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    PROPOSAL
    Maryland Register
    Issue Date:  October 13, 2017
    Volume 44 • Issue 21 • Pages 988—1000
     
    Title 10
    MARYLAND DEPARTMENT OF HEALTH
    [17-250-P]
    The Secretary of Health proposes to:
    (1) Amend Regulations .03, .04, and .08 under COMAR 10.01.04 Fair Hearing Appeals Under the Maryland State Medical Assistance Program;
    (2) Amend Regulation .01 under COMAR 10.09.62 Maryland Medicaid Managed Care Program: Definitions;
    (3) Amend Regulations .02, .03, and .06 under COMAR 10.09.63 Maryland Medicaid Managed Care Program: Eligibility and Enrollment;
    (4) Amend Regulations .03 and .11 under COMAR 10.09.64 Maryland Medicaid Managed Care Program: MCO Application;
    (5) Amend Regulations .02, .04, .15, .17, .19, and .20 and repeal Regulation .28 under COMAR 10.09.65 Maryland Medicaid Managed Care Program: Managed Care Organizations;
    (6) Amend Regulations .01 and .02 under COMAR 10.09.66 Maryland Medicaid Managed Care Program: Access;
    (7) Amend Regulations .01, .04, and .19 under COMAR 10.09.67 Maryland Medicaid Managed Care Program: Benefits;
    (8) Adopt new Regulations .01—.03 under new chapter, COMAR 10.09.68 Maryland Medicaid Managed Care Program: Program Integrity;
    (9) Amend Regulations .02, .04, and .05 under COMAR 10.09.71 Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures; and
    (10) Amend Regulations .01 and .06 under COMAR 10.09.72 Maryland Medicaid Managed Care Program: Departmental Dispute Resolution Procedures.
    Statement of Purpose
    The purpose of this action is to implement regulations to comply with newly adopted federal regulations impacting MCO requirements and oversight (42 CFR Parts 438, 457, and 495). The new requirements include member rights, member materials, appeals and grievances, and program integrity. In order to coincide with current policy, this proposal also corrects the number of long-term care days for which an MCO is responsible.
    Comparison to Federal Standards
    There is a corresponding federal standard to this proposed action, but the proposed action is not more restrictive or stringent.
    Estimate of Economic Impact
    The proposed action has no economic impact.
    Economic Impact on Small Businesses
    The proposed action has minimal or no economic impact on small businesses.
    Impact on Individuals with Disabilities
    The proposed action has no impact on individuals with disabilities.
    Opportunity for Public Comment
    Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through November 13, 2017. A public hearing has not been scheduled.
     
    10.01.04 Fair Hearing Appeals Under the Maryland State Medical Assistance Program
    Authority: Health-General Article, §2-104, Annotated Code of Maryland
    .03 Notification of Right to Request a Fair Hearing.
    A. The Program [or], delegate agency, or MCO shall notify an individual and his or her authorized representative, if previously designated by the individual or recognized as valid by the Program, in writing:
    (1)—(3) (text unchanged)
    B.C. (text unchanged)
    .04 Request for Fair Hearing.
    A.—C. (text unchanged)
    D. Timeliness of Appeal. A request for a fair hearing may not be granted unless the request in §A of this regulation is:
    (1) Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 120 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied by an MCO;
    [(1)] (2) Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 90 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied [to the recipient] by the fee-for-service program; or
    [(2)] (3) Postmarked, delivered in person, or sent by facsimile to the Office of Administrative Hearings; or emailed to Maryland Health Benefit Exchange; telephoned or faxed to the Consolidated Services Center or postmarked, telephoned, faxed, or delivered in person to the delegate agency within 90 days of the receipt of the notification specified in Regulation .03A of this chapter if the appeal concerns the appellant’s eligibility.
    E.—F. (text unchanged)
    .08 Findings, Timing of Decision, and Effect of Decision.
    A—C. (text unchanged)
    D. Effect of Decision.
    (1)—(3) (text unchanged)
    (4) When the decision is favorable to the appellant and is an MCO service, the MCO shall authorize or provide the disputed services no later than 72 hours from the date it receives notice reversing the MCO’s determination.
     
    Subtitle 09 MEDICAL CARE PROGRAMS
    10.09.62 Maryland Medicaid Managed Care Program: Definitions
    Authority: Health-General Article, §15-101, Annotated Code of Maryland
    .01 Definitions.
    A. (text unchanged)
    B. Terms Defined.
    (1)—(2) (text unchanged)
    (3) “Action” means:
    (a) Denial or limited authorization of a requested service, including [the]:
    (i) The type or level of service;
    (ii) Requirements for medical necessity;
    (iii) Appropriateness;
    (iv) Setting; or
    (v) Effectiveness of a covered benefit.
    (b)—(e) (text unchanged)
    (4)—(63) (text unchanged)
    (64) “Grievance” means an expression of dissatisfaction about any matter other than an action, including but not limited to:
    (a) The quality of care or services provided, and aspects of interpersonal relationships such as rudeness of a provider or employee;
    (b) Failure to respect the enrollee’s rights regardless of whether remedial action is requested; or
    (c) A dispute over an extension of time proposed by the MCO to make an authorized decision.
    (65)—(96) (text unchanged)
    (96-1) “Limited English proficiency” means the special need status of potential enrollees and enrollees who do not speak English as their primary language and who have a limited ability to read, write, speak, or understand English, and are therefore eligible to receive language assistance for a particular type of service, benefit, or encounter.
    (97)—(123) (text unchanged)
    (123-1) “Network provider” means a provider that is a member of the MCO’s provider panel.
    (124)—(129) (text unchanged)
    (129-1) “Overpayment” means:
    (a) Any payment made by the Program to a provider in excess of the correct Program payment amount for a service; or
    (b) Any payment for services under COMAR 10.09.67 made by the Program or an MCO which at the time of payment, or at a subsequent date, is determined to be inappropriate, inaccurate or in excess of the correct amount of the procedural code billed, for reasons including but not limited to:
    (i) Improper claiming;
    (ii) Lack of medical necessity;
    (iii) Unacceptable practices;
    (iv) Fraud, waste, or abuse; or
    (v) Provider mistake.
    [(130) “Panel provider” means a provider that is a member of the MCO’s provider panel.]
    [(131)] (130)[(154)] (153) (text unchanged)
    (154) “Readily accessible” means electronic information and services which comply with modern accessibility standards such as:
    (a) Section 508 guidelines;
    (b) Section 504 of the Rehabilitation Act; or
    (c) W3C’s Web Content Accessibility Guidelines (WCAG) 2.0 AA and successor versions.
    (155)—(171) (text unchanged)
    [(172) “Subcontractor provider” or “subcontractor” means a provider with whom the MCO has a subcontract under which the subcontractor agrees to provide a service or services that the MCO is required to provide under the Medicaid Managed Care Program.]
    (172) “Subcontractor” means an individual or entity that has a contract with an MCO that relates directly or indirectly to the performance of the MCO’s obligations under its contract with the Department; provided, however, that a contract does not by itself cause an MCO’s network provider to be a subcontractor.
    (173)—(180) (text unchanged)
    (181) “Whistleblower” means an individual who exposes any kind of information or activity that alleges any violation of regulation, statute, contract, policy, or unethical behavior that may be indicative of an individual or entity committing fraud, waste, or abuse against the Medicaid program.
    [(181)] (182) (text unchanged)
     
    10.09.63 Maryland Medicaid Managed Care Program: Eligibility and Enrollment
    Authority: Health-General Article, §15-103(b)(16). Annotated Code of Maryland
    .02 Enrollment.
    A. The Department shall provide to waiver-eligible individuals:
    (1) Materials regarding each MCO providing services in the eligible individual’s county of residence including, but not limited to:
    [(a) The names and addresses of all participating providers, upon enrollee’s request;]
    (a) Information about how to access the provider directory and drug formulary, with instructions for how to request paper copies if needed;
    (b) A schedule of the benefits offered, including any benefits offered beyond the basic required package described in COMAR 10.09.67; [and]
    (c) Which, if any, benefits are provided directly by the Department;
    [(c)] (d) If applicable, a list of services that the MCO does not provide, reimburse for, or provide coverage of, because of moral or religious objections, and information about where and how to obtain these services;
    (e) The requirements for each MCO to provide adequate access to covered services, including the network adequacy standards established in COMAR 10.09.66; and
    (f) Quality and performance indicators for each MCO, including enrollee satisfaction; and
    (2) Materials about the managed care program, including:
    (a) The MCO enrollment and disenrollment process; and
    (b) The basic features of managed care.
    [(2)] (3)—[(3)] (4) (text unchanged)
    B.—C. (text unchanged)
    D. Upon determination of Maryland Medicaid Managed Care Program eligibility, the Department shall enroll eligible individuals into an MCO by:
    (1)—(2) (text unchanged)
    (3) Face-to-face meeting, if requested; [or]
    (4) Face-to-face meeting in the recipient’s home, if medically necessary; or
    (5) Online.
    E. Children.
    (1) A newborn shall be automatically enrolled from birth in its biological mother’s MCO.
    (2) The MCO is responsible for the newborn’s health care from birth until the newborn enrolls into another MCO[, except if the newborn is hospitalized at the time of enrollment into the new MCO, in which case the original MCO is responsible for the hospitalization].
    (3) A newborn, automatically assigned to its biological mother’s MCO, is not eligible to change MCOs for family unity as described in COMAR 10.09.63.06 A(1)(b) and (c) during the first 90 days of enrollment.
    [(2)] (4) (text unchanged)
    F.—L. (text unchanged)
    .03 Health Service Needs Information.
    A. The Department, MCO, or [its agent] agents of the Department or MCO shall attempt to complete the health service needs information at the time of enrollment.
    B. The Department shall transmit any information obtained from health service needs information to the [recipient’s] enrollee’s MCO within 5 business days.
    C. (text unchanged)
    D. If the Department does not transmit health services needs information for an enrollee to the MCO within 10 days of enrollment, the MCO shall make at least two attempts to conduct an initial screening of the enrollee’s needs, within 90 days of the effective date of enrollment. At least one of these attempts shall be during non-working hours.
    [D.] E. The Department shall inform [a recipient] an enrollee identified in connection with the health service needs information as having a behavioral health problem that the individual may self-refer to the behavioral health ASO for services as described in COMAR 10.09.59 and 10.09.80.
    .06 Disenrollment.
    A (text unchanged)
    B. Department-Initiated Disenrollment. The Department shall disenroll from an MCO an enrollee:
    (1) Subject to the MCO or long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary, who has been continuously institutionalized for a period of more than [30] 90 successive days in a long-term care facility;
    (2)—(10) (text unchanged
    C. —I. (text unchanged)
     
    10.09.64 Maryland Medicaid Managed Care Program: MCO Application
    Authority: Health-General Article §15-102 and 15-103, Annotated Code of Maryland
    .03 Organization, Operations, and Financing.
    Except as provided in Regulation .02B of this chapter, an MCO applicant shall include the following information or descriptions in its application:
    A.—S. (text unchanged)
    T. Copies of the applicant’s written Medicaid marketing plan [with draft copies of all materials,] including[, but not limited to, brochures, fact sheets, and posters that the applicant would like distributed to potential enrollees, and including appropriate foreign language versions required when English is not the native language of a substantial minority of the population to be served]:
    (1) A description of how the applicant plans to address the special access provisions in COMAR 10.09.66.01D; and
    (2) Sample version of all material and communication the applicant would like to distribute to potential enrollees, including but not limited to:
    (a) Brochures;
    (b) Fact sheets; and
    (c) Posters. 
    .11 Management Information System and Data Reporting.
    An MCO applicant shall include in its application the following information or descriptions:
    A. A description of the applicant’s management information system, including, but not limited to:
    (1) Capacities, including:
    (a) The ability to generate and transmit electronic claims data consistent with the Medicaid Statistical Information System (MSIS) requirements or successor systems;
    (b) The ability to collect and report data on enrollee and provider characteristics and on all services furnished to enrollees through an encounter data system;
    (c) The ability to screen the data collected for completeness, logic, and consistency; and
    (d) The ability to collect and report data from providers in standardized formats using secure information exchanges and technologies utilized for Medicaid quality improvement and care coordination efforts;
    (2)—(4) (text unchanged)
    B.—C. (text unchanged)
    D. A description of the applicant’s operational procedures for generating financial reports, including, but not limited to:
    (1)—(2) (text unchanged)
    (3) Quarterly unaudited financial statements; [and]
    E. Evidence of the applicant’s ability to collect and report all data necessary to derive indicators for Healthcare Effectiveness Data and Information Set (HEDIS) [report cards]; and
    F. A description of the applicant’s procedures for verifying the accuracy and timeliness of reported data, including data from network providers the MCO was compensating on the basis of capitation payments or other payment arrangements that are not fee-for-service.
     
    10.09.65 Maryland Medicaid Managed Care Program: Managed Care Organizations
    Authority: Health-General Article, §2-104 and 15-103; Annotated Code of Maryland
    .02 Conditions for Participation.
    A. (text unchanged)
    [B. An MCO’s service area shall contain a minimum of 10,000 waiver-eligible residents.]
    [C.] B.[D.] C. (text unchanged)
    [E.] D. Assurance Against Insolvency.
    (1)—(3) (text unchanged)
    (4) If the Commissioner determines and reports to the Secretary that the applicant’s initial surplus is less than $1,250,000 before approval the Department may, at its discretion, designate funds in trust in an amount equal to:
    (a) The sum of the amounts due to the owners of the applicant from the Department for Medicaid services provided on a fee-for-service basis, so long as the owners of the applicant have waived in writing their right to receive Medicaid payments until such time as the Department is permitted to remove its funds from the trust account pursuant to §D(6) of this regulation; or
    (b) (text unchanged)
    (5) If, in accordance with [§E(4)] §D(4) of this regulation, the Department designates funds sufficient to increase the applicant’s initial surplus to $1,250,000, the Department shall designate $250,000 in trust for the applicant.
    (6) Funds designated by the Secretary pursuant to [§E(3)—(5)] §D(3)—(5) of this regulation shall remain in trust until such time as the Commissioner has determined that the MCO meets the minimum statutory surplus requirements based on the MCO’s annual report submitted pursuant to Insurance Article, §5-605, Annotated Code of Maryland.
    [F.] E. Health Care Delivery. An MCO shall:
    (1)—(3) (text unchanged)
    (4) Provide enrollees, within 30 days before the intended effective date, written notice when there is a significant change in the nature or location of services provided; and
    (5) Provide on the card required in [§G(3)] §E(3) of this regulation, on a separate prescription benefit card, or other technology, prescription billing information that:
    (a)—(b) (text unchanged)
    [G.] F. An MCO:
    (1)—(2) (text unchanged)
    (3) Shall prepare and make available all publications in a manner consistent with COMAR 10.09.66.01A, including, but not limited to[, provider]:
    (a) Provider directories[, enrollee];
    (b) Enrollee handbooks[, health];
    (c) Health education materials[,]; and[informational]
    (d) Informational brochures[:
    (a) In a culturally sensitive manner;
    (b) At an appropriate reading comprehension level; and
    (c) In the prevalent non-English languages, identified by the State; and
    (4) Shall pay Maryland hospital providers on the basis of rates approved by the Maryland Health Services Cost Review Commission (HSCRC)].
    [H.] G.[M.] L. (text unchanged)
    [N.] M. The requirements of Regulation .17A(2) of this chapter, or [§M(1)] §L(1) of this regulation, may not be construed to:
    (1)—(3) (text unchanged)
    [O. An MCO shall permit the Department or the U.S. Department of Health and Human Services to inspect or otherwise evaluate the quality, appropriateness, and timeliness of services performed by or on behalf of the MCO or by or on behalf of any subcontractor.
    P. An MCO and its subcontractors shall permit the following organizations to inspect, evaluate, or audit books, records, documents, files, accounts, and facilities maintained by or on behalf of the MCO or by or on behalf of any subcontractor:
    (1) The Department;
    (2) The Medicaid Fraud Control Unit of the Office of the Attorney General;
    (3) The Insurance Fraud Division of the Maryland Insurance Administration; or
    (4) Other authorized State or federal agencies.
    Q. On the request of the following organizations, an MCO shall, within 10 business days of the request, or within a shorter time if provided by other applicable law, regulation, subpoena, or court order, furnish a copy of any books, records, files, accounts, or other documents, and provide access to the facilities maintained by the MCO or its subcontractor:
    (1) The Department;
    (2) The Medicaid Fraud Control Unit of the Office of the Attorney General;
    (3) The Insurance Fraud Division of the Maryland Insurance Administration; or
    (4) Other authorized State or federal agency.
    R. The chief executive officer of an MCO or his or her designee shall certify, under penalty of perjury, that any books, records, files, accounts, or other documents requested under §§P and Q of this regulation are current, accurate, and complete to the best of that individual’s knowledge.
    S. An MCO shall promptly but within 30 calendar days of the suspected fraud report to the Medicaid Fraud Control unit all suspected fraud and abuse, including fraud by employees and subcontractors of the MCO, enrollment agents, and recipients.
    T. An MCO shall report to the Department any identified inaccuracies in the encounter data reported by the MCO or its subcontractors within 30 days of the date discovered, regardless of the effect which the inaccuracy has upon MCO reimbursement.]
    [U.] N. Disclosure of Provider Incentive Plans.
    (1) (text unchanged)
    (2) An MCO shall include in the disclosures required by [§U(1)] §N(1) of this regulation information sufficient for the Department to determine whether the incentive plans meet the requirements of 42 CFR §417.479(d)—(g) and, as applicable (i), when there exist compensation arrangements under which payment for designated health services furnished to an individual on the basis of a physician referral would otherwise be denied under §1903(a) of the Social Security Act.
    [V.] O. (text unchanged)
    [W. Upon the direction of the Department, an MCO shall reduce payments, by 20 percent, to a hospital located in a contiguous state, or in the District of Columbia, for services rendered to its enrollees, if the hospital has failed to supply appropriate discharge data to the Health Services Cost Review Commission.]
    [X.] P. (text unchanged)
    Q. An MCO shall meet all program integrity requirements as set forth in COMAR 10.09.68.
    [Y. The records available for inspection, evaluation, or audit under §§P and Q of this regulation shall also include the books, records, files, accounts or other documents of any related organization that provides supplies or services to the MCO.
    Z. An MCO shall meet the requirements of §6032 of the Deficit Reduction Act of 2005, Pub.L. 109—171, which establishes 42 U.S.C. §1396a(a)(68), and relates to Employee Education about False Claims.
    AA. Federal financial participation is not available for amounts expended for excluded providers in §M(2) of this regulation, except for emergency services.
    BB. For complaints of provider fraud and abuse that warrant a preliminary investigation, the MCO’s report required in §S of this regulation shall include:
    (1) The number of complaints;
    (2) The name and identification (ID) number of the provider being investigated;
    (3) The source of the complaint;
    (4) The type of provider;
    (5) The nature of the complaint;
    (6) The approximate dollar amount involved;
    (7) The legal and administrative disposition of the case; and
    (8) The method by which the MCO verified that the services being investigated were actually provided to the enrollee.
    CC. Effective July 1, 2011, MCOs shall participate in the Maryland Health Care Commission’s Patient Centered Medical Home Program authorized under Health-General Article, §§19-103 and 19-109, Annotated Code of Maryland, and follow the policies and procedures established by the Maryland Health Care Commission.
    DD. All MCOs participating in the Program as of January 1, 2013, shall be accredited by the National Committee on Quality Assurance (NCQA) not later than January 1, 2015.]
    [EE.] R. (text unchanged)
    .04 Special Needs Populations.
    A.—B. (text unchanged)
    C. General Requirements for Special Needs Populations.
    (1)—(4) (text unchanged)
    (5) To meet the commitment outlined in §C(4) of this regulation, an MCO shall:
    (a)—(e) (text unchanged)
    (f) Document the plan of care and treatment modalities provided to enrollees in special populations, assuring that the plan of care:
    (i) Is updated at least annually, when the enrollee’s circumstances or needs change significantly, or at the enrollee’s request; and
    (ii) (text unchanged)
    (g) Be familiar with [community-based resources available] community and social support providers for the special populations.
    (6) An MCO shall make documented outreach efforts to contact and educate enrollees who fail to appear for appointments or who have been noncompliant with a regimen of care. These efforts may include, but may not be limited to, notification:
    (a) (text unchanged)
    (b) By telephone; [and]
    (c) By email;
    (d) By text messaging; and
    [(c)] (e) (text unchanged)
    (7)—(9) (text unchanged)
    (10) An MCO shall have mechanisms in place to allow enrollees with special health care needs to access a specialist directly as appropriate for the enrollee’s condition and identified needs.
    .15 Data Collection and Reporting.
    A. (text unchanged)
    B. Encounter Data.
    (1) (text unchanged)
    (2) An MCO may use alternative formats including:
    (a) ASC X12N 837 and NCPDP formats; and
    (b) ASC X12N 835 format, as appropriate.
    (3) An MCO shall submit encounter data that identifies the provider who delivers any items or services to enrollees at a frequency and level of detail to be specified by CMS and the Department.
    [(2)] (4) (text unchanged)
    [(3)] (5) An MCO shall submit encounter data utilizing [an] a secure on-line data transfer system.
    C. (text unchanged)
    D. Quarterly Reports. An MCO shall submit to the Department:
    (1)—(3) (text unchanged)
    (4) [On a quarterly basis and in] In a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter.
    (5) Not later than 45 days after the end of each quarterly rebate period, drug utilization data necessary for the Department to bill manufacturers for rebates in accordance with §1927(b)(1)(A) of the Social Security Act, that:
    (a) Include, at a minimum, the following information by National Drug Code of each covered outpatient drug dispensed or covered by the MCO:
    (i) Total number of units of each dosage form;
    (ii) Total number of units of each dosage strength; and
    (iii) Total number of units of each dosage package size; and
    (b) Distinguish utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program.
    E. Annual Reports. Except as provided in §E(5) of this regulation, an MCO shall submit to the Department annually, within 90 days after the end of the calendar year:
    (1)—(3) (text unchanged)
    (4) Any revisions to the MCO’s quality assurance, utilization management, and case management plans; [and]
    (5) HealthChoice Financial Monitoring Reports (HFMRs), including any supplemental schedules required by the Department:
    (a)—(b) (text unchanged)
    (c) Submitted according to the following schedule:
    (i) (text unchanged)
    (ii) Services incurred January 1—December 31 of the prior year, reported through September 30 of the current year—due on November 15 of the current year; and
    (6) A detailed description of its drug utilization program activities.
    F. HEDIS Reporting. By July 1 of each year, an MCO shall submit to the Department a record of its health care delivery and organizational performance during the preceding year measured utilizing the most recent version of the [Health Plan Employer] Healthcare Effectiveness Data and Information Set (HEDIS) applicable to the reporting period.
    G.—K. (text unchanged)
    .17 Subcontractual Relationships.
    A. Subcontracting Permitted.
    (1)—(2) (text unchanged)
    [(3) A subcontractor shall be legally qualified to furnish the services provided for in the subcontract in return for the compensation provided in the subcontract.
    (4) An MCO may not knowingly enter into a subcontractual relationship with providers who have been convicted of certain crimes or received certain sanctions as specified in §1128 of the Social Security Act.]
    [(5)] (3) An MCO shall [use subcontracts that are in writing,] have written agreements with subcontractors that comply with 42 CFR §§438.214 and 455.105, as amended, and include at least the following:
    (a)—(c) (text unchanged)
    (d) A provision requiring that [subcontractor’s facilities and records be open to inspection by the MCO, the Department, and other government agencies, and that the subcontractor is subject to all audits and inspections to the same extent that audits and inspections may be required of the MCO under law or under its contract with the Department] the subcontractor complies with all State and federal requirements regarding audit, inspection, and evaluation;
    (e)—(i) (text unchanged)
    (j) If the subcontractor is authorized by the MCO to make referrals, a provision requiring the subcontractor to use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06; [and]
    (k) A provision to the effect that each provision of the subcontract that is required under this section supersede and be controlling over any conflicting terms that appear in the subcontract;
    (l) A provision for revocation of the delegation of activities or obligations, or specifying other remedies in instances where the Department or the MCO determines that the subcontractor has not performed satisfactorily;
    (m) A provision stating that the MCO has the right to audit the subcontractor pursuant to 42 CFR §438.230(c)(3)(i) for 10 years from the final date of the contract period or from the date of completion of any audit, whichever is later; and
    (n) A provision to the effect that all providers and subcontractors are subject to a grievance and appeal system consistent with the requirements of COMAR 10.09.71.
    [(6)] (4)—[(7)] (5) (text unchanged)
    B. Subcontractual Relations Reporting Requirements.
    (1)—(3) (text unchanged)
    (4) Network Provider Termination.
    (a)—(b) (text unchanged)
    (c) If the provider is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided within [10 days] 15 days after the MCO receives the notice from the terminating provider.
    (d)—(f) (text unchanged)
    (5) Subcontractor Termination.
    (a) When an MCO terminates a subcontract impacting its operations, covered services, or enrollees, the MCO shall provide the Department with written notice regarding the termination that describes:
    (i) The dollar amount of the subcontract;
    (ii) The effect of the termination on MCO operations;
    (iii) The effect of the termination on MCO covered services or enrollees; and
    (iv) The MCO’s plan to replace the subcontractor, if applicable.
    (b) If the termination of the subcontract impacts MCO operations, the notice required in §B(5)(a) of this regulation shall be provided at least 90 days before the effective date of the termination.
    [C. Effect of Subcontract.]
    [(1)] C. (text unchanged)
    [(2) By entering into a subcontract to provide health care services on behalf of an MCO, the subcontracting provider becomes responsible for providing the specified health care services in compliance with all of the requirements imposed by COMAR 10.09.62—10.09.75, including, but not limited to, requirements concerning access, quality assurance, medical records, and reporting requirements.
    (3) When entering into a subcontract to transfer to the subcontracting provider the initial responsibility for providing specified health care services to the MCO’s enrollees, an MCO retains a primary duty to the Department and to its enrollees to ensure that its subcontractor delivers the required services in a manner that is consistent with the requirements of COMAR 10.09.62—10.09.75.]
    D.—E. (text unchanged)
    .19 MCO Reimbursement.
    A. Generally.
    (1)—(3) (text unchanged)
    [(4) The Department has the authority to recover any overpayments made to MCOs.]
    [(5)] (4)[(6)] (5) (text unchanged)
    [(7)] (6) [Effective January 1, 2005, the] The Department may consider a retroactive capitation payment to an MCO, if the MCO notifies the Department within 9 months of the first missed capitation payment for an enrollee for whom the MCO has not received all appropriate capitation payments.
    [(8)] (7) (text unchanged)
    B.—D. (text unchanged)
    .20 MCO Payment for Self-Referred, Emergency, Physician, and Hospital [Administrative Days] Services.
    A.—D. (text unchanged)
    [E. An MCO shall reimburse hospital administrative days at the Medicaid fee-for-service rate.]
    E. Payment for Hospital Services.
    (1) An MCO shall reimburse Maryland hospital providers on the basis of rates approved by the Maryland Health Services Cost Review Commission (HSCRC).
    (2) An MCO shall reimburse hospital administrative days at the Medicaid fee-for-service rate.
    (3) Upon the direction of the Department, an MCO shall reduce payments by 20 percent to a hospital located in a contiguous state or in the District of Columbia for services rendered to its enrollees, if the hospital has failed to supply appropriate discharge data to the Health Services Cost Review Commission.
     
    10.09.66 Maryland Medicaid Managed Care Program: Access
    Authority: Health-General Article, §15-102.1(b)(10) and 15-103(b) Annotated Code of Maryland
    .01 Access Standards: Addressing Enrollees’ Individualized Needs.
    A. (text unchanged)
    B. Special Access.
    [(1) An MCO shall on request make interpretation services available free of charge to each enrollee and potential enrollee who:
    (a) Does not speak English; or
    (b) Is hearing impaired.
    (2) As a part of its initial application, a prospective MCO shall describe, for the Department’s consideration, what special access provisions the applicant has made to fulfill the requirements of this section.]
    (1) An MCO shall notify enrollees of the following services and make them available free of charge to the enrollee:
    (a) Written materials in the prevalent non-English languages identified by the State;
    (b) Written materials in alternative formats;
    (c) Oral interpretation services in all non-English languages; and
    (d) Auxiliary aids and services, such as:
    (i) Teletypewriter/Telecommunication Device for the Deaf (TTY/TDD); and
    (ii) American Sign Language.
    (2) An MCO shall include taglines with its written materials that:
    (a) Explain the availability of written translation or oral interpretation to understand the information provided; and
    (b) Provide the toll-free and TTY/TDD telephone number of the MCO’s customer service unit.
    (3) An MCO shall format taglines included with written materials in the following manner:
    (a) In a font size no smaller than 18 point; and
    (b) In the prevalent non-English languages identified by the State.
    C. Written Materials. An MCO shall provide all its written materials in the following manner:
    (1) Using language and a format that is easily understood;
    (2) In a font size no smaller than 12 point;
    (3) Available in alternative formats and through the provision of auxiliary aids and services; and
    (4) Available in an appropriate manner that takes into consideration the special needs of enrollees or potential enrollees with disabilities or limited English proficiency.
    D. An MCO may provide enrollee information electronically so long as all of the following requirements are met:
    (1) The format is readily accessible;
    (2) The information is placed in a location on the MCO’s website that is prominent and readily accessible;
    (3) The information is provided in an electronic form which can be electronically retained and printed;
    (4) The information is consistent with the content and language requirements of this section;
    (5) The enrollee is informed that the information is available in paper form without charge upon request; and
    (6) Should the enrollee request it, the MCO provides the information in paper form within 5 business days.
    .02 Access Standards: Enrollee Handbook and Provider Directory.
    A. An MCO shall inform and educate its enrollees about [the]:
    (1) Basic information about the MCO;
    (2) [Availability] The availability of health care services and how to access them;
    (3) The definitions of managed care terminology in accordance with 42 CFR §438.10(c)(4)(i); and
    [(3)] (4) (text unchanged)
    B. An MCO shall, at the time of enrollment, and anytime upon request, furnish each enrollee with a copy of the MCO’s enrollee handbook that includes all language in the template provided by the Department and the following current information:
    (1) (text unchanged)
    (2) Information on how to access urgent care and emergency care services [and the fact that prior authorization is not required for these services.], including:
    (a) What constitutes an emergency medical condition and emergency services;
    (b) The following facts:
    (i) Prior authorization is not required for these services; and
    (ii) The enrollee has a right to use any hospital or other setting for emergency care;
    (3) (text unchanged)
    (4) How and where to access any benefits provided by the State, including any cost sharing, and how transportation is provided;
    (5) The amount, duration, and scope of benefits available in sufficient detail to ensure that enrollees understand the benefits to which they are entitled;
    [(4)] (6) (text unchanged)
    [(5)] (7) Information on the availability of self-referral services as well as any restrictions on the enrollee’s freedom of choice among network providers;
    (8) Information about how enrollees may obtain benefits from out-of-network providers;
    [(6)] (9) Any policies and procedures necessary to facilitate accessing needed services in compliance with the Maryland Medicaid Managed Care Program, including any requirements for service authorizations or referrals for specialty care and for other benefits not furnished by the enrollee’s primary care provider;
    [(7)] (10) (text unchanged)
    (11) A statement that the MCO cannot require an enrollee to obtain a referral before choosing a family planning provider;
    (12) The process of selecting and changing the enrollee’s primary care provider;
    [(8)] (13) (text unchanged)
    (14) Information on how to access auxiliary aids and services, including additional information in alternative formats or languages;
    [(9)] (15) The toll-free telephone number for member services, medical management, and any other unit providing services directly to enrollees, including:
    (a) A description of [the MCO’s consumer services hotline, including toll-free telephone number,] each unit and number;
    (b) [explaining how it] An explanation of how the phone numbers can be used to obtain information and assistance; and
    (c) An explanation of the MCO’s internal grievance procedure.
    [(10)] (16)[(15)] (21) (text unchanged)
    (22) Information on how to report suspected fraud or abuse;
    [(16)] (23)[(17)] (24) (text unchanged)
    C. Provider Directory.
    (1) An MCO shall provide enrollees with information regarding their provider networks including:
    (a)—(c) (text unchanged)
    (d) A listing of the individual practitioners who are the MCO’s primary and specialty care providers in the enrollee’s county, grouped by medical specialty, giving:
    (i)—(iii) (text unchanged)  
    (iv) Telephone number or numbers;
    (v) Website URL, as appropriate;
    (vi) Any group affiliation, as appropriate;
    (vii) Cultural and linguistic capabilities, including languages offered by the provider or a skilled medical interpreter at the provider’s offices, American Sign Language interpretation, and whether the provider has completed cultural competence training;
    (viii) An indication of whether the provider’s office or facility has accommodations for physical disabilities, including offices, exam room or rooms and equipment;
    [(iv)] (ix)[(vi)] (xi) (text unchanged)
    (2) (text unchanged)
    D. (text unchanged)
    E. The Department may consider the information listed in §§B and C of this regulation to be provided if the MCO:
    (1) Mails a printed copy of the information to the enrollee’s mailing address;
    (2) Provides the information by email after obtaining the enrollee’s agreement to receive the information by email;
    (3) Posts the information on the MCO’s website and advises the enrollee in paper or electronic form that the information is available on the internet and includes the applicable internet address, provided that enrollees with disabilities who cannot access this information online are provided auxiliary aids and services upon request at no cost; or
    (4) Provides the information by any other method that can reasonably be expected to result in the enrollee receiving that information.
    [E.] F. An MCO shall [make a good faith effort to keep the Department’s online provider directory accurate by submitting regular updates when its provider’s network status changes] update its online provider directory no later than 30 days after the MCO receives updated provider information.
    G. An MCO shall update its paper directory on a monthly basis.
    H. An MCO shall make provider directories available on its website in a machine-readable file and format as specified by the Secretary for the U.S. Department of Health and Human Services.
     
    10.09.67 Maryland Medicaid Managed Care Program: Benefits
    Authority: Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland
    .01 Required Benefits Package — In General.
    A. (text unchanged)
    B. An MCO shall ensure that the services provided are sufficient in amount, duration, or scope to reasonably achieve the purpose for which the services are furnished.
    [B.] C.[C.] D. (text unchanged)
    E. An MCO may place appropriate limits on a service on the basis of criteria applied under the State plan, such as medical necessity.
    [E.] F. Cost Sharing and Prohibitions.
    (1) (text unchanged)
    (2) An MCO may not:
    (a)—(b) (text unchanged)
    (c) Arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the enrollee.
    [F.] G. (text unchanged)
    [G.] H. [The] An MCO shall provide for a second opinion from a qualified health care professional within the network, or, if necessary, arrange for the enrollee to obtain one outside the MCO network.
    .04 Benefits — Pharmacy Services.
    A. An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act.
    [A.] B. (text unchanged)
    [B.] C. Except as provided in [§C] §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by:
    (1)—(3) (text unchanged)
    [C.] D. (text unchanged)
    [D.] E. Drug Formulary.
    (1) An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program[.], and include at a minimum:
    (a) Covered generic and name brand medications; and
    (b) The tier each medication is on.
    (2)—(3) (text unchanged)
    (4) [Effective July 1, 2009, an] An MCO shall include in its formulary the following drugs:
    (a)—(e) (text unchanged)
    (5)—(6) (text unchanged)
    [E.] F. Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in [§F.] §G of this regulation.
    [F.] G.[G.] H. (text unchanged)
    [H.] I. An MCO shall:
    (1) Establish and maintain a drug [use management] utilization review program; [and]
    (2) Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components:
    (a)—(c) (text unchanged)
    (d) Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act;
    (e)—(f) (text unchanged)
    (g) Pharmacy and Therapeutic Committee[.];
    (3) Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and
    (4) Provide to the Department a detailed description of its drug utilization review program activities on an annual basis.
    [I.] J. The Department shall:
    (1) Review each MCO’s drug [use management] utilization review program annually; and
    (2) Notify an MCO annually if any of the standards established in [§H(2)] §I(2) of this regulation have not been met.
    [J.] K. For any performance standard identified in [§I(2)] §J(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.09.73.01A and B.
    .19 Benefits — Family Planning Services.
    A. An MCO shall provide to its enrollees comprehensive family planning services, including but not limited to medically necessary office visits and laboratory tests, all FDA-approved contraceptive devices, methods, and supplies, and voluntary sterilizations.
    B. An MCO may place appropriate limits on family planning services for the purpose of utilization control, provided that the services are provided in a manner that protects and enables the enrollee’s freedom to choose the method of family planning to be used consistent with 42 CFR §441.20.
    C. An MCO may not apply a copayment or coinsurance requirement for contraceptive drugs or devices.
    D. An MCO shall provide coverage for a single dispensing of a supply of prescription contraceptives for a 6-month period.
    E. The requirement in §D of this regulation does not apply to the first 2-month supply of prescription contraceptives dispensed to a member under:
    (1) The initial prescription for the contraceptives; or
    (2) Any subsequent prescription for a contraceptive that is different than the last contraceptive dispensed.
     
    10.09.68 Maryland Medicaid Managed Care Program: Program Integrity
    Authority: Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland
    .01 Requirements to Detect and Prevent Fraud, Waste, and Abuse.
    A. An MCO or its responsible subcontractor shall implement and maintain arrangements or procedures that are designed to detect and prevent fraud, waste, and abuse, which includes a compliance program that has, at a minimum, the following elements:
    (1) Written policies, procedures, and standards of conduct that include the MCO’s commitment to comply with all applicable:
    (a) Requirements and standards under the contract; and
    (b) Federal and State requirements including:
    (i) Written policies for all employees and those of any contractor or agent that provide detailed information about the False Claims Act and other Federal and State laws described in section 1902(a)(68)of the Social Security Act; and
    (ii) Information about rights of employees to be protected as whistleblowers.
    (2) The designation of a compliance officer, who reports directly to the chief executive officer and the board of directors and is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements of the contract, and at minimum the following staff members:
    (a) An investigator who is responsible for fraud, waste, and abuse investigations;
    (b) An auditor who is responsible for identifying potential fraud, waste, and abuse through analysis of claims and related information; and
    (c) An analyst capable of reviewing data and codes who is responsible for reviewing and researching evidence of potential fraud, waste, and abuse.
    (3) Staffing and resources located in Maryland to identify and investigate potential fraud, waste, and abuse, which shall be based on criteria determined by the Department that may include but are not limited to:
    (a) Number of enrollees;
    (b) Number of claims received on an annual basis;
    (c) Volume of suspected fraudulent and abusive claims currently being detected;
    (d) Other factors relating to the vulnerability of the MCO to fraud and abuse; and
    (e) An assessment of optimal caseload which can be handled by an investigator on an annual basis.
    (4) The establishment of a regulatory compliance committee, which reports to the board of directors and to the MCO’s senior management level and is charged with overseeing the organization’s compliance program and its compliance with the requirements under the contract;
    (5) A system for training and educating the compliance officer, the organization’s senior management, and the organization’s employees regarding the federal and State standards and requirements under the contract;
    (6) Effective lines of communication between the compliance officer and the organization’s employees;
    (7) Enforcement of standards through well-publicized disciplinary guidelines;
    (8) Establishment and implementation of procedures and a system with dedicated staff for:
    (a) Routine internal monitoring and auditing of compliance risks;
    (b) Prompt response to compliance issues as they are raised;
    (c) Investigation of potential compliance problems as identified in the course of self-evaluation and audits;
    (d) Correction of problems, identified under §A(7)(c) of this regulation, promptly and thoroughly, or coordination of suspected criminal acts with law enforcement agencies, to reduce the potential for recurrence; and
    (e) Ongoing compliance with the requirements under the contract.
    B. An MCO shall ensure that a subcontractor is legally qualified to furnish the services provided for in the subcontract.
    C. An MCO may not contract with the State unless conflict of interest safeguards at least equal to federal safeguards under section 27 of 41 U.S.C. §423, as amended, are in place.
    D. An MCO may not knowingly have a relationship of the type described in §E of this regulation with the following:
    (1) An individual or entity that is debarred, suspended, or otherwise excluded from:
    (a) Participating in procurement activities under the Federal Acquisition Regulation; or
    (b) Participating in non-procurement activities under Executive Order Numbers 12549 or. 12549; or
    (2) An individual or entity who is an affiliate, as defined in 48 CFR §2.101, of a person described in §D(1) of this section.
    E. The relationships described in §D of this Regulation, are as follows:
    (1) A director, officer, or partner of the MCO;
    (2) A subcontractor of the MCO;
    (3) A person with beneficial ownership of 5 percent or more of the MCO’s equity; or
    (4) A network provider or person with an employment, consulting or other arrangement with the MCO for the provision of items and services that is significant and material to the MCO’s obligations under its contract with the Department.
    F. An MCO may not have a relationship with an individual or entity that is excluded from participation in any Federal health care program under section 1128 or 1128A of the Social Security Act.
    G. An MCO shall monitor the Department’s correspondence and any database publicizing Department-initiated terminations of providers from the Program.
    H. An MCO shall terminate the contract of, or refrain from contracting with, providers terminated or excluded from participation in the Program. 
    I. An MCO shall suspend payments to a network provider for which the Department has determined that there is a credible allegation of fraud in accordance with 42 CFR §455.23.
    J. An MCO shall establish a system to verify, by sampling or other methods, whether services that have been represented to have been delivered by network providers were received by enrollees and shall apply such verification processes at least annually.
    K. An MCO shall require and have a mechanism for a network provider to report to the MCO when it has received an overpayment and to:
    (1) Return the overpayment to the MCO within 60 calendar days after the date on which the overpayment was identified; and
    (2) Notify the MCO in writing of the reason for the overpayment.
    L. Overpayments to Providers and Subcontractors.
    (1) Overpayments recovered by an MCO, including those recovered due to waste, fraud and abuse, may be retained by the MCO, so long as it is reported to the Department.
    (2) If the Department, Federal government, or its agents identified the potential fraud, waste, or abuse that leads to recovery of funds paid to an MCO provider, and the MCO did not previously identify and report the provider for potential overpayments, the State shall have the right to recover from the MCO the entire amount of the overpayment.
    (3) The State shall have the sole right of recovery of an overpayment when the MCO has identified the overpayment and the MCO has not initiated recovery within 90 days after the completion of the MCO’s investigation.
    (4) The MCO shall have the right to appeal, pursuant to COMAR 10.09.72, the Department’s recovery of an overpayment.
    M. The Department has the authority to recover any overpayments made to MCOs.
    .02 Access to Information.
    A. An MCO, its subcontractors, and its subcontractor’s subcontractors shall permit the following organizations or their designees to inspect, evaluate, or audit books, records, contracts, computer or other electronic systems, premises, and facilities that pertain to the MCO’s Medicaid enrollees, and any aspect of services and activities performed, or determination of amounts payable under, the MCO’s contract with the Department:
    (1) The Department and its agents;
    (2) The Medicaid Fraud Control Unit of the Office of the Attorney General;
    (3) The Insurance Fraud Division of the Maryland Insurance Administration;
    (4) The Centers for Medicare and Medicaid Services;
    (5) The Inspector General of the Department of Health and Human Services;
    (6) The Comptroller General; and
    (7) Other authorized State or federal agencies.
    B. The right to inspect, audit, and evaluate shall exist for 10 years from the final date of the contract period or from the completion of any audit, whichever is later, except, if the Department, Centers for Medicare and Medicaid Services, or the Department of Health and Human Services Inspector General determines that there is a reasonable possibility of fraud, or similar risk, those agencies may inspect, audit, and evaluate at any time.
    C. Notwithstanding §B of this regulation, the Department has the right to inspect the accuracy, truthfulness, and completeness of the encounter data submitted by, or on behalf of, the MCO. 
    .03 Reporting.
    A. An MCO shall submit to the Department the following:
    (1) Encounter data in the form and manner described in COMAR 10.09.65.15B, 42 CFR §438.242(c), and 42 CFR §438.818.
    (2) Data required by the Department in order to certify the actuarial soundness of capitation rates to an MCO, under 42 CFR §438.3, including base data described in 42 CFR §438.5(c) that is generated by the MCO.
    (3) Data required by the Department to determine compliance of the MCO with the medical loss ratio requirement described in 42 CFR §438.8.
    (4) Data required by the Department and the Maryland Insurance Administration to determine that the MCO has made adequate provision against the risk of insolvency as required under 42 CFR §438.116.
    (5) Documentation described in 42 CFR §438.207(b) on which the Department bases its certification that the MCO has complied with the State’s requirements for availability and accessibility of services, including the adequacy of the provider network, as set forth in 42 CFR §438.206.
    (6) In accordance with §F of this regulation, information on ownership and control described in 42 CFR §455.104 from an MCO and its subcontractors, as governed by 42 CFR §438.230.
    (7) An annual report of overpayment recoveries as required in 42 CFR §438.608(d)(3).
    (8) Any other data, documentation, or information relating to the performance of the entity’s obligations under its contract with the Department, or required by the Department or the Secretary of the Department of Health and Human Services.
    B. An MCO shall report to the Department any identified inaccuracies in the encounter data reported by the MCO or its subcontractors within 30 days of the date discovered regardless of the effect which the inaccuracy has upon MCO reimbursement.
    C. An MCO shall promptly report to the Department’s Office of Inspector General (OIG) any potential fraud, waste, abuse, or information it has received from whistleblowers relating to the integrity of the MCO, its network providers, or its subcontractors.
    D. An MCO shall report any potential fraud directly to the Medicaid Fraud Control Unit and the Department’s OIG, including fraud by providers, employees and subcontractors of the MCO, enrollment agents, and enrollees.
    E. After reporting any potential fraud, waste, or abuse to the Department’s OIG and to the Medicaid Fraud Control Unit, the MCO may not take the following actions without prior written approval from the State:
    (1) Contact the subject of the investigation about any matter related to the investigation;
    (2) Enter into or attempt to negotiate any settlement or agreement regarding the incident; or
    (3) Accept any monetary or other type of consideration offered by the subject of the investigation in connection with the incident.
    F. For complaints of provider fraud and abuse that warrant a preliminary investigation, the MCO’s reports required in §§C and D of this regulation shall include:
    (1) The number of complaints;
    (2) The name and identification number of the provider being investigated;
    (3) The source of the complaint;
    (4) The type of provider;
    (5) The nature of the complaint;
    (6) The approximate dollar amount involved;
    (7) The legal and administrative disposition of the case; and
    (8) The method by which the MCO verified that the services being investigated were actually provided to the enrollee.
    G. An MCO shall provide to the Department written disclosure of any affiliation prohibited under 42 CFR §438.610 and take action as directed by the Department.
    H. An MCO shall provide to the Department written disclosures of information on ownership and control required under 42 CFR §455.104, including:
    (1) The following information for any individual or corporation with an ownership or control interest in the MCO:
    (a) For individuals:
    (i) Name;
    (ii) Address;
    (iii) Date of birth; and
    (iv) Social Security number; and
    (b) For corporate entities:
    (i) Name;
    (ii) Applicable primary business address;
    (iii) Every business location and applicable P.O. Box address; and
    (iv) Other tax identification number or any subcontractor in which the MCO has a 5 percent or more interest;
    (2) Whether the individual or corporation with an ownership or control interest in the MCO:
    (a) Is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling; or
    (b) Whether the individual or corporation with an ownership or control interest in any subcontractor in which the MCO has a 5 percent or more interest is related to another person with ownership or control interest in the MCO as a spouse, parent, child, or sibling;
    (3) The name of any other MCO in which an owner of the MCO has an ownership or control interest;
    (4) The name, address, date of birth, and Social Security number of any managing employee or agent of the MCO;
    (5) Disclosures of ownership and control information from MCOs are due at the following times:
    (a) Upon application;
    (b) Upon the managed care entity executing the contract with the State;
    (c) Upon renewal or extension of the contract; and
    (d) Within 35 days after any change in ownership of the managed care entity.
    I. An MCO shall report to the Department all overpayments identified and recovered, specifying the overpayments due to fraud.
    J. An MCO shall report third-party liability collection activities as described in COMAR 10.09.65.18.
    K. An MCO shall report to the Department the amounts the MCO has cost-avoided and the number of third-party liability cases the MCO has handled. 
    L. An MCO shall notify the Department promptly when it has knowledge of an enrollee’s change of residence or death.
    M. An MCO shall notify the Department promptly when the MCO receives information about a change in a network provider’s circumstances that may affect the network provider’s eligibility to participate in the Program, including the termination of the provider agreement with the MCO. 
    N. An MCO shall submit all required data, documentation and information in the format specified by the Department.
    O. An MCO’s chief executive officer, chief financial officer, or directly-reporting authorized employee shall certify to the best of that individual’s information, knowledge, and belief, that any records, data, or other documents requested under regulations are accurate, complete and truthful.
    P. As directed by the Department’s OIG, the MCO shall submit written reports documenting its Program Integrity efforts, including but not limited to:
    (1) The dollar amount of losses and recoveries attributable to overpayment, abuse, and fraud; and
    (2) The number of referrals to the Department’s OIG during the prior State fiscal year.
     
    10.09.71 Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures
    Authority: Health-General Article, §[15-103(b)(i)(4)] 15-103(b)(9)(i)4, Annotated Code of Maryland
    .02 Internal Complaint Process for Enrollees.
    A. An MCO shall have written complaint procedures by which an enrollee who is dissatisfied with the MCO or its network providers, or decisions made by the MCO or a provider, may seek recourse verbally or in writing within the MCO at any time.
    B. An MCO shall:
    (1) (text unchanged)
    [(2) Include as part of the written complaint procedures a form for the enrollee’s use when filing an appeal or grievance, and a process, which shall include providing interpreter services and toll-free numbers with TTY/TDD, by which an MCO staff member can assist in its completion;]
    (2) Give enrollees any reasonable assistance in completing forms and taking other procedural steps related to a grievance or appeal in a manner consistent with COMAR 10.09.66.01A;
    (3) Prepare the document describing the MCO’s internal complaint process:
    (a)—(b) (text unchanged)
    (c) In the prevalent non-English languages, identified by the State; [and]
    (4) Deliver a copy of the MCO’s complaint procedures to each enrollee:
    (a) With the MCO’s initial [mailing to] contact with a new enrollee; and
    (b) At any time upon an enrollee’s request;
    (5) Maintain an accurate and accessible record of grievances and appeals for monitoring by the State and CMS, which includes, at a minimum:
    (a) A general description of the reason for the appeal or grievance;
    (b) The date received;
    (c) The date of each review or, if applicable, review meeting;
    (d) Resolution at each level of the appeal or grievance, if applicable;
    (e) Date of resolution at each level, if applicable; and
    (f) Name of the enrollee for whom the appeal or grievance was filed; and
    (6) Provide in its written procedures that an enrollee may file appeals and grievances orally or in writing.
    C. An MCO shall include in the internal complaint process the procedures for registering and responding to appeals and grievances in a timely fashion, which:
    (1)—(8) (text unchanged)
    [(9) Include an appeal process which provides at its final level an opportunity for the enrollee to be heard by the MCO’s chief executive officer, or the chief executive officer’s designee;]
    [(10)] (9) (text unchanged)
    [(11)] (10) Include a documented procedure for written notification of the MCO’s determination:
    (a) (text unchanged)
    (b) To those individuals and entities required to be notified of the grievance pursuant to [§C(10)] §C(9) of this regulation; and
    (c) (text unchanged)
    [(12)] (11) Ensure that decision makers on appeals and grievances [were not involved in previous levels of review or decision-making and are health care professionals with clinical expertise in treating the enrollee’s condition if any of the following apply]:
    (a) Were not involved in previous levels of decision-making;
    (b) Are not subordinates of people involved in previous levels of decision-making;
    (c) Are health care professionals with clinical expertise in treating the enrollee’s condition or disease, if any of the following apply:
    [(a)] (i)—[(b)] (ii) (text unchanged)
    [(c)] (iii) The grievance involves clinical issues; and
    (d) Take into account all comments, documents, records, and other information submitted by the enrollee or their representative, without regard to whether such information was submitted or considered in the initial action.
    .04 Actions and Decisions.
    A. For certain services to enrollees that require preauthorization [by the MCO, the MCO shall make a determination in a timely manner so as not to adversely affect the health of the enrollee and within 2 business days of receipt of necessary clinical information, but not later than 7 calendar days from the date of the initial request.] the following conditions apply:
    (1) For standard authorization decisions, the MCO shall make a determination within 2 business days of receipt of necessary clinical information, but not later than 14 calendar days from the date of the initial request so as not to adversely affect the health of the enrollee;
    (2) For expedited authorization decisions, the MCO shall make a determination and provide notice no later than 72 hours after receipt of the request for service if the provider indicates or the MCO determines that the standard timeframe stated in §A(1) of this regulation could jeopardize:
    (a) The enrollee’s life;
    (b) The enrollee’s health; or
    (c) The enrollee’s ability to attain, maintain, or regain maximum function; and
    (3) For all covered outpatient drug authorization decisions, the MCO shall provide notice by telephone or other telecommunication device within 24 hours of a preauthorization request in accordance with section 1927(d)(5)(A) of the Social Security Act.
    B. (text unchanged)
    C. An MCO shall ensure that compensation to individuals or entities that conduct utilization management activities is not structured to provide incentives for the individual or entity to deny, limit, or discontinue medically necessary services to any enrollee.
    [C.] D. Notices of a decision to deny an authorization shall be provided to the enrollee and the [regulation] requesting provider within the following time frames:
    (1) [24] For standard authorization decisions, within 72 hours from the date of the determination [for emergency, medically related requests]; [and]
    (2) [72] For expedited authorization decisions, within 24 hours from the date of determination [for nonemergency, medically related requests];
    (3) Standard and expedited authorization decisions may be extended up to 14 calendar days, if the following conditions are met:
    (a) The enrollee or the provider requests an extension; or
    (b) The MCO justifies to the Department, upon request, a need for additional information and how the extension is in the enrollee’s interest;
    (4) If the MCO successfully justifies extending the standard service authorization decision timeframe, the MCO shall:
    (a) Give the enrollee written notice of the reason for the decision to extend the timeframe;
    (b) Inform the enrollee of the right to file a grievance if he or she disagrees with the extension decision; and
    (c) Issue and carry out the MCO’s determination as expeditiously as the enrollee’s health condition requires but not later than the date the extension expires.
    [D.] E. An MCO shall give an enrollee written notice of any action[, except for denials of payment which do not require notice to the enrollee,] within the following time frames:
    (1)—(3) (text unchanged)
    (4) As soon as practicable for nursing facility transfers or discharges when:
    (a) The safety or health of individuals in the facility would be endangered;
    (b) The enrollee’s health improves sufficiently to allow a more immediate transfer or discharge; or
    (c) An immediate transfer or discharge is required by the enrollee’s urgent medical needs; [or] and
    [(d) An enrollee has not resided in the nursing facility for 30 days.]
    (5) For denial of payment, at the time of any action affecting the claim.
    [E.] F. A notice of adverse action shall:
    (1) Be in writing; [and]
    (2) Meet the following requirements:
    (a)—(d) (text unchanged)
    (e) Inform enrollees that information is available in alternative formats and how to access those formats[.]; and
    (3) Contain the following information:
    (a) The action the MCO has made or intends to make;
    (b) The reasons for the action, including the right for the enrollee to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the MCO’s action, including:
    (i) Medical necessity criteria; and
    (ii) Any processes, strategies, or evidentiary standards used in setting coverage limits;
    (c) The enrollee’s right to request an appeal of the MCO’s action, including information on:
    (i) Exhausting the MCO’s one level of appeal; and
    (ii) The right to request a State fair hearing;
    (d) The procedures for exercising the rights described;
    (e) The circumstances under which an appeal process can be expedited and how to request it;
    (f) The enrollee’s right to have benefits continue pending resolution of the appeal;
    (g) How to request that benefits be continued; and
    (h) The circumstances under which the enrollee may be required to pay the costs of the services.
    [F.] G. (text unchanged)
    .05 Appeal Process for Enrollees.
    A. An MCO’s appeal process shall:
    (1) Require that an enrollee, or a provider acting on the enrollee’s behalf, file an appeal within [90] 60 days from the date on the MCO’s notice of action;
    (2) (text unchanged)
    (3) Permit an enrollee to request an appeal either orally or in writing;
    (4) Provide that oral requests for appeal are considered the initiation of the appeal to establish the earliest possible filing date, and are confirmed in writing, unless the enrollee, their representative, or the provider requests an expedited appeal;
    [(3)] (5) (text unchanged)
    [(4)] (6) Allow the enrollee and the enrollee’s representative the opportunity [before and during the appeal process] to examine the enrollee’s case file, [including medical records and any other documents and records;] free of charge, at least 5 business days after the enrollee files the appeal which includes:
    (a) Medical records;
    (b) Other documents and records; and
    (c) Any new or additional evidence considered, relied upon, or generated by the MCO in connection with the action.
    [(5)] (7) Allow a provider or authorized representative acting on behalf of an enrollee to file an appeal with the enrollee’s written consent;
    [(6)] (8) (text unchanged)
    [(7) Provide at its final level an opportunity for the enrollee to be heard by the MCO’s chief executive officer, or the chief executive officer’s designee; and]
    [(8)] (9) Establish and maintain an expedited review process, when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize the enrollee’s life, physical or mental health, or ability to attain, maintain, or regain maximum function[.]; and
    (10) Ensure that punitive action is not taken against a provider who requests an expedited resolution or supports an enrollee’s appeal.
    B. Resolution.
    (1)—(2) (text unchanged)
    (3) For any extension not requested by the enrollee, the MCO shall [give]:
    (a) Give the enrollee written notice; and
    (b) Make reasonable efforts to give the enrollee verbal notice of the reason for the delay.
    [(4) Expedited appeals shall be resolved within 3 business days after the MCO receives the appeal.
    (5) If the MCO denies a request for expedited resolution of an appeal, the MCO shall:
    (a) Transfer the appeal to the standard time frame of not longer than 30 days from the day the MCO receives the appeal with a possible 14-day extension as described in §B(2) of this regulation; and
    (b) Make reasonable efforts to give the enrollee prompt verbal notice of the denial of expedited resolution and provide a written notice within 2 calendar days.]
    [(6)] (4) Continuation of Benefits. The MCO shall continue the enrollee’s benefits pending the outcome of the appeal if all of the following occur:
    [(a) The enrollee requests extension of benefits]
    (a) The enrollee timely files for continuation of benefits;
    (b) (text unchanged)
    (c) The appeal involves the termination, suspension, or reduction of a previously authorized [course of treatment] service;
    (d)—(e) (text unchanged)
    [(7)] (5) (text unchanged)
    (6) If the MCO or State fair hearing officer reverses a decision to deny, limit or delay services, the MCO shall authorize or provide the disputed services within 72 hours of the date the MCO receives the reversal.
    C. Expedited Appeals.
    (1) An expedited resolution may be approved when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize:
    (a) The enrollee’s life;
    (b) The enrollee’s physical or mental health; or
    (c) The enrollee’s ability to attain, maintain, or regain maximum function.
    (2) Expedited appeals shall be resolved within 72 hours after the MCO receives the appeal.
    (3) If the MCO denies a request for expedited resolution of an appeal, the MCO shall:
    (a) Transfer the appeal to the standard time frame of not longer than 30 days from the day the MCO receives the appeal with a possible 14-day extension as described in §B(2) of this regulation; and
    (b) Make reasonable efforts to give the enrollee prompt verbal notice of the denial of expedited resolution and provide a written notice within 2 calendar days.
    [C.] D. Notification.
    (1) The MCO shall provide written notice of resolution which includes:
    [(1)] (a) The results and date of the appeal resolution; [and]
    (b) The reasons for the action;
    [(2)] (c) For decisions not wholly in the enrollee’s favor:
    [(a)] (i)[(d)] (iv) (text unchanged)
    [(e)] (v) (text unchanged)
    (2) For notice of an expedited resolution, in addition to requirements listed in §D(1) of this regulation, the MCO shall also make reasonable efforts to provide oral notice of the decision.
    E. If an MCO fails to adhere to the notice and timing requirements, as described in §§A—D of this regulation, the enrollee is deemed to have exhausted the MCO’s appeals process and may initiate a State fair hearing.
     
    10.09.72 Maryland Medicaid Managed Care Program: Departmental Dispute Resolution Procedures
    Authority: Health-General Article, §15-103(b)(9)(i)4, Annotated Code of Maryland
    .01 Department’s Complaint Process.
    A.—B. (text unchanged)
    C. For appeals or grievances received from the Department, an MCO shall provide the Department with ongoing updates in a timeframe specified by the Department, based on the urgency of the appeal or grievance.
    .06 MCO Appeal.
    A. (text unchanged)
    B. The following Department decisions are appealable by the MCO or MCO applicant:
    (1)—(6) (text unchanged)
    (7) The amount of a penalty or incentive as described in COMAR 10.09.65.03; [and]
    (8) The denial of a hepatitis C payment as described in 10.09.65.19; and
    (9) Overpayments recovered by the Department.
    C.—H. (text unchanged)
    DENNIS SCHRADER
    Secretary of Health