ray services performed for Medicare beneficiaries are ordered by a physician or a nonphysician practitioner as provided in § 410.32(a) of this chapter or by a nonphysician practitioner as provided in § 410.32(a)(2) and records are properly preserved.
(a) Standard—referral by a physician or nonphysician practitioners. Portable X-ray examinations are performed only on the order of a physician licensed to practice in the State or by a nonphysician practitioner acting within the scope of State law. Such nonphysician practitioners may be treated the same as physicians treating beneficiaries for the purpose of this paragraph. The supplier's records show that:
(1) The portable X-ray test was ordered by a licensed physician or a nonphysician practitioner acting within the State scope of law; and
(2) Such physician or non-physician practitioner's order meets the requirements at § 410.32 of this chapter, and includes a statement concerning the condition of the patient which indicates why portable X-ray services are necessary.
(b) Standard—records of examinations performed. The supplier makes for each patient a record of the date of the portable X-ray examination, the name of the patient, a description of the procedures ordered and performed, the referring physician or nonphysician practitioner, the operator(s) of the portable X-ray equipment who performed the examination, the physician to whom the radiograph was sent, and the date it was sent.
(c) Standard—preservation of records. Such reports are maintained for a period of at least 2 years, or for the period of time required by State law for such records (as distinguished from requirements as to the radiograph itself), whichever is longer.
§ 486.108   Condition for coverage: Safety standards.
X-ray examinations are conducted through the use of equipment which is free of unnecessary hazards for patients, personnel, and other persons in the immediate environment, and through operating procedures which provide minimum radiation exposure to patients, personnel, and other persons in the immediate environment.
(a) Standard—tube housing and devices to restrict the useful beam. The tube housing is of diagnostic type. Diaphragms, cones, or adjustable collimators capable of restricting the useful beam to the area of clinical interest are used and provide the same degree of protection as is required of the housing.
(b) Standard—total filtration. (1) The aluminum equivalent of the total filtration in the primary beam is not less than that shown in the following table except when contraindicated for a particular diagnostic procedure.
(2) If the filter in the machine is not accessible for examination or the total filtration is unknown, it can be assumed that the requirements are met if the half-value layer is not less than that shown in the following table:
(c) Standard—termination of exposure. A device is provided to terminate the exposure after a preset time or exposure.
(d) Standard—control panel. The control panel provides a device (usually a milliammeter or a means for an audible signal to give positive indication of the production of X-rays whenever the X-ray tube is energized. The control panel includes appropriate indicators (labelled control settings and/or meters) which show the physical factors (such as kVp, mA, exposure time or whether timing is automatic) used for the exposure.
(e) Standard—exposure control switch. The exposure control switch is of the dead-man type and is so arranged that the operator can stand at least 6 feet from the patient and well away from the useful beam.
(f) Standard—protection against electrical hazards. Only shockproof equipment is used. All electrical equipment is grounded.
(g) Standard—mechanical supporting or restraining devices. Mechanical supporting or restraining devices are provided so that such devices can be used when a patient must be held in position for radiography.
(h) Standard—protective gloves and aprons. Protective gloves and aprons are provided so that when the patient must be held by an individual, that individual is protected with these shielding devices.
(i) Standard—restriction of the useful beam. Diaphragms, cones, or adjustable collimators are used to restrict the useful beam to the area of clinical interest.
(j) Standard—personnel monitoring. A device which can be worn to monitor radiation exposure (e.g., a film badge) is provided to each individual who operates portable X-ray equipment. The device is evaluated for radiation exposure to the operator at least monthly and appropriate records are maintained by the supplier of portable X-ray services of radiation exposure measured by such a device for each individual.
(k) Standard—personnel and public protection. No individual occupationally exposed to radiation is permitted to hold patients during exposures except during emergencies, nor is any other individual regularly used for this service. Care is taken to assure that pregnant women do not assist in portable X-ray examinations.
§ 486.110   Condition for coverage: Inspection of equipment.
Inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than every 24 months.
(a) Standard—qualified inspectors. Inspections are made at least every 24 months by a radiation health specialist who is on the staff of or approved by an appropriate State or local government agency.
(b) Standard—records of inspection and scope of inspection. The supplier maintains records of current inspections which include the extent to which equipment and shielding are in compliance with the safety standards outlined in § 486.108.
§ 486.301   Basis and scope.
(a) Statutory basis. (1) Section 1138(b) of the Act sets forth the requirements that an organ procurement organization (OPO) must meet to have its organ procurement services to hospitals covered under Medicare and Medicaid. These include certification as a “qualified” OPO and designation as the OPO for a particular service area.
(2) Section 371(b) of the Public Health Service Act sets forth the requirements for certification and the functions that a qualified OPO is expected to perform.
(3) Section 1102 of the Act authorizes the Secretary of Health and Human Services to make and publish rules and regulations necessary to the efficient administration of the functions that are assigned to the Secretary under the Act.
(4) Section 1871 of the Act authorizes the Secretary to prescribe regulations as may be necessary to carry out the administration of the Medicare program under title XVIII.
(b) Scope. This subpart sets forth—
(1) The conditions and requirements that an OPO must meet;
(2) The procedures for certification and designation of OPOs; and
(3) The terms of the agreement with CMS and the basis for and the effect of de-certification.
(4) The requirements for an OPO to be re-certified.
§ 486.302   Definitions.
As used in this subpart, the following definitions apply:
Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. As applied to OPOs, adverse events include but are not limited to transmission of disease from a donor to a beneficiary, avoidable loss of a medically suitable potential donor for whom consent for donation has been obtained, or delivery to a transplant center of the wrong organ or an organ whose blood type does not match the blood type of the intended beneficiary.
Agreement cycle refers to the time period of at least 4 years when an agreement is in effect between CMS and an OPO.
Assessment period is a 12-month period in which an OPO's outcome measures will be evaluated for performance. The final assessment period is the 12-month assessment period used to calculate outcome measures for re-certification.
Certification means a CMS determination that an OPO meets the requirements for certification at § 486.303.
Death record review means an assessment of the medical chart of a deceased patient to evaluate potential for organ donation.
Death that is consistent with organ donation means all deaths from the state death certificates with the primary cause of death listed as the ICD-10-CM codes I20-I25 (ischemic heart disease); I60-I69 (cerebrovascular disease); V-1-Y89 (external causes of death): Blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and asphyxiation.
Decertification means a CMS determination that an OPO no longer meets the requirements for certification at § 486.303.
Designated requestor or effective requestor is an individual (generally employed by a hospital), who is trained to handle or participate in the donation consent process. The designated requestor may request consent for donation from the family of a potential donor or from the individual(s) responsible for making the donation decision in circumstances permitted under State law, provide information about donation to the family or decision-maker(s), or provide support to or collaborate with the OPO in the donation consent process.
Designation means CMS assignment of a geographic service area to an OPO. Once an OPO is certified and assigned a geographic service area, organ procurement costs of the OPO are eligible for Medicare and Medicaid payment under section 1138(b)(1)(F) of the Act.
Donation rate is the number of donors as a percentage of the donor potential.
Donation service area (DSA) means a geographical area of sufficient size to ensure maximum effectiveness in the procurement and equitable distribution of organs and that either includes an entire metropolitan statistical area or does not include any part of such an area and that meets the standards of this subpart.
Donor means a deceased individual from whom at least one vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) is transplanted. An individual also would be considered a donor if only the pancreas is procured and is used for research or islet cell transplantation.
Donor after cardiac death (DCD) means an individual who donates after his or her heart has irreversibly stopped beating. A donor after cardiac death may be termed a non-heartbeating or asystolic donor.
Donor document means any documented indication of an individual's choice regarding his or her wishes concerning organ and/or tissue donation that was made by that individual or another authorized individual in accordance with any applicable State law.”
Donor potential is the number of inpatient deaths within the DSA among patients 75 and younger with a primary cause of death that is consistent with organ donation. For OPOs servicing a hospital with a waiver under § 486.308(e), the donor potential of the county for that hospital will be adjusted using the proportion of Medicare beneficiary inpatient deaths in the hospital compared with the total Medicare beneficiary inpatient deaths in the county.
Entire metropolitan statistical area means a metropolitan statistical area (MSA), a consolidated metropolitan statistical area (CMSA), or a primary metropolitan statistical area (PMSA) listed in the State and Metropolitan Area Data Book published by the U.S. Bureau of the Census. CMS does not recognize a CMSA as a metropolitan area for the purposes of establishing a geographical area for an OPO.
Kidney transplantation rate is the number of kidneys transplanted from kidney donors in the DSA as a percentage of the donor potential.
Lowest rate among the top 25 percent will be calculated by taking the number of total DSAs in the time period identified for establishing the threshold rate. The total number of DSAs will be multiplied by 0.25 and rounded to the closest integer (0.5 will round to the higher integer). The donation rates and organ transplantation rates in each DSA will be separately ranked and the threshold rate will be the rate that corresponds to that integer when counting down the ranking.
Open area means an OPO service area for which CMS has notified the public that it is accepting applications for designation.
Organ means a human kidney, liver, heart, lung, pancreas, or intestine (or multivisceral organs when transplanted at the same time as an intestine). The pancreas counts as an organ even if it is used for research or islet cell transplantation.
Organ procurement organization (OPO) means an organization that performs or coordinates the procurement, preservation, and transport of organs and maintains a system for locating prospective beneficiaries for available organs.
Organ transplantation rate is the number of organs transplanted from donors in the DSA as a percentage of the donor potential. Organs transplanted into patients on the OPTN waiting list as part of research are included in the organ transplantation rate. The organ transplantation rate will be risk-adjusted for the average age of the donor potential using the following methodology:
(1) The age groups used for the adjusted transplantation rates are: <1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-75.
(2) Calculate a national age-specific transplantation rate for each age group.
An expected transplantation rate for each OPO is calculated as ∑(g=1)Gdg*Rg/∑gdg, where dg is the number of potential donors in the OPO in age group g, Rg is the age-specific national transplantation rate in age group g, and ∑gdg is the OPO's total number of individuals in the donor potential. This can be interpreted as the overall expected transplantation rate for an OPO if each of its age-specific transplantation rates were equal to the national age-specific.
(3) Calculate the age-adjusted organ transplantation rate as (O/E)*P, where O is the OPO's observed unadjusted transplantation rate, E is the expected transplantation rate calculated in Step 2, and P is the unadjusted national transplantation rate.
Re-certification cycle means the 4-year cycle during which an OPO is certified.
Transplant hospital means a hospital that provides organ transplants and other medical and surgical specialty services required for the care of transplant patients. There may be one or more types of organ transplant centers operating within the same transplant hospital.
Urgent need occurs when an OPO's noncompliance with one or more conditions for coverage has caused, or is likely to cause, serious injury, harm, impairment, or death to a potential or actual donor or an organ beneficiary.
§ 486.303   Requirements for certification.
In order to be certified as a qualified organ procurement organization, an organ procurement organization must:
(a) Have received a grant under 42 U.S.C. 273(a) or have been certified or re-certified by the Secretary within the previous 4 years as being a qualified OPO.
(b) Be a non-profit entity that is exempt from Federal income taxation under section 501 of the Internal Revenue Code of 1986.
(c) Have accounting and other fiscal procedures necessary to assure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non-renal organs provided to transplant hospitals.
(d) Have an agreement with CMS, as the Secretary's designated representative, to be reimbursed under title XVIII for the procurement of kidneys.
(e) Have been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005.
(f) Have procedures to obtain payment for non-renal organs provided to transplant centers.
(g) Agree to enter into an agreement with any hospital or critical access hospital in the OPO's service area, including a transplant hospital that requests an agreement.
(h) Meet the conditions for coverage for organ procurement organizations, which include both outcome and process performance measures.
(i) Meet the provisions of titles XI, XVIII, and XIX of the Act, section 371(b) of the Public Health Services Act, and any other applicable Federal regulations.
§ 486.304   Requirements for designation.
(a) Designation is a condition for payment. Payment may be made under the Medicare and Medicaid programs for organ procurement costs attributable to payments made to an OPO by a hospital only if the OPO has been designated by CMS as an OPO.
(b) An OPO must be certified as a qualified OPO by CMS under 42 U.S.C. 273(b) and § 486.303 to be eligible for designation.
(c) An OPO must enter into an agreement with CMS in order for the organ procurement costs attributable to the OPO to be reimbursed under Medicare and Medicaid.
§ 486.306   OPO service area size designation and documentation requirements.
(a) General documentation requirement. An OPO must make available to CMS documentation verifying that the OPO meets the requirements of paragraphs (b) and (c) of this section at the time of application and throughout the period of its designation.
(b) Service area designation. The defined service area either includes an entire metropolitan statistical area or a New England county metropolitan statistical area as specified by the Director of the Office of Management and Budget or does not include any part of such an area.
(c) Service area location and characteristics. An OPO must define and document a proposed service area's location through the following information:
(1) The names of counties (or parishes in Louisiana) served or, if the service area includes an entire State, the name of the State.
(2) Geographic boundaries of the service area.
(3) The number and the names of all hospitals and critical access hospitals in the service area that have both a ventilator and an operating room.
§ 486.308   Designation of one OPO for each service area.
(a) CMS designates only one OPO per service area. A service area is open for competition when the OPO for the service area is de-certified and all administrative appeals under § 486.314 are exhausted.
(b) Designation periods—
(1) General. An OPO is normally designated for a 4-year agreement cycle. The period may be shorter, for example, if an OPO has voluntarily terminated its agreement with CMS and CMS selects a successor OPO for the balance of the 4-year agreement cycle. In rare situations, a designation period may be longer, for example, a designation may be extended if additional time is needed to select a successor OPO to replace an OPO that has been de-certified.
(2) Re-Certification. Re-certification must occur not more frequently than once every 4 years.
(c) Unless CMS has granted a hospital a waiver under paragraphs
(d) through (f) of this section, the hospital must enter into an agreement only with the OPO designated to serve the area in which the hospital is located.
(d) If CMS changes the OPO designated for an area, hospitals located in that area must enter into agreements with the newly designated OPO or submit a request for a waiver in accordance with paragraph (e) of this section within 30 days of notice of the change in designation.
(e) A hospital may request and CMS may grant a waiver permitting the hospital to have an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located. To qualify for a waiver, the hospital must submit data to CMS establishing that—
(1) The waiver is expected to increase organ donations; and
(2) The waiver will ensure equitable treatment of patients listed for transplants within the service area served by the hospital's designated OPO and within the service area served by the OPO with which the hospital seeks to enter into an agreement.
(f) In making a determination on waiver requests, CMS considers—
(1) Cost effectiveness;
(2) Improvements in quality;
(3) Changes in a hospital's designated OPO due to changes in the definitions of metropolitan statistical areas, if applicable; and
(4) The length and continuity of a hospital's relationship with an OPO other than the hospital's designated OPO.
(g) A hospital may continue to operate under its existing agreement with an out-of-area OPO while CMS is processing the waiver request. If a waiver request is denied, a hospital must enter into an agreement with the designated OPO within 30 days of notification of the final determination.
§ 486.309   Re-certification from August 1, 2006 through July 31, 2010.
An OPO will be considered to be re-certified for the period of August 1, 2006 through July 31, 2010 if an OPO met the standards to be a qualified OPO within a 4-year period ending December 31, 2001 and has an agreement with the Secretary that is scheduled to terminate on July 31, 2006. Agreements based on the August 1, 2006 through July 31, 2010 re-certification cycle will end on January 31, 2011.
§ 486.310   Changes in control or ownership or service area.
(a) OPO requirements. (1) A designated OPO considering a change in control (see § 413.17(b)(3)) or ownership or in its service area must notify CMS before putting it into effect. This notification is required to ensure that the OPO, if changed, will continue to satisfy Medicare and Medicaid requirements. The merger of one OPO into another or the consolidation of one OPO with another is considered a change in control or ownership.
(2) A designated OPO considering a change in its service area must obtain prior CMS approval. In the case of a service area change that results from a change of control or ownership due to merger or consolidation, the OPOs must resubmit the information required in an application for designation. The OPO must provide information specific to the board structure of the new organization, as well as operating budgets, financial information, and other written documentation CMS determines to be necessary for designation.
(b) CMS requirements. (1) If CMS finds that the OPO has changed to such an extent that it no longer satisfies the requirements for OPO designation, CMS may de-certify the OPO and declare the OPO's service area to be an open area. An OPO may appeal such a de-certification as set forth in § 486.314. The OPO's service area is not opened for competition until the conclusion of the administrative appeals process.
(2) If CMS finds that the changed OPO continues to satisfy the requirements for OPO designation, the period of designation of the changed OPO is the remaining portion of the 4-year term of the OPO that was reorganized. If more than one designated OPO is involved in the reorganization, the remaining designation term is the longest of the remaining periods unless CMS determines that a shorter period is in the best interest of the Medicare and Medicaid programs. The changed OPO must continue to meet the requirements for certification at § 486.303 throughout the remaining period.
§ 486.312   De-certification.
(a) Voluntary termination of agreement. If an OPO wishes to terminate its agreement, the OPO must send CMS written notice of its intention to terminate its agreement and the proposed effective date. CMS may approve the proposed date, set a different date no later than 6 months after the proposed effective date, or set a date less than 6 months after the proposed effective date if it determines that a different date would not disrupt services to the service area. If CMS determines that a designated OPO has ceased to furnish organ procurement services to its service area, the cessation of services is deemed to constitute a voluntary termination by the OPO, effective on a date determined by CMS. CMS will de-certify the OPO as of the effective date of the voluntary termination.
(b) Involuntary termination of agreement. During the term of the agreement, CMS may terminate an agreement with an OPO if the OPO no longer meets the requirements for certification at § 486.303. CMS may also terminate an agreement immediately in cases of urgent need, such as the discovery of unsound medical practices. CMS will de-certify the OPO as of the effective date of the involuntary termination.
(c) Non-renewal of agreement. CMS will not voluntarily renew its agreement with an OPO if the OPO fails to meet the requirements for certification at § 486.318, based on findings from the most recent re-certification cycle, or the other requirements for certification at § 486.303. CMS will de-certify the OPO as of the ending date of the agreement.
(d) Notice to OPO. Except in cases of urgent need, CMS gives written notice of de-certification to an OPO at least 90 days before the effective date of the de-certification. In cases of urgent need, CMS gives written notice of de-certification to an OPO at least 3 calendar days prior to the effective date of the de-certification. The notice of de-certification states the reasons for de-certification and the effective date.
(e) Public notice. Once CMS approves the date for a voluntary termination, the OPO must provide prompt public notice in the service area of the date of de-certification and such other information as CMS may require. In the case of involuntary termination or nonrenewal of an agreement, CMS also provides notice to the public in the service area of the date of de-certification. No payment under titles XVIII or XIX of the Act will be made with respect to organ procurement costs attributable to the OPO on or after the effective date of de-certification.
§ 486.314   Appeals.
If an OPO's de-certification is due to involuntary termination or non-renewal of its agreement with CMS, the OPO may appeal the de-certification on substantive and procedural grounds.
(a) Notice of initial determination. CMS mails notice to the OPO of an initial de-certification determination. The notice contains the reasons for the determination, the effect of the determination, and the OPO's right to seek reconsideration.
(b) Reconsideration. (1) Filing request. If the OPO is dissatisfied with the de-certification determination, it has 15 business days from receipt of the notice of de-certification to seek reconsideration from CMS. The request for reconsideration must state the issues or findings of fact with which the OPO disagrees and the reasons for disagreement.
(2) An OPO must seek reconsideration before it is entitled to seek a hearing before a hearing officer. If an OPO does not request reconsideration or its request is not made timely, the OPO has no right to further administrative review.
(3) Reconsideration determination. CMS makes a written reconsidered determination within 10 business days of receipt of the request for reconsideration, affirming, reversing, or modifying the initial determination and the findings on which it was based. CMS augments the administrative record to include any additional materials submitted by the OPO, and a copy of the reconsideration decision and sends the supplemented administrative record to the CMS hearing officer.
(c) Request for hearing. An OPO dissatisfied with the CMS reconsideration decision, must file a request for a hearing before a CMS hearing officer within 40 business days of receipt of the notice of the reconsideration determination. If an OPO does not request a hearing or its request is not received timely, the OPO has no right to further administrative review.
(d) Administrative record. The hearing officer sends the administrative record to both parties within 10 business days of receipt of the request for a hearing.
(1) The administrative record consists of, but is not limited to, the following:
(i) Factual findings from the survey(s) on the OPO conditions for coverage.
(ii) Data from the outcome measures.
(iii) Rankings of OPOs based on the outcome data.
(iv) Correspondence between CMS and the affected OPO.
(2) The administrative record will not include any privileged information.
(e) Pre-Hearing conference. At any time before the hearing, the CMS hearing officer may call a pre-hearing conference if he or she believes that a conference would more clearly define the issues. At the pre-hearing conference, the hearing officer may establish the briefing schedule, sets the hearing date, and addresses other administrative matters. The hearing officer will issue an order reflecting the results of the pre-hearing conference.
(f) Date of hearing. The hearing officer sets a date for the hearing that is no more than 60 calendar days following the receipt of the request for a hearing.
(g) Conduct of hearing. (1) The hearing is open to both parties, CMS and the OPO.
(2) The hearing officer inquires fully into all the matters at issue and receives in evidence the testimony of witnesses and any documents that are relevant and material.
(3) The hearing officer provides the parties with an opportunity to enter an objection to the inclusion of any document. The hearing officer will consider the objection and will rule on the document's admissibility.
(4) The hearing officer decides the order in which the evidence and the arguments of the parties are presented and the conduct of the hearing.
(5) The hearing officer rules on the admissibility of evidence and may admit evidence that would be inadmissible under rules applicable to court procedures.
(6) The hearing officer rules on motions and other procedural items.
(7) The hearing officer regulates the course of the hearing and conduct of counsel.
(8) The hearing officer may examine witnesses.
(9) The hearing officer takes any action authorized by the rules in this subpart.
(h) Parties' rights. CMS and the OPO may:
(1) Appear by counsel or other authorized representative, in all hearing proceedings.
(2) Participate in any pre-hearing conference held by the hearing officer.
(3) Agree to stipulations as to facts which will be made a part of the record.
(4) Make opening statements at the hearing.
(5) Present relevant evidence on the issues at the hearing.
(6) Present witnesses, who then must be available for cross-examination, and cross-examine witnesses presented by the other party.
(7) Present oral arguments at the hearing.
(i) Hearing officer's decision. The hearing officer renders a decision on the appeal of the notice of de-certification within 20 business days of the hearing.
(1) Reversal of de-certification. If the hearing officer reverses CMS' determination to de-certify an OPO in a case involving the involuntary termination of the OPO's agreement, CMS will not terminate the OPO's agreement and will not de-certify the OPO.
(2) De-certification is upheld. If the de-certification determination is upheld by the hearing officer, the OPO is de-certified and it has no further administrative appeal rights.
(j) Extension of agreement. If there is insufficient time prior to expiration of an agreement with CMS to allow for competition of the service area and, if necessary, transition of the service area to a successor OPO, CMS may choose to extend the OPO's agreement with CMS.
(k) Effects of de-certification. Medicare and Medicaid payments may not be made for organ procurement services the OPO furnishes on or after the effective date of de-certification. CMS will then open the de-certified OPO's service area for competition as set forth in § 486.316(c).
§ 486.316   Re-certification and competition processes.
(a) Re-certification of OPOs. Based upon performance on the outcome measures set forth in § 486.318 and the re-certification survey, each OPO will be designated into either Tier 1, Tier 2, or Tier 3. The tier in which the OPO is designated will determine whether the OPO is re-certified (Tier 1), must compete to retain its DSA (Tier 2), or will receive an initial de-certification determination (Tier 3).
(1) Tier 1. An OPO is re-certified for at least an additional 4 years, the OPO's DSA is not opened for competition, and the OPO can compete for any open DSA if it meets all of the following:
(i) It has been shown by survey to be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360; and
(ii) It meets the outcome requirements as described in § 486.318(e)(4) for the final assessment period of the agreement cycle.
(2) Tier 2. An OPO's DSA is open for competition and the OPO is eligible to compete to retain its DSA and for any open DSA if it meets all of the following:
(i) It has been shown by survey to be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360; and
(ii) It meets the outcome requirements as described in § 486.318(e)(5) at the final assessment period of the agreement cycle.
(3) Tier 3. An OPO will receive a notice of de-certification determination under § 486.314 and cannot compete for any open DSA if it meets either of the following:
(i) Has been shown by survey to not be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360; or
(ii) Has outcome requirements as described in § 486.318(e)(6) at the final assessment period of the agreement cycle.
(b) De-certification and competition. If an OPO fails to meet the outcome measures set forth in § 486.318(e)(6) at the final assessment period prior to the end of the agreement cycle, or it meets the requirements described in paragraph (a)(3) of this section:
(1) CMS will send the OPO a notice of its initial de-certification determination and the OPO has the right to appeal as established in § 486.314;
(2) If the OPO does not appeal or the OPO appeals and the reconsideration official and CMS hearing officer uphold the de-certification, the OPO's service area is opened for competition from other OPOs that qualify to compete for open service areas as set forth in paragraph (c) of this section. The de-certified OPO is not permitted to compete for its open area or any other open area.
(3) The OPO competing for the open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.
(c) Criteria to compete. To compete for an open DSA, an OPO must meet the performance requirements of the outcome measures for Tier 1 or Tier 2 at § 486.318(e)(4) and (5), and the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360 at the most recent routine survey. The OPO must compete for the entire DSA.
(d) Criteria for selection. CMS will designate an OPO for an open service area based on the following criteria:
(1) Performance on the outcome measures at § 486.318;
(2) Relative success in meeting the process performance measures and other conditions at §§ 486.320 through 486.348;
(3) Contiguity to the open service area.
(4) Success in identifying and overcoming barriers to donation within its own service area and the relevance of those barriers to barriers in the open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.
(e) No OPO applies. If no OPO applies to compete for a de-certified OPO's open area, CMS may select a single OPO to take over the entire open area or may adjust the service area boundaries of two or more contiguous OPOs to incorporate the open area. CMS will make its decision based on the criteria in paragraph (d) of this section.
(f) Extension of the agreement cycle for extraordinary circumstances. OPOs can seek a 1-year extension of the agreement cycle if there are extraordinary circumstances beyond the control of the OPOs that has affected the data of the final assessment period so that it does not accurately capture their performance. OPOs must request this extension within 90 days of the end of the occurrence of the extraordinary circumstance but no later than the last day of the final assessment period.
(g) Exception. For the 2022 recertification cycle only, an OPO is recertified for an additional 4 years and its service area is not opened for competition when the OPO meets one out of the two outcome measure requirements described in § 486.318(a)(1) and (3) for OPOs not operating exclusively in the noncontiguous States, Commonwealths, Territories, or possessions; or § 486.318(b)(1) and (3) for OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, and possessions. An OPO is not required to meet the second outcome measure described in § 486.318(a)(2) or (b)(2) for the 2022 recertification cycle. If an OPO does not meet one of the outcome measures as described in paragraphs § 486.318(a)(1), (a)(3), (b)(1), or (b)(3), or has been shown by survey to not be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360, the OPO is de-certified. If the OPO does not appeal or the OPO appeals and the reconsideration official and CMS hearing officer uphold the de-certification, the OPO's service area is opened for competition from other OPOs. The de-certified OPO is not permitted to compete for its open area or any other open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.
§ 486.318   Condition: Outcome measures.
(a) With the exception of OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, or possessions, an OPO must meet two out of the three following outcome measures:
(1) The OPO's donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard deviations below the mean national donation rate of eligible donors as a percentage of eligible deaths, averaged over the 4 years of the re-certification cycle. Both the numerator and denominator of an individual OPO's donation rate ratio are adjusted by adding a 1 for each donation after cardiac death donor and each donor over the age of 70;
(2) The observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by the SRTR;
(3) The OPO data reports, averaged over the 4 years of the recertification cycle, must meet the rules and requirements of the most current OPTN aggregate donor yield measure.
(i) The initial criteria used to identify OPOs with lower than expected organ yield, for all organs as well as for each organ type, will include all of the following:
(A) More than 10 fewer observed organs per 100 donors than expected yield (Observed per 100 donors—Expected per 100 donors <−10);
(B) A ratio of observed to expected yield less than 0.90; and
(C) A two-sided p-value is less than 0.05.
(ii) The number of organs used for research per donor, including pancreata used for islet cell research.
(4) The outcome measures described in § 486.318(a)(1) through (3) are effective until July 31, 2022.
(b) For OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, and possessions, an OPO must meet two out of the three following outcome measures:
(1) The OPO's donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard deviations below the mean national donation rate of eligible donors as a percentage of eligible deaths, averaged over the 4 years of the re-certification cycle. Both the numerator and denominator of an individual OPO's donation rate ratio are adjusted by adding a 1 for each donation after cardiac death donor and each donor over the age of 70;
(2) The observed donation rate is not significantly lower than the expected donation rate for 18 or more months of the 36 months of data used for re-certification, as calculated by the SRTR;
(3) The OPO data reports, averaged over the 4 years of the recertification cycle, must meet the rules and requirements of the most current OPTN aggregate donor yield measure.
(i) The initial criteria used to identify OPOs with lower than expected organ yield, for all organs as well as for each organ type, will include all of the following:
(A) More than 10 fewer observed organs per 100 donors than expected yield (Observed per 100 donors—Expected per 100 donors <−10);
(B) A ratio of observed to expected yield less than 0.90; and
(C) A two-sided p-value is less than 0.05.
(ii) The number of organs used for research per donor, including pancreata used for islet cell research.
(4) The outcome measures described in § 486.318(b)(1) through (3) are effective until July 31, 2022.
(c) Data for the outcome measures.
(1) An OPO's performance on the outcome measures is based on 36 months of data, beginning with January 1 of the first full year of the re-certification cycle and ending 36 months later on December 31, 7 months prior to the end of the re-certification cycle.
(2) If an OPO takes over another OPO's service area on a date later than January 1 of the first full year of the re-certification cycle so that 36 months of data are not available to evaluate the OPO's performance in its new service area, we will not hold the OPO accountable for its performance in the new area until the end of the following re-certification cycle when 36 months of data are available.
(3) An OPO's performance on the outcome measures described in § 486.318(a)(1) through (3) and § 486.318(b)(1) through (3) is based on the data described in § 486.318(c)(1) and (2) until July 31, 2022.
(d) An OPO is evaluated by measuring the donation rate and the organ transplantation rate in their DSA.
(1) For all OPOs, except as set forth in paragraph (d)(2) of this section, for all OPOs:
(i) The donation rate is calculated as the number of donors in the DSA as a percentage of the donor potential.
(ii) The organ transplantation rate is calculated as the number of organs transplanted from donors in the DSA as a percentage of the donor potential. The organ transplantation rate is adjusted for the average age of the donor potential.
(iii) The numerator for the donation rate is the number of donors in the DSA. The numerator for the organ transplantation rate is the number of organs transplanted from donors in the DSA. The numbers of donors and organs transplanted are based on the data submitted to the OPTN as required in § 486.328 and § 121.11 of this title. For calculating each measure, the data used is from the same time period as the data for the donor potential.
(iv) The denominator for the outcome measures is the donor potential and is based on inpatient deaths within the DSA from patients 75 or younger with a primary cause of death that is consistent with organ donation. The data is obtained from the most recent 12-months data from state death certificates.
(2) For the OPO representing the Hawaii DSA:
(i) The donation rate is calculated as the number of donors in the DSA as a percentage of the donor potential.
(ii) The kidney transplantation rate is calculated as the number of kidneys transplanted from kidney donors in the DSA as a percentage of the donor potential.
(iii) The numerator for the donation rate is the number of donors in the DSA. The numerator for the kidney transplantation rate is the number of kidneys transplanted from kidney donors in the DSA. The numbers of donors and kidneys transplanted are based on the data submitted to the OPTN as required in § 486.328 and § 121.11 of this title. For calculating each measure, the data used is from the same time period as the data for the donor potential.
(iv) The denominator for the outcome measures is the donor potential and is based on inpatient deaths within the DSA from patients 75 or younger with a primary cause of death that is consistent with organ donation. The data is obtained from the most recent 12-months data from state death certificates.
(e) An OPO must demonstrate a success rate on the outcome measures in accordance with the following parameters and requirements:
(1) For each assessment period, threshold rates will be established based on donation rates during the 12-month period immediately prior to the period being evaluated:
(i) The lowest rate among the top 25 percent in DSAs, and
(ii) The median rate among the DSAs.
(2) For each assessment period, threshold rates will be established based on the organ transplantation or kidney transplantation rates during the 12-month period prior to the period being evaluated:
(i) The lowest rate among the top 25 percent, and
(ii) The median rate among the DSAs.
(3) The 95 percent confidence interval for each DSA's donation and organ transplantation rates will be calculated using a one-sided test.
(4) Tier 1—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are at or above the top 25 percent threshold rate established for their DSA will be identified at each assessment period.
(5) Tier 2—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are at or above the median threshold rate established for their DSA but is not in Tier 1 as described in paragraph (e)(4) of this section will be identified at each assessment period.
(6) Tier 3—OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation or organ transplantation rates that are below the median threshold rate established for their DSA will be identified at each assessment period. OPOs that have an upper limit of the one-sided 95 percent confidence interval for their donation and organ transplantation rates that are below the median threshold rate for their DSA are also included in Tier 3.
(7) For the OPO exclusively serving the DSA that includes the non-contiguous state of Hawaii and surrounding territories, the kidney transplantation rate will be used instead of the organ transplantation rate. The comparative performance and designation to a Tier will be the same as in paragraphs (e)(4), (5), and (6) of this section except kidney transplantation rates will be used.
(f)(1) An OPO's performance on the outcome measures is based on an evaluation at least every 12 months, with the most recent 12 months of data available from the OPTN and state death certificates, beginning January 1 of the first year of the agreement cycle and ending December 31, prior to the end of the agreement cycle.
(2) An assessment period is the most recent 12 months prior to the evaluation of the outcome measures in which data is available.
(3) If an OPO takes over another OPO's DSA on a date later than January 1 of the first year of the agreement cycle so that 12 months of data are not available to evaluate the OPO's performance in its new DSA, we will hold the OPO accountable for its performance on the outcome measures in the new area once 12 months of data are available.
§ 486.320   Condition: Participation in Organ Procurement and Transplantation Network.
After being designated, an OPO must become a member of, participate in, and abide by the rules and requirements of the OPTN established and operated in accordance with section 372 of the Public Health Service Act (42 U.S.C. 274). The term “rules and requirements of the OPTN” means those rules and requirements approved by the Secretary. No OPO is considered out of compliance with section 1138(b)(1)(D) of the Act or this section until the Secretary approves a determination that the OPO failed to comply with the rules and requirements of the OPTN. The Secretary may impose sanctions under section 1138 only after such non-compliance has been determined in this manner.
§ 486.322   Condition: Relationships with hospitals, critical access hospitals, and tissue banks.
(a) Standard: Hospital agreements. An OPO must have a written agreement with 95 percent of the Medicare and Medicaid participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room and have not been granted a waiver by CMS to work with another OPO. The agreement must describe the responsibilities of both the OPO and hospital or critical access hospital in regard to donation after cardiac death (if the OPO has a protocol for donation after cardiac death) and the requirements for hospitals at § 482.45 or § 485.643. The agreement must specify the meaning of the terms “timely referral” and “imminent death.”
(b) Standard: Designated requestor training for hospital staff. The OPO must offer to provide designated requestor training on at least an annual basis for hospital and critical access hospital staff.
(c) Standard: Cooperation with tissue banks.
(1) The OPO must have arrangements to cooperate with tissue banks that have agreements with hospitals and critical access hospitals with which the OPO has agreements. The OPO must cooperate in the following activities, as may be appropriate, to ensure that all usable tissues are obtained from potential donors:
(i) Screening and referral of potential tissue donors.
(ii) Obtaining informed consent from families of potential tissue donors.
(iii) Retrieval, processing, preservation, storage, and distribution of tissues.
(iv) Providing designated requestor training.
(2) An OPO is not required to have an arrangement with a tissue bank that is unwilling to have an arrangement with the OPO.
§ 486.324   Condition: Administration and governing body.
(a) While an OPO may have more than one board, the OPO must have an advisory board that has both the authority described in paragraph (b) of this section and the following membership:
(1) Members who represent hospital administrators, either intensive care or emergency room personnel, tissue banks, and voluntary health associations in the OPO's service area.
(2) Individuals who represent the public residing in the OPO's service area.
(3) A physician with knowledge, experience, or skill in the field of human histocompatibility, or an individual with a doctorate degree in a biological science and with knowledge, experience, or skills in the field of human histocompatibility.
(4) A neurosurgeon or other physician with knowledge or skills in the neurosciences.
(5) A transplant surgeon representing each transplant hospital in the service area with which the OPO has arrangements to coordinate its activities. The transplant surgeon must have practicing privileges and perform transplants in the transplant hospital represented.
(6) An organ donor family member.
(b) The OPO board described in paragraph (a) of this section has the authority to recommend policies for the following:
(1) Procurement of organs.
(2) Effective agreements to identify potential organ donors with a substantial majority of hospitals in its service area that have facilities for organ donation.
(3) Systematic efforts, including professional education, to acquire all useable organs from potential donors.
(4) Arrangements for the acquisition and preservation of donated organs and provision of quality standards for the acquisition of organs that are consistent with the standards adopted by the OPTN, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immunodeficiency syndrome (AIDS).
(5) Appropriate tissue typing of organs.
(6) A system for allocation of organs among transplant patients that is consistent with the rules and requirements of the OPTN, as defined in § 486.320 of this part.
(7) Transportation of organs to transplant hospitals.
(8) Coordination of activities with transplant hospitals in the OPO's service area.
(9) Participation in the OPTN.
(10) Arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all useable tissues are obtained from potential donors.
(11) Annual evaluation of the effectiveness of the OPO in acquiring organs.
(12) Assistance to hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.
(c) The advisory board described in paragraph (a) of this section has no authority over any other activity of the OPO and may not serve as the OPO's governing body or board of directors. Members of the advisory board described in paragraph (a) of this section are prohibited from serving on any other OPO board.
(d) The OPO must have bylaws for each of its board(s) that address potential conflicts of interest, length of terms, and criteria for selecting and removing members.
(e) A governing body must have full legal authority and responsibility for the management and provision of all OPO services and must develop and oversee implementation of policies and procedures considered necessary for the effective administration of the OPO, including fiscal operations, the OPO's quality assessment and performance improvement (QAPI) program, and services furnished under contract or arrangement, including agreements for these services. The governing body must appoint an individual to be responsible for the day-to-day operation of the OPO.
(f) The OPO must have procedures to address potential conflicts of interest for the governing body described in paragraph (d) of this section.
(g) The OPO's policies must state whether the OPO recovers organs from donors after cardiac death.
§ 486.326   Condition: Human resources.
All OPOs must have a sufficient number of qualified staff, including a director, a medical director, organ procurement coordinators, and hospital development staff to obtain all usable organs from potential donors, and to ensure that required services are provided to families of potential donors, hospitals, tissue banks, and individuals and facilities that use organs for research.
(a) Standard: Qualifications. (1) The OPO must ensure that all individuals who provide services and/or supervise services, including services furnished under contract or arrangement, are qualified to provide or supervise the services.
(2) The OPO must develop and implement a written policy that addresses potential conflicts of interest for the OPO's director, medical director, senior management, and procurement coordinators.
(3) The OPO must have credentialing records for physicians and other practitioners who routinely recover organs in hospitals under contract or arrangement with the OPO and ensure that all physicians and other practitioners who recover organs in hospitals with which the OPO has agreements are qualified and trained.
(b) Standard: Staffing. (1) The OPO must provide sufficient coverage, either by its own staff or under contract or arrangement, to assure both that hospital referral calls are screened for donor potential and that potential donors are evaluated for medical suitability for organ and/or tissue donation in a timely manner.
(2) The OPO must have a sufficient number of qualified staff to provide information and support to potential organ donor families; request consent for donation; ensure optimal maintenance of the donor, efficient placement of organs, and adequate oversight of organ recovery; and conduct QAPI activities, such as death record reviews and hospital development.
(3) The OPO must provide a sufficient number of recovery personnel, either from its own staff or under contract or arrangement, to ensure that all usable organs are recovered in a manner that, to the extent possible, preserves them for transplantation.
(c) Standard: Education, training, and performance evaluation. The OPO must provide its staff with the education, training, and supervision necessary to furnish required services. Training must include but is not limited to performance expectations for staff, applicable organizational policies and procedures, and QAPI activities. OPOs must evaluate the performance of their staffs and provide training, as needed, to improve individual and overall staff performance and effectiveness.
(d) Standard: Medical director. The OPO's medical director is a physician licensed in at least one of the States or territories within the OPO's service area or as required by State or territory law or by the jurisdiction in which the OPO is located. The medical director is responsible for implementation of the OPO's protocols for donor evaluation and management and organ recovery and placement. The medical director is responsible for oversight of the clinical management of potential donors, including providing assistance in managing a donor case when the surgeon on call is unavailable.
§ 486.328   Condition: Reporting of data.
(a) An OPO must provide individually-identifiable, hospital-specific organ donation and transplantation data and other information to the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients, and HHS, as requested by the Secretary. The data may include, but are not limited to:
(1) Number of hospital deaths;
(2) Results of death record reviews;
(3) Number and timeliness of referral calls from hospitals;
(4) [Reserved]
(5) Data related to non-recovery of organs;
(6) Data about consents for donation;
(7) Number of donors;
(8) Number of organs recovered, by type of organ; and
(9) Number of organs transplanted, by type of organ.
(b) An OPO must provide hospital-specific organ donation data annually to the transplant hospitals with which it has agreements.
(c) Data to be used for OPO re-certification purposes must be reported to the OPTN and must include data for all deaths in all hospitals and critical access hospitals in the OPO's donation service area, unless a hospital or critical access hospital has been granted a waiver to work with a different OPO.
(d) Data reported by the OPO to the OPTN must be reported within 30 days after the end of the month in which a death occurred. If an OPO determines through death record review or other means that the data it reported to the OPTN was incorrect, it must report the corrected data to the OPTN within 30 days of the end of the month in which the error is identified.
(e) For the purpose of determining the information to be collected under paragraph (a) of this section, the following definitions apply:
(1) Kidneys procured. Each kidney recovered will be counted individually. En bloc kidneys recovered will count as two kidneys procured.
(2) Kidneys transplanted. Each kidney transplanted will be counted individually. En bloc kidney transplants will be counted as two kidneys transplanted.
(3) Extra-renal organs procured. Each organ recovered is counted individually.
(4) Extra-renal organs transplanted. Each organ or part thereof transplanted will be counted individually. For example, a single liver is counted as one organ procured and each portion that is transplanted will count as one transplant. Further, a heart and double lung transplant will be counted as three organs transplanted. A kidney/pancreas transplant will count as one kidney transplanted and one extra-renal organ transplanted.
§ 486.330   Condition: Information management.
An OPO must establish and use an electronic information management system to maintain the required medical, social and identifying information for every donor and transplant beneficiary and develop and follow procedures to ensure the confidentiality and security of the information.
(a) Donor information. The OPO must maintain a record for every donor. The record must include, at a minimum, information identifying the donor (for example, name, address, date of birth, social security number or other unique identifier, such as Medicare health insurance claim number), organs and (when applicable) tissues recovered, date of the organ recovery, donor management data, all test results, current hospital history, past medical and social history, the pronouncement of death, and consent and next-of-kin information.
(b) Disposition of organs. The OPO must maintain records showing the disposition of each organ recovered for the purpose of transplantation, including information identifying transplant beneficiaries.
(c) Data retention. Donor and transplant beneficiary records must be maintained in a human readable and reproducible paper or electronic format for 7 years.
(d) Format of records. The OPO must maintain data in a format that can readily be transferred to a successor OPO and in the event of a transfer must provide to CMS copies of all records, data, and software necessary to ensure uninterrupted service by a successor OPO. Records and data subject to this requirement include donor and transplant beneficiary records and procedural manuals and other materials used in conducting OPO operations.
§ 486.342   Condition: Requesting consent.
An OPO must encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of potential donor families.
(a) An OPO must have a written protocol to ensure that, in the absence of a donor document, the individual(s) responsible for making the donation decision are informed of their options to donate organs or tissues (when the OPO is making a request for tissues) or to decline to donate. The OPO must provide to the individual(s) responsible for making the donation decision, at a minimum, the following:
(1) A list of the organs and/or tissues that may be recovered.
(2) The most likely uses for the donated organs or tissues.
(3) A description of the screening and recovery processes.
(4) Information about the organizations that will recover, process, and distribute the tissue.
(5) Information regarding access to and release of the donor's medical records.
(6) An explanation of the impact the donation process will have on burial arrangements and the appearance of the donor's body.
(7) Contact information for individual(s) with questions or concerns.
(8) A copy of the signed consent form if a donation is made.
(b) If an OPO does not request consent to donation because a potential donor consented to donation before his or her death in a manner that satisfied applicable State law requirements in the potential donor's State of residence, the OPO must provide information about the donation to the family of the potential donor, as requested.
§ 486.344   Condition: Evaluation and management of potential donors and organ placement and recovery.
The OPO must have written protocols for donor evaluation and management and organ placement and recovery that meet current standards of practice and are designed to maximize organ quality and optimize the number of donors and the number of organs recovered and transplanted per donor.
(a) Potential donor protocol management. (1) The medical director is responsible for ensuring that potential donor evaluation and management protocols are implemented correctly and appropriately to ensure that potential donors are thoroughly assessed for medical suitability for organ donation and clinically managed to optimize organ viability and function.
(2) The OPO must implement a system that ensures that a qualified physician or other qualified individual is available to assist in the medical management of a potential donor when the surgeon on call is unavailable.
(b) Potential donor evaluation. The OPO must do the following:
(1) Verify that death has been pronounced according to applicable local, State, and Federal laws.
(2) Determine whether there are conditions that may influence donor acceptance.
(3) If possible, obtain the potential donor's medical and social history.
(4) Review the potential donor's medical chart and perform a physical examination of the donor.
(5) Obtain the potential donor's vital signs and perform all pertinent tests.
(c) Testing. The OPO must do the following:
(1) Arrange for screening and testing of the potential donor for infectious disease according to current standards of practice, including testing for the human immunodeficiency virus.
(2) Ensure that screening and testing of the potential donor (including point-of-care testing and blood typing) are conducted by a laboratory that is certified in the appropriate specialty or subspecialty of service in accordance with part 493 of this chapter.
(3) Ensure that the potential donor's blood is typed using two separate blood samples.
(4) Document potential donor's record with all test results, including blood type, before organ recovery.
(d) Standard: Collaboration with transplant programs. (1) The OPO must establish protocols in collaboration with transplant programs that define the roles and responsibilities of the OPO and the transplant program for all activities associated with the evaluation and management of potential donors, organ recovery, and organ placement, including donation after cardiac death, if the OPO has implemented a protocol for donation after cardiac death.
(2) The protocol must ensure that:
(i) The OPO is responsible for two separate determinations of the donor's blood type;
(ii) If the identity of the intended recipient is known, the OPO has a procedure to ensure that prior to organ recovery, an individual from the OPO's staff compares the blood type of the donor with the blood type of the intended recipient, and the accuracy of the comparison is verified by a different individual;
(iii) Documentation of the donor's blood type accompanies the organ to the hospital where the transplant will take place.
(3) The established protocols must be reviewed regularly with the transplant programs to incorporate practices that have been shown to maximize organ donation and transplantation.
(e) Documentation of beneficiary information. If the intended beneficiary has been identified prior to recovery of an organ for transplantation, the OPO must have written documentation from the OPTN showing, at a minimum, the intended organ beneficiary's ranking in relation to other suitable candidates and the recipient's OPTN identification number and blood type.
(f) Donation after cardiac death. If an OPO recovers organs from donors after cardiac death, the OPO must have protocols that address the following:
(1) Criteria for evaluating patients for donation after cardiac death;
(2) Withdrawal of support, including the relationship between the time of consent to donation and the withdrawal of support;
(3) Use of medications and interventions not related to withdrawal of support;
(4) Involvement of family members prior to organ recovery;
(5) Criteria for declaration of death and the time period that must elapse prior to organ recovery.
(g) Organ allocation. The OPO must have a system to allocate donated organs among transplant patients that is consistent with the rules and requirements of the OPTN, as defined in § 486.320 of this part.
(h) Organ placement. The OPO must develop and implement a protocol to maximize placement of organs for transplantation.
§ 486.346   Condition: Organ preparation and transport.
(a) The OPO must arrange for testing of organs for infectious disease and tissue typing of organs according to current standards of practice. The OPO must ensure that testing and tissue typing of organs are conducted by a laboratory that is certified in the appropriate specialty or subspecialty of service in accordance with part 493 of this chapter.
(b)(1) The OPO must send complete documentation of donor information to the transplant center with the organ, including donor evaluation, the complete record of the donor's management, documentation of consent, documentation of the pronouncement of death, and documentation for determining organ quality. This information is available to the transplant center electronically.
(2) The OPO must physically send a paper copy of the following documentation with each organ:
(i) Blood type;
(ii) Blood subtype, if used for allocation; and
(iii) Infectious disease testing results available at the time of organ packaging.
(3) The source documentation must be placed in a watertight container in either of the following:
(i) A location specifically designed for documentation; or
(ii) Between the inner and external transport materials.
(4) Two individuals, one of whom must be an OPO employee, must verify that the documentation that accompanies an organ to a transplant center is correct.
(c) The OPO must develop and follow a written protocol for packaging, labeling, handling, and shipping organs in a manner that ensures their arrival without compromise to the quality of the organ. The protocol must include procedures to check the accuracy and integrity of labels, packaging, and contents prior to transport, including verification by two individuals, one of whom must be an OPO employee, that information listed on the labels is correct.
(d) All packaging in which an organ is transported must be marked with the identification number, specific contents, and donor's blood type.
§ 486.348   Condition: Quality assessment and performance improvement (QAPI).
The OPO must develop, implement, and maintain a comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all donation services, including services provided under contract or arrangement.
(a) Standard: Components of a QAPI program. The OPO's QAPI program must include objective measures to evaluate and demonstrate improved performance with regard to OPO activities, such as hospital development, designated requestor training, donor management, timeliness of on-site response to hospital referrals, consent practices, organ recovery and placement, and organ packaging and transport. The OPO must take actions that result in performance improvements and track performance to ensure that improvements are sustained.
(b) Standard: Death record reviews. As part of its ongoing QAPI efforts, an OPO must conduct at least monthly death record reviews in every Medicare and Medicaid participating hospital in its service area that has a Level I or Level II trauma center or 150 or more beds, a ventilator, and an intensive care unit (unless the hospital has a waiver to work with another OPO), with the exception of psychiatric and rehabilitation hospitals. When missed opportunities for donation are identified, the OPO must implement actions to improve performance.
(c) Standard: Adverse events. (1) An OPO must establish written policies to address, at a minimum, the process for identification, reporting, analysis, and prevention of adverse events that occur during the organ donation process.
(2) The OPO must conduct a thorough analysis of any adverse event and must use the analysis to affect changes in the OPO's policies and practices to prevent repeat incidents.
(d) Standard: Review of outcome measures. (1) An OPO must include a process to review its performance on the outcome measure requirements at § 486.318. The process must be a continuous activity to improve performance.
(2) An OPO must incorporate data on the outcome measures into their QAPI program.
(3) If the outcome measure at each assessment period during the re-certification cycle is statistically significantly lower than the top 25 percent of donation rates or organ or kidney transplantation (Tier 2 and Tier 3 OPOs) rates as described in § 486.318(e)(5) and (6), the OPO must identify opportunities for improvement and implement changes that lead to improvement in these measures.
§ 486.360   Condition for Coverage: Emergency preparedness.
The Organ Procurement Organization (OPO) must comply with all applicable Federal, State, and local emergency preparedness requirements. The OPO must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a) Emergency plan. The OPO must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every 2 years. The plan must do all of the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b) Policies and procedures. The OPO must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and, the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:
(1) A system to track the location of on-duty staff during and after an emergency. If on-duty staff is relocated during the emergency, the OPO must document the specific name and location of the receiving facility or other location.
(2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records.
(c) Communication plan. The OPO must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Volunteers.
(iv) Other OPOs.
(v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA).
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) OPO's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(d) Training and testing. The OPO must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.
(1) Training. The OPO must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the OPO must conduct training on the updated policies and procedures.
(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the OPO's emergency plan, as needed.
(e) Continuity of OPO operations during an emergency. Each OPO must have a plan to continue operations during an emergency.
(1) The OPO must develop and maintain in the protocols with transplant programs required under § 486.344(d), mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the OPO during an emergency.
(2) The OPO must have the capability to continue its operation from an alternate location during an emergency. The OPO could either have:
(i) An agreement with one or more other OPOs to provide essential organ procurement services to all or a portion of its DSA in the event the OPO cannot provide those services during an emergency;
(ii) If the OPO has more than one location, an alternate location from which the OPO could conduct its operation; or
(iii) A plan to relocate to another location as part of its emergency plan as required by paragraph (a) of this section.
(f) Integrated healthcare systems. If an OPO is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the OPO may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
§ 486.500   Basis and scope.
Section 1861(s)(2)(iii) of the Act requires the Secretary to establish the conditions that home infusion therapy suppliers must meet in order to participate in the Medicare program and which are considered necessary to ensure the health and safety of patients.
§ 486.505   Definitions.
As used in §§ 486.520 and 486.525:
Applicable provider means a physician, a nurse practitioner, and a physician assistant.
Home means a place of residence used as the home of an individual, including an institution that is used as a home. An institution that is used as a home may not be a hospital, CAH, or SNF as defined in section 1861(e)(1), 1861(mm)(1), or 1819(a)(1) of the Act, respectively.
Home infusion drug means a parental drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment. The term does not include insulin pump systems or a self-administered drug or biological on a self-administered drug exclusion list.
Infusion drug administration calendar day means the day on which home infusion therapy services are furnished by skilled professionals in the individual's home on the day of infusion drug administration. The skilled services provided on such day must be so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel.
Qualified home infusion therapy supplier means a supplier of home infusion therapy that meets the all of the following criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act:
(1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
(2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
(3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act.
(4) Meets such other requirements as the Secretary determines appropriate.
§ 486.520   Plan of care.
The qualified home infusion therapy supplier ensures the following:
(a) All patients must be under the care of an applicable provider.
(b) All patients must have a plan of care established by a physician that prescribes the type, amount, and duration of the home infusion therapy services that are to be furnished.
(c) The plan of care for each patient must be periodically reviewed by the physician.
§ 486.525   Required services.
(a) The qualified home infusion therapy supplier must provide the following services on a 7-day-a-week, 24-hour-a-day basis in accordance with the plan of care:
(1) Professional services, including nursing services.
(2) Patient training and education not otherwise paid for as durable medical equipment as described in § 424.57(c)(12) of this chapter.
(3) Remote monitoring and monitoring services for the provision of home infusion therapy services and home infusion drugs.
(b) All home infusion therapy suppliers must provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations.