Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical Amendments
This technical regulation would amend CMS rules-- To simplify and rationalize the system of definitions and increase uniformity in the use of terms; To clarify which steps of th...
Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION:
Proposed rule.
SUMMARY:
This technical regulation would amend CMS rules—
To simplify and rationalize the system of definitions and increase uniformity in the use of terms;
To clarify which steps of the appeals process are “final” and which are “binding”;
To correct outdated addresses and organizational unit names;
To remove content that is outdated or duplicative; and
To make other editorial changes and technical corrections.
These revisions are necessary to preclude confusion regarding our regulations and to better ensure uniform understanding and application. By updating and removing content that is outdated, unnecessary, or duplicative, these changes would also shorten our rules and make them easier to use.
DATES:
Comment date:
We will consider all comments received at one of the addresses indicated below no later than 5 p.m. on March 26, 2002.
ADDRESSES:
Please mail written comments (one original and three copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: HCF-9877-FC, P.O. Box 8013, Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received in the event of delivery delays.
If you prefer, you may deliver your written comments by courier (one original and three copies) to one of the following addresses:
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or
Comments mailed to the above addresses indicated as appropriate for hand or courier delivery may be delayed and could be considered late.
Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code CMS-9877-FC. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room C5-12-08 of the headquarters Centers for Medicare & Medicaid Services, 7500 Security Blvd., Baltimore, MD, on Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone: (410) 786-7197.
FOR FURTHER INFORMATION CONTACT:
Margaret Teeters, (410) 786-4678.
SUPPLEMENTARY INFORMATION:
A Simplification and Rationalization of the System of Definitions
In revising the definitions system, we aim to ensure that each definition would meet the following conditions:
1. Is worded so as to preclude confusion or misinterpretation.
2. Is not duplicated.
3. Does not include requirements or prohibitions (which belong in the text of the rules); or personnel qualifications (which need to be identified as such).
4. If it is of general applicability, is located at the beginning of chapter IV.
5. If it is of limited applicability, is presented as a basic definition in that part of the regulations to which it is most pertinent or in which it is most frequently used. (When the term is used elsewhere, with the same meaning it has in the basic definition, we cite that basic definition and do not duplicate it. A separate definition of that term would be presented only if it is used with a special, different meaning (for example, in a broader or more limited sense).
We do not include definitions of terms that are not used in the text, are used in their ordinary, usual sense, or are used only once or twice. (In the latter case, the word is explained where used, not placed in a definitions section.)
We would keep all the acronyms for both programs in § 400.200.
Because of the great number of definitions in CMS's regulations, attempting to deal with all of them now would unduly delay issuance of this rule. That would not be desirable for a rule that includes content (updating and correcting) that must be made available promptly to those who implement our regulations and to the general public. We will be developing another technical rule to deal with the remaining definitions.
With respect to personnel qualifications, which have sometimes been presented as “definitions,” our goal has been to include in a new § 400.210, the qualifications for the practitioners whose services are most frequently used in the Medicare program. The personnel qualifications for practitioners who furnish less frequently used services would be retained in their current locations.
Qualifications that are different from the basic qualifications set forth in the new section would also be retained where they have been.
A proposed rule identified as BPD-819-P was published on March 10, 1997 at 62 FR 11005. The final rule, identified as CMS-3819-F, will revise part 484 of the CMS regulations, which
( printed page 3642)
sets forth the conditions of participation for home health agencies. The revision includes changes to the personnel qualifications for speech language pathologists, physical and occupational therapists and their assistants, and social workers and social work assistants. For that reason, this rule proposes no changes in part 484, and does not include in the new § 400.210 the qualifications for the above-noted skilled professionals.
B. Effect of Appeals Decisions
Several sections in part 417 pertaining to the appeals process would be revised to clarify which steps in the process are “binding” but not “final.” The aim is to make clear that the last step in the administrative appeals process must be completed before the appellant has any right to judicial review.
C. Correction of Addresses
We would revise the following sections of the regulations to reflect CMS's new address and any applicable name changes that result from the reorganization of CMS: 401.128, 401.148, 412.63, 412.210, 430.62, 483.102, 485.623.
D. Conforming Amendments
We would correct or remove cross-references to reflect removal or transfer of definitions and personnel qualifications, and outdated or duplicative rules.
E. Clarifying Editorial Revisions
The editorial revisions would—
1. Shorten the regulations and, in order to improve clarity, make the following kinds of changes:
Eliminate repetition and highlight the similarities and differences among rules that apply to different types of providers or practitioners. Part 456 (Utilization Control) currently includes 3 subparts that repeat all the requirements that apply equally to hospitals, mental hospitals, and intermediate care facilities for the mentally retarded (ICFs/MR).
Shorten the content and highlight the similarities and differences by presenting the common requirements once in subpart C (“Utilization Control: All Hospitals”) and revising subparts D and F to set forth only the additional requirements that apply to mental hospitals and to ICFs/MR, respectively.
Remove undesignated centered headings and either substitute designated subparts, or incorporate the content of the undesignated heading into the section headings. Undesignated centered headings, unlike designated subparts, cannot be used to refer to the whole group of sections they encompass. They are usually followed by incomplete section headings because the writer depends too much on the centered heading language—even when the section may appear many pages after the centered heading. This kind of change would be made in part 456 and also in part 447 (Payments for Services).
Provide an overview of disclosure of information rules set forth in several sections. A single section lists and designates the kinds of information that must be disclosed and the entities that must make disclosure. (Part 420—Program Integrity: Medicare)
2. Make numerous minor modifications to—
Reflect the fact that the nursing home reform amendments identify Medicaid facilities as “nursing facilities” (NFs) rather than “skilled nursing facilities” (SNFs); and
Limit “intermediate care facilities” (ICFs) to those that serve persons with mental retardation and related conditions.
3. In part 498, which establishes rules for appeals from CMS determinations, we are proposing to—
Remove references to the Office of the Inspector General (OIG) because the OIG now has its own appeals regulations in part 1005 of chapter V of this title; and
In § 498.3(d), restore a sentence removed by a previous technical amendment. That sentence makes absolutely clear that the only administrative actions that qualify as “initial determinations” are those listed in paragraph (b) of the section.
4. Remove regulations that are no longer in effect.
Subpart E of part 417 would be removed because the requirements applicable to employer group health plans that include HMOs have become outdated.
Subpart I of part 456 would be removed because section 4751 of the Balanced Budget Act (BBA) of 1997 amended sections 1902(a)(26) and 1902(a)(31) of the Social Security Act to remove the requirement for States to perform Inspection of Care (IoC) reviews in institutions for mental diseases and ICFs/MR.
5. Correct cross-references that have become outdated through changes made by other regulations, as in parts 410 and 424.
F. Deferred Changes
The definitions in subpart J of part 411 and parts 435 and 436 would not be revised because those rules are undergoing extensive changes included in other
Federal Register
documents.
Other Required Information
A. Response to Comments
Because of the large number of items of correspondence we normally receive on
Federal Register
documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the
DATES
section of this preamble, and, if we proceed with a subsequent document, we will respond to the major comments in the preamble to that document.
B. Paperwork Reduction Act
This rule contains no information collection requirements subject to review by the Office of Management and Budget.
C. Regulatory Impact Statement
We have examined the impacts of this rule as required by Executive Order 12866 (Regulatory Planning and Review) and the Regulatory Flexibility Act (RFA), Public Law 96-354. Executive Order 12866 directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for rules that constitute significant regulatory action, including rules that have an economic effect of $100 million or more annually (major rules). We have reviewed this rule and have determined that it is not a major rule. Therefore, we are not required to perform an assessment of the costs and savings.
The RFA requires agencies to analyze options for regulatory relief of small businesses in issuing a proposed rule and a final rule that has been preceded by a proposed rule. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $5 million or less annually. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and we certify, that this rule would not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a proposed rule or a final rule preceded by a proposed rule
( printed page 3643)
may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of sections 603 and 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and we certify, that this rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandate Reform Act of 1995, Public Law 104-4, also requires that agencies assess anticipated costs and benefits before issuing any proposed rule and a final rule preceded by a proposed rule that may result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million or more. This rule would have no consequential effect on the governments mentioned or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this proposed rule and have determined that it would not have a substantial effect on State or local governments.
We have reviewed this rule and determined that, under the provisions of Public Law 104-121, the Contract with America Act, it is not a major rule.
In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget.
Anesthetist
means a physician anesthetist, an anesthesiologist assistant, or a certified registered nurse anesthetist.
* * * * *
CAH
stands for critical access hospital.
* * * * *
Departmental Appeals Board
means either of the following:
(1) A panel of members of a Board established in the office of the Secretary to provide impartial review of disputed decisions made by the operating components of the Department or by ALJs.
(2) The Medicare Appeals Council designated by the Board Chair to review ALJ decisions under part 405, subparts G and H; part 417, subpart Q; part 422, subpart M; and part 478, subpart B.
EACH
stands for essential access community hospital.
* * * * *
FMAP
stands for Federal medical assistance percentage.
* * * * *
HIO
stands for health insuring organization.
* * * * *
Hospital
means an institution that meets the requirements of section 1861(e) of the Act.
ICD-9-CM
stands for International Classification of Diseases, Ninth Revision, Clinical Modification.
* * * * *
IMD
stands for institution for mental diseases.
* * * * *
MCO
stands for managed care organization.
* * * * *
NF
stands for nursing facility.
* * * * *
PHP
stands for prepaid health plan.
PHS
stands for Public Health Service, and PHS Act means the Public Health Service Act.
Practitioner
means a physician or any other individual who has the credentials to practice within a recognized health care discipline and who furnishes the services of that discipline to patients.
* * * * *
Qualified practitioner
means a practitioner who meets the personnel qualification requirements set forth in the statute, or in this part or elsewhere in this chapter, as a condition for coverage of his or her services under Medicare or Medicaid, or both.
* * * * *
Religious nonmedical health care institution
means an institution that meets the requirements of section 1861(ss)(1) of the Act.
* * * * *
RNHCI
stands for religious nonmedical health care institution.
* * * * *
Significant business transaction
means a business transaction or series of transactions carried out by an entity involved in the furnishing of health care services, the total of which, during any fiscal year, exceeds 5 per cent of the facility's total operating expenses or $25,000, whichever is less.
* * * * *
State
means any of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, or the Northern Mariana Islands.
State survey agency
means the State health agency or other appropriate State or local agency that—
(1) Has an agreement with CMS under section 1864 of the Act, under which it performs surveys and inspections of health care facilities and recommends to CMS whether they meet the applicable requirements of section 1819, section 1832, section 1861, or subpart C of title XVIII of the Act; and
(2) Is used by the State to determine, on the basis of surveys and inspections,
( printed page 3645)
whether health care facilities meet the requirements for participation in Medicaid.
* * * * *
5. In § 400.202, the following changes are made:
a. In the definition of “Carrier”, the phrase “payable on a charge basis” is removed.
b. In the definition of “Intermediary”, “(or under any Prospective Payment System)” is added immediately after “payable on a cost basis”.
c. The following definitions are added in alphabetical order to read as follows:
Assignment
means that the beneficiary transfers the right to claim payment for a service to the physician or other supplier of the service.
* * * * *
Covered services
means services for which payment may be made to or on behalf of a Medicare beneficiary, subject to all requirements and limitations imposed by title XVIII of the Act and by this chapter.
* * * * *
Deductible
means any of the following:
(1) The fixed amount for which the beneficiary is liable when he or she receives inpatient services in a hospital or CAH for the first time in a benefit period.
(2) The specified amount of expenses that a beneficiary must incur for covered Part B services in a calendar year before Medicare payment may be made, on his or her behalf, for additional Part B services (other than those specifically exempted under section 1833(b) of the Act and elsewhere in this chapter) furnished in that year.
(3) The expenses incurred for the first three pints of whole blood or units of packed red cells furnished to a beneficiary during a calendar year under Medicare Part A or Part B.
* * * * *
Medicare enrollee
means a beneficiary who has elected to have his or her Medicare coverage provided through an HMO, CMP, HCPP, or M+C organization that participates in Medicare.
* * * * *
Physician
means—
(1) A doctor of medicine or osteopathy authorized to practice medicine and surgery in the State in which he or she performs the function; and
(2) For certain specified services, a doctor of dental surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, and a chiropractor. (The specific services are set forth in subpart B of part 410 of this chapter.)
* * * * *
Skilled nursing facility (SNF)
means a facility that meets the requirements of sections 1819(a) through 1819(d) of the Act.
* * * * *
6. In § 400.203, the following changes are made:
a. The definition of “State” is removed.
b. A definition of “Institution for mental diseases” is added in alphabetical order.
c. The definitions of “FMAP” and “Nursing facility” are revised to read as set forth below.
Federal medical assistance percentage (FMAP)
means the percentage used to calculate the amount of the Federal share of State expenditures under the Medicaid program in accordance with section 1905(b) of the Act.
* * * * *
Institution for mental diseases (IMD)
means a facility that meets the requirements of section 1905(i) of the Act and the definition in § 435.1009 of this chapter.
* * * * *
Nursing facility (NF)
means a facility that meets the requirements of sections 1919(a) through 1919(d) of the Act.
(a)
Basis and scope.
(1)
Basis.
In order to participate in the Medicare program, providers and certain suppliers must use qualified staff. In order to be paid for the services they furnish to Medicare beneficiaries, physicians and other practitioners must meet specified qualifications.
(2)
Scope.
(i) This section sets forth the specific qualifications that must be met by those practitioners whose services are most frequently and widely used in the Medicare program.
(ii) Qualifications required of practitioners whose services are less frequently used or that are different for a particular program aspect are set forth in the subparts or sections that deal with those program aspects.
(b)
Specific requirements.
As a condition for Medicare payment to the providers and suppliers that employ them, or for the services that they furnish in independent practice, practitioners must meet the requirements for State licensing, certification, or approval, and the additional qualifications set forth in this section.
(c) An
anesthesiologist assistant
must meet the following requirements:
(1) Work under the direction of an anesthesiologist.
(2) Be in compliance with all applicable requirements of State law, including any licensure requirements the State imposes on anesthetists who are not physicians.
(3) Be a graduate of a medical school-based anesthesiologist's assistant educational program that—
(i) Is accredited by the Committee on Allied Health Education and Accreditation; and
(ii) Includes approximately 2 years of specialized basic science and clinical education in anesthesia at a level that builds on a premedical undergraduate science background.
(d) A
certified registered nurse anesthetist
must meet the following requirements:
(1) Be licensed as a registered professional nurse by the State in which he or she practices.
(2) Meet any licensure requirements the State imposes on anesthetists who are not physicians.
(3) Be a graduate of a nurse anesthesia educational program that meets the standards of the Council on Accreditation of Nurse Anesthesia Programs or any other accreditation organization that CMS designates.
(4) Meet one of the following conditions:
(i) Have passed a certification examination of the Council on Certification of Nurse Anesthetists, the Council on Recertification of Nurse Anesthetists, or any other certification organization that CMS designates.
(ii) Be a graduate of a program described in the qualification in paragraph (d)(3) of this section and, within 24 months after that graduation, meet the condition in paragraph (d)(4)(i) of this section.
(e) A
nurse-midwife
must meet the requirements in paragraphs (e)(1) and (2) of this section, and the requirement in paragraph (e)(3) or the requirement in paragraph (e)(4):
(1) Be currently licensed to practice in the State as a registered professional nurse.
(2) Be legally authorized under State law or regulations to practice as a nurse-midwife.
(3) Have completed a State-specified program of study and clinical experience for nurse-midwives.
( printed page 3646)
(4) If there is no State-specified program of study and clinical experience for nurse-midwives, meet one of the following conditions:
(i) Be currently certified as a nurse-midwife by the American College of Nurse-Midwives.
(ii) Have successfully completed a formal educational program (of a least 1 academic year) that, upon completion, qualifies the nurse to take the certification examination offered by the American College of Nurse-Midwives.
(iii) Have successfully completed a formal educational program for preparing registered nurses to furnish gynecological and obstetrical care to women during pregnancy, delivery, and the post-partum period and care to normal newborns; and have practiced as a nurse-midwife for a total of 12 months during any 18-month period between August 8, 1976 and July 16, 1982.
(f) A
nurse practitioner
must meet one of the following requirements:
(1) Be a registered professional nurse who—
(i) Is authorized by the State in which he or she furnishes the services to practice as a nurse practitioner in accordance with State law; and
(ii) Is certified as a nurse practitioner by a recognized national certifying body that has established standards for nurse practitioners.
(2) Be a registered professional nurse who—
(i) Is authorized by the State in which he or she furnishes the services to practice as a nurse practitioner under State law; and
(ii) Has been granted a Medicare billing number as a nurse practitioner by December 31, 2000.
(3) Be a nurse practitioner who—
(i) On or after January 1, 2001, applies for a Medicare billing number for the first time; and
(ii) Meets the requirements specified in paragraph (f)(1) of this section
(4) Be a nurse practitioner who—
(i) On or after January 1, 2003, applies for a Medicare billing number for the first time;
(ii) Has a master’s degree in nursing; and
(iii) Meets the requirements specified in paragraph (f)(1) of this section.
(g) A
physician assistant
must meet all of the following requirements:
(1) Have graduated from a physician assistant educational program that is accredited by the National Commission on Accreditation of Allied Health Education Programs;
(2) Have passed the national certification examination of the National Commission on Certification of Physician Assistants; and
(3) Be licensed by the State to practice as a physician assistant.
PART 401—GENERAL ADMINISTRATIVE REQUIREMENTS
B. Part 401 is amended as set forth below.
1. The authority citation for part 401 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1895hh). Subpart F is also issued under the authority of the Federal Claims Collection Act (31 U.S.C. 3711).
2. In paragraph (a)(3), under “Region IX”, “Trust Territory of Pacific Islands” is removed, and “Northern Mariana Islands” is added after “American Samoa”.
3. In paragraph (b), the address “Director, Office of Research, Demonstrations, and Statistics, CMS, Baltimore, Maryland 21235” is revised to read “Privacy Officer, CMS, 7500 Security Boulevard, Baltimore, MD 21244-1850”, and “, Office of Research, Demonstrations and Statistics”, the second time it appears, is removed.
4. In § 401.148, the address “CMS, 700 East High Rise Building, 6401 Security Boulevard, Baltimore, Maryland 21235,” is revised to read “Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850”.
PART 402—CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
C. Part 402 is amended as set forth below.
1. The authority citation for part 402 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Minimum requirements for approval of a State system.
(a)
Application and submission of documentation.
The State Governor or his or her designee is responsible for submitting the application for system approval and any assurances and other documentation required under this subpart.
(b)
Basis for approval: Specific requirements.
(1) CMS may approve the making of Medicare payments under a State reimbursement control system if CMS determines that the system meets the requirements of paragraphs (b) and (c) and, if applicable, paragraph (d), of this section.
(i) CMS evaluates any application for approval of a State system and gives the State notice of its determination within 60 days.
(ii) CMS may reconsider a denied application in accordance with § 403.316.
10. In § 405.2401, the definitions of “Act”, “Beneficiary”, “Carrier”, “CMS”, “Covered services”, “Deductible”, “Nurse-midwife”, “Nurse practitioner and physician assistant”, “Reporting period”, and “Secretary” are removed, and the definition of “Physician” is revised to read as follows:
Physician
includes residents who meet the definition of § 415.152 of this chapter and meet the requirements of § 415.206(b) of this chapter for payment under the physician fee schedule.
* * * * *
PART 406—HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT
F. Part 406 is amended as set forth below.
1. The authority citation for part 406 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
2. In § 406.21, paragraph (f)(1) is revised to read as follows:
(f)
Transfer enrollment period for HMO and CMP enrollees.
(1)
Applicability.
This paragraph applies to an enrollee of an HMO or CMP that has a contract with CMS under subpart L of part 417 of this chapter.
* * * * *
PART 409—HOSPITAL INSURANCE BENEFITS
G. Part 409 is amended as set forth below.
1. The authority citation for part 409 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
5. In § 410.50, in paragraph (b), the word “independent” is removed and “subpart M of part 405 of this chapter.” is revised to read “part 493 of this chapter.”.
Services of a certified registered nurse anesthetist or an anesthesiologist assistant.
Medicare Part B pays for anesthesia services and related care furnished by a certified registered nurse anesthetist or an anesthesiologist assistant who—
(a) Is legally authorized to perform the services by the State in which he or she performs them; and
(b) Meets the qualifications specified in § 400.210 of this chapter.
(b)
Qualifications.
For Medicare Part B coverage of his or her services, a nurse practitioner must meet one of the requirements specified in § 400.210(f) of this chapter.
* * * * *
( printed page 3648)
PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
I. Part 411 is amended as set forth below.
1. The authority citation for part 411 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
3. In § 412.63(b)(3) and § 412.210(b)(2), the address “CMS, East High Rise Building, Room 132, 6325 Security Boulevard, Baltimore, Maryland, 21207” is revised to read “Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850”.
(B) The hospital must, as of January 1, 1988, have employed or contracted with a certified registered nurse anesthetist or an anesthesiologist's assistant to perform anesthesia services in that hospital.
* * * * *
PART 413—PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES
K. Part 413 is amended as set forth below.
1. The authority citation for part 413 continues to read as follows:
(c)
Business transaction defined.
As used in paragraph (b) of this section, a business transaction is any of the following kinds of transactions:
(1) Sale, exchange, or lease of property.
(2) Goods, services, or facilities furnished for a monetary consideration, including management services but not including—
(i) Salaries paid to employees for services performed in the normal course of their employment; or
(ii) Health services furnished to the HMO's enrollees by hospitals and other providers and by HMO staff, medical groups, IPAs, or any combination of these entities.
(a)
Basis and scope.
This subpart is based on sections 1124, 1124A, 1126, and 1861(v)(1)(I) of the Act. It sets forth requirements for providers, Part B suppliers, health maintenance organizations, and intermediaries and carriers to disclose information about the following matters and persons.
(1) The hiring of an intermediary's former employees by a provider.
(2) Any person who—
(i) Has an ownership or control interest in the provider or supplier or serves as the agent or managing employee of the provider or supplier;
(ii) Has been convicted of a criminal offense, subjected to a civil money penalty, or excluded from the program, as a result of any activities related to involvement in Medicare, Medicaid, the Maternal and Child Health program under title V of the Act, or the Social Services program under title XX of the Act, at any time since the inception of these programs; or
(iii) Has an ownership or control interest in, or is the agent or managing employee of, an entity that has been sanctioned as described in paragraph (a)(2)(ii) of this section.
(3) Significant business transactions between the provider or supplier and any subcontractor or wholly owned supplier.
(b)
Applicability.
The following are subject to the requirements of this subpart as disclosing entities:
(1) A provider of services as defined in section 1861(u) of the Act or a Part B supplier.
(2) A clinical laboratory.
(3) A renal disease facility.
(4) A rural health clinic.
(5) A Federally qualified health center.
(6) A health maintenance organization as defined in section 1301(a) of the PHS Act.
(7) A Medicare intermediary or carrier.
(8) A Medicare+Choice organization, as defined in section 1859 of the Act.
(9) A managed care entity as defined in section 1932 of the Act.
3. In § 420.201, the following changes are made:
a. The definition of “Significant business transaction” is removed.
b. The definitions of “Disclosing entity”, “Other disclosing entity”, “Indirect ownership interest” and “Ownership interest” are revised and the newly revised definition of
Other disclosing entity
is transferred to proper alphabetical order, to read as follows:
Disclosing entity
means any of the entities specified in § 420.200(b).
Indirect ownership interest
means an ownership interest in an entity that has a direct or indirect ownership interest in a disclosing entity.
* * * * *
Other disclosing entity
means any entity (other than an individual practitioner or group of practitioners) that—
(1) Is not listed in § 420.200 (b) and does not participate in Medicare; but
(2) Is required to disclose ownership and control information because it furnishes health-related services under any of the programs established under title V, XIX, or XX of the Act, or serves as a Medicaid fiscal agent.
* * * * *
Ownership interest
means the possession of equity in the capital, the stock, or the profits of a disclosing entity.
(a)
Basis.
(1) This part is based on the indicated provisions of the following sections of the Act:
1124—Requirements for disclosure of certain information.
1816 and 1842—Use of organizations and agencies to make Medicare payments to providers and suppliers of covered services.
(2) Section 421.118 is also based on 42 U.S.C. 1395b-1(a)(1)(F), which authorizes demonstration projects involving intermediary agreements and carrier contracts.
(b)
Scope.
This part sets forth—
(1) The procedures for selecting intermediaries and carriers;
(2) The requirements for approval of intermediary agreements and carrier contracts;
(3) The functions that intermediaries and carriers are required to perform;
( printed page 3650)
(4) The criteria for—
(i) Evaluating intermediary and carrier performance;
(ii) Designating intermediaries and carriers to serve a class of providers on a regional or national basis; and
(iii) Assigning and reassigning providers or suppliers to particular intermediaries.
(5) CMS's authority to perform certain functions directly or by contract; and
(6) The appeal rights of intermediaries and carriers dissatisfied with specified adverse actions.
For purposes of designation of intermediaries (§ 421.117) and application of performance criteria and standards (§§ 421.120 and 421.122) “intermediary” includes a Blue Cross plan that has entered into a CMS-approved subcontract with the Blue Cross and Blue Shield Association to perform intermediary functions.
PART 422—MEDICARE+CHOICE PROGRAM
R. Part 422 is amended as set forth below.
1. The authority citation for part 422 continues to read as follows:
4. In § 430.62, the name and address “Docket Clerk, Hearing Staff, Bureau of Eligibility, Reimbursement, and Coverage, 300 East High Rise, 6325 Security Boulevard, Baltimore, Maryland 21207. Telephone: (301) 594-8261” is revised to read “Centers for Medicare & Medicaid Services, Office of Hearings, 7500 Security Boulevard, Baltimore, MD 21244-1850”.
PART 431—STATE ORGANIZATION AND GENERAL ADMINISTRATION
U. Part 431 is amended as set forth below.
1. The authority citation for part 431 continues to read as follows:
Authority:Sec. 1102 of the Social Security Act (42 U.S.C. 1302).2. Throughout this subpart E, all references to “skilled nursing facility” are removed.
Except as permitted under §§ 431.213 and 431.214, the State or local agency must mail the notice required under § 431.206(c)(2) through (c)(4) at least 10 days before the intended effective date of the action.
9. In § 431.213, the following changes are made:
a. The introductory text and paragraph (h) are revised to read as set forth below.
b. Remove the semicolons at the end of paragraphs (a) through (g) and add periods in their place, and remove the “or” after paragraph (g).
The agency may mail the notice no later than the effective date of the action or the date of the determination, as applicable, under any of the following circumstances:
* * * * *
(h) The discharge or transfer of the recipient will be effective in less that 10 days and the timing exception of § 483.12(a)(5)(ii) of this chapter applies.
10. In § 431.214, the introductory text is revised to read as follows:
The agency may shorten the period of advance notice to 5 days before the effective date of the action or the date of the determination, as applicable, if—
Relations with standard-setting and survey agencies.
* * * * *
(g) * * *
(3) Have qualified personnel perform on-site inspections at least once during each certification period, or more often if there is a compliance question.
* * * * *
15. In § 431.620, paragraph (b) is revised to read as follows:
Active case
means an individual or family that the State agency has determined to be currently eligible for Medicaid.
Administrative period
means the 2-month period (review month and preceding month) during which a case error is not cited for the State agency's failure to take any action required by a change in case circumstances.
* * * * *
PART 433—STATE FISCAL ADMINISTRATION
V. Part 433 is amended as set forth below.
1. The authority citation for part 433 is revised to read as follows:
Authority:Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
(a)
Basis.
Most of the sections in this subpart identify the statutory provisions on which the rules are based. Certain portions of section 1902(a) of the Act are the basis for general administrative requirements such as those for accounting systems, cost allocation, reporting, and the handling of checks that are uncashed or canceled.
(b)
Scope.
This subpart sets forth the conditions for, and the rates of, FFP and the general administrative requirements related to the State's fiscal activities.
4. Section 433.111 is amended to revise the section heading and paragraph (b) to read as follows:
(b)
Mechanized claims processing and information retrieval system
or
system
means the system of hardware and software used to process Medicaid claims and to produce and retrieve services utilization and management information required by the Medicaid single State agency and the Federal Government for program administration and auditing.
(1) The claims are from providers of medical care and services furnished to recipients under the Medicaid program.
(2) The system consists of the following:
(i) Required subsystems specified in the State Medicaid Manual.
(ii) Required changes to the required system or subsystem, published in accordance with § 433.123, and specified in the State Medicaid Manual.
(iii) System enhancements approved by CMS.
(3) Eligibility determination systems are not part of the claims processing and information retrieval system or enhancements to that system.
5. In § 433.304, the following changes are made:
a. The definitions of “Provider” and “Recoupment” are removed.
b. The definitions of “Abuse”, “Fraud”, “Overpayment”, and “Third party” are revised; and a definition of “Sixty-day period” is added to read as set forth below.
Abuse
has the meaning given the term in § 455.2 of this chapter.
* * * * *
Fraud
has the meaning given the term in § 455.2 of this chapter.
Overpayment
means the portion of a Medicaid payment to a provider—
(1) That is in excess of the amount allowable for the services under section 1902 of the Act and implementing regulations; and
(2) That must be refunded to CMS by the State under section 1903 of the Act and this subpart.
* * * * *
Sixty-day period
means the 60 calendar days immediately following discovery of an overpayment, allowed for the State agency to recover or seek to recover the overpayment.
Third party
has the meaning given the term in § 433.136.
PART 434—CONTRACTS
W. Part 434 is amended as set forth below.
1. The authority citation for part 434 continues to read as follows:
Authority:Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Outpatient hospital services and rural health clinic services.
* * * * *
(b)
Rural health clinic services
means the following services when they are furnished by a rural health clinic that has been certified in accordance with part 491 of this chapter, and by practitioners who are acting within the scope of their practice under State law and who meet the conditions specified in this paragraph:
( printed page 3652)
(1) Services furnished by a physician in the clinic and services furnished away from the clinic if the physician's contract with the clinic so provides.
4. In § 440.40, paragraph (a) is revised to read as follows:
Nursing facility services for individuals age 21 or older (other than services in institutions for mental diseases), EPSDT, and family planning services and supplies.
(a)
Nursing facility services.
(1) “Nursing facility services for individuals age 21 or older other than services in an institution for mental disease” means inpatient care that meets the requirements of paragraphs (a)(2) and (a)(3) of this section and includes the following:
(i) Skilled nursing care and related services for residents who require medical or nursing care.
(ii) Rehabilitation services for the rehabilitation of injured, disabled, or sick persons.
(iii) Health related care and services for individuals who, because of their mental or physical condition, require, on a regular basis, services that—
(A) Are above the level of room and board; and
(B) Must be made available on an inpatient basis.
(2) The services must be ordered by, and furnished under the direction of, a physician.
(3) The services must be provided by one of the following:
(i) A facility or distinct part of a facility that is certified as meeting the requirements for participation that are set forth in subpart B of part 483 of this chapter.
(ii) If specified in the State plan, a swing-bed hospital that has CMS approval to furnish SNF services under Medicare.
(iii) Any facility located on an Indian reservation if the facility is certified by the Secretary as meeting the requirements of subpart B of part 483 of this chapter.
(c) Services furnished to a recipient whose place of residence is a hospital or a nursing facility are not “home health services”. However, home health services may be furnished to residents of an ICF/MR if they are services other than those required under subpart I of part 483 of this chapter. For example, a registered nurse may provide short-term care for a recipient in an ICF/MR to avoid having to transfer the recipient to a nursing facility.
7. In § 440.80(c)(3), “A skilled nursing facility” is revised to read “A nursing facility”.
8. In § 440.140, the following changes are made:
a. The section heading is revised to read as follows: “§ 440.140 Inpatient hospital services and nursing facility services for individuals age 65 or older in institutions for mental diseases.”
b. In paragraph (a), introductory text, “(b), (c), and (e)” is removed.
c. In paragraph (a)(2), “subpart H of” is removed.
a. The word “subchapter”, wherever it appears, is revised to read “chapter”.
b. Revise “intermediate care facility services for the mentally retarded” to read “nursing facilities and intermediate care facilities for persons with mental retardation”.
(a) The plan must provide for payment for laboratory services as defined in § 440.30 of this chapter, if they are furnished by entities that meet the following additional requirements, as appropriate:
(1) For hospital-based laboratories, the requirements of § 482.27 of this chapter.
(2) For services furnished by rural health clinics, the requirements of § 491.9(c)(2) of this chapter.
(3) For NF-based laboratories, the requirements of § 483.75(j) of this chapter
(b) Laboratory records must contain the name (or other identifier approved by the Medicaid agency) of the person from whom the specimen was taken.
a. In paragraph (b)(1), “an SNF or ICF” is revised to read “an NF”, and “(NF effective October 1, 1990)” is removed.
b. In paragraph (c), in the “P” and “Q” factors of the formula, “for SNF and ICF” is revised to read “for NF”, and “(NF effective October 1, 1990)” is removed.
PART 442—STANDARDS FOR PAYMENT TO NURSING FACILITIES AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED
Z. Part 442 is amended as set forth below.
1. The authority citation for part 442 continues to read as follows:
Authority:Sec. 1102 of the Social Security Act (42 U.S.C. 1302), unless otherwise noted.
Deductibles, coinsurance, and copayment, or similar charges: General rules.
* * * * *
(b)
Exceptions.
The plan may not provide for imposition of a deductible, coinsurance, copayment, or similar charge for the following services furnished to categorically needy or medically needy individuals:
(1)
Services to children.
This means services to individuals under 18 years of age or (at State option) to individuals under 21, 20, or 19 years of age, or any reasonable category of individuals 18 years of age or over but under 21.
(2)
Services related to pregnancy.
This means services furnished to pregnant women if the services are related to the pregnancy or to any other condition that may complicate the pregnancy. These services include the following:
(i) Routine prenatal care.
(ii) Labor and delivery.
(iii) Routine postpartum care.
(iv) Family planning services.
(v) Services for complications likely to affect pregnancy or delivery, such as hypertension, diabetes, or urinary tract infection.
(vi) Services furnished during the postpartum period for conditions or complications related to the pregnancy.(The postpartum period begins on the last day of the pregnancy and ends on the last day of the month in which the subsequent 60-day period ends.)
(3)
Services to individuals in institutions.
This means services furnished to any individual who—
(i) Is an inpatient of a hospital, NF, other medical institution, or ICF/MR; and
(ii) Is required, as a condition for receiving services in the institution, to contribute to the medical care costs all but the minimum amount of income he or she needs for personal expenses. (Sections 435.725, 435.733, 435.832, and 436.832 of this chapter specify the groups to which this requirement applies.)
(4)
Emergency services.
This means services furnished in a hospital, clinic, office, or other facility that is equipped to furnish emergency services, that is, services that are required after the sudden onset of a medical condition manifesting itself by acute symptoms so severe (including severe pain) that failure to provide immediate medical attention could reasonably be expected to result in—
(i) Serious jeopardy to the patient's health;
(ii) Serious impairment of bodily functions; or
(iii) Serious dysfunction of any bodily organ or part.
(5)
Family planning services.
This means family planning services furnished to individuals of child-bearing age.
(6)
Hospice care.
This means hospice care as defined in section 1905(o) of the Act.
(c)
Optional exclusions.
States may, at their option—
(1) Exempt from cost sharing all services furnished to pregnant women; and
(2) Exempt from copayment charges any HMO services furnished to medically needy Medicaid enrollees.
Federal financial participation (FFP): Limits related to cost sharing.
(a)
Basic rule.
Except as provided in paragraph (b) of this section, FFP is not available for expenditures for cost sharing amounts (enrollment fees or premiums, deductibles, coinsurance, copayment, or similar charges) that a recipient should have paid.
(b)
Exception.
FFP is available for the amounts that the agency pays as bad debts of providers under § 447.57. (We note that FFP is not available for payments the agency makes on behalf of an ineligible individual even if he or she has paid any required premium or enrollment fee.)
13. The undesignated center headings immediately preceding §§ 447.251, 447.257, 447.271, and 447.280 are removed.
14. Section 447.253 is amended to revise paragraph (b)(1)(ii)(B) to read as follows:
(B) If a State elects to cover services furnished at an inappropriate level of care (hospital inpatient services furnished to patients who require nursing facility level of care), the State's methods and standards specify that payment for this type of care is at the lower rates appropriate for nursing facility care, consistent with section 1861(v)(1)(G) of the Act; and
(b)
Specific upper limits.
(1) The agency's payments for multiple source drugs identified and listed in accordance with paragraph (a) of this section may not exceed, in the aggregate, payment levels determined by applying, for each drug entity—
(i) A reasonable dispensing fee established by the agency; plus
(ii) An amount established by CMS that is equal to 150 percent of the published price at which the least costly therapeutic equivalent can be purchased by pharmacists.
(2) In selecting the size of the drug entity, the agency must—
(i) For non-liquids commonly available in quantities of 100 tablets or capsules, use that size;
(ii) For non-liquids not commonly available in quantities of 100 tablets or capsules, use the commonly listed package size; and
(iii) For liquids, use the commonly listed package size.
(3) In determining the least costly equivalent, the agency must use all available national compendia.
Exclusion
means denial of participation in the Medicaid program for a provider that has defrauded or abused the program, or been convicted of a program-related offense under a Federal, State, or local law.
* * * * *
3. In § 455.3, the following changes are made:
a. The introductory text is republished and paragraph (a) is revised to read as set forth below.
b. In paragraph (b), “or suspended practitioners” is removed.
(a) This subpart implements sections 1124, 1126, 1902(a)(38), and 1903(i)(2) of the Act.
(b) It sets forth State plan requirements for disclosure of information regarding—
(1) Ownership and control of providers and fiscal agents, and their subcontractors;
(2) Persons convicted of criminal offenses related to their involvement in any program under Medicare, Medicaid, or the social services program under title XX of the Act; and
(3) Business transactions between providers and their subcontractors or wholly owned suppliers.
(c) It also provides instructions for determining ownership or control percentages, and specifies the penalties for failure to furnish the required information timely.
5. In § 455.101, the definition of “Significant business transaction” is removed, and the definitions of “Indirect ownership interest” and “Ownership interest” are revised to read as follows:
1. In paragraph (b)(2), in the last full sentence of the introductory text, “and intermediate care facilities (ICF's).” is revised to read “and ICFs/MR.”.
2. In paragraph (b)(5), “(IMD's)” is revised to read “(IMDs)”, and “ICF's” is revised to read “ICFs/MR”.
This subpart sets forth the requirements that all hospitals must meet for certification of need for care, plan of care, and utilization review (UR) plans.
The State plan must provide that each hospital furnishing inpatient services under the plan has in effect a written UR plan that meets the requirements of this subpart.
(a) The committee assigns subsequent continued stay review dates in accordance with §§ 456.128 and 456.134(a).
(b) The committee assigns a subsequent review date each time it decides that the continued stay is needed and, for a mental hospital patient, it schedules subsequent reviews for at least every 90 days.
(c) The committee ensures that each continued stay review date it assigns is entered in the recipient's record.
j. Section 456.135 is amended to revise paragraphs (f), (g), and (h) to read as follows:
(f) If the committee, subgroup, or designee finds that a continued stay is not needed, it notifies the recipient's attending physician (in the case of a mental hospital patient, it may be the attending or staff physician) and provides an opportunity for the physician to present his or her views before it makes a final decision.
(g) If the attending or staff physician does not present additional information or clarification of the need for continued stay, the decision of the committee, subgroup, or designees is final.
(h) If the attending or staff physician presents additional information or clarification, at least two physician members of the committee (at least one of which is knowledgeable about mental diseases) review the need for continued stay. If they find that the patient no longer needs inpatient care, their decision is final.
k. Section 456.136 is amended to revise paragraph (b), to read as follows:
This subpart sets forth the utilization control requirements that mental hospitals must meet in addition to those required of all hospitals as set forth in subpart C of this part.
For mental hospital patients, the following rules apply:
(a) The plan of care required under § 456.80 must be expanded to include—
( printed page 3656)
(1) Objectives;
(2) Any orders for therapies or for special procedures recommended for the patient's health and safety; and
(3) Provision for modifying the plan of care as needed.
(b) The attending or staff physician must participate in reviewing the plan at least every 90 days (rather than every 60 days as is required for all other hospitals).
The UR plan must provide for a review of each recipient's continued stay in a mental hospital to decide whether it is needed, in accordance with the applicable requirements of subpart C of this part and this subpart.
(a) For mental hospital patients, the following rules apply, in addition to those set forth in § 456.128.
(b) If an individual applies for Medicaid while a patient in a mental hospital—
(1) The committee sets the date for initial continued stay review within 1 working day after the hospital receives notice of the application; and
(2) That date may not be later than 30 days after admission of the patient or 30 days after receipt of notice of his or her application for Medicaid, whichever is earlier.
This subpart sets forth the requirements that ICFs/MR must meet in addition to those specified, for hospitals, in subparts C and D of this part. In applying the rules of those subparts, references to “hospitals” must be read as references to “ICF/MR”.
ICF/MR services
means services that meet the conditions specified in § 440.150 of this chapter, but exclude services furnished in a religious nonmedical health care institution as defined in § 440.170(b) of this chapter.
(a) Before admission to an ICF/MR, or before authorization of payment, an interdisciplinary team of health professionals must make a comprehensive medical and social evaluation, and if appropriate, a psychological evaluation, of each applicant's or recipient's need for care in an ICF/MR.
(b) The psychological evaluation must be made not more than 3 months before admission.
(a) Provide that each ICF/MR has on file and implements a written UR plan that provides for review of each recipient's need for the services the ICF/MR furnishes, and meets the requirements of this subpart; and
(b) Specify the method used to perform UR, which may be any of the following:
(1) Review conducted by the facility.
(2) Direct review in the facility by individuals who are—
(i) Employed by the medical assistance unit of the Medicaid agency; or
(a)
Recipient records.
The UR plan must provide that each recipient's record contains the information specified in § 456.111 and also the name of the qualified mental retardation professional. (The qualifications for this professional are set forth in § 483.430 of this chapter.)
(b)
Other records and reports, and confidentiality.
The requirements set forth in §§ 456.112 and 456.113 apply also to ICFs/MR.
1. In paragraph (c), “ICF” is revised to read “ICF/MR”, “§ 456.411” is revised to read “§ 456.411(a)”, “§ 456.432” is revised to read “§ 456.5(b)(1)”, and “§ 456.432(b)” is revised to read “§ 456.5(b)(2)”.
2. Paragraph (f) is revised to read as set forth below.
3. In paragraphs (g) and (h), “attending physician or” is removed.
4. In paragraph (i), “ICF services” is revised to read “ICF/MR services”.
(f) If the group or subgroup making the review under paragraph (e) of this section finds that a continued stay is not needed, it notifies the recipient's qualified mental retardation professional within one working day of its decision and allows 2 working days from the date of notice for the professional to present his or her views before it makes a final decision.
Affiliate of a payor organization
means an organization with a governing body, two or more members of which are—
(1) Governing body members, officers, partners, or 5 percent or more owners of the payor organization; or
(2) Managing employees of an HMO or CMP.
* * * * *
Non-facility organization
means a corporate entity that—
(1) Is not a health care facility;
(2) Is not a 5 percent or more owner of a health care facility; and
(3) Is not owned by one or more health care facilities or any association of facilities in the PRO area.
Payor organization
means any organization (other than a self-insured employer) that pays providers or practitioners (directly or indirectly) for services that the organization reviews,
( printed page 3658)
or would review if it entered into a PRO contract.
Physician
includes—
(1) An intern, resident, or Federal Government employee authorized under State or Federal law to practice medicine, surgery, or osteopathy in the PRO area; and
(2) An individual licensed to practice medicine in American Samoa or the Northern Mariana Islands.
PRO area
means the geographic area designated as the area within which a designated PRO performs utilization and quality control review under its PRO contract with CMS.
4. In paragraph (b) of § 475.105, “Effective November 15, 1984, the” is removed, and “The” is added in its place, and “will not apply” is revised to read “does not apply”.
Prohibition against contracting with payor organizations and affiliates of payor organizations.
Payor organizations and their affiliates are not eligible to become PROs for the area in which they make payments unless CMS determines, on the basis of lack of response to an appropriate Request for Proposal, that there is not available any eligible organization that is not a payor organization or affiliate of a payor organization.
a. The definitions of “Five percent or more owner”, “Health care facility or facility”, “Health care practitioners other than physicians”, “Hospital”, “Non-facility organization”, “Physician”, “Practitioner”, “Preadmission certification”, “Review responsibility” and “Skilled nursing facility” are removed.
b. The following definitions are revised to read as follows:
Active staff privileges
means authorization, on a regular, rather than an infrequent or courtesy basis—
(1) For a physician or other health care practitioner to order the admission of patients to a facility; and
(2) For a physician to perform diagnostic and treatment services in the facility.
* * * * *
Diagnosis related group (DRG)
means a system for classifying inpatient hospital discharges as a basis for Medicare payment under the prospective payment system.
DRG validation
means PRO validation to the effect that the DRG classification assigned to a discharge is based on the correct diagnostic and procedural information.
* * * * *
Hospital
means a health care institution or distinct part of an institution as defined in section 1861(e) through (g) of the Act, including a religious nonmedical health care institution as defined in section 1861(ss)(1) of the Act.
* * * * *
Peer review
means review of services by health care practitioners in the same professional field as the practitioner who ordered or furnished the services.
General requirements for the assumption of review.
In assuming review responsibility, a PRO must comply with the following conditions:
(a) Assume review responsibility in accordance with the schedule, functions, and negotiated objectives specified in its contract with CMS.
(b) Notify the appropriate Medicare fiscal intermediary or carrier of its assumption of review in particular health care facilities no later than 5 working days after the day it assumes review in the facility.
(c) Maintain and make available for public inspection at its principal business office—
(1) A copy of each agreement with a Medicare intermediary or carrier;
(2) A copy of its current approved review plan, including its method for implementing review; and
(3) Copies of all subcontracts for the conduct of review.
(d) Limit subcontracts for review by health care facilities to review of quality of care. (There is no limit to the types of review that the PRO may subcontract to organizations that are not health care facilities.)
(e) If required by CMS—
(1) Compile statistics based on the criteria specified in § 411.402 of this chapter;
(2) Make limitation of liability determinations in accordance with subpart K of part 411 of this chapter; and
(3) Notify providers regarding these determinations. (Appeals from these determinations are subject to the rules set forth in part 405 of this chapter—subpart G for Part A services, and subpart H for Part B services.)
(f) Make its responsibilities under its contract with CMS primary to all its other interests and activities.
Departmental Appeals Board review and judicial review.
(a)
Board review.
The circumstances under which the Departmental Appeals Board (the “Board”) will review an ALJ hearing decision or dismissal are the same as those set forth at 20 CFR 404.970 for Appeals Council review.
(b)
Basis for seeking judicial review.
(1) The affected party may seek judicial review of the Board's decision, or of the ALJ's hearing decision if the Board denies review, if the amount in controversy is $2,000 or more.
(2) The party must file the civil action within 60 days from the date of receipt
( printed page 3659)
of the notice of the Board's determination or denial of review.
PART 480—ACQUISITION, PROTECTION, AND DISCLOSURE OF PEER REVIEW INFORMATION
GG. Part 480 is amended as set forth below.
1. The authority citation for part 480 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Subpart B—PRO Information: General Provisions
2. The heading of subpart B is revised to read as set forth above.
3. The undesignated centered heading immediately preceding § 480.101 is removed.
Implicitly identifies
refers to data so unique, or to numbers so small, that the identity of a particular patient, practitioner, or reviewer would be obvious.
5. § 480.103 is amended to revise paragraph (b) to read as follows:
(b) Section 1160 of the Act provides that PRO information must be held in confidence and not disclosed to any person except—
(1) To the extent necessary to carry out the purposes of title XI, part B, of the Act;
(2) In cases and circumstances specified by regulation to ensure adequate protection of the rights and interests of patients, practitioners, and providers of health care; and
(3) As necessary to assist the following agencies in the performance of their duties:
(i) Federal and State agencies recognized by the Secretary as having responsibility for identifying and investigating cases or patterns of fraud or abuse.
(ii) Federal and State agencies recognized by the Secretary as having responsibility for identifying cases or patterns involving risks to the public health.
(iii) Appropriate State agencies responsible for licensing or certifying providers or practitioners.
(iv) Federal or State health planning agencies that need PROs to furnish them aggregate statistical data on a geographical, institutional, or other basis.
Subpart C—PRO Access to Information and PRO Responsibilities
6. The heading of subpart C is revised to read as set forth above.
7. The undesignated center heading immediately preceding § 480.115 is removed.
Subpart D—Disclosure of Nonconfidential Information
8. The heading of subpart D is revised to read as set forth above.
Subpart E—Disclosure of Confidential Information
9. The heading of subpart E is revised to read as set forth above.
PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
HH. Part 482 is amended as set forth below.
1. The authority citation for part 482 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
2. In § 483.40, in paragraph (e)(1)(i), “the applicable definition in § 491.2 of this chapter” is revised to read “the qualifications set forth in § 400.210 of this chapter”.
a. The section heading is revised to read as set forth above.
b. The paragraph heading
Applicability
is inserted immediately after the designation (a).
c. The heading of paragraph (b) is revised to read
Evaluation criteria.
d. Footnotes 1 and 2 are revised to read as set forth below.
* * * * *
1
The Diagnostic and Statistical Manual of Mental Disorders is available for inspection at the Centers for Medicare & Medicaid Services, CMS Library, Room C2-07-13, 7500 Security Boulevard, Baltimore, MD 21244-1850, or at the Office of the Federal Register, suite 700, 800 North Capitol St., NW., Washington, DC. Copies may be obtained from the American Psychiatric Association, Division of Publications and Marketing, 4100 K Street, NW., Washington, DC 20005.
* * * * *
2
The American Association on Mental Retardation's Manual on Classification in Mental Retardation is available for inspection at the Centers for Medicare & Medicaid Services, CMS Library, Room C2-07-13, 7500 Security Boulevard, Baltimore, MD 21244-1850, or at the Office of the Federal Register, suite 700, 800 North Capitol St., NW., Washington, DC. Copies may be obtained from the American Association on Mental Retardation, 1719 Kalorama Rd., NW., Washington, DC 20009.
As used in this subpart, unless the context indicates otherwise,
Comprehensive outpatient rehabilitation facility, CORF,
or
facility
means a nonresidential facility that is established and operated, at a single fixed location, exclusively for the purpose of providing outpatient diagnostic, therapeutic, and restorative services that are for the rehabilitation of injured, disabled, or sick persons, and that are furnished by, or under the supervision of, a physician.
Immediate jeopardy
means a situation in which the provider's noncompliance with one or more of the requirements for participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient or resident.
* * * * *
c. In the definition of “Substantial allegation of noncompliance”, “raises doubts as to a provider's or supplier's noncompliance” is revised to read “raises doubts as to a provider's or supplier's compliance”.
3. In § 488.56, in paragraph (b) introductory text and paragraph (b)(2), “§ 488.75(i)” is corrected to read “§ 483.75”.
4. In § 488.64, the following changes are made:
a. Paragraph (b) is revised to read as set forth below.
b. In paragraphs (c), and (d), “§ 405.1137 of this chapter, or § 482.30 of this chapter, as applicable.” is revised to read “§ 482.30 of this chapter.”.
c. In paragraph (g), “pursuant to § 405.1137 of this chapter or § 482.30” is revised to read “in accordance with § 482.30 of this chapter”.
Remote facility variances for utilization review requirements.
* * * * *
(b) The Secretary may grant a facility a variance from the utilization review time-frames set forth in § 482.30 of this chapter if the requesting facility can show, to CMS's satisfaction, that it has been unable to comply with those time-frames by reason of lack of sufficient professional personnel available to conduct the reviews.
2. In § 489.3, the definition of “Immediate jeopardy” is revised and a definition of “Supplier approval” is added, in alphabetical order, to read as follows:
3. In § 491.3, “subpart S of 42 CFR part 405” is revised to read “subparts A through C of part 488 of this chapter.”.
PART 493—LABORATORY REQUIREMENTS
NN. Part 493 is amended as set forth below.
1. The authority citation for part 493 is revised to read as follows:
Authority:
Sec. 353 of the Public Health Service Act and secs. 1102 and 1871 of the
( printed page 3661)
Social Security Act (42 U.S.C. 263a, 1302, and 1395hh).
Immediate jeopardy
has the meaning given that term in § 488.1 of this chapter.
* * * * *
Sample,
in relation to proficiency testing, means the material that is to be tested by the participants in the proficiency testing program.
State
includes any political subdivision to which the State has expressly delegated powers sufficient to enable it to enforce requirements equal to, or more stringent than, CLIA requirements.
* * * * *
Substantial allegation of noncompliance
has the meaning given that term in § 488.1 of this chapter.
a. In paragraph (e)(2), “for a certificate as defined in subpart C of this part; and” is revised to read “for one of the certificates specified in subpart C of this part; and”.
b. In paragraph (i)(2), “for a certificate as defined in subpart C of this part; ” is revised to read “for any of the certificates specified in subpart C of this part;”
PART 498—APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/MR AND CERTAIN NFs IN THE MEDICAID PROGRAM
OO. Part 498 is amended as set forth below.
1. The authority citation for part 498 continues to read as follows:
Authority:Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
a. Paragraph (a)(1) is revised to read as set forth below.
b. In paragraph (c), the introductory text is designated as “(1)”, paragraph designations “(1)”, “(2)”, and “(3)” are revised to read “(i)”, “(ii)”, and “(iii)”, respectively.
c. A new paragraph (c)(2) is added to read as set forth below.
d. Paragraph (d) introductory text is revised as set forth below.
(a)
Scope.
(1) This part sets forth procedures for reviewing initial determinations that CMS makes with respect to the matters specified in paragraph (b) of this section, and identifies, in paragraph (c) of this section, matters for which the OIG makes initial determinations and provides appeals procedures. It also specifies, in paragraph (d) of this section, administrative actions that are not subject to appeal under this part.
* * * * *
(c) * * *
(2) Appeals procedures for OIG determinations are set forth in part 1005 of this chapter.
* * * * *
(d)
CMS Administrative actions that are not initial determinations.
CMS administrative actions other than those specified in paragraph (b) of this section are not initial determinations and thus are not subject to appeal under this part. Administrative actions that are not initial determinations (and therefore not subject to appeal under this part) include but are not limited to the following:
6. In § 498.40, in paragraph (a)(1), “or the OIG, as appropriate, or with OHA.” is removed and “or the Departmental Appeals Board.” is added in its place.
(a) The Chair of the Departmental Appeals Board (the Board) or his or her delegate designates an ALJ or a member or members of the Board to conduct the hearing.
(b) If appropriate, the Chair or the delegate may substitute a different ALJ or member or members of the Board to conduct the hearing.
(c) As used in this part, “ALJ” includes a member or members of the Board who are designated to conduct a hearing.
Departmental Appeals Board action on request for review.
* * * * *
(d)
Review panel.
If the Board grants a request for review of the ALJ decision, the review is conducted by a panel of three members of the Board designated by the Chair or Deputy Chair.
PP. Nomenclature changes.
1. Throughout this chapter IV:
a. “DAB”, wherever it appears, is revised to read “Board”.
b. “DAB's”, wherever it appears, is revised to read “Board's”.
( printed page 3662)
c. “(DAB)”, wherever it appears, is removed.
2. Throughout this chapter IV, “a SNF”, and “a NF”, wherever they appear, are revised to read “an SNF” and “an NF”, respectively.
3. Throughout chapter IV, “intermediate care facility for the mentally retarded” wherever it appears, is revised to read “intermediate care facility for persons with mental retardation and related conditions”.
4. In the following locations, “co-payment” wherever it appears, is revised to read “copayment”: §§ 447.54(a)(3) (table heading), 447.55(a) and (b), 447.56, and 447.58.
5. In § 447.54(a)(3) text, “co-payments” is revised to read “copayments”.
6. In the following locations, “the OIG, as appropriate,” is removed: § 498.20(a)(1), § 498.25(b)(1), and § 498.32(a)(1).
7. In the following locations, “or the OIG” is removed:§ 498.32(b)(2), § 498.56(a)(2), § 498.56(d), heading and text, § 498.66(b)(2),§ 498.78(a), and § 498.83(a), heading and text.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare—Supplementary Medical Insurance; Program No. 93.778, Medical Assistance)
Dated: August 8, 2001.
Ruben J. King-Shaw, Jr.,
Deputy Administrator and Chief Operating Officer, Centers for Medicare & Medicaid Services.
Public Law 104-4
42 CFR Part 400