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DEPARTMENT OF HEALTH CARE FINANCE
NOTICE OF PROPOSED RULEMAKING
The Director of the Department of Health Care Finance (DHCF), pursuant to the authority set forth in An Act to enable the District of Columbia to receive federal financial assistance under Title XIX of the Social Security Act for a medical assistance program, and for other purposes, approved December 27, 1967 (81 Stat. 744; D.C. Official Code § 1-307.02) and the Department of Health Care Finance Establishment Act of 2007, effective February 27, 2008 (D.C. Law 17-109; D.C. Official Code § 7-771.05(6)), hereby gives notice of intent to adopt the following new Chapter 90 of Title 29 of the District of Columbia Municipal Regulations (“DCMR”), entitled “Medical Necessity: General and Specific Standards.” The proposed rulemaking establishes criteria for determining whether a service is medically necessary, a prerequisite for reimbursement by the Medicaid Program. Federal law requires that State Plans for Medical Assistance (State Plans) assure that care and services covered under State Plans or early and periodic screening, diagnostic, and treatment services are medically necessary and provided in a manner consistent with the best interests of beneficiaries. Federal law also requires State Plans to assure methods and procedures pertaining to utilization of and payment for care and services under the State Plan, as may be necessary to safeguard against unnecessary utilization of such care and services, and to assure that payments are consistent with efficiency, economy, and quality of care.
This rulemaking establishes a process for prospective, concurrent and retrospective reviews to ensure that services reimbursed by the Medicaid Program are both covered and medically necessary. The rules also clarify the relationship between the review procedures that will be used by DHCF to make initial determinations of medical necessity and to reconsider its initial determinations. The rules further clarify the process for requesting an appeal of any DHCF action involving the medical necessity of coverage. These rules also will enable DHCF to recover any payment for a service determined not to be medically necessary.
An initial notice of proposed rulemaking was published in the D.C. Register on August 29, 2008 (55 DCR 009330). Numerous comments were received and taken into account in the release of a second notice of proposed rulemaking on May 15, 2009 (56 DCR 003969). This third notice of proposed rulemaking responds to comments submitted after publication of the May 15, 2009 proposed rule.
The Director of DHCF also gives notice of the intent to take final rulemaking action to adopt these proposed rules not less than thirty (30) days from the date of publication of this notice in the D.C. Register.
Title 29 of the District of Columbia Municipal Regulations (Public Welfare) is amended by adding the following new Chapter 90 to read as follows:
9000 MEDICAL NECESSITY: GENERAL AND SPECIFIC STANDARDS
9000.1 Subject to the provisions of this Chapter, these rules shall apply to the following benefits, treatments, items and services:
(a) Required and optional benefits, treatments, items and services covered under the District of Columbia State Plan for Medical Assistance (State Plan) pursuant to 42 U.S.C. §§ 1396a(a)(10) and 1396d(a);
(b) Required benefits, treatments, items and services described in 42 U.S.C. §§ 1396d(a)(4)(b) and 1396d(r) (relating to early and periodic diagnosis and treatment for individuals under age 21);
(c) Benefits, treatments, items and services provided under waivers of State Plan requirements, as authorized by sections 1915 and 1115 of the Social Security Act and approved by the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS);
(d) Benefits, treatments, items and services set forth in § 9000.1 through § 9000.20 that are administered by managed care organizations and by Health Services for Children with Special Needs under contracts with the Department of Health Care Finance (DHCF); and
(e) In the case of Medicaid beneficiaries who are participants in clinical research that satisfies the Medicare definition of a clinical investigational trial, covered benefits, treatments, items and services that fall within any of the following categories:
(i) they are related to investigational treatment pre-care and aftercare;
(ii) they are related to the ongoing treatment for the condition that is the subject of the clinical trial; or
(iii) they are related to conditions that could complicate the condition whose treatment is the subject of the clinical trial.
9000.2 These rules shall not apply to the following benefits, treatments, items and services:
(a) Transportation services provided by a transportation broker, as part of an approved contract with DHCF and in accordance with the State Plan and waiver;
(b) Preventive treatments, benefits, items and services set forth in § 9000.8; and
(c) Benefits, treatments, items and services covered under the Healthy D.C. program.
9000.3 The specific evidentiary criteria governing coverage requests by managed care enrollees for non-formulary prescribed drugs are set forth in
§ 9000.20. Coverage requests for prescribed drugs that are not identified in a preferred drug list are governed by the evidentiary criteria set forth in
§§ 9000.17 and 9000.18.
9000.4 A proposed or furnished benefit, treatment, item or service covered under the State Plan, or covered as an early and periodic screening, diagnostic and treatment service (EPSDT) pursuant to 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r), or covered pursuant to a waiver of otherwise applicable federal Medicaid requirements under section 1915 or 1115 of the Social Security Act, shall be considered payable if the benefit, treatment, item or service is medically necessary and furnished by a health care provider enrolled in the District of Columbia Medicaid program. The requirement that the health care provider be enrolled in the Medicaid program shall not apply to emergency medical services furnished out-of-state as set forth in 42 CFR § 431.52.
9000.5 A proposed or furnished benefit, treatment, item or service shall be considered medically necessary in the case of individuals under age twenty-one (21) if the benefit, treatment, item or service is covered under the State Plan or pursuant to 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r) (“EPSDT”) and if relevant medical evidence supports the conclusion that the proposed or furnished treatment, item or service is:
(a) Appropriate to the age, functional, and developmental status of the individual;
(b) Consistent with current and generally accepted standards of medical, developmental health, behavioral, or dental practice; and
(c) Likely to assist in achieving one or more of the following:
(i) Promoting growth and development;
(ii) Preventing, correcting, or ameliorating a physical, mental, developmental, behavioral, genetic or congenital condition, injury, or disability that can affect a child’s healthy growth and development; or
(iii) Achieving, maintaining, or restoring health and functional capabilities.
(d) In the case of individuals who have been determined to be qualified individuals with a disability pursuant to the Americans with Disabilities Act, 42 U.S.C. §§ 12101 et seq., or qualified handicapped persons under section 504 of the Rehabilitation Act of 1973, DHCF also shall consider whether the proposed benefit, treatment, item or service is furnished in the most community-integrated setting desired by the individual and appropriate to the individual’s specific needs.
(e) In the case of individuals ages eighteen (18) through twenty-one (21) who are covered by an Elderly & Physically Disabled (EPD) waiver, the medical necessity determination shall take into account the additional factors not addressed in this section and enumerated in § 9000.6(c).
9000.6 A proposed or furnished benefit, treatment, item or service shall be considered medically necessary in the case of a Medicaid beneficiary age twenty-one (21) or older, if it is a covered benefit under the State Plan, a section 1915 or section 1115 waiver, and if relevant medical evidence supports the conclusion that the benefit, treatment, item or service is:
(a) Appropriate to the individual’s physical, mental, developmental, psychological, or functional health;
(b) Consistent with current and generally accepted standards of medical, behavioral, or dental practice; and
(c) Clinically appropriate in terms of type, frequency, extent, setting and duration, and likely to assist in:
(i) Preventing, diagnosing or treating an illness, condition or disability; or
(ii) Achieving, maintaining, or regaining maximum functional capacity in performing Activities of Daily Living (e.g., bathing, dressing, toileting, or eating) or Instrumental Activities of Daily Living (e.g., grocery shopping, laundry).
(d) In the case of individuals who have been determined to be qualified individuals with a disability pursuant to the Americans with Disabilities Act, 42 U.S.C. §§ 12101 et seq., or qualified handicapped persons under section 504 of the Rehabilitation Act of 1973, DHCF also shall consider whether the proposed benefit, treatment, item or service is furnished in the most community-integrated setting desired by the individual and appropriate to the individual’s specific needs.
9000.7 In the case of a public agency that has entered into a memorandum of understanding with DHCF and is acting pursuant to an explicit and written delegation of authority by DHCF to make determinations of medical necessity, covered benefits, treatments, items and services that are specified by such public agency in a written plan of treatment shall be presumed medically necessary by DHCF. DHCF retains the right to perform retrospective reviews of the medical necessity decisions made by the public agency.
9000.8 When covered under the State Plan the following preventive benefits, treatments, items and services shall be considered medically necessary:
(a) Family planning services and supplies, as defined under 42 U.S.C. § 1396d(a)(4)(C), including routine examinations to determine reproductive health undertaken in accordance with professional guidelines; all recommended immunizations (including HPV vaccine and vaccine to prevent cervical cancer); and pap smears and other routine tests to detect conditions that could affect reproductive health;
(b) Periodic and inter-periodic EPSDT screening services furnished to individuals under age twenty-one (21) as described in 42 U.S.C.
§ 1396d(r), that are provided in accordance with established professional standards and are included within the following service categories:
(i) Comprehensive health examinations to ascertain physical and mental health;
(ii) Laboratory tests (including tests to assess a child’s blood-lead levels);
(iii) Developmental assessments;
(iv) Anticipatory guidance;
(v) Nutritional assessments;
(vi) Dental, vision and hearing assessments;
(vii) Immunizations recommended by the Advisory Committee on Immunization Practices;
(viii) HIV screening for children in the care and custody of the District of Columbia’s Child and Family Services Agency (CFSA); and
(viv) Medical examinations required by CFSA for children in their care and custody.
(c) Preventive services furnished to individuals ages twenty-one (21) and older in accordance with recommended guidelines of the U.S. Clinical Preventive Services Task Force, the Advisory Committee on Immunization Practices, or another government agency or commission, or in accordance with professional standards issued by a relevant professional association. These services include:
(i) Routine mammography screening;
(ii) Routine colorectal cancer screening;
(iii) Routine and as-indicated screening for serious and chronic physical or mental health conditions including but not limited to mental illness, substance abuse, sexually transmitted diseases, HIV/AIDS, and other conditions and health risks;
(iv) Semi-annual dental care to prevent disease and maintain oral health;
(v) Routine hearing exams;
(vi) Routine vision exams;
(vii) Pregnancy-related care, as defined pursuant to 42 U.S.C.
§ 1396a(a)(10), including prenatal, delivery and postpartum care, as well as treatment for conditions that could complicate pregnancy, up to the end of the month in which the sixtieth postpartum day following childbirth occurs;
(viii) Immunizations recommended by the Advisory Committee on Immunization Practice;
(viv) Well-women’s care as described in governmental guidelines; and
(x) Health assessments of new managed care enrollees.
9000.9 Evidence regarding the cost of various treatment alternatives that are determined to be equally effective for an individual’s condition based on a review of relevant medical evidence described in § 9000.10 shall be considered relevant to, but not dispositive of, any medical necessity coverage determination.
9000.10 Medical evidence may be furnished as part of the initial medical necessity determination or as part of a reconsideration. Medical evidence shall consist of one or more of the following evidentiary categories:
(a) Written and oral clinical judgments furnished by any medical or health care professional caring for the Medicaid beneficiary. The opinion of a treating medical or health professional shall always be considered as part of a medical necessity review, whether at the initial determination or reconsideration stage;
(b) The beneficiary’s medical record;
(c) Written and oral information furnished by a public agency with the authority to provide or arrange for medical treatment, health care, and other services to be furnished to the beneficiary;
(d) Written and oral information furnished by the Medicaid beneficiary or, when appropriate, the beneficiary’s family, guardian or caregiver, or anyone designated by the beneficiary for whom the beneficiary executes an appropriate release authorization pursuant to the requirements set forth in the Health Insurance Portability and Accountability Act (HIPAA), regarding the beneficiary’s health and functional status, symptoms, and the need for the requested services to enable the beneficiary to prevent or ameliorate physical or mental health conditions, gain health benefits, improve or maintain functional capacity, or avert deterioration in health or functional status from particular interventions and treatments;
(e) Scientifically conducted studies and research, including randomized controlled clinical trials, that either directly or indirectly demonstrate the effect of the intervention on health outcomes or observational studies that indicate a correlation between the intervention and the desired health outcome;
(f) Written treatment guidelines issued by professional societies, peer-review and quality improvement organizations, government and non-governmental organizations, or organizations and entities that specialize in the development of treatment guidelines for use in health care administration; or
(g) Objective evidence obtained from government sources, peer review literature, or other impartial and reliable sources, regarding the cost of health care treatment alternatives under consideration, including estimated and actual costs associated with the provision of covered medical and health care in both institutional and community settings.
9000.11 Any review undertaken by DHCF regarding payment for benefits, treatments, items and services under these rules, including reviews of transfers or discharges of residents from Medicaid-financed institutional facility placements, or eligibility for institutional care following pre-admission screening and annual resident review, shall at a minimum take into account the evidence described in § 9000.10(a) through (c) and, if available, the evidence described in § 9000.10(d).
9000.12 A medical necessity coverage determination may be prospective, concurrent or retrospective.
9000.13 The State Plan covers the following required benefit classes enumerated in 42 U.S.C. § 1396d(a):
(a) Inpatient hospital services (other than services in an institution for mental diseases);
(b) Outpatient hospital services;
(c) Rural health clinic services and any other ambulatory services which are offered by a rural health clinic and which are otherwise included in the State Plan;
(d) Federally qualified health center services and any other ambulatory services offered by a federally qualified health center and which are otherwise included in the State Plan;
(e) Other laboratory and x-ray services;
(f) Nursing facility services (other than services in an institution for mental diseases) for individuals twenty-one (21) years of age or older;
(g) Early and periodic screening, diagnostic, and treatment services as defined in 42 U.S.C. § 1396d(r) for individuals who are eligible under the State Plan and under the age of twenty-one (21);
(h) Family planning services and supplies to individuals of childbearing age (including minors who can be considered sexually active) who are eligible under the State Plan and who desire such services and supplies;
(i) Physician services furnished by a physician, whether furnished in the office, the patient’s home, a hospital, a nursing facility, or elsewhere;
(j) Medical and surgical services provided by a dentist, to the extent that such services may be performed under state law by either a doctor of medicine or a doctor of dental surgery or dental medicine and would be a physician’s service if furnished by a physician;
(k) Services furnished by a nurse midwife which the nurse midwife is legally authorized to furnish under state law, whether or not the nurse midwife is under the supervision of, or associated with, a physician or other health care provider, and without regard to whether the services are performed in the area of management of the care of mothers and babies throughout the maternity cycle;
(l) Services furnished by a pediatric nurse practitioner or certified family nurse practitioner, which the certified pediatric nurse practitioner or certified family nurse practitioner is legally authorized to perform under state law, whether or not the certified pediatric nurse practitioner or certified family nurse practitioner is under the supervision of, or associated with, a physician or other health care provider; and
(m) Home health care services for individuals entitled to nursing facility care, including medical supplies, equipment, and appliances suitable for use in a home.
9000.14 The State Plan covers the following optional benefit classes described in 42 U.S.C. § 1396d(a), except that in the case of beneficiaries under age twenty-one (21), all optional state plan benefit classes (with the exception of the waiver benefit class described in (cc)) shall be treated as required, pursuant to 42 U.S.C. § 1396d(r):
(a) Medical and surgical services furnished by a dentist;
(b) Podiatrists’ services;
(c) Optometrists’ services;
(d) Private duty nursing services;
(e) Clinic services;
(f) Dental services;
(g) Physical therapy and related services;
(h) Occupational therapy;
(i) Services for individuals with speech, hearing and language disorders provided by or under the supervision of a speech pathologist or audiologist;
(j) Prescribed drugs;
(k) Dentures;
(l) Prosthetic devices;
(m) Eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist;
(n) Diagnostic services;
(o) Screening services;
(p) Preventive services;
(q) Rehabilitative services;
(r) Services for individuals age sixty-five (65) or older in institutions for mental diseases to include inpatient hospital services;
(s) Skilled nursing services and intermediate care facility services for the mentally retarded (other than in an institution for mental diseases);
(t) Intermediate care facility (ICF) services other than such services in an institution for mental disease;
(u) Inpatient psychiatric facility services for individuals under twenty-two (22) years of age;
(v) Hospice care;
(w) Special tuberculosis related services;
(x) Extended services for pregnant women;
(y) Ambulatory prenatal care for pregnant women furnished during a presumptive eligibility period;
(z) Skilled nursing facility services for patients under twenty-one (21) years of age;
(aa) Emergency hospital services;
(bb) Personal care services when furnished to an individual who is not an inpatient or resident of a hospital, nursing facility, intermediate care facility for the mentally retarded, or institution for mental disease, that are:
(i) Authorized for the individual by a physician in accordance with a plan of treatment or otherwise authorized for the individual in accordance with a service plan approved by DHCF;
(ii) Provided by an individual who is qualified to provide such services and who is not a member of the individual’s family; and
(iii) Furnished in a home or other location; and
(cc) Additional benefit classes covered for individuals eligible to participate in a Medicaid waiver program.
9000.15 Benefit classes covered for individuals under age twenty-one (21) pursuant to 42 U.S.C. §§ 1396d(a)(4)(B) and 1396d(r) (“EPSDT”) are as follows:
(a) The classes of items and services enumerated in § 9000.13;
(b) The classes of items and services enumerated in § 9000.14;
(c) Ambulatory services offered by rural health clinics and federally-qualified health centers to pregnant women or individuals under eighteen (18) years of age; and
(d) The following benefit classes that are included within the definition of “medical assistance” under 42 U.S.C. § 1396d(a) but that are not covered as optional benefit classes for individuals ages twenty-one (21) and older under the State Plan (except in those instances in which a benefit class may be covered pursuant to a waiver):
(i) Case management services as defined in 42 U.S.C. § 1396n(g)(2);
(ii) Respiratory care services;
(iii) Primary care case management services; and
(iv) Primary and secondary medical treatments and services for individuals who have Sickle Cell Disease, subject to the
requirements set forth in 42 U.S.C. § 1396d(x).
9000.16 In order to be covered, items, treatments and services shall be included within one or more covered benefit classes described in §§ 9000.13 through 9000.15.
9000.17 Prescribed outpatient drugs not enumerated on the preferred drug list maintained by DHCF may be covered in accordance with the requirements governing medical necessity set forth in § 9000.5 and § 9000.6, when supported by medical evidence pursuant to § 9000.10.
9000.18 Pursuant to 42 U.S.C. § 1396r(8)(d)(5), a request for prior authorization of a prescribed outpatient drug shall be responded to by telephone or other telecommunication device within twenty-four (24) hours of the request. In the case of an outpatient prescribed drug (except with respect to those restricted drugs referred to at 42 U.S.C. § 1396r(d)(2)) prescribed for a condition considered by a prescribing health professional to be necessary to treat an emergency medical condition, a seventy-two (72)-hour supply of the prescribed drug shall be covered and dispensed, regardless of whether the prior authorization has occurred.
9000.19 Prescribed outpatient drugs that are not listed in a formulary administered by a managed care organization or by Health Services for Children with Special Needs, and outpatient formulary drugs prescribed for off-label use, shall be considered medically necessary, pursuant to § 9000.5 or § 9000.6, under the following circumstances:
(a) When the request is made by the prescribing physician that complies with the form and manner specified by DHCF;
(b) When the request is supported by the classes of medical evidence described in § 9000.10 (a), (b), and (e)-(g); and
(c) When the prescribing physician provides written certification, in a form and manner specified by DHCF, of compliance with the requirements governing off-label use of medications set forth in D.C. Official Code § 48-841.03.
9001 PROSPECTIVE COVERAGE DETERMINATION
9001.1 The list of benefits, treatments, items and services that shall be prior-authorized by DHCF and that are subject to the procedures governing prospective coverage determinations set forth in this section can be found on the DHCF website at www.dhcf.dc.gov.
9001.2 A request for a prospective coverage determination may be made by the Medicaid beneficiary, the beneficiary’s representative, the beneficiary’s primary care physician, or the health care professional or provider who has prescribed or will be furnishing the services or treatment.
9001.3 The request for a prospective coverage determination shall be made in writing and in a form and manner prescribed by DHCF. The written request shall also indicate whether the request is an expedited request.
9001.4 The request for a prospective coverage determination shall be accompanied by the relevant medical evidence in support of the request. Copies of all relevant medical evidence submitted to DHCF shall be made available to the beneficiary or beneficiary’s representative at no cost.
9001.5 A written request for an expedited prospective coverage determination may be made by the prescribing or treating health care professional or provider or the beneficiary’s primary care physician. .
9001.6 The written request for an expedited coverage determination shall be consistent with the requirements set forth in §§ 9001.3 and 9001.4.. .
9001.7 Within one (1) business day after receipt of an expedited request as described in § 9001.5 and § 9001.6, DHCF shall issue a written notice of intended action. DHCF may take up to an additional twenty-four (24) hours to respond in writing unless reasonable evidence indicates that to do so would jeopardize the health and safety of the beneficiary.
9001.8 The notice issued pursuant to § 9001.7 shall include a description of the results of the review, including a statement indicating whether the treatment is authorized or whether there was an adverse determination, and shall comply with the requirements set forth in § 9003.6 (b), (c), (d), (f) and (g). The notice shall be issued to the Medicaid beneficiary or beneficiary’s representative, with copies sent to the prescribing or treating health care professional or health care provider who sought prior authorization.
9001.9 Where a request for prior authorization is not expedited, DHCF shall issue a notice of intended action conforming to § 9001.8 within twenty-one (21) calendar days of the written request. The notice shall be mailed to the Medicaid beneficiary or the beneficiary’s representative, with copies sent to the health care professional or health care provider who made the request.
9001.10 Where the notice of intended action involves a denial of an expedited request for prior authorization, the beneficiary or beneficiary’s representative, health care professional or provider may request in writing, an expedited reconsideration of the denial not later than twenty-four (24) hours after receipt of the determination.
9001.11 Within twenty-four (24) hours of receipt of an expedited reconsideration request, DHCF shall issue a written notice of the results of the reconsideration. The written notice shall comply with the requirements set forth in § 9003.9. The notice shall be issued to the Medicaid beneficiary or the beneficiary’s representative, with copies sent to the health care professional or health care provider who made the request. DHCF or the beneficiary may request an additional twenty-four (24) hour extension of the deadlines set forth in this section, but in no event shall the reconsideration request jeopardize the health and safety of the beneficiary.
9001.12 Where the notice of intended action involves a non-expedited request for prior authorization, the beneficiary or beneficiary’s representative may submit a written request for reconsideration within twenty-one (21) calendar days of the date on which the initial notice of intended action is mailed. DHCF shall complete its reconsideration within twenty-one (21) calendar days of the date on which the request is made and shall comply with the procedural and notice requirements set forth in § 9001.11.
9001.13 A beneficiary may request a hearing with the Office of Administrative Hearings either upon receipt of the notice of intended action described in
§ 9001.10 or § 9001.12 or following the results of the reconsideration of either an expedited or non-expedited request for prior authorization.
9001.14 In the case of a hearing that is sought either before or following the reconsideration of a non-expedited or expedited prior authorization request, the beneficiary or beneficiary’s representative may orally request a hearing or submit a written request to the Office of Administrative Hearings within ninety (90) calendar days from the date that the notice is mailed. Where the hearing is sought following the reconsideration, the written request for a hearing shall include a copy of the reconsideration determination by DHCF.
9001.15 Each notice issued to a beneficiary shall comply with the requirements set forth in the Language Access Act of 2004, approved June 19, 2004 (D.C. Law 15-167; D.C. Official Code §§ 1-1932 et seq.) and shall be provided in alternative formats and large typeface to accommodate individuals with disabilities.
9002 CONCURRENT COVERAGE DETERMINATION
9002.1 DHCF may conduct a concurrent coverage determination of any benefit, treatment, item or service, including procedures related to the diagnosis of a condition for which payment will be sought from DHCF.
9002.2 DHCF may conduct a concurrent coverage determination on the following benefits, treatments, items and services, which shall be subject to the procedures set forth in this section:
(a) Acute inpatient and general hospital services;
(b) Nursing facility services;
(c) Extended home health services;
(d) Specialty hospital services for children and adolescents; and
(e) Inpatient mental health services.
9002.3 DHCF shall consider all relevant medical evidence submitted by the treating health care professional or provider when making a concurrent coverage determination.
9002.4 DHCF shall issue a written notice describing the review and indicating whether the treatment, item or service is medically necessary and covered or whether an adverse determination has been made. The notice shall indicate the date on which action shall take place.
9002.5 The written notice shall comply with the requirements set forth in § 9003.6. The written notice shall be issued to the beneficiary or the beneficiary’s representative, with copies to the treating health care professional or provider.
9002.6 The beneficiary or beneficiary’s representative may submit a request for reconsideration of an adverse determination within twenty-one (21) calendar days of receipt of the notice issued pursuant to § 9002.4.
9002.7 A reconsideration shall be conducted pursuant to the requirements set forth in §§ 9003.10 and 9003.11.
9002.8 Within twenty-one (21) calendar days of receipt of the request for reconsideration, DHCF shall issue a written notice of the results of the reconsideration. If an adverse determination has been made, the notice shall comply with the requirements set forth in § 9003.9. The written notice shall be issued to the beneficiary or beneficiary’s representative, with copies to the treating health care professional or provider.
9002.9 The beneficiary or beneficiary’s representative may orally request a hearing or submit a written request to the Office of Administrative Hearings within ninety (90) calendar days from the date of mailing of the notice described in § 9002.4 or §9002.8. Where the hearing is sought following the reconsideration, the written request for a hearing shall include a copy of the reconsideration determination by DHCF.
9002.10 Treatments, items, or services shall not be terminated or reduced if the beneficiary requests a reconsideration or administrative hearing before the date of action referenced in § 9002.4.
9002.11 Each notice issued to a beneficiary shall comply with the requirements set forth in the Language Access Act of 2004, approved June 19, 2004 (D.C. Law 15-167; D.C. Official Code §§ 1-1932 et seq.) and shall be provided in alternative formats and large typeface to accommodate individuals with disabilities.
9003 RETROSPECTIVE COVERAGE DETERMINATIONS
9003.1 Except for the preventive benefits, treatments, items and services set forth in § 9000.8, DHCF may conduct a retrospective coverage determination of any benefit, treatment, item or service, including procedures related to the diagnosis of a condition for which payment has been made by DHCF.
9003.2 DHCF shall mail a written notice of intent to conduct a retrospective coverage determination to the beneficiary, the beneficiary’s representative (if known), and the provider whose benefits, items, treatments or services are under review.
9003.3 The written notice of intent mailed to the beneficiary shall include all of the following information:
(a) An explanation of the retrospective coverage determination to be undertaken, including the process that will be used by DHCF in conducting the review;
(b) A description of the benefits, treatments, items and services to be reviewed;
(c) The date(s) on which such benefits, treatments, items and services occurred;
(d) The name of the provider whose benefits, treatments, items or services are to be reviewed;
(e) The legal authority on which such a review is based; and
(f) A specific list of the information sought from the provider whose services or treatments are under review.
9003.4 In conducting the retrospective review, DHCF shall consider all relevant medical evidence submitted by the beneficiary, the beneficiary’s representative (if known), the provider whose benefits, items, treatments or services are under review, and any public or private agency that is involved in the management or oversight of the beneficiary’s treatment.
9003.5 Within ninety (90) calendar days after receipt of all requested information obtained from the beneficiary and the provider whose benefits, items, treatments or services are under review, including but not limited to the beneficiary’s medical records, DHCF shall issue a notice of intended action to the beneficiary, or the beneficiary’s representative (if known), regarding the results of the retrospective coverage determination. DHCF retains the power to issue the notice of intended action, in the event that requested information is not furnished. Copies of the notice also shall be mailed to the following individuals and entities:
(a) The provider whose benefits, treatments, items or services were the subject of the retrospective review;
(b) The beneficiary’s primary care provider, if known; and
(c) Any public or private agency involved in the management or oversight of the beneficiary’s care, if known.
9003.6 The notice of intent issued pursuant to § 9003.5 shall include the following information:
(a) A statement of what action DHCF intends to take and the date of intended action, which shall be no fewer than thirty (30) calendar days from the date on which the notice is mailed;
(b) The specific regulations, rules and policies that support the decision regarding whether the treatment is considered medically necessary or whether there was an adverse determination;
(c) An explanation of the beneficiary’s right to request a reconsideration in writing, which shall be made no later than twenty-one (21) days from the date on which the notice of intended action is mailed;
(d) An explanation of the process that the beneficiary can use to secure copies of all medical evidence on which DHCF relied (which shall be furnished to the beneficiary at no cost no later than seven (7) calendar days following the date of the request);
(e) An explanation of the beneficiary’s right to have the benefits, treatments, items, or services in question continued if the request for a reconsideration as specified in subsection (c) or a hearing as specified in subsection (f) of this section is made before the date on which the action will occur;
(f) An explanation of the beneficiary’s right to request a hearing by
submitting a written or oral request to the Office of Administrative
Hearings within ninety (90) calendar days from the date that the
notice described in § 9003.5 is mailed;
(g) An explanation that the beneficiary, pursuant to D.C. Official Code § 4-210.04, has the right to be represented by legal counsel or by a lay person who is not an employee of the District at the hearing; that the beneficiary may bring witnesses on his or her behalf to the hearing; that transportation for the beneficiary and his or her witnesses will be provided; and that legal services are available to the beneficiary; and
(h) In the event of a notice of intent to pursue recovery of payment for
medical assistance benefits, treatments, items or services, an explanation that the beneficiary has no responsibility either to:
(i). Repay DHCF for any treatment or services found to be medically unnecessary; or
(ii). Pay the treating provider whose medical assistance payments
are the subject of recovery.
9003.7 Within twenty-one (21) calendar days of the date on which the notice of intended action described in § 9003.5 is mailed, the beneficiary or beneficiary’s representative may submit a written request for reconsideration by DHCF of its initial determination.
9003.8 In the event of a request for reconsideration, the beneficiary, the beneficiary’s representative, a provider acting on the beneficiary’s behalf, or a public or private agency responsible for planning and managing the beneficiary’s treatment may provide additional written information to DHCF for review. The reconsideration of the initial determination shall be completed no later than twenty-one (21) calendar days from the date on which DHCF receives any additional information from the beneficiary, which shall be no later than seven (7) days from the date on which the beneficiary submits a written request for reconsideration by DHCF. Either party may request an extension of time not to exceed fourteen (14) days for completion of the reconsideration.
9003.9 DHCF shall issue the written notice of the results of its reconsideration to the beneficiary or the beneficiary’s representative, with copies mailed to the provider whose benefits, items, treatments or services are under review, and any public or private agency involved in the beneficiary’s treatment or management. The written notice of the results of the reconsideration shall contain all of the following information:
(a) An explanation of the action that DHCF intends to take and the date on which such intended action will commence;
(b) An explanation of the results of the reconsideration, including an explanation of the evidence in support of the decision;
(c) The specific laws that support the decision;
(d) An explanation that the benefits, items, treatments or services subject to the reconsideration will not be reduced or terminated if an administrative hearing described in D.C. Official Code §§ 4-210.01 et seq. is requested prior to the date of action;
(e) An explanation of the beneficiary’s right to request a hearing by
submitting a written or an oral request to the Office of Administrative Hearings within ninety (90) calendar days from the date that the notice is mailed;
(f) An explanation that the beneficiary, pursuant to D.C. Official Code § 4-210.04, has the right to be represented by legal counsel or by a lay person who is not an employee of the District at the hearing; that the beneficiary may bring witnesses on his or her behalf to the hearing; that transportation for the beneficiary and his or her witnesses to the hearing will be provided; and that legal services are available to the beneficiary; and
(g) In the event of a notice of intent to pursue recovery of payment for
medical assistance benefits, treatments, items or services, an explanation that the beneficiary has no responsibility either to:
(i). Repay DHCF for any treatment or services found to be medically unnecessary; or
(ii). Pay the treating provider whose medical assistance payments
payments are the subject of recovery.
9003.10 A reconsideration of a retrospective coverage determination shall be conducted by an individual who:
(a) Possesses professional credentials, skills, and training relevant to the beneficiary’s condition and the course of treatment under review; and
(b) Is someone other than the individual who made the initial adverse determination and who is not a subordinate of such individual.
9003.11 As part of the reconsideration process, the beneficiary or beneficiary’s representative shall have the right to:
(a) Submit additional relevant medical evidence, including a second
opinion;
(b) Request an in-person or telephonic meeting with the individual conducting the reconsideration; and
(c) Access copies of all medical evidence examined as part of the reconsideration process.
9003.12 All notices issued to beneficiaries or beneficiaries’ representatives shall comply with the requirements set forth in the Language Access Act of 2004, approved June 19, 2004 (D.C. Law 15-167; D.C. Official Code
§§ 1-1932 et seq.), and shall be provided in alternative formats and large typeface to accommodate individuals with disabilities.
9003.13 The beneficiary or beneficiary’s representative may request a hearing by submitting a written or oral request to the Office of Administrative Hearings within ninety (90) calendar days from the date that the notice of intended action described in § 9003.5 or the reconsideration notice described in § 9003.9 is mailed.
9003.14 If DHCF fails to comply with the timeframes set forth in § 9003.5 or
§ 9003.8, the services shall be deemed medically necessary and approved.
9003.15 If the beneficiary fails to timely request a reconsideration as set forth in section § 9003.7 or a hearing as set forth in § 9003.13, the initial decision issued by DHCF shall become effective.
9004 PROVIDER APPEALS
9004.1 Except for preventive benefits, treatments, items and services set forth in § 9000.8, DHCF may conduct a retrospective coverage determination of any benefit, treatment, item or service, including procedures related to the diagnosis of a condition for which payment has been made by DHCF and reimbursement is sought by DHCF from the provider.
9004.2 DHCF shall issue a written notice to conduct a retrospective coverage determination to the beneficiary and the provider. DHCF shall have one-hundred-and-twenty (120) days from the date that information sought from the provider is furnished to complete the retrospective review.
9004.3 The written notice issued to the provider shall include the following information:
(a) An explanation of the retrospective coverage determination, including the procedures that will be used by DHCF in conducting the review;
(b) The name and Medicaid identification number of the beneficiary whose treatment or services are subject to review;
(c) A description of the benefits, treatments, items and services to be reviewed and the specific information that the provider must submit;
(d) The date(s) on which such benefits, treatments, items and services occurred; and
(e) A request for copies of the beneficiary’s medical record, including the time frame for responding to the request, if required.
9004.4 DHCF shall consider all relevant medical evidence submitted by the treating health care professional or provider.
9004.5 If DHCF proposes to seek reimbursement from a provider because a service is not covered or medically necessary, DHCF shall send a written notice of intent seeking reimbursement from the provider. The notice shall include the following:
(a) The basis for the proposed action;
(b) The amount of the overpayment;
(c) The specific action DHCF intends to take;
(d) The provider’s right to dispute the allegations, and to submit relevant medical evidence to support his or her position; and
(e) Specific reference to the particular sections of the rules or regulations, statutes, transmittals or provider manuals in support of the proposed action.
9004.6 Within thirty (30) calendar days of the date on the notice set forth in
§ 9004.5, the provider may submit relevant medical evidence and a written argument against the proposed action.
9004.7 For good cause shown, DHCF may extend the thirty (30) day period prescribed in § 9004.6.
9004.8 If DHCF decides to seek reimbursement after the provider has filed a response under § 9004.7 or after the provider fails to respond within thirty (30) days, DHCF shall send written notice of the final decision to the provider at least thirty (30) calendar days before the date of intended action. The notice shall include the following:
(a) The basis for the final action, including the evidence on which DHCF relied, the amount of the overpayment, and the specific action DHCF intends to take;
(b) Specific reference to the particular sections of the rules or regulations, statutes, transmittals, or provider manuals in support of the final action; and
(c) The provider’s right to request a hearing by filing a notice of appeal with the Office of Administrative Hearings.
9004.9 A request for a hearing to appeal the DHCF decision seeking reimbursement shall not stay the effectiveness of that decision, if DHCF determines that there is reasonable cause to believe that the provider will not refund the payment for that service that is not covered or medically necessary other than through offset of program payments.
9004.10 A copy of the notice prescribed in §§ 9004.5 and 9004.8 shall also be sent to the Medicaid beneficiary and the beneficiary’s primary care physician, if known.
9005 APPLICABILITY OF MEDICAL NECESSITY DETERMINATION PROCEDURES TO MANAGED CARE ORGANIZATIONS
9005.1 The procedures described in §§ 9001 through 9004 (other than those related to prior authorization of prescribed drugs not included in a formulary administered by a managed care organization (MCO) under
§ 9000.20) shall not apply to benefits, treatments, items or services enumerated in a contract with an MCO.
9005.2 DHCF shall review each request for a hearing before the Office of Administrative Hearings filed by a managed care enrollee. DHCF retains the right to reverse or modify any adverse determination issued by a managed care organization or by Health Services for Children with Special Needs.
9006 NURSING FACILITY ADMISSIONS AND CONTINUED STAY
9006.1 Each Medicaid beneficiary seeking admission for placement in a nursing facility or each Medicaid beneficiary seeking the receipt of services available under the Home and Community-based Waiver for Persons who are Elderly and Individuals with Physical Disabilities shall meet the following requirements:
(a) The beneficiary shall require extensive assistance or total dependence with at least two (2) of the five (5) basic activities of daily living listed on Form-1728; or
(b) The beneficiary shall require at least supervision or limited assistance with at least two (2) of the five (5) basic activities of daily living listed on Form-1728 and extensive assistance, total dependence, supervision, or limited assistance in at least three (3) of the (5) instrumental activities of daily living listed on Form-1728.
9006.2 In addition to the requirements set forth in § 9006.1, each Medicaid beneficiary seeking admission for placement in a nursing facility shall have a negative Level I Pre-Admission Screen Resident Review (PASRR), a positive Level I PASRR screen with clearance for nursing facility placement by the Department on Disability Services or the Department of Mental Health, or meet qualifications for PASRR screen exemption.
9006.3 The Form-1728 and, where applicable, the Level I PASRR screen forms shall be completed, appropriately signed, and submitted to DHCF’s Quality Improvement Organization (QIO) for review;
9006.4 Following the initial admission review in a nursing facility, a continued stay review shall be conducted by the QIO every ninety (90) days to determine whether the continued stay in a facility is medically necessary. The elements of a continued stay review shall include, but are not limited to:
(a) Appropriateness of level of care;
(b) Minimum Data Set (MDS) validation;
(c) Annual PASRR screening, if due; and
(d) Referral for community placement opportunities.
9099.99 DEFINITIONS
Adverse determination - a decision or finding that an individual does not require the level of services provided by a nursing facility or does not need a benefit, treatment, item or service covered under the State Plan; or a decision to deny, terminate, or reduce the amount, duration, or scope of a benefit, treatment, item or service covered under the State Plan.
Beneficiary - any individual who has been designated as eligible to receive, or who receives, any benefit, treatment, item or service under the D.C. Medicaid Program.
Beneficiary Representative - an individual who has been authorized in writing, by a beneficiary or by the parent or guardian of such beneficiary, to represent the interests of the beneficiary.
Concurrent coverage determination - a determination made regarding whether a benefit, treatment, item or service is medically necessary and covered at the time of, or during, a proposed course of treatment.
EPSDT - early and periodic screening, diagnosis, and treatment services for individuals under the age of twenty-one (21) as defined in 42 U.S.C. §§ 1396a(a)(43), 1396d(a)(4)(B), and 1396d(r).
Expedited request - a request that a coverage and medical necessity determination be made quickly because, in the opinion of the treating medical or health care professional or health care provider, such action is necessary to:
(a) Avert jeopardy to the life or health of the beneficiary; or
(b) Prevent or manage severe pain.
Investigational - treatments, items or services that otherwise would be considered as falling within one or more classes of benefits covered under the State Plan, but that are excluded because they are furnished as part of the research protocol within a clinical investigational trial that meets Medicare-applicable standards, as specified in the Decision Memorandum for the Clinical Trial Policy issued by the Centers for Medicare and Medicaid Services on July 9, 2007.
DHCF - the Department of Health Care Finance or its authorized agent.
Managed Care Organizations - entities defined in 42 U.S.C.
§§ 1396b(m)(1)(A) and 1396u-2(a)(1)(B).
Medicaid beneficiary - an individual enrolled in the District of Columbia Medicaid program.
Memorandum of Understanding (MOU) - a written agreement between the District of Columbia Department of Health Care Finance and one or more District of Columbia agencies or Departments that sets forth respective duties of the public agencies and programs of the District of Columbia and of any contractors.
Minimum Data Set (MDS) - the resident assessment instrument and data used to classify nursing facility residents into groups based on each resident’s needs and functional, mental and psychosocial characteristics.
Prospective Coverage Determination - a prior authorization determination made, in advance of treatment, regarding whether the proposed benefit, treatment, item or service is medically necessary and covered.
Relevant Medical Evidence - information that falls within one or more of the evidentiary categories listed in § 9000.10 and that relates to the physical, mental, or developmental health condition of a particular beneficiary or to a particular course of furnished or recommended treatment.
Retrospective Coverage Determination - a decision or finding regarding whether a furnished benefit, treatment, item or service is covered and medical necessary following the provision of the benefit, treatment, item or service.
Comments on the proposed rules shall be submitted in writing to Julie Hudman, Director, Department of Health Care Finance, 825 North Capitol Street, N.E., 6th Floor, Washington, DC 20002, within thirty (30) days from the date of publication of this notice in the DC Register. Copies of the proposed rules may be obtained from the same address.
