EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. [Brackets] indicate matter deleted from existing law. *sb0791* SENATE BILL 791 J5, J4 4lr2880 CF 4lr1877 By: Senator Klausmeier Introduced and read first time: February 1, 2024 Assigned to: Finance A BILL ENTITLED AN ACT concerning 1 Health Insurance – Utilization Review – Revisions 2 FOR the purpose of altering and establishing requirements and prohibitions related to 3 health insurance utilization review; altering requirements related to internal 4 grievance procedures and adverse decision procedures; altering certain reporting 5 requirements on health insurance carriers relating to adverse decisions; establishing 6 requirements on health insurance carriers and health care providers relating to the 7 provision of patient benefit information; and generally relating to health insurance 8 and utilization review. 9 BY adding to 10 Article – Health – General 11 Section 19–108.5 12 Annotated Code of Maryland 13 (2023 Replacement Volume) 14 BY repealing and reenacting, without amendments, 15 Article – Insurance 16 Section 15–851 and 15–10B–01(a) 17 Annotated Code of Maryland 18 (2017 Replacement Volume and 2023 Supplement) 19 BY repealing and reenacting, with amendments, 20 Article – Insurance 21 Section 15–854 and 15–10B–06 22 Annotated Code of Maryland 23 (2017 Replacement Volume and 2023 Supplement) 24 (As enacted by Chapters 364 and 365 of the Acts of the General Assembly of 2023) 25 BY adding to 26 Article – Insurance 27 2 SENATE BILL 791 Section 15–854.1 1 Annotated Code of Maryland 2 (2017 Replacement Volume and 2023 Supplement) 3 BY repealing and reenacting, with amendments, 4 Article – Insurance 5 Section 15–10A–01, 15–10A–02, 15–10A–04(c), 15–10A–06, 15–10A–08, 6 15–10B–01(b), 15–10B–02, 15–10B–05, 15–10B–07, and 15–10B–09.1 7 Annotated Code of Maryland 8 (2017 Replacement Volume and 2023 Supplement) 9 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 10 That the Laws of Maryland read as follows: 11 Article – Health – General 12 19–108.5. 13 (A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 14 INDICATED. 15 (2) “CARRIER” HAS THE MEANING STATE D IN § 15–1301 OF THE 16 INSURANCE ARTICLE. 17 (3) “HEALTH CARE PROVIDER ” HAS THE MEANING STAT ED IN § 18 19–108.3 OF THIS SUBTITLE. 19 (B) (1) ON OR BEFORE JULY 1, 2026, A CARRIER SHALL ESTA BLISH AND 20 MAINTAIN AN ONLINE P ROCESS THAT: 21 (I) LINKS DIRECTLY TO ALL E–PRESCRIBING SYSTEMS AND 22 ELECTRONIC HEALTH RE CORD SYSTEMS THAT US E THE NATIONAL COUNCIL FOR 23 PRESCRIPTION DRUG PROGRAMS SCRIPT STANDARD AND THE NATIONAL 24 COUNCIL FOR PRESCRIPTION DRUG PROGRAMS REAL TIME BENEFIT STANDARD; 25 (II) CAN ACCEPT ELECTRONIC PRI OR AUTHORIZATION 26 REQUESTS FROM A HEAL TH CARE PROVIDER ; 27 (III) CAN APPROVE ELECTRONI C PRIOR AUTHORIZATIO N 28 REQUESTS: 29 1. FOR WHICH NO ADDITION AL INFORMATION IS 30 NEEDED BY THE CARRIE R TO PROCESS THE PRI OR AUTHORIZATION REQ UEST; 31 2. FOR WHICH NO CLINICAL REVIEW IS REQUIRED ; AND 32 SENATE BILL 791 3 3. THAT MEET THE CARRIER ’S CRITERIA FOR 1 APPROVAL; AND 2 (IV) LINKS DIRECTLY TO REA L–TIME PATIENT OUT –OF–POCKET 3 COSTS, INCLUDING COPAYMENT , DEDUCTIBLE, AND COINSURANCE COST S, AND 4 MORE AFFORDABLE MEDI CATION ALTERNATIVES MA DE AVAILABLE BY THE 5 CARRIER. 6 (2) A CARRIER MAY NOT : 7 (I) IMPOSE A FEE OR CHARG E ON A PERSON FOR AC CESSING 8 THE ONLINE PROCESS R EQUIRED UNDER PARAGR APH (1) OF THIS SUBSECTION ; OR 9 (II) ACCESS, WITHOUT HEALTH CARE PROVIDER CONSENT , 10 HEALTH CARE PROVIDER DATA VIA THE ONLINE PROCESS OTHER THAN F OR THE 11 INSURED OR ENROLLEE . 12 (C) ON OR BEFORE JULY 1, 2025, A CARRIER SHALL : 13 (1) ON REQUEST OF A HEALT H CARE PROVIDER , PROVIDE CONTACT 14 INFORMATION FOR EACH THIRD–PARTY VENDOR OR OTHE R ENTITY THAT THE 15 CARRIER WILL USE TO MEET THE REQUIREMENT S OF SUBSECTION (B) OF THIS 16 SECTION; AND 17 (2) POST THE CONTACT INFO RMATION REQUIRED TO BE PROVIDED 18 UNDER ITEM (1) OF THIS SUBSECTION O N ITS WEBSITE. 19 (D) (1) ON OR BEFORE JULY 1, 2026, EACH HEALTH CARE PROVIDER 20 SHALL ENSURE THAT EA CH E–PRESCRIBING SYSTEM O R ELECTRONIC HEALTH 21 RECORD SYSTEM OWNED OR CONTRACTED FOR BY THE HEALTH CARE PROV IDER TO 22 MAINTAIN A HEALTH RE CORD OF AN INSURED O R ENROLLEE HAS THE A BILITY TO 23 ACCESS, AT THE POINT OF PRES CRIBING: 24 (I) THE ELECTRONIC PRIOR AUTHORIZATION PROCES S 25 ESTABLISHED BY A CAR RIER UNDER SUBSECTIO N (B) OF THIS SECTION; AND 26 (II) THE REAL –TIME PATIENT OUT –OF–POCKET COST 27 INFORMATION AND AVAI LABLE MEDICATION ALT ERNATIVES REQUIRED U NDER 28 SUBSECTION (B) OF THIS SECTION. 29 4 SENATE BILL 791 (2) THE COMMISSION SHALL ESTA BLISH BY REGULATION A PROCESS 1 THROUGH WHICH A HEAL TH CARE PROVIDER MAY REQUEST AND RECEIVE A WAIVER 2 OF COMPLIANCE FROM T HE REQUIREMENTS OF T HIS SUBSECTION . 3 (E) (1) ON OR BEFORE JULY 1, 2026, EACH CARRIER , OR A PHARMACY 4 BENEFITS MANAGER ON BEHALF OF THE CARRIE R, SHALL: 5 (I) PROVIDE REAL –TIME PATIENT –SPECIFIC BENEFIT 6 INFORMATION TO INSUR EDS AND ENROLLEES AN D CONTRACTED HEALTH CARE 7 PROVIDERS, INCLUDING ANY OUT –OF–POCKET COSTS AND MOR E AFFORDABLE 8 MEDICATION ALTERNATI VES OR PRIOR AUTHORIZATIO N REQUIREMENTS ; AND 9 (II) ENSURE THAT THE INFOR MATION PROVIDED UNDE R ITEM 10 (I) OF THIS PARAGRAPH IS ACCURATE. 11 (2) EACH CARRIER, OR A PHARMACY BENEFI TS MANAGER ON BEHALF 12 OF THE CARRIER , SHALL MAKE AVAILABLE THE INFORMATION REQU IRED TO BE 13 PROVIDED UNDER PARAG RAPH (1) OF THIS SUBSECTION T O THE HEALTH CARE 14 PROVIDER AT THE POIN T OF PRESCRIBING IN AN ACCESSIBLE AND 15 UNDERSTANDABLE FORMA T, SUCH AS THROUGH THE HEALTH CARE PROVIDER ’S 16 E–PRESCRIBING SYSTEM O R ELECTRONIC HEALTH RECORD SYSTEM TH AT THE 17 CARRIER, PHARMACY BENEFITS MA NAGER, OR DESIGNATED SUBCON TRACTOR HAS 18 ADOPTED THAT USES TH E NATIONAL COUNCIL FOR PRESCRIPTION DRUG 19 PROGRAMS SCRIPT STANDARD AND THE NATIONAL COUNCIL FOR PRESCRIPTION 20 DRUG PROGRAMS REAL TIME BENEFIT STANDARD FROM WHICH T HE HEALTH 21 CARE PROVIDER MAKES THE REQUEST . 22 Article – Insurance 23 15–851. 24 (a) (1) This section applies to: 25 (i) insurers and nonprofit health service plans that provide coverage 26 for substance use disorder benefits or prescription drugs under individual, group, or 27 blanket health insurance policies or contracts that are issued or delivered in the State; and 28 (ii) health maintenance organizations that provide coverage for 29 substance use disorder benefits or prescription drugs under individual or group contracts 30 that are issued or delivered in the State. 31 (2) An insurer, a nonprofit health service plan, or a health maintenance 32 organization that provides coverage for substance use disorder benefits under the medical 33 benefit or for prescription drugs through a pharmacy benefits manager is subject to the 34 requirements of this section. 35 SENATE BILL 791 5 (b) An entity subject to this section may not apply a prior authorization 1 requirement for a prescription drug: 2 (1) when used for treatment of an opioid use disorder; and 3 (2) that contains methadone, buprenorphine, or naltrexone. 4 15–854. 5 (a) (1) This section applies to: 6 (i) insurers and nonprofit health service plans that provide coverage 7 for prescription drugs through a pharmacy benefit under individual, group, or blanket 8 health insurance policies or contracts that are issued or delivered in the State; and 9 (ii) health maintenance organizations that provide coverage for 10 prescription drugs through a pharmacy benefit under individual or group contracts that 11 are issued or delivered in the State. 12 (2) An insurer, a nonprofit health service plan, or a health maintenance 13 organization that provides coverage for prescription drugs through a pharmacy benefits 14 manager or that contracts with a private review agent under Subtitle 10B of this article is 15 subject to the requirements of this section. 16 (3) This section does not apply to a managed care organization as defined 17 in § 15–101 of the Health – General Article. 18 (b) (1) (i) If an entity subject to this section requires a prior authorization 19 for a prescription drug, the prior authorization request shall allow a health care provider 20 to indicate whether a prescription drug is to be used to treat a chronic condition. 21 (ii) If a health care provider indicates that the prescription drug is 22 to treat a chronic condition, an entity subject to this section may not request a 23 reauthorization for a repeat prescription for the prescription drug for 1 year or for the 24 standard course of treatment for the chronic condition being treated, whichever is less. 25 (2) For a prior authorization that is filed electronically, the entity shall 26 maintain a database that will prepopulate prior authorization requests with an insured’s 27 available insurance and demographic information. 28 (c) [If an entity subject to this section denies coverage for a prescription drug, the 29 entity shall provide a detailed written explanation for the denial of coverage, including 30 whether the denial was based on a requirement for prior authorization. 31 (d)] (1) On receipt of information documenting a prior authorization from the 32 insured or from the insured’s health care provider, an entity subject to this section shall 33 6 SENATE BILL 791 honor a prior authorization granted to an insured from a previous entity for at least the 1 [initial 30] LESSER OF 90 days [of an insured’s prescription drug benefit coverage under 2 the health benefit plan of the new entity] OR THE LENGTH OF THE COURSE OF 3 TREATMENT . 4 (2) During the time period described in paragraph (1) of this subsection, an 5 entity may perform its own review to grant a prior authorization for the prescription drug. 6 [(e)] (D) (1) An entity subject to this section shall honor a prior authorization 7 issued by the entity for a prescription drug AND MAY NOT REQUIRE A HEALTH CARE 8 PROVIDER TO SUBMIT A REQUEST FOR ANOTHER PRIOR AUTHOR IZATION FOR THE 9 PRESCRIPTION DRUG : 10 (i) if the insured changes health benefit plans that are both covered 11 by the same entity and the prescription drug is a covered benefit under the current health 12 benefit plan; or 13 (ii) except as provided in paragraph (2) of this subsection, when the 14 dosage for the approved prescription drug changes and the change is consistent with federal 15 Food and Drug Administration labeled dosages. 16 (2) [An] EXCEPT AS PROVIDED IN § 15–851 OF THIS SUBTITLE , AN 17 entity may [not be required to honor] REQUIRE a prior authorization for a change in dosage 18 for an opioid under this subsection. 19 [(f)] (E) (1) If an entity under this section implements a new prior 20 authorization requirement for a prescription drug, the entity shall provide notice of the new 21 requirement at least [30] 60 days before the implementation of a new prior authorization 22 requirement: 23 [(1)] (I) in writing to any insured who is prescribed the prescription drug; 24 and 25 [(2)] (II) either in writing or electronically to all contracted health care 26 providers. 27 (2) THE NOTICE REQUIRED U NDER PARAGRAPH (1) OF THIS 28 SUBSECTION SHALL IND ICATE THAT THE INSUR ED MAY REMAIN ON THE 29 PRESCRIPTION DRUG AT THE TIME OF REAUTHOR IZATION IN ACCORDA NCE WITH 30 SUBSECTION (G) OF THIS SECTION. 31 [(g)] (F) (1) Except as provided in paragraph (2) of this subsection, an entity 32 subject to this section may not require more than one prior authorization if two or more 33 tablets of different dosage strengths of the same prescription drug are: 34 SENATE BILL 791 7 (i) prescribed at the same time as part of an insured’s treatment 1 plan; and 2 (ii) manufactured by the same manufacturer. 3 (2) This subsection does not prohibit an entity from requiring more than 4 one prior authorization if the prescription is for two or more tablets of different dosage 5 strengths of an opioid that is not an opioid partial agonist. 6 (G) (1) THIS SUBSECTION DOES NOT APPLY WITH RESPE CT TO A 7 REAUTHORIZATION OF A PRESCRIPTION DRUG RE QUESTED BY A PROVIDE R 8 EMPLOYED BY A GROUP MODE L HEALTH MAINTENANCE ORGANIZATION , AS DEFINED 9 IN § 19–713.6 OF THE HEALTH – GENERAL ARTICLE. 10 (2) AN ENTITY SUBJECT TO THIS SECTION MAY NOT ISSUE AN 11 ADVERSE DECISION ON A REAUTHORIZATION FO R THE SAME PRESCRIPT ION DRUG 12 OR REQUEST ADDIT IONAL DOCUMENTATION FROM THE PRESCRIBER FOR THE 13 REAUTHORIZATION REQU EST IF: 14 (I) THE ENTITY PREVIOUSL Y APPROVED A PRIOR 15 AUTHORIZATION FOR TH E PRESCRIPTION DRUG FOR THE INSURED ; 16 (II) THE INSURED HAS BEEN TREATED WITH THE PRE SCRIPTION 17 DRUG WITHOUT INTERRUPTION SINCE T HE INITIAL APPROVAL OF THE PRIOR 18 AUTHORIZATION ; AND 19 (III) THE PRESCRIBER ATTES TS THAT, BASED ON THE 20 PRESCRIBER’S PROFESSIONAL JUDGM ENT, THE PRESCRIPTION DRU G CONTINUES 21 TO BE NECESSARY TO E FFECTIVELY TREAT THE INSURED’S CONDITION. 22 (3) IF THE PRESCRIPTION D RUG THAT IS BEING RE QUESTED HAS 23 BEEN REMOVED FROM TH E FORMULARY OR HAS B EEN MOVED TO A HIGHE R 24 DEDUCTIBLE, COPAYMENT , OR COINSURANCE TIER , THE ENTITY SHALL PRO VIDE 25 THE INSURED AND INSU RED’S HEALTH CARE PROVID ER THE INFORMATION 26 REQUIRED UNDER § 15–831 OF THIS SUBTITLE . 27 15–854.1. 28 (A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 29 INDICATED. 30 (2) “ACTIVE COURSE OF TREA TMENT” MEANS A COURSE OF 31 TREATMENT FOR WHICH AN INSURED IS ACTIVE LY SEEING A HEALTH C ARE 32 PROVIDER AND FOLLOWING THE COURSE OF TREATMENT . 33 8 SENATE BILL 791 (3) “COURSE OF TREATMENT ” MEANS TREATMENT THAT : 1 (I) IS PRESCRIBED TO TRE AT OR ORDERED FOR TH E 2 TREATMENT OF AN INSU RED WITH A SPECIFIC CONDITION; 3 (II) IS OUTLINED AND AGRE ED TO BY THE INSURED AND THE 4 HEALTH CAR E PROVIDER BEFORE TH E TREATMENT BEGINS ; AND 5 (III) MAY BE PART OF A TRE ATMENT PLAN . 6 (B) (1) THIS SECTION APPLIES TO: 7 (I) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 8 PROVIDE HOSPITAL , MEDICAL, OR SURGICAL BENEFITS TO INDIVIDUALS OR GR OUPS 9 ON AN EXPENSE–INCURRED BASIS UNDER HEALTH INSURANCE POL ICIES OR 10 CONTRACTS THAT ARE I SSUED OR DELIVERED I N THE STATE; AND 11 (II) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 12 HOSPITAL, MEDICAL, OR SURGICAL BENEFITS TO INDIVIDUALS OR GR OUPS UNDER 13 CONTRACTS THA T ARE ISSUED OR DELI VERED IN THE STATE. 14 (2) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 15 MAINTENANCE ORGANIZA TION THAT CONTRACTS WITH A PRIVATE REVIE W AGENT 16 UNDER SUBTITLE 10B OF THIS TITLE IS SUB JECT TO THE REQUIREM ENTS OF THIS 17 SECTION. 18 (3) AN INSURER, A NONPROFIT HEALTH S ERVICE PLAN, OR A HEALTH 19 MAINTENANCE ORGANIZA TION THAT CONTRACTS WITH A THIRD PARTY T O 20 DISPENSE MEDICAL DEV ICES, MEDICAL APPLIANCES , OR MEDICAL GOODS FOR THE 21 TREATMENT OF A HUMAN DISEASE OR DYSFUNCTI ON IS SUBJECT TO THE 22 REQUIREMENTS OF THIS SECTION. 23 (C) (1) NOTWITHSTANDING § 15–854 OF THIS SUBTITLE AS IT APPLIES TO 24 COVERAGE FOR PRESCRI PTION DRUGS , AN ENTITY SUBJECT TO THIS SECTION 25 SHALL APPROVE A REQU EST FOR THE PRIOR AU THORIZATION OF A COU RSE OF 26 TREATMENT , INCLUDING FO R CHRONIC CONDITIONS , REHABILITATIVE SERVI CES, 27 SUBSTANCE USE DISORD ERS, AND MENTAL HEALTH CO NDITIONS, THAT IS: 28 (I) FOR A PERIOD OF TIME THAT IS AS LONG AS N ECESSARY TO 29 AVOID DISRUPTIONS IN CARE; AND 30 SENATE BILL 791 9 (II) DETERMINED IN ACCORD ANCE WITH APPLICABLE 1 COVERAGE CRITERIA , THE INSURED’S MEDICAL HISTORY , AND THE HEALTH CARE 2 PROVIDER’S RECOMMENDATION . 3 (2) FOR NEW ENROLLEES , AN ENTITY SUBJECT TO THIS SECTION MAY 4 NOT DISRUPT OR REQUI RE REAUTHORIZATION F OR AN ACTIVE COURSE OF 5 TREATMENT FOR AT LEA ST 90 DAYS AFTER THE DATE OF ENROLL MENT. 6 15–10A–01. 7 (a) In this subtitle the following words have the meanings indicated. 8 (b) (1) “Adverse decision” means: 9 (i) a utilization review determination by a private review agent, a 10 carrier, or a health care provider acting on behalf of a carrier that: 11 1. a proposed or delivered health care service covered under 12 the member’s contract is or was not medically necessary, appropriate, or efficient; and 13 2. may result in noncoverage of the health care service; or 14 (ii) a denial by a carrier of a request by a member for an alternative 15 standard or a waiver of a standard to satisfy the requirements of a wellness program under 16 § 15–509 of this title. 17 (2) “ADVERSE DECISION ” INCLUDES A UTILIZATI ON REVIEW 18 DETERMINATION BASED ON A PRIOR AUT HORIZATION OR STEP T HERAPY 19 REQUIREMENT . 20 [(2)] (3) “Adverse decision” does not include a decision concerning a 21 subscriber’s status as a member. 22 (c) “Carrier” means a person that offers a health benefit plan and is: 23 (1) an authorized insurer that provides health insurance in the State; 24 (2) a nonprofit health service plan; 25 (3) a health maintenance organization; 26 (4) a dental plan organization; 27 (5) a self–funded student health plan operated by an independent 28 institution of higher education, as defined in § 10–101 of the Education Article, that 29 provides health care to its students and their dependents; or 30 10 SENATE BILL 791 (6) except for a managed care organization as defined in Title 15, Subtitle 1 1 of the Health – General Article, any other person that provides health benefit plans 2 subject to regulation by the State. 3 (d) “Complaint” means a protest filed with the Commissioner involving an 4 adverse decision or grievance decision concerning the member. 5 (e) “Designee of the Commissioner” means any person to whom the Commissioner 6 has delegated the authority to review and decide complaints filed under this subtitle, 7 including an administrative law judge to whom the authority to conduct a hearing has been 8 delegated for recommended or final decision. 9 (f) “Grievance” means a protest filed by a member, a member’s representative, or 10 a health care provider on behalf of a member with a carrier through the carrier’s internal 11 grievance process regarding an adverse decision concerning the member. 12 (g) “Grievance decision” means a final determination by a carrier that arises from 13 a grievance filed with the carrier under its internal grievance process regarding an adverse 14 decision concerning a member. 15 (h) “Health Advocacy Unit” means the Health Education and Advocacy Unit in 16 the Division of Consumer Protection of the Office of the Attorney General established under 17 Title 13, Subtitle 4A of the Commercial Law Article. 18 (i) “Health benefit plan” has the meaning stated in § 2–112.2(a) of this article. 19 (j) “Health care provider” means: 20 (1) an individual who is licensed under the Health Occupations Article to 21 provide health care services in the ordinary course of business or practice of a profession 22 and is a treating provider of the member; or 23 (2) a hospital, as defined in § 19–301 of the Health – General Article. 24 (k) “Health care service” means a health or medical care procedure or service 25 rendered by a health care provider that: 26 (1) provides testing, diagnosis, or treatment of a human disease or 27 dysfunction; [or] 28 (2) dispenses drugs, medical devices, medical appliances, or medical goods 29 for the treatment of a human disease or dysfunction; OR 30 SENATE BILL 791 11 (3) PROVIDES ANY OTHER C ARE, SERVICE, OR TREATMENT OF 1 DISEASE OR INJURY , THE CORRECTION OF DEFECTS, OR THE MAINTENANCE O F 2 PHYSICAL OR MENTAL W ELL–BEING OF INDIVIDUALS . 3 (l) (1) “Member” means a person entitled to health care benefits under a 4 policy, plan, or certificate issued or delivered in the State by a carrier. 5 (2) “Member” includes: 6 (i) a subscriber; and 7 (ii) unless preempted by federal law, a Medicare recipient. 8 (3) “Member” does not include a Medicaid recipient. 9 (m) “Member’s representative” means an individual who has been authorized by 10 the member to file a grievance or a complaint on the member’s behalf. 11 (n) “Private review agent” has the meaning stated in § 15–10B–01 of this title. 12 15–10A–02. 13 (a) Each carrier shall establish an internal grievance process for its members. 14 (b) (1) An internal grievance process shall meet the same requirements 15 established under Subtitle 10B of this title. 16 (2) In addition to the requirements of Subtitle 10B of this title, an internal 17 grievance process established by a carrier under this section shall: 18 (i) include an expedited procedure for use in an emergency case for 19 purposes of rendering a grievance decision within 24 hours of the date a grievance is filed 20 with the carrier; 21 (ii) provide that a carrier render a final decision in writing on a 22 grievance within 30 working days after the date on which the grievance is filed unless: 23 1. the grievance involves an emergency case under item (i) of 24 this paragraph; 25 2. the member, the member’s representative, or a health care 26 provider filing a grievance on behalf of a member agrees in writing to an extension for a 27 period of no longer than 30 working days; or 28 3. the grievance involves a retrospective denial under item 29 (iv) of this paragraph; 30 12 SENATE BILL 791 (iii) allow a grievance to be filed on behalf of a member by a health 1 care provider or the member’s representative; 2 (iv) provide that a carrier render a final decision in writing on a 3 grievance within 45 working days after the date on which the grievance is filed when the 4 grievance involves a retrospective denial; and 5 (v) for a retrospective denial, allow a member, the member’s 6 representative, or a health care provider on behalf of a member to file a grievance for at 7 least 180 days after the member receives an adverse decision. 8 (3) For purposes of using the expedited procedure for an emergency case 9 that a carrier is required to include under paragraph (2)(i) of this subsection, the 10 [Commissioner shall define by regulation the standards required for a grievance to be 11 considered an emergency case] CARRIER SHALL INITIA TE THE EXPEDITED PRO CEDURE 12 FOR AN EMERGENCY CAS E IF THE HEALTH CARE PROVIDER ATTESTS THA T: 13 (I) THE ADVERSE DECISION WAS RENDERED FOR HEA LTH CARE 14 SERVICES THAT ARE PR OPOSED BUT HAVE NOT BEEN PROVIDED ; AND 15 (II) THE SERVICES ARE NECESSA RY TO TREAT A CONDIT ION OR 16 ILLNESS THAT, WITHOUT IMMEDIATE ME DICAL ATTENTION , WOULD: 17 1. SERIOUSLY JEOPARDIZE THE LIFE OR HEALTH O F THE 18 MEMBER OR THE MEMBER ’S ABILITY TO REGAIN MAXIMUM FUNCTIONS ; 19 2. CAUSE THE MEMBER TO BE IN DANGER TO SELF OR 20 OTHERS; OR 21 3. CAUSE THE MEMBER TO CONTINUE USING 22 INTOXICATING SUBSTAN CES IN AN IMMINENTLY DANGEROUS MANNER . 23 (c) Except as provided in subsection (d) of this section, the carrier’s internal 24 grievance process shall be exhausted prior to filing a complaint with the Commissioner 25 under this subtitle. 26 (d) (1) (i) A member, the member’s representative, or a health care 27 provider filing a complaint on behalf of a member may file a complaint with the 28 Commissioner without first filing a grievance with a carrier and receiving a final decision 29 on the grievance if: 30 1. the carrier waives the requirement that the carrier’s 31 internal grievance process be exhausted before filing a complaint with the Commissioner; 32 SENATE BILL 791 13 2. the carrier has failed to comply with any of the 1 requirements of the internal grievance process as described in this section; or 2 3. the member, the member’s representative, or the health 3 care provider provides sufficient information and supporting documentation in the 4 complaint that demonstrates a compelling reason to do so. 5 (ii) The Commissioner shall define by regulation the standards that 6 the Commissioner shall use to decide what demonstrates a compelling reason under 7 subparagraph (i) of this paragraph. 8 (2) Subject to subsections (b)(2)(ii) and (h) of this section, a member, a 9 member’s representative, or a health care provider may file a complaint with the 10 Commissioner if the member, the member’s representative, or the health care provider does 11 not receive a grievance decision from the carrier on or before the 30th working day on which 12 the grievance is filed. 13 (3) Whenever the Commissioner receives a complaint under paragraph (1) 14 or (2) of this subsection, the Commissioner shall notify the carrier that is the subject of the 15 complaint within 5 working days after the date the complaint is filed with the 16 Commissioner. 17 (e) Each carrier shall: 18 (1) file for review with the Commissioner and submit to the Health 19 Advocacy Unit a copy of its internal grievance process established under this subtitle; and 20 (2) file any revision to the internal grievance process with the 21 Commissioner and the Health Advocacy Unit at least 30 days before its intended use. 22 (f) (1) For nonemergency cases, when a carrier renders an adverse decision, 23 the carrier shall: 24 [(1)] (I) inform the member, the member’s representative, or the health 25 care provider acting on behalf of the member of the adverse decision: 26 [(i)] 1. orally by telephone; or 27 [(ii)] 2. with the affirmative consent of the member, the member’s 28 representative, or the health care provider acting on behalf of the member, by text, 29 facsimile, e–mail, an online portal, or other expedited means; and 30 [(2)] (II) send, within 5 working days after the adverse decision has been 31 made, a written notice to the member, the member’s representative, and a health care 32 provider acting on behalf of the member that: 33 14 SENATE BILL 791 [(i)] 1. states in detail in clear, understandable language the 1 specific factual bases for the carrier’s decision AND THE REASONING USED TO 2 DETERMINE THAT THE H EALTH CARE SERVICE I S NOT MEDICALLY NECE SSARY AND 3 DID NOT MEET THE CAR RIER’S CRITERIA AND STAND ARDS USED IN CONDUCT ING 4 THE UTILIZATION REVI EW; 5 [(ii)] 2. [references] PROVIDES the specific REFERENCE , 6 LANGUAGE, OR REQUIREMENTS FROM TH E criteria and standards, including ANY 7 interpretive guidelines, on which the decision was based, and may not solely use: 8 A. generalized terms such as “experimental procedure not 9 covered”, “cosmetic procedure not covered”, “service included under another procedure”, or 10 “not medically necessary”; OR 11 B. LANGUAGE DIRECTING T HE MEMBER TO REVIEW THE 12 ADDITIONAL COVERAGE CRITERIA IN THE MEMB ER’S POLICY OR PLAN DOC UMENTS; 13 [(iii)] 3. states the name, business address, and business telephone 14 number of: 15 [1.] A. IF THE CARRIER IS A HEALTH MAINTENANCE 16 ORGANIZATION , the medical director or associate medical director, as appropriate, who 17 made the decision [if the carrier is a health maintenance organization]; or 18 [2.] B. IF THE CARRIER IS NO T A HEALTH 19 MAINTENANCE ORGANIZA TION, the designated employee or representative of the carrier 20 who has responsibility for the carrier’s internal grievance process [if the carrier is not a 21 health maintenance organization] AND THE PHYSICIA N WHO IS REQUIRED TO MAKE 22 ALL ADVERSE DECISION S AS REQUIRED IN § 15–10B–07(A) OF THIS TITLE; 23 [(iv)] 4. gives written details of the carrier’s internal grievance 24 process and procedures under this subtitle; and 25 [(v)] 5. includes the following information: 26 [1.] A. that the member, the member’s representative, or a 27 health care provider on behalf of the member has a right to file a complaint with the 28 Commissioner within 4 months after receipt of a carrier’s grievance decision; 29 [2.] B. that a complaint may be filed without first filing a 30 grievance if the member, the member’s representative, or a health care provider filing a 31 grievance on behalf of the member can demonstrate a compelling reason to do so as 32 determined by the Commissioner; 33 SENATE BILL 791 15 [3.] C. the Commissioner’s address, telephone number, 1 and facsimile number; 2 [4.] D. a statement that the Health Advocacy Unit is 3 available to assist the member or the member’s representative in both mediating and filing 4 a grievance under the carrier’s internal grievance process; and 5 [5.] E. the address, telephone number, facsimile number, 6 and electronic mail address of the Health Advocacy Unit. 7 (2) THE BUSINESS TELEPHON E NUMBER INCLUDED IN THE NOTICE AS 8 REQUIRED UNDER PARAG RAPH (1)(II)3 OF THIS SUBSECTION MUST BE A DE DICATED 9 NUMBER FOR ADVERSE D ECISIONS AND MAY NOT BE THE GENERAL CUSTO MER CALL 10 NUMBER FOR THE CARRI ER. 11 (g) If within 5 working days after a member, the member’s representative, or a 12 health care provider, who has filed a grievance on behalf of a member, files a grievance 13 with the carrier, and if the carrier does not have sufficient information to complete its 14 internal grievance process, the carrier shall: 15 (1) AFTER CONFIRMING THR OUGH A COMPLETE REVI EW OF ANY 16 INFORMATION ALREADY SUBMITTED BY THE HEALTH CA RE PROVIDER: 17 (I) notify the member, the member’s representative, or the health 18 care provider that it cannot proceed with reviewing the grievance unless additional 19 information is provided; 20 (II) REQUEST THE SPECIFIC INFORMATION , INCLUDING ANY 21 LAB OR DIAGNOSTIC TE ST OR OTHER MEDICAL INFORMATION THAT MUS T BE 22 SUBMITTED TO COMPLET E THE INTERNAL GRIEV ANCE PROCESS ; AND 23 (III) PROVIDE THE SPECIFIC REFERENCE , LANGUAGE, OR 24 REQUIREMENTS FROM TH E CRITERIA AND STAND ARDS USED BY THE CAR RIER TO 25 SUPPORT THE NEED FOR THE ADDITIONAL INFOR MATION; and 26 (2) assist the member, the member’s representative, or the health care 27 provider in gathering the necessary information without further delay. 28 (h) A carrier may extend the 30–day or 45–day period required for making a final 29 grievance decision under subsection (b)(2)(ii) of this section with the written consent of the 30 member, the member’s representative, or the health care provider who filed the grievance 31 on behalf of the member. 32 (i) (1) For nonemergency cases, when a carrier renders a grievance decision, 33 the carrier shall: 34 16 SENATE BILL 791 (i) document the grievance decision in writing after the carrier has 1 provided oral communication of the decision to the member, the member’s representative, 2 or the health care provider acting on behalf of the member; and 3 (ii) send, within 5 working days after the grievance decision has been 4 made, a written notice to the member, the member’s representative, and a health care 5 provider acting on behalf of the member that: 6 1. states in detail in clear, understandable language the 7 specific factual bases for the carrier’s decision AND THE REASONING US ED TO 8 DETERMINE THAT THE H EALTH CARE SERVICE I S NOT MEDICALLY NECE SSARY AND 9 DID NOT MEET THE CAR RIER’S CRITERIA AND STAND ARDS USED IN CONDUCTING 10 UTILIZATION REVIEW ; 11 2. [references] PROVIDES the specific REFERENCE , 12 LANGUAGE, OR REQUIREMENTS FROM THE criteria and standards, including ANY 13 interpretive guidelines USED BY THE CARRIER , on which the grievance decision was 14 based; 15 3. states the name, business address, and business telephone 16 number of: 17 A. IF THE CARRIER IS A HEALTH MAINTENANCE 18 ORGANIZATION , the medical director or associate medical director, as appropriate, who 19 made the grievance decision; or 20 B. IF THE CARRIER IS NOT A HEA LTH MAINTENANCE 21 ORGANIZATION , the designated employee or representative of the carrier who has 22 responsibility for the carrier’s internal grievance process [if the carrier is not a health 23 maintenance organization] AND THE DESIGNATED E MPLOYEE OR REPRESENTATI VE’S 24 TITLE AND CLINICAL S PECIALTY; and 25 4. includes the following information: 26 A. that the member or the member’s representative has a 27 right to file a complaint with the Commissioner within 4 months after receipt of a carrier’s 28 grievance decision; 29 B. the Commissioner’s address, telephone number, and 30 facsimile number; 31 C. a statement that the Health Advocacy Unit is available to 32 assist the member or the member’s representative in filing a complaint with the 33 Commissioner; and 34 SENATE BILL 791 17 D. the address, telephone number, facsimile number, and 1 electronic mail address of the Health Advocacy Unit. 2 (2) THE BUSINESS TELEPHON E NUMBER INCLUDED IN THE NOTICE AS 3 REQUIRED UNDER PARAG RAPH (1)(II)3 OF THIS SUBSECTION M UST BE A DEDICATED 4 NUMBER FOR GRIEVANCE DECISIONS AND MAY NO T BE THE GENERAL CUS TOMER 5 CALL NUMBER FOR THE CARRIER. 6 [(2)] (3) [A] TO SATISFY THE REQUIR EMENTS OF THIS SUBSE CTION, 7 A carrier may not use solely in [a] THE WRITTEN notice sent under paragraph (1) of this 8 subsection: 9 (I) generalized terms such as “experimental procedure not covered”, 10 “cosmetic procedure not covered”, “service included under another procedure”, or “not 11 medically necessary” [to satisfy the requirements of this subsection]; OR 12 (II) LANGUAGE DI RECTING THE MEMBER T O REVIEW THE 13 ADDITIONAL COVERAGE CRITERIA IN THE MEMB ER’S POLICY OR PLAN DOC UMENTS. 14 (j) (1) For an emergency case under subsection (b)(2)(i) of this section, within 15 1 day after a decision has been orally communicated to the member, the member’s 16 representative, or the health care provider, the carrier shall send notice in writing of any 17 adverse decision or grievance decision to: 18 (i) the member and the member’s representative, if any; and 19 (ii) if the grievance was filed on behalf of the member under 20 subsection (b)(2)(iii) of this section, the health care provider. 21 (2) A notice required to be sent under paragraph (1) of this subsection shall 22 include the following: 23 (i) for an adverse decision, the information required under 24 subsection (f) of this section; and 25 (ii) for a grievance decision, the information required under 26 subsection (i) of this section. 27 (k) (1) Each carrier shall include the information required by subsection 28 [(f)(2)(iii), (iv), and (v)] (F)(1)(II)3, 4, AND 5 of this section in the policy, plan, certificate, 29 enrollment materials, or other evidence of coverage that the carrier provides to a member 30 at the time of the member’s initial coverage or renewal of coverage. 31 (2) Each carrier shall include as part of the information required by 32 paragraph (1) of this subsection a statement indicating that, when filing a complaint with 33 the Commissioner, the member or the member’s representative will be required to 34 18 SENATE BILL 791 authorize the release of any medical records of the member that may be required to be 1 reviewed for the purpose of reaching a decision on the complaint. 2 (l) (1) Nothing in this subtitle prohibits a carrier from delegating its internal 3 grievance process to a private review agent that has a certificate issued under Subtitle 10B 4 of this title and is acting on behalf of the carrier. 5 (2) If a carrier delegates its internal grievance process to a private review 6 agent, the carrier shall be: 7 (i) bound by the grievance decision made by the private review 8 agent acting on behalf of the carrier; and 9 (ii) responsible for a violation of any provision of this subtitle 10 regardless of the delegation made by the carrier under paragraph (1) of this subsection. 11 15–10A–04. 12 (c) (1) It is a violation of this subtitle for a carrier to fail to fulfill the carrier’s 13 obligations to provide or reimburse for health care services specified in the carrier’s policies 14 or contracts with members. 15 (2) If, in rendering an adverse decision or grievance decision, a carrier fails 16 to fulfill the carrier’s obligations to provide or reimburse for health care services specified 17 in the carrier’s policies or contracts with members, the Commissioner may: 18 (i) issue an administrative order that requires the carrier to: 19 1. cease inappropriate conduct or practices by the carrier or 20 any of the personnel employed or associated with the carrier; 21 2. fulfill the carrier’s contractual obligations; 22 3. provide a health care service or payment that has been 23 denied improperly; or 24 4. take appropriate steps to restore the carrier’s ability to 25 provide a health care service or payment that is provided under a contract; or 26 (ii) impose any penalty or fine or take any action as authorized: 27 1. for an insurer, nonprofit health service plan, or dental 28 plan organization, under this article; or 29 2. for a health maintenance organization, under the Health 30 – General Article or under this article. 31 SENATE BILL 791 19 (3) In addition to paragraph (1) of this subsection, it is a violation of this 1 subtitle, if the Commissioner, in consultation with an independent review organization, 2 medical expert, the Department, or other appropriate entity, determines that the criteria 3 and standards used by a health maintenance organization to conduct utilization review are 4 not[: 5 (i) objective; 6 (ii) clinically valid; 7 (iii) compatible with established principles of health care; or 8 (iv) flexible enough to allow deviations from norms when justified on 9 a case by case basis] IN ACCORDANCE WITH § 15–10B–06 OF THIS TITLE. 10 15–10A–06. 11 (a) On [a quarterly] AN ANNUAL basis, each carrier shall submit to the 12 Commissioner, on the form the Commissioner requires, a report that describes: 13 (1) the activities of the carrier under this subtitle, including: 14 (i) the outcome of each grievance filed with the carrier; 15 (ii) the number and outcomes of cases that were considered 16 emergency cases under § 15–10A–02(b)(2)(i) of this subtitle; 17 (iii) the time within which the carrier made a grievance decision on 18 each emergency case; 19 (iv) the time within which the carrier made a grievance decision on 20 all other cases that were not considered emergency cases; 21 (v) the number of grievances filed with the carrier that resulted from 22 an adverse decision involving length of stay for inpatient hospitalization as related to the 23 medical procedure involved; [and] 24 (vi) the number of adverse decisions issued by the carrier under § 25 15–10A–02(f) of this subtitle, THE TYPE OF UTILIZAT ION REVIEW PROCESS U SED, IF 26 APPLICABLE, and the type of service at issue in the adverse decisions; [and] 27 (VII) THE TIME WITHIN WHIC H THE CARRIER MADE T HE ADVERSE 28 DECISIONS UNDER EACH TYPE OF SERVICE AT ISSUE IN THE ADVERSE DECISION S; 29 (VIII) THE NUMBER OF ADVERS E DECISIONS OVERTURN ED AFTER 30 A RECONSIDERATION RE QUEST UNDER § 15–10B–06 OF THIS TITLE; AND 31 20 SENATE BILL 791 (IX) THE NUMBER OF REQUES TS MADE AND GRANTED UNDER § 1 15–831(C)(1) AND (2) OF THIS TITLE; AND 2 (2) the number and outcome of all other cases that are not subject to 3 activities of the carrier under this subtitle that resulted from an adverse decision involving 4 the length of stay for inpatient hospitalization as related to the medical procedure involved. 5 (b) The Commissioner shall: 6 (1) compile an annual summary report based on the information provided: 7 (i) under subsection (a) of this section; and 8 (ii) by the Secretary under § 19–705.2(e) of the Health – General 9 Article; [and] 10 (2) REPORT ANY VIOLATION S OR ACTIONS TAKEN U NDER § 11 15–10B–11 OF THIS TITLE; AND 12 [(2)] (3) provide copies of the summary report to the Governor and, 13 subject to § 2–1257 of the State Government Article, to the General Assembly. 14 15–10A–08. 15 (a) On or before November 1, 1999, and each November 1 thereafter, the Health 16 Advocacy Unit shall publish an annual summary report and provide copies of the report to 17 the Governor and, subject to § 2–1257 of the State Government Article, the General 18 Assembly. 19 (b) (1) The annual summary report required under subsection (a) of this 20 section shall be on the grievances and complaints filed with or referred to a carrier, the 21 Commissioner, the Health Advocacy Unit, or any other federal or State government agency 22 or unit under this subtitle during the previous fiscal year. 23 (2) In consultation with the Commissioner and any affected State 24 government agency or unit, the Health Advocacy Unit shall: 25 (i) evaluate the effectiveness of the internal grievance process and 26 complaint process available to members; and 27 (ii) include in the annual summary report the results of the 28 evaluation and any proposed changes TO THE LAW that it considers necessary TO ENSURE 29 COMPLIANCE WITH THE PURPOSES OF THE LAW . 30 15–10B–01. 31 SENATE BILL 791 21 (a) In this subtitle the following words have the meanings indicated. 1 (b) (1) “Adverse decision” means a utilization review determination made by a 2 private review agent that a proposed or delivered health care service: 3 (i) is or was not medically necessary, appropriate, or efficient; and 4 (ii) may result in noncoverage of the health care service. 5 (2) “ADVERSE DECISION ” INCLUDES A UTILIZATI ON REVIEW 6 DETERMINATION BASED ON A PRIOR AUTHORIZA TION OR STEP THERAPY 7 REQUIREMENT . 8 [(2)] (3) “Adverse decision” does not include a decision concerning a 9 subscriber’s status as a member. 10 15–10B–02. 11 The purpose of this subtitle is to: 12 (1) promote the delivery of quality health care in a cost effective manner 13 THAT ENSURES TIMELY ACCESS TO HEALTH CAR E SERVICES; 14 (2) foster greater coordination, COMMUNICATION , AND TRANSPARENCY 15 between payors, PATIENTS, and providers conducting utilization review activities; 16 (3) protect patients, business, and providers by ensuring that private 17 review agents are qualified to perform utilization review activities and to make informed 18 decisions on the appropriateness of medical care; and 19 (4) ensure that private review agents maintain the confidentiality of 20 medical records in accordance with applicable State and federal laws. 21 15–10B–05. 22 (a) In conjunction with the application, the private review agent shall submit 23 information that the Commissioner requires including: 24 (1) a utilization review plan that includes: 25 (i) the specific criteria and standards to be used in conducting 26 utilization review of proposed or delivered health care services; 27 (ii) those circumstances, if any, under which utilization review may 28 be delegated to a hospital utilization review program; and 29 22 SENATE BILL 791 (iii) if applicable, any provisions by which patients, physicians, or 1 hospitals may seek reconsideration; 2 (2) the type and qualifications of the personnel either employed or under 3 contract to perform the utilization review; 4 (3) a copy of the private review agent’s internal grievance process if a 5 carrier delegates its internal grievance process to the private review agent in accordance 6 with § 15–10A–02(l) of this title; 7 (4) the procedures and policies to ensure that a representative of the 8 private review agent is reasonably accessible to patients and health care providers 7 days 9 a week, 24 hours a day in this State; 10 (5) if applicable, the procedures and policies to ensure that a representative 11 of the private review agent is accessible to health care providers to make all determinations 12 on whether to authorize or certify an emergency inpatient admission, or an admission for 13 residential crisis services as defined in § 15–840 of this title, for the treatment of a mental, 14 emotional, or substance abuse disorder within 2 hours after receipt of the information 15 necessary to make the determination; 16 (6) the policies and procedures to ensure that all applicable State and 17 federal laws to protect the confidentiality of individual medical records are followed; 18 (7) a copy of the materials designed to inform applicable patients and 19 providers of the requirements of the utilization review plan; 20 (8) a list of the third party payors for which the private review agent is 21 performing utilization review in this State; 22 (9) the policies and procedures to ensure that the private review agent has 23 a formal program for the orientation and training of the personnel either employed or under 24 contract to perform the utilization review; 25 (10) a list of the persons involved in establishing the specific criteria and 26 standards to be used in conducting utilization review, INCLUDING EACH PERSO N’S 27 BOARD CERTIFICATION OR PRACTICE SPECIALT Y, LICENSURE CATEGORY , AND 28 TITLE WITHIN THE PER SON’S ORGANIZATION; and 29 (11) certification by the private review agent that the criteria and standards 30 to be used in conducting utilization review are GENERALLY RECOGNIZED BY HEALTH 31 CARE PROVIDERS PRACT ICING IN THE RELEVAN T CLINICAL SPECIALTI ES AND ARE: 32 (i) objective; 33 (ii) clinically valid; 34 SENATE BILL 791 23 [(iii) compatible with established principles of health care; and 1 (iv) flexible enough to allow deviations from norms when justified on 2 a case by case basis;] 3 (III) REFLECTED IN PEER –REVIEWED SCIENTIFIC STUDIES AND 4 MEDICAL LITERATURE ; 5 (IV) DEVELOPED BY : 6 1. A NONPROFIT HEALTH C ARE PROVIDER 7 PROFESSIONAL MEDICAL OR CLINICAL SPECIALT Y SOCIETY, INCLUDING THROUGH 8 THE USE OF PATIENT P LACEMENT CRITERIA AN D CLINICAL PRACTICE GUIDELINES; 9 OR 10 2. FOR CRITERIA NOT WITHIN THE SCOPE OF A 11 NONPROFIT HEALTH CAR E PROVIDER PROFESSIO NAL MEDICAL OR CLINI CAL 12 SPECIALTY SOCIETY , AN ORGANIZATION THAT WORKS DIRECTLY WITH HEALTH 13 CARE PROVIDERS IN TH E SAME SPECIALTY FOR THE DESIGNATED CRITE RIA WHO 14 ARE EMPLOYED OR ENGA GED WITHIN THE ORGANIZATION OR OUTSIDE THE 15 ORGANIZATION TO DEVE LOP THE CLINICAL CRI TERIA, IF THE ORGANIZATION : 16 A. DOES NOT RECEIVE DIR ECT PAYMENTS BASED O N THE 17 OUTCOME OF THE UTILI ZATION REVIEW ; AND 18 B. DEMONSTRATES THAT IT S CLINICAL CRITERIA ARE 19 CONSISTENT WITH CRITERIA AND ST ANDARDS GENERALLY RE COGNIZED BY HEALTH 20 CARE PROVIDERS PRACT ICING IN THE RELEVAN T CLINICAL SPECIALTI ES; 21 (V) RECOMMENDED BY FEDER AL AGENCIES; 22 (VI) APPROVED BY THE FEDE RAL FOOD AND DRUG 23 ADMINISTRATION AS PAR T OF DRUG LABELING ; 24 (VII) TAKING INTO ACCOUNT THE NEEDS OF ATYPICA L PATIENT 25 POPULATIONS AND DIAG NOSES, INCLUDING THE UNIQUE NEEDS OF CHILDREN AN D 26 ADOLESCENTS ; 27 (VIII) SUFFICIENTLY FLEXIBL E TO ALLOW DEVIATION S FROM 28 NORMS WHEN JUSTIFIED ON A CASE–BY–CASE BASIS, INCLUDING TH E NEED TO USE 29 AN OFF–LABEL PRESCRIPTION D RUG; 30 (IX) ENSURING QUALITY OF CARE OF HEALTH CARE SERVICES; 31 24 SENATE BILL 791 (X) REVIEWED, EVALUATED, AND UPDATED AT LEAST 1 ANNUALLY AND AS NECE SSARY TO REFLECT ANY CHANGES; AND 2 (XI) IN COMPLIANCE WITH A NY OTHER CRITERIA AND 3 STANDARDS REQUIRED F OR COVERAGE UNDER TH IS TITLE, INCLUDING 4 COMPLIANCE WITH § 15–802(D) OF THIS TITLE FOR TH E TREATMENT OF SUBST ANCE 5 USE DISORDERS . 6 (b) [On the written request of any person or health care facility, the] THE private 7 review agent shall [provide 1 copy of]: 8 (1) POST ON ITS WEBSITE OR THE CARRIER ’S WEBSITE the specific 9 criteria and standards to be used in conducting utilization review of proposed or delivered 10 services and any subsequent revisions, modifications, or additions to the specific criteria 11 and standards to be used in conducting utilization review of proposed or delivered services 12 [to the person or health care facility making the request]; AND 13 (2) ON THE REQUEST OF A PERSON, INCLUDING A HEALTH C ARE 14 FACILITY, PROVIDE A COPY OF THE INFORMATION S PECIFIED UNDER ITEM (1) OF 15 THIS SUBSECTION TO T HE PERSON MAKING THE REQUEST. 16 (c) The private review agent may charge a reasonable fee for a HARD copy of the 17 specific criteria and standards or any subsequent revisions, modifications, or additions to 18 the specific criteria to any person or health care facility requesting a copy under subsection 19 [(b)] (B)(2) of this section. 20 (d) A private review agent shall advise the Commissioner, in writing, of a change 21 in: 22 (1) ownership, medical director, or chief executive officer within 30 days of 23 the date of the change; 24 (2) the name, address, or telephone number of the private review agent 25 within 30 days of the date of the change; or 26 (3) the private review agent’s scope of responsibility under a contract. 27 15–10B–06. 28 (a) (1) Except as OTHERWISE provided in [paragraph (4) of] this subsection, 29 a private review agent shall: 30 (i) make all initial determinations on whether to authorize or certify 31 a nonemergency course of treatment OR HEALTH CARE SERVICE , INCLUDING 32 SENATE BILL 791 25 PHARMACEUTICAL SERVI CES NOT SUBMITTED EL ECTRONICALLY , for a patient within 1 2 working days after receipt of the information necessary to make the determination; 2 (ii) make all determinations on whether to authorize or certify an 3 extended stay in a health care facility or additional health care services within 1 working 4 day after receipt of the information necessary to make the determination; [and] 5 (III) MAKE ALL DETERMINATI ONS TO AUTHORIZE OR CERTIFY A 6 REQUEST FOR ADDITION AL VISITS OR DAYS OF CARE SUBMITTED AS PART OF AN 7 EXISTING COURSE OF T REATMENT OR TREATMEN T PLAN WITHIN 1 WORKING DAY 8 AFTER RECEIPT OF THE INFORMATION NECESSAR Y TO MAKE THE DETERM INATION; 9 AND 10 [(iii)] (IV) promptly notify the health care provider of the 11 determination. 12 (2) [If within 3 calendar days after] AFTER receipt of the initial request 13 for health care services AND CONFIRMING THROU GH A COMPLETE REVIEW OF 14 INFORMATION ALREADY SUBMITTED BY THE HEA LTH CARE PROVIDER , IF the private 15 review agent DETERMINES THAT THE PRIVATE REV IEW AGENT does not have sufficient 16 information to make a determination, the private review agent shall PROMPTLY, BUT NOT 17 LATER THAN 3 CALENDAR DAYS AFTER RECEIPT OF THE INITI AL REQUEST, inform 18 the health care provider that additional information must be provided BY SPECIFYING: 19 (I) THE INFORMATION , INCLUDING ANY LAB OR DIAGNOSTIC 20 TEST OR OTHER MEDICA L INFORMATION , THAT MUST BE SUBMITT ED TO COMPLETE 21 THE REQUEST ; AND 22 (II) THE CRITERIA AND STA NDARDS TO SUPPORT TH E NEED FOR 23 ADDITIONAL INFORMATION . 24 [(3)] (B) If a private review agent requires prior authorization for an 25 emergency inpatient admission, or an admission for residential crisis services as defined in 26 § 15–840 of this title, for the treatment of a mental, emotional, or substance abuse disorder, 27 the private review agent shall: 28 [(i)] (1) make all determinations on whether to authorize or certify 29 an inpatient admission, or an admission for residential crisis services as defined in § 30 15–840 of this title, within 2 hours after receipt of the information necessary to make the 31 determination; [and] 32 (2) IF ADDITIONAL INFORM ATION IS NEEDED , PROMPTLY REQUEST 33 THE SPECIFIC INFORMA TION NEEDED, INCLUDING ANY LAB OR DIAGNOSTIC TEST OR 34 OTHER MEDICAL INFORM ATION; AND 35 26 SENATE BILL 791 [(ii)] (3) promptly notify the health care provider of the 1 determination. 2 [(4)] (C) (1) For a step therapy exception request submitted 3 electronically in accordance with a process established under § 15–142(f) of this title or a 4 prior authorization request submitted electronically for pharmaceutical services, a private 5 review agent shall make a determination: 6 (i) in real time if: 7 1. no additional information is needed by the private review 8 agent to process the request; and 9 2. the request meets the private review agent’s criteria for 10 approval; or 11 (ii) if a request is not approved IN REAL TIME under item (i) of this 12 paragraph, within 1 [business] WORKING day after the private review agent receives all of 13 the information necessary to make the determination. 14 (2) IF ADDITIONAL INFORMA TION IS NEEDED TO MA KE A 15 DETERMINATION AFTER CONFIRMING THROUGH A COMPLETE REVIEW OF T HE 16 INFORMATION ALREADY SUBMITTED BY THE HEA LTH CARE PROVIDER , THE PRIVATE 17 REVIEW AGENT SHALL R EQUEST THE INFORMATI ON PROMPTLY , BUT NOT LATER 18 THAN 3 CALENDAR DAYS AFTER RECEIPT OF THE INITI AL REQUEST, BY SPECIFYING: 19 (I) THE INFORMATION , INCLUDING ANY LAB OR DIAGNOSTIC 20 TEST OR OTHER MEDICA L INFORMATION , THAT MUST BE SUBMITT ED TO COMPLETE 21 THE REQUEST ; AND 22 (II) THE CRITERIA AND STA NDARDS TO SUPPORT THE N EED FOR 23 THE ADDITIONAL INFOR MATION. 24 (D) (1) (I) A PRIVATE REVIEW AGENT SHALL MAKE INITIAL 25 DETERMINATIONS ON WH ETHER TO AUTHORIZE O R CERTIFY AN EMERGEN CY 26 COURSE OF TREATMENT OR HEALTH CARE SERVI CE FOR A MEMBER WITH IN 24 27 HOURS AFTER THE INITIAL REQUEST AFTE R RECEIPT OF THE INF ORMATION 28 NECESSARY TO MAKE TH E DETERMINATION . 29 (II) IF THE PRIVATE REVIEW AGENT DETERMINES THA T 30 ADDITIONAL INFORMATI ON IS NEEDED AFTER C ONFIRMING THROUGH A COMPLETE 31 REVIEW OF THE INFORM ATION ALREADY SUBMIT TED BY THE HEALTH CARE 32 PROVIDER, THE PRIVATE REVIEW A GENT SHALL: 33 SENATE BILL 791 27 1. PROMPTLY REQUEST THE SPECIFIC INFORMATION 1 NEEDED, INCLUDING ANY LAB OR DIAGNOSTIC TEST OR O THER MEDICAL 2 INFORMATION ; AND 3 2. PROMPTLY, BUT NOT LATER THAN 2 HOURS AFTER 4 RECEIPT OF THE INF ORMATION, NOTIFY THE HEALTH CA RE PROVIDER OF AN 5 AUTHORIZATION OR CER TIFICATION DETERMINA TION WHEN MADE BY TH E PRIVATE 6 REVIEW AGENT . 7 (2) A PRIVATE REVIEW AGENT SHALL INITIATE THE E XPEDITED 8 PROCEDURE FOR AN EME RGENCY CASE IF THE H EALTH CARE PROVIDER ATTESTS 9 THAT THE SERVICES AR E NECESSARY TO TREAT A CONDITION OR ILLNE SS THAT, 10 WITHOUT IMMEDIATE ME DICAL ATTENTION , WOULD: 11 (I) SERIOUSLY JEOPARDIZE THE LIFE OR HEALTH O F THE 12 MEMBER OR THE MEMBER ’S ABILITY TO REGAIN MAXIMUM FUNCTIONS ; 13 (II) CAUSE THE MEMBE R TO BE IN DANGER TO SELF OR OTHERS ; 14 OR 15 (III) CAUSE THE MEMBER TO CONTINUE USING INTOX ICATING 16 SUBSTANCES IN AN IMM INENTLY DANGEROUS MA NNER. 17 (E) IF A PRIVATE REVIEW A GENT FAILS TO MAKE A DETERMINATION WITHIN 18 THE TIME LIMITS REQU IRED UNDER THIS SECT ION, THE REQUEST SHALL BE 19 DEEMED APPROVED . 20 [(b)] (F) (1) If an initial determination is made by a private review agent not 21 to authorize or certify a health care service and the health care provider believes the 22 determination warrants an immediate reconsideration, a private review agent [may] 23 SHALL provide the health care provider the opportunity to speak with the physician that 24 rendered the determination, by telephone on an expedited basis, within a period of time not 25 to exceed 24 hours of the health care provider seeking the reconsideration. 26 (2) IF THE PHYSICIAN IS U NABLE TO IMMEDIATELY SPEAK WITH THE 27 HEALTH CARE PROVIDER SEEKING THE RECONSID ERATION, THE PHYSICIAN SHALL 28 PROVIDE THE HEALTH C ARE PROVIDER WITH TH E FOLLOWING CONTACT 29 INFORMATION FOR THE HEALTH CARE PROVIDER TO USE TO CONTACT TH E 30 PHYSICIAN: 31 (I) A DIRECT TELEPHONE N UMBER THAT IS NOT TH E GENERAL 32 CUSTOMER CALL NUMBER ; OR 33 28 SENATE BILL 791 (II) A MONITORED E –MAIL ADDRESS THAT IS DEDICATED TO 1 COMMUNICATION RELATE D TO UTILIZATION REV IEW. 2 [(c)] (G) For emergency inpatient admissions, a private review agent may not 3 render an adverse decision solely because the hospital did not notify the private review 4 agent of the emergency admission within 24 hours or other prescribed period of time after 5 that admission if the patient’s medical condition prevented the hospital from determining: 6 (1) the patient’s insurance status; and 7 (2) if applicable, the private review agent’s emergency admission 8 notification requirements. 9 [(d)] (H) (1) Subject to paragraph (2) of this subsection, a private review 10 agent may not render an adverse decision as to an admission of a patient during the first 11 24 hours after admission when: 12 (i) the admission is based on a determination that the patient is in 13 imminent danger to self or others; 14 (ii) the determination has been made by the patient’s physician or 15 psychologist in conjunction with a member of the medical staff of the facility who has 16 privileges to make the admission; and 17 (iii) the hospital immediately notifies the private review agent of: 18 1. the admission of the patient; and 19 2. the reasons for the admission. 20 (2) A private review agent may not render an adverse decision as to an 21 admission of a patient to a hospital for up to 72 hours, as determined to be medically 22 necessary by the patient’s treating physician, when: 23 (i) the admission is an involuntary admission under §§ 10–615 and 24 10–617(a) of the Health – General Article; and 25 (ii) the hospital immediately notifies the private review agent of: 26 1. the admission of the patient; and 27 2. the reasons for the admission. 28 [(e)] (I) (1) A private review agent that requires a health care provider to 29 submit a treatment plan in order for the private review agent to conduct utilization review 30 of proposed or delivered services for the treatment of a mental illness, emotional disorder, 31 or a substance abuse disorder: 32 SENATE BILL 791 29 (i) shall accept: 1 1. the uniform treatment plan form adopted by the 2 Commissioner under § 15–10B–03(d) of this subtitle as a properly submitted treatment 3 plan form; or 4 2. if a service was provided in another state, a treatment plan 5 form mandated by the state in which the service was provided; and 6 (ii) may not impose any requirement to: 7 1. modify the uniform treatment plan form or its content; or 8 2. submit additional treatment plan forms. 9 (2) A uniform treatment plan form submitted under the provisions of this 10 subsection: 11 (i) shall be properly completed by the health care provider; and 12 (ii) may be submitted by electronic transfer. 13 15–10B–07. 14 (a) (1) Except as provided in paragraphs (2) and (3) of this subsection, all 15 adverse decisions shall be made by a LICENSED physician, or a panel of other appropriate 16 health care service reviewers with at least one physician on the panel who is: 17 (I) board certified or eligible in the same specialty as the treatment 18 under review; AND 19 (II) KNOWLEDGEABLE ABOUT THE REQUESTED HEALTH CARE 20 SERVICE OR TREATMENT THROUGH ACTUAL CLINI CAL EXPERIENCE . 21 (2) When the health care service under review is a mental health or 22 substance abuse service, the adverse decision shall be made by a LICENSED physician, or 23 a panel of other appropriate health care service reviewers with at least one LICENSED 24 physician, selected by the private review agent who: 25 (i) is board certified or eligible in the same specialty as the 26 treatment under review; or 27 (ii) is actively practicing or has demonstrated expertise in the 28 substance abuse or mental health service or treatment under review. 29 30 SENATE BILL 791 (3) When the health care service under review is a dental service, the 1 adverse decision shall be made by a licensed dentist, or a panel of other appropriate health 2 care service reviewers with at least one licensed dentist on the panel WHO IS 3 KNOWLEDGEABLE ABOUT THE REQUESTED HEALTH CARE SERVICE OR TREA TMENT 4 THROUGH ACTUAL CLINI CAL EXPERIENCE . 5 (b) All adverse decisions shall be made by a physician or a panel of other 6 appropriate health care service reviewers who are not compensated by the private review 7 agent in a manner that violates § 19–705.1 of the Health – General Article or that deters 8 the delivery of medically appropriate care. 9 (c) Except as provided in subsection (d) of this section, if a course of treatment 10 has been preauthorized or approved for a patient, a private review agent may not 11 retrospectively render an adverse decision regarding the preauthorized or approved 12 services delivered to that patient. 13 (d) A private review agent may retrospectively render an adverse decision 14 regarding preauthorized or approved services delivered to a patient if: 15 (1) the information submitted to the private review agent regarding the 16 services to be delivered to the patient was fraudulent or intentionally misrepresentative; 17 (2) critical information requested by the private review agent regarding 18 services to be delivered to the patient was omitted such that the private review agent’s 19 determination would have been different had the agent known the critical information; or 20 (3) the planned course of treatment for the patient that was approved by 21 the private review agent was not substantially followed by the provider. 22 (e) If a course of treatment has been preauthorized or approved for a patient, a 23 private review agent may not revise or modify the specific criteria or standards used for the 24 utilization review to make an adverse decision regarding the services delivered to that 25 patient. 26 15–10B–09.1. 27 A grievance decision shall be made based on the professional judgment of: 28 (1) (i) a LICENSED physician who is board certified or eligible in the 29 same specialty as the treatment under review AND KNOWLEDGEABLE AB OUT THE 30 REQUESTED HEALTH CAR E SERVICE OR TREATME NT THROUGH ACTUAL CL INICAL 31 EXPERIENCE ; or 32 (ii) a panel of other appropriate health care service reviewers with 33 at least one LICENSED physician on the panel who is board certified or eligible in the same 34 specialty as the treatment under review AND KNOWLEDGEABLE AB OUT THE 35 SENATE BILL 791 31 REQUESTED HEALTH CAR E SERVICE OR TREATME NT THROUGH ACTUAL CL INICAL 1 EXPERIENCE; 2 (2) when the grievance decision involves a dental service, a licensed 3 dentist, or a panel of appropriate health care service reviewers with at least one dentist on 4 the panel who is a licensed dentist, who shall consult with a dentist who is board certified 5 or eligible in the same specialty as the service under review AND KNOWLEDGEABLE 6 ABOUT THE REQUESTED HEALTH CARE SERVICE OR TREATMENT THROUGH ACTUAL 7 CLINICAL EXPERIENCE ; or 8 (3) when the grievance decision involves a mental health or substance 9 abuse service: 10 (i) a licensed physician who: 11 1. is board certified or eligible in the same specialty as the 12 treatment under review; or 13 2. is actively practicing or has demonstrated expertise in the 14 substance abuse or mental health service or treatment under review; or 15 (ii) a panel of other appropriate health care service reviewers with 16 at least one LICENSED physician, selected by the private review agent who: 17 1. is board certified or eligible in the same specialty as the 18 treatment under review; or 19 2. is actively practicing or has demonstrated expertise in the 20 substance abuse or mental health service or treatment under review. 21 SECTION 2. AND BE IT FURTHER ENACTED, That: 22 (a) The Maryland Health Care Commission and the Maryland I nsurance 23 Administration, in consultation with health care practitioners and payors of health care 24 services, jointly shall conduct a study on the development of standards for the 25 implementation of payor programs to modify prior authorization requirements fo r 26 prescription drugs, medical care, and other health care services based on health care 27 practitioner–specific criteria. 28 (b) The study conducted under subsection (a) of this section shall include, through 29 an examination of literature review and legislatively or voluntarily established programs 30 that have been implemented or are being considered in other states, an analysis of: 31 (1) adjustments to payor prior authorization requirements based on a 32 health care practitioner’s: 33 32 SENATE BILL 791 (i) prior approval rates; 1 (ii) ordering and prescribing patterns; and 2 (iii) participation in a payor’s two–sided incentive arrangement or a 3 capitation program; and 4 (2) any other information or metrics necessary to implement the payor 5 programs. 6 (c) On or before December 1, 2024, the Maryland Health Care Commission and 7 the Maryland Insurance Administration jointly shall submit a report to the General 8 Assembly, in accordance with § 2–1257 of the State Government Article, with the findings 9 and recommendations from the study, including recommendations for legislative initiatives 10 necessary for the establishment of payor programs modifying prior authorization 11 requirements based on health care practitioner–specific criteria. 12 SECTION 3. AND BE IT FURTHER ENACTED, That: 13 (a) The Maryland Health Care Commission and the Maryland Insurance 14 Administration jointly shall establish a workgroup to: 15 (1) assess the progress toward implementing the requirements in § 16 19–108.5 of the Health – General Article, as enacted by Section 1 of this Act, including 17 monitoring any federal or State developments relating to the requirements; and 18 (2) review issues or recommendations from other states that are 19 implementing a real–time benefit requirement, including establishing a link at the point of 20 prescribing for any available coupons. 21 (b) On or before December 1, 2025, the Maryland Health Care Commission and 22 the Maryland Insurance Administration jointly shall submit a report to the General 23 Assembly, in accordance with § 2–1257 of the State Government Article, with findings and 24 recommendations from the workgroup. 25 SECTION 4. AND BE IT FURTHER ENACTED, That Section 1 of this Act shall take 26 effect January 1, 2025. 27 SECTION 5. AND BE IT FURTHER ENACTED, That, except as provided in Section 28 4 of this Act, this Act shall take effect July 1, 2024. 29