In this chapter, the following terms have the meanings indicated. Terms Defined. “Amount that would otherwise have been paid (AWOP)” means the amount the Program expects to have paid for services for a PACE participant under the State Plan had the participant not enrolled under the PACE program. “Community spouse” means an individual who: Lives in the community outside a long-term care facility; Is not determined to meet the criteria for participation for: PACE under this chapter; or A waiver under §1915(c) of the Social Security Act; and Is married to an institutionalized spouse. “Continuous period of institutionalization” means at least 30 consecutive days of institutional care in a long-term care facility. “Contract” means a written agreement between a PACE provider and a third party under which the third party agrees to perform one or more of the PACE provider's obligations under this chapter or the PACE agreement. “Capitation payment” means the sum of money paid in advance on a monthly per capita basis to a PACE provider by the Department on a participant's behalf for the PACE provider benefit package specified in the PACE Program Agreement. “Centers for Medicare and Medicaid Services (CMS)” means the federal administering agency for the Medicare and Medicaid program benefits in PACE. “Contractor” means an entity with which the PACE provider has a contract agreement. “Contract year” means the term of a PACE Program Agreement, which is a calendar year, except that a PACE provider's initial contract year may be from 12 to 23 months, as determined by CMS. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01B, or its authorized agents acting on its behalf. “Eligible person” means any person who meets the eligibility requirements for enrollment in the PACE program as specified in the PACE program agreement and Regulation .05 of this chapter. “Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in: Placing the individual's health in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part. “Emergency services” means health care services that are: Covered under the PACE provider benefit package; Provided to a PACE participant with an emergency medical condition; Rendered by entities who are not employees or agents of the PACE provider and with whom the PACE provider does not have a contract; and Provided in a hospital emergency facility or a free-standing urgent care center as defined in COMAR 10.09.77.01. “Insolvency” means that the entity's net tangible equity or fund balance is negative and results from total program expenditures exceeding total program revenues to date. “Institutionalized spouse” means an individual who is married to a community spouse and who is: An inpatient in a long-term care facility with a length of stay exceeding 30 days; or Determined to meet the criteria for participation for: PACE under this chapter; or A waiver under §1915(c) of Title XIX of the Social Security Act. “Long-term care facility” means a nursing facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or psychiatric hospital. “Medicaid Provider Agreement” means the agreement between Medicaid providers, including PACE providers, and the Department that allows providers to provide services to Medicaid participants “Medical Assistance Program” means the Maryland Medical Assistance Program, as defined in COMAR 10.09.36.01B. “Medically necessary” means directly related to diagnostic, preventive, curative, palliative, or rehabilitative treatment. “Medicare” means the federal program that provides benefits to aged or disabled individuals under Title XVIII of the Social Security Act. “PACE enrollment limit” means the maximum number of Medicaid participants permitted to the PACE provider as declared in the State Certification Page of the CMS PACE provider application. “PACE benefit package” means a prepaid, comprehensive package of all the health care services to which a PACE provider's participants are entitled under the State Plan when the services are medically necessary and appropriate. “PACE center” means a facility operated by a PACE provider where primary care is furnished to participants. “PACE Organization Provider Agreement” is the agreement between the PACE Provider and the Department that contains provisions to provide additional protections to PACE participants. “PACE participant” means an eligible person who voluntarily enrolls and enters into an agreement with a PACE provider or an eligible person who is enrolled by a legal representative. “PACE provider” means an entity that is approved by the Department and CMS to provide the PACE benefit package covered under this chapter to Medical Assistance participants. “PACE Program Agreement” means a written, signed agreement between the Department, CMS, and the PACE provider, which specifies the terms of the relationship between the Department and the PACE provider and authorizes the PACE provider to operate in the State. “Participant” means an individual who is certified by the Department as eligible to receive Medical Assistance Program benefits. “Primary care” means health care services that address an individual's general health needs, including the coordination of the individual's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the individual's health records, and referral for medically necessary and appropriate specialty care. “Primary care provider” means a practitioner who provides a participant's primary care services and is the primary coordinator of all other health care services for the participant, responsible for providing or assuring access to continuous, comprehensive, and coordinated health care services covered in the PACE benefit package. “Professional standards” means professional requirements set forth in the Annotated Code of Maryland or by the national accrediting body for a practitioner's profession. “Program” means the Medical Assistance Program, as defined in COMAR 10.09.36. “Programs of All-Inclusive Care for the Elderly (PACE)” means a jointly administered capitated Medicare/Medicaid program providing medical and long term care services to nursing home eligible, frail, elderly participants. “Quality Assurance and Performance Improvement Plan (QAPI)” means a document or series of documents that set forth a PACE provider's strategy for systematically monitoring, evaluating, and improving all facets of operations including, but not limited to, clinical health care delivery, participant assistance and outreach services, and administrative services. “Secretary” means the Secretary of Health. “Service area” means a defined geographic area selected by the PACE provider and approved by the Department in the PACE program agreement, in which the complete PACE benefit package is available to all the PACE provider's participants, and beyond which the PACE provider is restricted from directly marketing its services. “Services” includes both items and services. “State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services pursuant to Title XIX of the Social Security Act, as modified or amended. “Trial period” means the first 3 contract years in which a PACE organization operates under a PACE program agreement, including any contract year during which the entity operated under a PACE demonstration waiver program. “Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition. An applicant for participation in the Program as a PACE provider shall submit to the Department and CMS a complete PACE application that describes how the entity meets all requirements in 42 CFR 460 et seq. The PACE provider shall comply with: 42 CFR 460 et seq.; This chapter; The Medicaid provider agreement and the PACE Organization Provider Agreement signed with the Department; COMAR 10.09.36; Standards in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; Any other applicable regulations, transmittals, and guidelines issued by the Department that are in effect; and All other requirements of applicable federal and State law. The PACE provider shall have a signed PACE program agreement with the Department and CMS which establishes the terms of the relationship between the PACE provider and the Department. The PACE provider shall obtain approval by the Department before establishing additional care sites. The PACE provider shall obtain approval by the Department before expanding its service area. Professional and Administrative Standards. The PACE provider shall have the professional and administrative ability and staffing to carry out its duties and responsibilities according to the PACE Program Agreement and PACE Organization Provider Agreement, which shall include the following: A full-time administrator; Sufficient allied health, medical social work, clerical, and support staff to provide proper medical care within acceptable professional standards; A demonstrated ability to deliver health services within the service area according to standards established by the Department; A management information system, which shall: Meet the requirements of Regulations .14 and .15 of this chapter; and Maintain medical and financial records for 10 years; An acceptable PACE participant grievance and appeals procedure and system for reporting the disposition of grievances and appeals to the Department, as specified in Regulation .19 of this chapter; A procedure established to provide PACE participants an ability to participate in matters of policy and operation; and A sufficient quality assurance and performance improvement system, as specified in Regulation .13 of this chapter. Nondiscrimination. In connection with the performance of its obligations under this chapter, the PACE provider shall comply with all applicable federal and State laws, regulations, or orders which prohibit discrimination on grounds of race, age, creed, sex, color, national origin, marital status, physical or mental handicap, health status, or need for health services. Provision of Services and Health Care Delivery. A PACE provider shall provide: The services set forth in Regulation .09 of this chapter and covered under the PACE provider benefit package: Promptly and continuously, consistent with accepted medical practice and community professional standards; and Through its own employees and agents or through contractors, except for emergency services; and Written notice to PACE participants if there is a significant change in the nature, location, or provider of services provided. The PACE provider may not knowingly have as a director, officer, partner, or owner of more than 5 percent of the entity's equity, a person or an affiliate of a person who is or has been debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued pursuant to federal Executive Order No. 12549 or under guidelines implementing such an order. The PACE provider may not knowingly have an employment, consulting, or other agreement with a person described in §H of this regulation, for the provision of items and services that are significant and material to the PACE provider's obligations under this chapter. The PACE provider and its agents and employees, in the performance of the services covered under this chapter, shall act in an independent capacity and may not act as officers, employees, or agents of the Department. An individual employed by the State or any department, commission, agency, or branch of the State, whose duties include matters relating to or affecting the subject matter of this chapter, may not be an employee of a PACE provider. Any obligations of the PACE provider set forth in this chapter may be waived by the Department, but the waiver extends only to the particular case, time, and manner specified by the Department and is not a waiver of any other provision of this chapter. If the PACE Program Agreement exempts the PACE provider from financial responsibility for any services available under the State Plan, the PACE provider shall be required by the PACE Organization Provider Agreement to provide for these services. Liability. The PACE provider shall be wholly at risk for all medically necessary and appropriate services covered under the PACE provider benefit package. The Department may not make additional payment for services under this section. The PACE provider may not collect any payment from a PACE participant except as specified in Regulation .05 of this chapter. The PACE provider is solely responsible for ensuring that it does not issue payments for services for which it is not liable in its PACE Organization Provider Agreement, and the Department may not accept responsibility for refunding to the PACE provider any excess payments made by the PACE provider. The duration or term of the agreement between the Department and the PACE provider is specified in the PACE Organization Provider Agreement. The PACE Organization Provider Agreement shall provide for automatic amendment, renegotiation, or termination, or all of the above, of the PACE Organization Provider Agreement by either party if any part of the PACE Organization Provider Agreement's provider benefit package is changed under the State Plan. Termination. The Department may terminate immediately the PACE Organization Provider Agreement upon notification: By the U. S. Department of Health and Human Services, that it is withdrawing federal financial participation in all or part of the cost of the PACE benefit package; By the Department of Budget and Management, of the unavailability of sufficient State funds for the PACE benefit package; or That the owners or managers of the PACE provider, or other persons with substantial Medicaid Provider Agreement relationships with the PACE provider, have been convicted of certain crimes or received certain sanctions as specified in §1128 of the Social Security Act. The Department may, at its sole discretion, offer to renegotiate any provision of the PACE Organization Provider Agreement if renegotiation would remove any of the causes of termination specified in §C(1) of this regulation. This offer is not a waiver of the Department's right of immediate termination. The PACE Organization Provider Agreement may be terminated by either the Department or the PACE provider if the other party fails to meet a provision of: This chapter; The PACE Organization Provider Agreement; or Applicable laws, rules, regulations, or guidelines effective as of the date of the PACE Organization Provider Agreement or enacted or established during the PACE Organization Provider Agreement's term. A PACE Organization Provider Agreement's termination is effective only after the terminating party has notified the breaching party in writing of the cause or causes of termination and has allowed 60 days for the correction or alleviation of the cause or causes by the breaching party. Termination of Agreement by PACE. The PACE provider may terminate an agreement after timely notice to CMS, the Department, and PACE participants, as follows: To CMS and the Department, 90 days before termination; and To PACE participants, 60 days before termination. Default by PACE. The Department may immediately terminate the PACE Organization Provider Agreement if the PACE provider defaults, as specified in §D(3) of this regulation. If the PACE provider defaults, the Department may recover any capitation payments issued to the PACE provider for periods after the termination effective date of the PACE Organization Provider Agreement. The following are defaults by the PACE provider: Inability to provide the services described in the PACE provider benefit package and in Regulation .09 of this chapter; or Insolvency. Nonexclusivity of Remedy. This regulation's provisions supplement, rather than replace, any other sanctions or remedies available to the Department under the provisions of Regulation .24 of this chapter, the PACE Organization Provider Agreement, the Medicaid Provider Agreement, or applicable law or regulations. If the PACE Program Provider Agreement is terminated under this regulation, the PACE provider shall furnish to the Department, within 45 days of the termination's effective date, all information necessary for the reimbursement of any outstanding claims for services rendered to the PACE provider's participants, including claims of its contractors. An eligible person shall: Reside in the PACE approved service area upon enrollment; Be 55 years old or older; Be able to be maintained in a community-based setting with the assistance of PACE at the time of enrollment without jeopardizing the PACE participant's health or others' health or safety; Be determined by the Department to need the level of care required under the State Plan for coverage of nursing facility services for longer than 4 months; and Be willing to abide by the provision that requires PACE participants to receive all health and long-term care services exclusively from the PACE provider and its contracted or referred providers. Medical Assistance Eligibility Services. Medical Assistance eligibility for services under this chapter is determined under this regulation and applicable sections of COMAR 10.09.24, as cited in §B(2)—(4) of this regulation. Categorically Needy. An individual is eligible for services under this chapter as categorically needy if the individual is receiving Medical Assistance as: A recipient of Supplemental Security Income (SSI); A member of a low income family with children, as described in §1931 of the Social Security Act; or Any other type of categorically needy person in accordance with COMAR 10.09.24.03. Optionally Categorically Needy. An individual is eligible for services under this chapter as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable: Income does not exceed 300 percent of the applicable payment rate for SSI; and Resources do not exceed the SSI resource standard for one individual. For the purpose of determining Medical Assistance eligibility for the optionally categorically needy: The individual is treated as an assistance unit of one individual; and Countable income and resources are determined based on the rules for income and resources set forth in COMAR 10.09.24 as applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions in §B(3)(g) of this regulation. An individual is not eligible under §B(3) of this regulation if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. The spousal impoverishment rules in §1924 of the Social Security Act and COMAR 10.09.24.10-1 are applicable, except for the differences specified in this regulation. Medical Assistance eligibility shall be redetermined at least every 12 months. If the applicant or participant is not aged, blind, or determined disabled by the Social Security Administration, the Department of Human Services shall determine whether the applicant or participant is technically eligible for Medical Assistance as a disabled person, in accordance with COMAR 10.09.24.05-4B. All provisions of COMAR 10.09.24 which apply to an aged, blind, or disabled individual who is institutionalized are applicable to applicants and PACE participants under this chapter who are considered optionally categorically needy, with the following exceptions in full or in part: COMAR 10.09.24.04-1D and E; COMAR 10.09.24.04-1F; COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08F(1); COMAR 10.09.24.08G; COMAR 10.09.24.09; COMAR 10.09.24.10; and COMAR 10.09.24.10-1. Home Exclusion. The home, as defined in COMAR 10.09.24.08F(1), is not a countable resource under §B(3) of this regulation if it is occupied by the applicant or PACE participant, the applicant's or PACE participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or PACE participant: Child; Parent; or Sibling. Medical Assistance eligibility shall be determined by the Department within 45 days after the Department or its representative receives a signed application according to COMAR 10.09.24.04-1D. Post-Eligibility Determination of Available Income for Optionally Categorically Needy. The countable monthly income considered for the post eligibility determination is calculated in accordance with §B(3) of this regulation and COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified in COMAR 10.09.24.07L are not applied. For individuals eligible under §B(3) of this regulation who reside in a licensed assisted living facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: A personal needs allowance of $60; A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); and Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). For individuals who reside in an assisted living facility whose contribution toward the cost of service is calculated under §B(4)(b) of this regulation, the provider shall collect the PACE participant's available income. The amount collected under this paragraph may not exceed the monthly capitation amount under this chapter for the PACE participant. For individuals eligible under §B(3) of this regulation who reside in a long-term care facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: A personal needs allowance in accordance with COMAR 10.09.24.10D(2)(c); A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); A residential allowance in accordance with COMAR 10.09.24.10D(2)(e); and Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). For individuals who reside in a long-term care facility whose contribution toward the cost of service is calculated under §B(4)(d) of this regulation, the provider shall collect the PACE participant's available income. Enrollment shall be on a voluntary basis, without respect to race, age greater than the lower limit required, creed, sex, color, national origin, marital status, or physical or mental handicap. An individual is not eligible for enrollment in PACE, regardless of whether the individual is otherwise eligible for benefits under the Program, if the individual is: Living outside the PACE provider's service area; Not included in the PACE provider's target population specified in the PACE Program Agreement; or Enrolled in: A managed care organization contracting with the Department; A Medicaid home and community-based services waiver under §1915(c) of the Social Security Act; Rare and expensive case management (REM) under COMAR 10.09.69; or A Medicaid capitated program that includes nursing facility or community-based long term care services. The Department shall enroll eligible persons who have chosen to enroll in the PACE provider. The PACE provider shall enter into an enrollment agreement with an eligible participant on the form approved by the Department. The PACE provider shall enroll eligible participants in the order in which they apply, and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures. Signature on Enrollment Forms. Except as indicated under §D(2) of this regulation, a participant 55 years old or older shall sign and submit the enrollment form; A legal guardian or legal representative shall sign enrollment forms for eligible persons determined to be incapacitated or incompetent to sign the form. Because the PACE provider is responsible for ensuring that participants whose primary language is not English understand the benefits and restrictions associated with enrollment in PACE, the PACE provider shall give to such a participant at the time of enrollment a: Notice that translation services are available; or List of primary care providers who speak foreign languages. Subject to verification of eligibility, enrollment shall be effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement. An individual eligible for enrollment under Regulation .05 of this chapter, may enroll at any time during the term of the PACE Provider Agreement, unless: Enrollment under the PACE Organization Provider Agreement has been suspended pursuant to Regulation .23 of this chapter; or The PACE provider exceeds the enrollment limit established by the Department. The PACE provider shall: Maintain a list of all individuals denied enrollment in the order in which they applied for enrollment; and Promptly offer enrollment to denied individuals when permitted. The PACE provider shall provide to each PACE participant an identification card, clearly indicating the bearer is enrolled with the PACE provider. The PACE provider shall provide in writing and explain to a new participant, at a minimum, the following: Notification of the PACE participant's right to terminate enrollment, the time frame required, and explanation of the required process; and Information about the proper utilization of pharmacy services including the requirement to use one pharmacy within the PACE provider network to fill all prescriptions. Termination of a PACE participant's enrollment may be initiated by the: PACE provider; Department; PACE participant; or PACE participant’s legal guardian or legal representative. All enrollment terminations require prior approval by the Department. General Requirements for Processing Disenrollments. The Department shall establish a timeline for the receipt of disenrollment forms as follows: A PACE participant’s involuntary disenrollment occurs after the PACE provider meets the requirements set forth in 42 CFR §460.164 and is effective on the first day of the next month that begins 30 days after the day the PACE organization sends notice of the disenrollment to the PACE participant; or A PACE participant’s voluntary disenrollment is effective on the first day of the month following the date the PACE organization receives the PACE participant’s notice of voluntary disenrollment. Disenrollment requests shall be submitted to the Department by the PACE provider within 3 working days from completion, except if the PACE participant requests that the form be mailed to the PACE participant's home address for completion. The PACE provider shall send the PACE participant a copy of the completed disenrollment forms, regardless of who initiated the disenrollment process. Voluntary Disenrollment by PACE Participant. In general, PACE participants may disenroll from the PACE provider at their discretion at any time without cause, by completing or having completed by a legal guardian or legal representative a disenrollment form provided by the Department. The PACE provider shall act to facilitate disenrollment, including mailing disenrollment request forms to PACE participants desiring to disenroll but having difficulty accessing the PACE provider's office. The PACE provider shall date-stamp PACE participants' disenrollment requests upon receipt. Disenrollment Initiated by the PACE Provider. The PACE provider shall have a written policy regarding termination of a PACE participant's enrollment by the PACE provider which shall address, at a minimum: Under what conditions a PACE participant is to be disenrolled by the PACE provider; and The time elements involved in processing terminations. A disenrollment initiated by the PACE provider shall require prior approval by the Department. A disenrollment may not occur because of an adverse change in the PACE participant's health status. The PACE participant's complete medical and utilization history shall be provided by the PACE provider to the Department, upon request, in order to determine an appropriate disenrollment date. The PACE provider shall notify the PACE participant within 14 days of when the disenrollment is approved, and the PACE participant may appeal the decision under the terms of COMAR 10.01.04. Disenrollment may be requested by the PACE provider by providing to the Department acceptable documentation that the: PACE participant's domicile was relocated outside the PACE provider's service area; PACE participant is no longer eligible in accordance with Regulation .05 of this chapter; PACE participant is discovered to be an individual for whom there existed legal documentation at the time of enrollment that the individual was mentally incompetent, but the PACE participant signed the enrollment form; PACE participant commits fraudulent or illegal acts, such as permitting use of the PACE participant's medical identification card by others, altering a prescription, theft or other criminal acts committed in any provider's or PACE provider's premises; PACE participant fails to complete and submit consents, releases, or assignments and other documents reasonably requested by the PACE provider in order to obtain or assure payment by Medicare, Medicaid, or other third party payers; or PACE participant has died. A PACE provider requesting disenrollment based on documentation under §E(6)(d) of this regulation shall report any illegal acts to law enforcement authorities or to the Medicaid Fraud Control Unit of the Department's Recipient Fraud Unit as appropriate. If a request for disenrollment is approved, the PACE provider shall facilitate a PACE participant's enrollment into other programs by: Making appropriate referrals; and Ensuring clinical records are made available to new providers within 10 days of disenrollment. Disenrollment by the Department. The Department shall disenroll a PACE participant if the: PACE Organization Provider Agreement between the PACE provider and the Department is terminated; PACE participant dies; PACE participant becomes ineligible for enrollment in accordance with Regulation .05 of this chapter; or PACE participant loses eligibility for Medical Assistance Program benefits or changes to a category of assistance not eligible for enrollment in PACE. Effective Date of Termination. The Department shall approve or disapprove requests for voluntary disenrollment within 5 working days of the date the request is received. A disenrollment initiated by either the Department or the PACE provider because the participant died or became ineligible for enrollment for one of the other reasons specified in this regulation is effective the day after the event causing the ineligibility. For disenrollments initiated by the Department, the Department shall provide the PACE provider with written notice. A disenrollment resulting from the PACE participant's loss of Program eligibility shall be effective on the day following the PACE participant's last date of eligibility. The Department may recover any capitation payments made on behalf of the PACE participant for periods following the effective date of the PACE participant's termination of enrollment or loss of eligibility, but not for a retroactive period greater than 3 months except in the case of: The PACE participant's death; or The PACE participant's relocation of domicile outside the PACE provider's service area. The Department may determine a retroactive disenrollment date based on the conditions present when the disenrollment is requested or indicated. The PACE provider shall ensure notification and protection of the rights of enrollees according to 42 CFR §460.110 and 42 CFR §460.112. Except as limited or expanded by the PACE benefit package specified in the PACE program agreement, the PACE provider shall directly provide, arrange, purchase, or otherwise make available, as medically necessary and appropriate, the services specified in the State Plan and the PACE benefit package. The PACE benefit package for all PACE participants, regardless of the source of payment, shall include the following: All Medicaid-covered services, as specified in the State Plan; Multidisciplinary assessment and treatment planning; Social work services; Nutritional counseling; Recreational therapy; Certain meals; Medical specialty services; Prosthetics, orthotics, corrective vision devices, such as eyeglasses and lenses, hearing aids, dentures, and repair and maintenance of these items; Assisted living; and Other services determined necessary by the multidisciplinary team to improve and maintain the PACE participant's overall health status. For access, including access to emergency services, the PACE provider shall comply with 42 CFR §460.100. Limitations on coverage are as specified in the PACE program agreement and 42 CFR §460.96. The PACE provider shall obtain approval by the Department before any changes in the following: Service contract agreements; PACE provider benefit package; PACE provider's service area; PACE provider's enrollment limit; PACE Organization Provider Agreement; or PACE provider structure. The PACE Organization Provider Agreement shall specify the methods by which the PACE provider will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or potential PACE participants. The PACE provider's marketing plan and all marketing procedures and materials require approval by the Department before implementation and utilization. The PACE provider may not participate in: Activities described in 42 CFR §460.82(e); or Face-to-face or telephone contact with a participant, or otherwise soliciting a participant who is not a PACE provider’s participant, unless authorized by the Department or initiated by the participant. Subject to prior approval by the Department, a PACE provider may engage in marketing activities designed to make [recipient] participants aware of the PACE provider's availability as well as any special services offered. Addressee-blind informational mailings to an entire zip code may be used. Enrollment Agreement and PACE Participant Enrollment Materials. The PACE provider shall distribute the enrollment agreement within 14 days of the PACE participant's effective date of coverage with the PACE Program. At a minimum the information in the enrollment agreement shall contain the following PACE participant enrollment materials which shall remain with the PACE participant: Location or locations and office hours of the PACE providers; Telephone number or numbers to call for more information; Choice and use of primary care providers and policies on changing primary care providers; How to access urgent care services and advice; How and when to use emergency services including ambulance; Information on the grievance and appeals process, including confidentiality and requesting an administrative hearing; How to access interpreter services including sign interpreters; PACE participant rights and responsibilities; PACE participant's possible responsibility for charges including Medicare deductibles and coinsurances if the participant goes outside of the PACE Program for nonemergency care, or obtains noncovered services or services not authorized by the interdisciplinary team; A clear statement that plan of care decisions are determined by the participant's interdisciplinary team; Information on the availability of social services and assistance in placement in community-based housing and facilities; Information on advance directives and physician order for life sustaining treatment; How to obtain copies of the PACE participant's records; How to obtain nonemergency ambulance services and other medical transportation to appointments, as appropriate; Explanation of covered and noncovered services; How to obtain prescriptions; and Confidentiality policy. The PACE provider shall review the enrollment agreement for accuracy at least yearly and update it with new or corrected information as needed to reflect the PACE provider's internal changes and regulatory changes. If changes impact the PACE participants' ability to use services or benefits, the PACE provider shall distribute the updated materials to all PACE participants after approval by the Department. The provider shall offer orientation to the PACE program to new participants in person within 30 days of enrollment. The PACE provider shall comply with 42 CFR Part 460, Subpart H (Quality Assessment and Performance Improvement). The PACE provider shall comply with requirements designated by the Department. The PACE provider shall comply with 42 CFR §460.210. The PACE provider shall collect and submit to the Department service-specific encounter data by service type in the format and at the frequency designated by the Department and in conformance with the Department's computer coding requirements. Encounter data submitted by PACE providers under §A of this regulation shall include, at a minimum: PACE participant and provider identifying information; Service, procedure, and diagnosis codes; Allowed, paid, and third-party liability amounts; and Service, claims submission, adjudication, and payment dates. The PACE provider shall prepare and submit to the Department reports related to third-party liability as required by Regulation .20 of this chapter. The PACE provider shall immediately notify the Department if it has knowledge of a PACE participant's death. The PACE provider shall have an effective procedure for reporting to the Department the following information: Patterns of utilization; Health status of PACE participants; and Appeals and grievances made by PACE participants. Quarterly Reports. A PACE provider shall submit to the Department quarterly, within 30 days of the close of each calendar quarter, and in a format designated by the Department: Financial reports specified by the PACE program agreement; Quality assurance reports including, but not limited, to quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; Grievance reports, including emergency room based grievances, as specified in Regulation .19 of this chapter that contain An analysis of PACE participant appeal and grievance records; Identification of significant trends or anomalies; The root causes of the trend or anomaly; and Actions taken to address the trend or anomaly; A list of all pre-service denials or reduction of services or benefits issued by the PACE provider or subcontractors during the preceding quarter; and A report of the PACE provider’s participant advisory committee outlining the committee’s activities and recommendations. Annual Reports. The PACE provider shall submit to the Department annually, within 90 days after the end of the calendar year: An annual summary of the information required by §E of this regulation; Any revisions to the PACE provider's quality assurance or utilization management plans; A copy of any changes in contractor agreements; On-site proof that the PACE provider has obtained adequate insurance coverage, issued by an insurer authorized by the Maryland Insurance Administration to engage in the insurance business in the State, to protect its financial viability, and its ability to carry out its PACE program agreement obligations, including at a minimum: Malpractice coverage for all professional and related employees of the PACE provider, as well as for the PACE provider itself; Bonding of all employees and officers who have any responsibilities for the accounting and financial management activities of the PACE provider; and Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws; A proposed budget and financial plan for the PACE provider's operation, including: An annualized cash flow chart; The cost of operations; Information demonstrating that the PACE provider has a fiscally sound operation; and A statement of policy and procedures for accounting, capitation collection, methods of reimbursing providers and contractors, and method of payment for emergency and out-of-area claims; and Financial monitoring reports, including any supplemental schedules required by the Department, prepared according to the criteria and reporting instructions and in the format and pursuant to the schedule required by the Department. For the purposes of Program administration or monitoring of the PACE provider's performance pursuant to this chapter, given a reasonable period of notice, the PACE provider shall supply other information the Department may request from time to time. Subject to the requirements of 42 CFR Part 431 Subpart F, the PACE provider and its contractors may not release or disclose any information concerning a PACE participant to anyone other than the Department except with the written permission of the: PACE participant; or PACE participant's attorney, legal representative, or legal guardian. For all information, records, data, and data elements collected and maintained by the PACE provider to facilitate operations under this chapter, the PACE provider shall: Protect this information, records, data, and data elements from unauthorized disclosure, in accordance with the provisions of applicable federal and State laws and regulations; and Assure that access is limited by the PACE provider to persons or agencies requiring the information to perform their duties in accordance with this chapter or other duties authorized by the Department. The PACE provider shall comply with 42 CFR §460.80 and 42 CFR §460.208. Consistent with this chapter, the PACE provider, in performing its obligations under this chapter and the PACE program agreement, may either engage its own employees and agents or utilize the services of persons, firms, and other entities by means of contractual relationships. The PACE provider shall have a contractor agreement for all services which are not provided directly by the PACE provider through its own employees and agents. A contractor agreement may not diminish or alter the legal responsibility of the PACE provider to the Department to assure that all obligations under this chapter and the PACE program agreement are carried out. All service contractor agreements require preapproval by the Department. If there are proposed changes in a contractor agreement with any contractor, the full contractor agreement shall be submitted to the Department for prior approval. If the Department determines that termination or expiration of a PACE provider's contractual relationship materially affects the PACE provider's ability to carry out its responsibilities under the PACE [provider agreement] Organization Provider Agreement, the Department may terminate the PACE Organization Provider Agreement. The PACE provider may contract for any health care services not furnished directly by PACE in its benefit package to a health care provider that is licensed, certified, and meets Medicaid and Medicare participation requirements. Contractors shall be legally and professionally qualified to furnish the services set forth in the contractor agreement in return for the compensation set forth in the contractor agreement. The PACE provider shall comply with the grievance procedures described at 42 CFR §460.120—124. The PACE provider shall identify and collect money owed from responsible third parties liable for the cost of health care services furnished by the PACE provider to its PACE participants. Upon request from the Department, the PACE provider shall convey any information regarding third-party liability to the Department and the U.S. Department of Health and Human Services. If both the Department and the PACE provider have a right of subrogation, the Department and the PACE provider shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount. For insurance coverage identified by the PACE provider with a retroactive effective date, the PACE provider shall ensure that procedures are in place for the collection of funds from either the provider or the insurance carrier for claims paid by the PACE provider during the coverage period, for up to 2 years from the date of health care services provided to the participant. The Department shall: Pay the PACE provider for each PACE participant based on the fixed capitation payment or payments specified in §E of this regulation; and Calculate the capitation payment or payments for the PACE provider using the methodology described in §B of this regulation. Calculation of PACE Capitation Payments. PACE capitation payments are calculated on a per-member per-month basis. Capitation payments are specific to both the regional service area, as described in §C of this regulation, and the participant age and coverage status, as described in §D of this regulation. Capitation payments are calculated using an AWOP analysis, which is determined using a base period of Medicaid fee for service participant data that: Spans two State fiscal years; Is specific to the PACE eligible population; Is weighted by the expected ratio of participants receiving long-term care services in institutional and community-based settings; and Excludes participants enrolled in the following programs: Medicaid managed care programs; PACE; and Home and community-based services waivers operated by the Developmental Disabilities Administration. The Department shall set the PACE capitation rate as 98 percent of the calculated AWOP. The Department shall recalculate PACE capitation rates annually by trending forward the base period by 1 year. Certain categories of costs not associated with a PACE-eligible, nursing facility-certified population are excluded from the claims data. Capitation rates shall be categorized by regional service area as follows: Baltimore Metro — Baltimore City and Anne Arundel, Baltimore, Carroll, Cecil, Harford, and Howard counties; Washington Metro — Calvert, Charles, Frederick, Montgomery, Prince George’s, and St. Mary’s counties; and Rural Regions — Allegany, Caroline, Dorchester, Garrett, Kent, Queen Anne’s, Somerset, Talbot, Washington, Wicomico, and Worcester counties. Capitation rates shall be categorized by participant age and coverage status as follows: Ages 55—64, Medicaid-only; Ages 65 and over, Medicaid-only; Ages 55—64, dual eligibility; and Ages 65 and over, dual eligibility. For services provided on or after January 1, 2024, the Department shall pay the PACE provider at the following per-member per-month capitation rates: The capitation rate paid by the Department to the PACE provider for a participant shall be accepted as payment in full for the PACE provider benefit package provided by the PACE provider according to its PACE Organization Provider Agreement, and additional charge may not be made to the participant, the Department, or any other entity except as provided under Regulation .05 of this chapter. The Department shall recover any overpayments made to the PACE provider. A capitation payment may not be made to the PACE provider on behalf of a participant for whom fee-for-service or a capitation payment for the same period has been made by the Department to any other provider, HMO, or managed care organization. Capitation payment may not be made to the PACE provider on behalf of a participant if the Department's eligibility verification system indicates that the participant is not eligible for Medicaid benefits. The Department shall provide retroactive capitation to the PACE provider on behalf of a participant when: The Department's eligibility verification system indicates that the participant has established a retroactive eligibility period to a previous PACE enrollment period; and Services were provided by the PACE provider and no other fee-for-service provider. Program Changes. Amendments, revisions, or additions to the State Plan or the State or federal regulations, guidelines, or policies shall, insofar as they affect the scope or nature of Program benefits available to eligible persons, be considered as amendments to the PACE provider benefit package, unless the Department shall otherwise notify the PACE provider. The Department or PACE may determine that a change in the PACE provider benefit package, or in the Program's reporting or other administrative requirements, is a substantial modification of the financial or other responsibilities of the PACE provider, and so may request an adjustment in the PACE provider's capitation payment. Refusal of an adjustment in the PACE provider's capitation payment by the other party shall, at the discretion of the party making the request, be grounds for termination of the PACE Organization Provider Agreement. The PACE provider shall be responsible for prompt payment for all emergency services received by PACE participants. If a claim is submitted to the PACE provider within 9 months of the date of service, the PACE provider shall reimburse a hospital emergency facility and provider or free-standing urgent care center, without requiring prior authorization or approval for payment from the PACE provider, for: Emergency services; Medical screening services rendered at an emergency facility to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; and Medically necessary and appropriate services if: The PACE provider authorized, referred, or otherwise allowed the PACE participant to use the emergency facility; and The services are related to the condition for which the PACE participant was allowed to use the emergency facility. Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may: Impose one or more of the actions under COMAR 10.09.36.08A; and Suspend the PACE provider’s ability to enroll new PACE participants. The PACE provider shall comply with 42 CFR §460.122. PACE provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09. PACE participant appeals are set forth in COMAR 10.01.04. Interpretation of this regulation is subject to COMAR 10.09.36. Health-General Article, §2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.25 adopted as an emergency provision effective November 1, 2002 (29:25 Md. R. 1979); adopted permanently effective April 28, 2003 (30:8 Md. R. 540) Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652); August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .03 amended effective January 29, 2018 (45:2 Md R. 68); July 21, 2025 (52:14 Md. R. 713) Regulation .04 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .05A, B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .06 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .07 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .09B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .11E amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .12 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .15 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .16A amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .18F amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .20A amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .21 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .22 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .23 amended effective August 19, 2024 (51:16 Md, R. 742) Regulation .23B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .24C amended effective July 21, 2025 (52:14 Md. R. 713)