A3591

An Act concerning medication management services for certain NJ FamilyCare enrollees and amending P.L.1968, c.413 and P.L.2003, c.280.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. Section 6 of P.L.1968, c.413 (C.30:4D-6) is amended to read as follows:

6. a. Subject to the requirements of Title XIX of the federal Social Security Act, the limitations imposed by this act and by the rules and regulations promulgated pursuant thereto, the department shall provide medical assistance to qualified applicants, including authorized services within each of the following classifications:

(1) Inpatient hospital services

(2) Outpatient hospital services;

(3) Other laboratory and X-ray services;

(4) (a) Skilled nursing or intermediate care facility services;

(b) Early and periodic screening and diagnosis of individuals who are eligible under the program and are under age 21, to ascertain their physical or mental health status and the health care, treatment, and other measures to correct or ameliorate defects and chronic conditions discovered thereby, as may be provided in regulation of the Secretary of the federal Department of Health and Human Services and approved by the commissioner;

(5) Physician's services furnished in the office, the patient's home, a hospital, a skilled nursing, or intermediate care facility or elsewhere.

As used in this subsection, "laboratory and X-ray services" includes HIV drug resistance testing, including, but not limited to, genotype assays that have been cleared or approved by the federal Food and Drug Administration, laboratory developed genotype assays, phenotype assays, and other assays using phenotype prediction with genotype comparison, for persons diagnosed with HIV infection or AIDS.

b. Subject to the limitations imposed by federal law, by this act, and by the rules and regulations promulgated pursuant thereto, the medical assistance program may be expanded to include authorized services within each of the following classifications:

(1) Medical care not included in subsection a.(5) above, or any other type of remedial care recognized under State law, furnished by licensed practitioners within the scope of their practice, as defined by State law;

(2) Home health care services;

(3) Clinic services;

(4) Dental services;

(5) Physical therapy and related services;

(6) Prescribed drugs, dentures, and prosthetic devices; and eyeglasses prescribed by a physician skilled in diseases of the eye or by an optometrist, whichever the individual may select;

(7) Optometric services;

(8) Podiatric services;

(9) Chiropractic services;

(10) Psychological services;

(11) Inpatient psychiatric hospital services for individuals under 21 years of age, or under age 22 if they are receiving such services immediately before attaining age 21;

(12) Other diagnostic, screening, preventative, and rehabilitative services, and other remedial care;

(13) Inpatient hospital services, nursing facility services, and immediate care facility services for individuals 65 years of age or over in an institution for mental diseases;

(14) Intermediate care facility services;

(15) Transportation services;

(16) Services in connection with the inpatient or outpatient treatment or care of substance use disorder, when the treatment is prescribed by a physician and provided in a licensed hospital or in a narcotic and substance use disorder treatment center approved by the Department of Health pursuant to P.L.1970, c.334 (C.26:2G-21 et. seq.) and whose staff includes a medical director, and limited those services eligible for federal financial participation under Title XIX of the federal Social Security Act;

(17) Any other medical care and any other type of remedial care recognized under State law, specified by the Secretary of the federal Department of Health and Human Services, and approved by the commissioner;

(18) Comprehensive maternity care, which may include: the basic number of prenatal and postpartum visits recommended by the American College of Obstetrics and Gynecology; additional prenatal and postpartum visits that are medically necessary; necessary laboratory, nutritional assessment and counseling, health education, personal counseling, managed care, outreach, and follow-up services; treatment of conditions which may complicate pregnancy doula care; and physician or certified nurse midwife delivery services. For the purposes of this paragraph, "doula" means a trained professional who provides continuous physical, emotional, and informational support to a mother before, during, and shortly after childbirth, to help her to achieve the healthiest, most satisfying experience possible;

(19) Comprehensive pediatric care, which may include: ambulatory, preventive, and primary care health services. The preventive services shall include, at a minimum, the basic number of preventive visits recommended by the American Academy of Pediatrics;

(20) Services provided by a hospice which is participating in the Medicare program established pursuant to Title XVIII of the Social Security Act, Pub.L.89-97 (42 U.S.C. s.1395 et seq.). Hospice services shall be provided subject to approval of the Secretary of the federal Department of Health and Human Services for federal reimbursement;

(21) Mammograms, subject to approval of the Secretary of the federal Department of Health and Human Services for federal reimbursement, including one baseline mammogram for women who are at least 35 but less than 40 years of age; one mammogram examination every two years or more frequently, if recommended by a physician, for women who are at least 40 but less than 50 years of age; and one mammogram examination every year for women age 50 and over;

(22) Upon referral by a physician, advanced practice nurse, or physician assistant of a person who has been diagnosed with diabetes, gestational diabetes, or pre-diabetes, in accordance with standards adopted by the American Diabetes Association:

(a) Expenses for diabetes self-management education or training to ensure that a person with diabetes, gestational diabetes, or pre-diabetes can optimize metabolic control, prevent and manage complications, and maximize quality of life. Diabetes self-management education shall be provided by an in-State provider who is:

(i) a licensed, registered, or certified health care professional who is certified by the National Certification Board of Diabetes Educators as a Certified Diabetes Educator, or certified by the American Association of Diabetes Educators with a Board Certified-Advanced Diabetes Management credential, including, but not limited to: a physician, an advanced practice or registered nurse, a physician assistant, a pharmacist, a chiropractor, a dietitian registered by a nationally recognized professional association of dietitians, or a nutritionist holding a certified nutritionist specialist (CNS) credential from the Board for Certification of Nutrition Specialists; or

(ii) an entity meeting the National Standards for Diabetes Self-Management Education and Support, as evidenced by a recognition by the American Diabetes Association or accreditation by the American Association of Diabetes Educators;

(b) Expenses for medical nutrition therapy as an effective component of the person's overall treatment plan upon a: diagnosis of diabetes, gestational diabetes, or pre-diabetes; change in the beneficiary's medical condition, treatment, or diagnosis; or determination of a physician, advanced practice nurse, or physician assistant that reeducation or refresher education is necessary. Medical nutrition therapy shall be provided by an in-State provider who is a dietitian registered by a nationally-recognized professional association of dietitians, or a nutritionist holding a certified nutritionist specialist (CNS) credential from the Board for Certification of Nutrition Specialists, who is familiar with the components of diabetes medical nutrition therapy;

(c) For a person diagnosed with pre-diabetes, items and services furnished under an in-State diabetes prevention program that meets the standards of the National Diabetes Prevention Program, as established by the federal Centers for Disease Control and Prevention; and

(d) Expenses for any medically appropriate and necessary supplies and equipment recommended or prescribed by a physician, advanced practice nurse, or physician assistant for the management and treatment of diabetes, gestational diabetes, or pre-diabetes, including, but not limited to: equipment and supplies for self-management of blood glucose; insulin pens; insulin pumps and related supplies; and other insulin delivery devices;

(23) Expenses incurred for the provision of group prenatal services to a pregnant woman, provided that:

(a) the provider of such services, which shall include, but not be limited to, a federally qualified health center or a community health center operating in the State:

(i) is a site accredited by the Centering Healthcare Institute, or is a site engaged in an active implementation contract with the Centering Healthcare institute, that utilizes the Centering Pregnancy model; and

(ii) incorporates the applicable information outlined in any best practices manual for prenatal and postpartum maternal care developed by the Department of Health into the curriculum for each group prenatal visit;

(b) each group prenatal care visit is at least 1.5 hours in duration, with a. minimum of two women and a maximum of 20 women in participation; and

(c) no more than 10 group prenatal care visits occur per pregnancy. As used in this paragraph, "group prenatal care services" means a series of prenatal care visits provided in a group setting which are based upon the Centering Pregnancy model developed by the Centering Healthcare Institute and which include health assessments, social and clinical support, and educational activities;

(24) Expenses incurred for the provision of pasteurized donated human breast milk, which shall include human milk fortifiers if indicated in a medical order provided by a licensed medical practitioner, to an infant under the age of six months; provided that the milk is obtained from a human milk bank that meets quality guidelines established by the Department of Health and a licensed medical practitioner has issued a medical order for the infant under at least one of the following circumstances:

(a) the infant is medically or physically unable to receive maternal breast milk or participate in breast feeding, or the infant's mother is medically or physically unable to produce maternal breast milk in sufficient quantities or participate in breast feeding despite optimal lactation support; or

(b) the infant meets any of the following conditions:

(i) a body weight below healthy levels, as determined by the licensed medical practitioner issuing the medical order for the infant;

(ii) the infant has a congenital or acquired condition that places the infant at a high risk for development of necrotizing enterocolitis; or

(iii) the infant has a congenital or acquired condition that may benefit from the use of donor breast milk and human milk fortifiers, as determined by the Department of Health;

(25) Comprehensive tobacco cessation benefits to an individual who is 18 years of age or older, or who is pregnant. Coverage shall include: brief and high intensity individual counseling, brief and high intensity group counseling, and telemedicine as defined by section 1 of P.L.2017, c.117 (C.45:1-61); all medications approved for tobacco cessation by the U.S. Food and Drug Administration; and other tobacco cessation counseling recommended by the Treating Tobacco Use and Dependence Clinical Practice Guideline issued by the U.S. Public Health Service. Notwithstanding the provisions of any other law, rule, or regulation to the contrary, and except as otherwise provided in this section:

(a) Information regarding the availability of the tobacco cessation services described in this paragraph shall be provided to all individuals authorized to receive the tobacco cessation services pursuant to this paragraph at the following times: no later than 90 days after the effective date of P.L.2019, c.473: upon the establishment of an individual's eligibility for medical assistance; and upon the redetermination of an individual's eligibility for medical assistance;

(b) The following conditions shall not be imposed on any tobacco cessation services provided pursuant to this paragraph: copayments or any other forms of cost-sharing, including deductibles; counseling requirements for medication; stepped care therapy or similar restrictions requiring the use of one service prior to another; limits on the duration of services; or annual or lifetime limits on the amount, frequency, or cost of services, including, but not limited to, annual or lifetime limits on the number of covered attempts to quit; and

(c) Prior authorization requirements shall not be imposed on any tobacco cessation services provided pursuant to this paragraph except in the following circumstances where prior authorization may be required: for a treatment that exceeds the duration recommended by the most recently published United States Public Health Service clinical practice guidelines on treating tobacco use and dependence; or for services associated with more than two attempts to quit within a 12-month period;

(26) Provided that there is federal financial participation available, benefits for expenses incurred in conducting a colorectal cancer screening in accordance with United States Preventive Services Task Force recommendations. The method and frequency of screening to be utilized shall be in accordance with the most recent published recommendations of the United States Preventive Services Task Force and as determined medically necessary by the covered person's physician, in consultation with the covered person.

No deductible, coinsurance, copayment, or any other cost-sharing requirement shall be imposed for a colonoscopy performed following a positive result on a non-colonoscopy, colorectal cancer screening test recommended by the United States Preventive Services Task Force; [and]

(27) (a) Within 24 months of the effective date of P.L.2023, c.187 (C.30:4D-6u et seq.), and conditional on the receipt of all necessary federal approvals and the securing of federal financial participation pursuant to section 2 of P.L.2023, c.187 (C.30:4D-6u), community-based palliative care benefits which shall include, but not be limited to, all of the following:

(i) specialized medical care and emotional and spiritual support for beneficiaries with serious advanced illnesses;

(ii) relief of symptoms, pain, and stress of serious illness;

(iii) improvement of quality of life for both the beneficiary and the beneficiary's family; and

(iv) appropriate care for any age and for any stage of serious illness, along with curative treatment.

(b) Benefits provided under this paragraph shall include, but shall not be limited to, services provided by a hospice pursuant to paragraph (20) of subsection b. of this section, provided that:

(i) hospice services may be provided at the same time that curative treatment is available, to the extent that services are not duplicative;

(ii) hospice services may be provided to beneficiaries whose conditions may result in death, regardless of the estimated length of the beneficiary's remaining period of life; and

(iii) the Division of Medical Assistance and Health Services in the Department of Human Services may include any other service deemed appropriate under the benefits provided under this paragraph.

(c) Providers authorized to deliver benefits provided under this paragraph shall include Medicaid-approved licensed hospice agencies, Medicaid-approved home health agencies licensed to provide hospice care, and other Medicaid-approved licensed health care providers.

(d) Nothing in this paragraph shall be construed to result in the elimination or reduction of covered benefits or services under the Medicaid program.

(e) This paragraph shall not affect a beneficiary's eligibility to receive, concurrently with services provided for in this paragraph, any services, including home health services, for which the beneficiary would have been eligible in the absence of this paragraph, to the extent that services are not duplicative ; and

(28) (a) Comprehensive medication management services for a medically complex pediatric patient when provided by a licensed clinical pharmacist, which services shall include:

(i) comprehensive reviews, conducted on a schedule to be determined in collaboration with the patient’s team of healthcare providers, of the patient’s prescription medications, over-the-counter medications, vitamins, and nutritional supplements;

(ii) development and implementation of patient-specific medication action plans;

(iii) ongoing monitoring of the patient’s adherence to the patient-specific medication action plan;

(iv) follow-up consultations and services as needed to ensure the efficacy and safety of the patient-specific medication action plan; and

(v) any other comprehensive medication management services deemed necessary by the division and the Board of Pharmacy for the appropriate care of a medically complex pediatric patient.

(b) The division and the Board of Pharmacy shall designate the educational, training, and credentialing requirements that licensed clinical pharmacists shall satisfy in order to be authorized to provide comprehensive medication management services under this paragraph.

(c) Notwithstanding the provisions of P.L.2003, c.280 (C.45:14-40 et seq.), a licensed clinical pharmacist who satisfies the requirements of this paragraph shall not be required to enter into a written agreement with a licensed physician in order to provide comprehensive medication management services for a medically complex pediatric patient.

(d) The division shall enter into value-based reimbursement contracts with licensed clinical pharmacists for the provision of comprehensive medication management services for medically complex pediatric patients;

(e) The division shall establish a quality assurance program in order to monitor and evaluate the outcomes and efficacy of the comprehensive medication management services provided for medically complex pediatric patients, and ensure that the services provided align with the division’s value-based payment strategies.

(f) As used in this paragraph:

“Board of Pharmacy” means the New Jersey State Board of Pharmacy of the Division of Consumer Affairs in the Department of Law and Public Safety.

“Clinical pharmacist” means a licensed pharmacist who has completed a clinical residency or a Board of Pharmacy Specialties certification to acquire expertise in the therapeutic use of medications to ensure optimal patient health outcomes. Clinical pharmacists work as part of a patient’s healthcare professional team to provide medication therapy evaluations and recommendations to patients and healthcare professionals.

“Comprehensive medication management services” means a standard of care that ensures that a patient’s medications, including prescription and nonprescription medications, vitamins, or nutritional supplements, are individually assessed to determine whether each medication is: appropriate for the patient, effective for the patient’s medical condition, safe given the patient’s comorbidities and other medications being taken, and able to be taken by the patient as intended. Comprehensive medication management services are provided by a clinical pharmacist as part of a patient’s healthcare professional team.

“Division” means the Division of Medical Assistance and Health Services in the Department of Human Services .

c. Payments for the foregoing services, goods and supplies furnished pursuant to this act shall be made to the extent authorized by this act, the rules and regulations promulgated pursuant thereto and, where applicable, subject to the agreement of insurance provided for under this act. The payments shall constitute payment in full to the provider on behalf of the recipient. Every provider making a claim for payment pursuant to this act shall certify in writing on the claim submitted that no additional amount will be charged to the recipient, the recipient's family, the recipient's representative or others on the recipient's behalf for the services, goods, and supplies furnished pursuant to this act.

No provider whose claim for payment pursuant to this act has been denied because the services, goods, or supplies were determined to be medically unnecessary shall seek reimbursement form the recipient, his family, his representative or others on his behalf for such services, goods, and supplies provided pursuant to this act; provided, however, a provided may seek reimbursement from a recipient for services, goods, or supplies not authorized by this act, if the recipient elected to receive the services, goods or supplies with the knowledge that they were not authorized.

d. Any individual eligible for medical assistance (including drugs) may obtain such assistance from any person qualified to 33 perform the service or services required (including an organization which provides such services, or arranges for their availability on a prepayment basis), who undertakes to provide the individual such services.

No copayment or other form of cost-sharing shall be imposed on any individual eligible for medical assistance, except as mandated by federal law as a condition of federal financial participation.

e. Anything in this act to the contrary notwithstanding, no payments for medical assistance shall be made under this act with respect to care or services for any individual who:

(1) Is an inmate of a public institution (except as a patient in a medical institution); provided, however, that an individual who is otherwise eligible may continue to receive services for the month in which he becomes an inmate, should the commissioner determine to expand the scope of Medicaid eligibility to include such an individual, subject to the limitations imposed by federal law and regulations, or

(2) Has not attained 65 years of age and who is a patient in an institution for mental diseases, or

(3) Is over 21 years of age and who is receiving inpatient psychiatric hospital services in a psychiatric facility; provided, however, that an individual who was receiving such services immediately prior to attaining age 21 may continue to receive such services until the individual reaches age 22. Nothing in this subsection shall prohibit the commissioner from extending medical assistance to all eligible persons receiving inpatient psychiatric services; provided that there is federal financial participation available.

f. (1) A third party as defined in section 3 of P.L.1968, c.413 (C.30:4D-3) shall not consider a person's eligibility for Medicaid in this or another state when determining the person's eligibility for enrollment or the provision of benefits by that third party.

(2) In addition, any provision in a contract of insurance, health benefits plan, or other health care coverage document, will, trust, agreement, court order, or other instrument which reduces or excludes coverage or payment for health care-related goods and services to or for an individual because of that individual's actual or potential eligibility for or receipt of Medicaid benefits shall be null and void, and no payments shall be made under this act as a result of any such provision.

(3) Notwithstanding any provision of law to the contrary, the provisions of paragraph (2) of this subsection shall not apply to a trust agreement that is established pursuant to 42 U.S.C. s.1396p(d)(4)(A) or (C) to supplement and augment assistance provided by government entities to a person who is disabled as defined in section 1614(a)(3) of the federal Social Security Act (42 31 U.S.C. s.1382c (a)(3)).

g. The following services shall be provided to eligible medically needy individuals as follows:

(1) Pregnant women shall be provided prenatal care and delivery services and postpartum care, including the services cited in subsections a.(1), (3), and (5) of this section and subsections b.(1)-(10), (12), (15), and (17) of this section, and nursing facility services cited in subsection b.(13) of this section.

(2) Dependent children shall be provided with services cited in subsections a.(3) and (5) of this section and subsections b.(1), (2), (3), (4), (5), (6), (7), (10), (12), (15), and (17) of this section, and nursing facility services cited in subsection b.(13) of this section.

(3) Individuals who are 65 years of age or older shall be provided with services cited in subsections a.(3) and (5) of this section and subsections b.(1)-(5), (6) excluding prescribed drugs, (7), (8), (10), (12), (15), and (17) of this section, and nursing facility services cited in subsection b.(13) of this section.

(4) Individuals who are blind or disabled shall be provided with services cited in subsections a.(3) and (5) of this section and subsections b.(1)-(5), (6) excluding prescribed drugs, (7), (8), (10), 3 (12), (15), and (17) of this section, and nursing facility services cited in subsection b.(13) of this section.

(5) (a) Inpatient hospital services, subsection a.(1) of this section, shall only be provided to eligible medically needy individuals, other than pregnant women, if the federal Department of Health and Human Services discontinues the State's waiver to establish inpatient hospital reimbursement rates for the Medicare and Medicaid programs under the authority of section 601(c)(3) of the Social Security Act Amendments of 1983, Pub.L.98-21 (42 U.S.C. s.1395ww(c)(5)). Inpatient hospital services may be extended to other eligible medically needy individuals if the federal Department of Health and Human Services directs that these services be included.

(b) Outpatient hospital services, subsection a.(2) of this section, shall only be provided to eligible medically needy individuals if the federal Department of Health and Human Services discontinues the State's waiver to establish outpatient hospital reimbursement rates for the Medicare and Medicaid programs under the authority of section 601(c)(3) of the Social Security Amendments of 1983, Pub.L.98-21 (42 U.S.C. s.1395ww(c)(5)). Outpatient hospital services may be extended to all or to certain medically needy individuals if the federal Department of Health and Human Services directs that these services be included. However, the use of outpatient hospital services shall be limited to clinic services and to emergency room services for injuries and significant acute medical conditions.

h. In the case of a qualified disabled and working individual pursuant to section h6408 of Pub.L.101-239 (42 U.S.C. s.1396d), the only medical assistance provided under this act shall be the payment of premiums for Medicare part A under 42 U.S.C. ss.1395i-2 and 1395r.

i. In the case of a specified low-income Medicare beneficiary pursuant to 42 U.S.C. s.1396a(a)10(E)iii, the only medical assistance provided under this act shall be the payment of premiums for Medicare part B under 42 U.S.C. s.1395r as provided for in 42 U.S.C. s.1396d(p)(3)(A)(ii).

j. In the case of a qualified individual pursuant to 42 U.S.C. s.1396a(aa), the only medical assistance provided under this act shall be payment for authorized services provided during the period in which the individual requires treatment for breast or cervical cancer, in accordance with criteria established by the commissioner.

k. In the case of a qualified individual pursuant to 42 U.S.C. s.1396a(ii), the only medical assistance provided under this act shall be payment for family planning services and supplies as described at 42 U.S.C. s.1396d(a)(4)(C), including medical diagnosis and treatment services that are provided pursuant to a family planning service in a family planning setting.

(cf: P.L.2023, c.187, s.1).

2. Section 9 of P.L.2003, c.280 (C.45:14-48) is amended to read as follows:

9. a. The board shall be responsible for the control and regulation of the practice of pharmacy in this State including, but not limited to, the following:

(1) The licensing by examination or by license transfer of applicants who are qualified to engage in the practice of pharmacy under the provisions of this act;

(2) The renewal of licenses to engage in the practice of pharmacy;

(3) The establishment and enforcement of professional standards and rules of conduct of pharmacists engaged in the practice of pharmacy;

(4) The establishment of requirements for pharmacists to engage in collaborative practice;

(5) The establishment of requirements jointly promulgated with the State Board of Medical Examiners for pharmacists to administer drugs directly to patients;

(6) The enforcement of those provisions of this act relating to the conduct or competence of pharmacists practicing in this State, and the suspension, revocation, failure to renew or restriction of licenses to engage in the practice of pharmacy pursuant to the provisions of P.L.1978, c.73 (C.45:1-14 et seq.);

(7) The regulation of pharmacy practiced through any technological means;

(8) The regulation and control of automated medication systems and automated medication devices within or outside of pharmacy practice sites;

(9) The right to seize any drugs and devices found by the board to constitute an imminent danger to the public health and welfare;

(10) The establishment of minimum specifications for record keeping, prescription and patient profile record maintenance, pharmacy practice sites including, but not limited to, the physical premises, technical equipment, environment, supplies, personnel and procedures for the storage, compounding and dispensing of drugs or devices, and for the monitoring of drug therapy;

(11) The inspection of any pharmacy practice site at all reasonable hours for the purpose of determining if any provisions of the laws governing the legal distribution of drugs or devices or the practice of pharmacy are being violated. The board, its officers, inspectors and representatives shall cooperate with all agencies charged with the enforcement of the laws of the United States, of this State, and of all other states relating to drugs, devices and the practice of pharmacy;

(12) The inspection of prescription files and the prescription records of a pharmacy and the removal from the files and taking possession of any original prescription, providing that the authorized agent removing or taking possession of an original prescription shall place in the file from which it was removed a copy certified by that person to be a true copy of the original prescription removed; provided further, that the original copy shall be returned by the board to the file from which it was removed after it has served the purpose for which it was removed;

(13) The establishment of requirements for patient counseling, patient profiles and drug utilization reviews;

(14) The establishment of regulations to protect the health and safety of pharmacy patients; [and]

(15) The prescribing or changing of the fees for examinations, certifications, licensures, renewals and other services performed pursuant to P.L.1974, c.46 (C.45:1-3.1 et seq.) and this act; and

(16) (a) Together with the Division of Medical Assistance and Health Services in the Department of Human Services, the establishment of educational, training, and credentialing requirements for pharmacists to engage in comprehensive medication management services for medically complex pediatric patients who are enrolled in the NJ FamilyCare program;

(b) As used in this paragraph:

“Clinical pharmacist” means a licensed pharmacist who has completed a clinical residency to acquire expertise in the therapeutic use of medications to ensure optimal patient health outcomes. Clinical pharmacists work as part of a patient’s healthcare professional team to provide medication therapy evaluations and recommendations to patients and healthcare professionals.

“NJ FamilyCare” means the program established pursuant to P.L.2005, c.156 (C.30:4J-8 et al.), which includes the State's Medicaid Program and the Children's Health Insurance Program .

b. The board shall have those other duties, powers and authority as may be necessary to the enforcement of this act and to the enforcement of rules and regulations of the board, which may include, but not be limited to, the following:

(1) The determination and issuance of standards, recognition and approval of degree programs of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this State, and the specifications and enforcement of requirements for practical training, including internships;

(2) The registration of externs, interns, pharmacy preceptors and pharmacy technicians;

(3) The regulation of the training, qualifications and conduct of applicants, externs, interns, pharmacy preceptors and pharmacy technicians;

(4) The collection of professional demographic data;

(5) The joining with those professional organizations and associations organized to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public or whose activities assist and facilitate the work of the board;

(6) The establishment of a bill of rights for patients concerning the health care services a patient may expect in regard to pharmaceutical care;

(7) The engagement in activities to educate consumers, to assist them in obtaining information necessary to make decisions about medication issues;

(8) The establishment of standards for the continuing education of registered pharmacists;

(9) The establishment of rules and regulations for extraordinary emergency situations that interfere with the ability to practice under the current rules and regulations;

(10) The establishment of guidelines for board approved pilot programs. The guidelines shall be complied with to implement a program that may not be presently acknowledged in this act or its rules or regulations; and

(11) The assurance that any credentialing or certification of a pharmacist is not misleading to the public.

c. (1) The board may place under seal all drugs, biologicals, radio pharmaceuticals or devices that are owned by or in the possession, custody or control of a licensee or permit holder at the time his license or permit is suspended or revoked or at the time the board refused to renew his license. Except as otherwise provided in this section, drugs, biologicals, radio pharmaceuticals or devices that are sealed pursuant to this paragraph shall not be disposed of until appeal rights under the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) have expired, or an appeal filed pursuant to that act has been determined. The court, involved in an appeal filed pursuant to the "Administrative Procedure Act," may order the board, during the pendency of the appeal, to sell sealed drugs, biologicals and radio pharmaceuticals that are perishable. The proceeds of a sale shall be deposited with the court.

(2) Notwithstanding any provisions of this act to the contrary, whenever a duly authorized representative of the board finds, or has probable cause to believe, that any drug or device is outdated, adulterated or misbranded within the meaning of the "Federal Food, Drug, and Cosmetic Act," 21 U.S.C.s.301 et seq., the representative shall affix to that drug or device a tag or other appropriate marking giving notice that the article is or is suspected of being outdated, adulterated or misbranded, had been detained or embargoed, and warning all persons not to remove or dispose of the article by sale or otherwise until provision for removing or disposal is given by the board, its agent or the court. No person shall remove or dispose of an embargoed drug or device by sale or otherwise without the permission of the board or its agent or, after summary proceedings have been instituted, without permission of the court.

(3) When a drug or device detained or embargoed under paragraph (2) of this subsection c. has been declared by the representative to be outdated, adulterated or misbranded, the board shall, as soon as practical thereafter, petition the judge of the court in which jurisdiction the article is detained or embargoed for an order for condemnation of that article. If the judge determines that this drug or device so detained or embargoed is not adulterated, outdated or misbranded, the board shall direct the immediate removal of the tag or other marking.

(4) If the court finds that a detained or embargoed drug or device is adulterated, outdated or misbranded, that drug or device, after entry of the decree, shall be destroyed at the expense of the owner under the supervision of a board representative and all court costs and fees, storage and other proper expenses shall be borne by the owner of that drug or device. When the outdating, adulteration or misbranding can be corrected by proper labeling or processing of the drug or device, the court, after entry of the decree and after the costs, fees and expenses have been paid and a good and sufficient bond has been posted, may direct that the drug or device be delivered to the owner thereof for labeling or processing under the supervision of a board representative. Expense of that supervision shall be paid by the owner. The bond shall be returned to the owner of the drug or device on representation to the court by the board that the drug or device is no longer in violation of the embargo and the expense of supervision has been paid.

d. Except as otherwise provided to the contrary, the board shall exercise all of its duties, powers and authority in accordance with the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.).

(cf: P.L.2003, c.280, s.9)

3. Section 25 of P.L.2003, c.280 (C.45:14-64) is amended to read as follows:

25. The provisions of this act regulating collaborative drug therapy management shall not apply to :

a. any pharmacist practicing in a hospital, provided that prescribing within these institutions takes place under the guidance of a pharmacy and therapeutics committee in accordance with procedures as determined by regulations jointly promulgated by the board and the State Board of Medical Examiners ; and

b. a clinical pharmacist authorized to provide comprehensive medication management to a medically complex pediatric patient, pursuant to the provisions of P.L. , c. (C. ) (pending before the Legislature as this bill).

(cf: P.L.2003, c.280, s.25)

4. (New section) The Commissioner of Human Services shall apply for such State plan amendments or waivers as may be necessary to implement the provisions of section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill) and to secure federal reimbursement for State Medicaid expenditures under the federal Medicaid program.

5. (New section) The Commissioner of Human Services and the New Jersey State Board of Pharmacy shall, in accordance with the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), adopt rules and regulations as necessary to implement this act.

6. This act shall take effect on the first day of the six month next following the date of enactment.

STATEMENT

This bill requires the NJ FamilyCare program to provide reimbursement for comprehensive medication management (CMM) services when provided by a licensed clinical pharmacist for a medically complex pediatric patient. “CMM services” is defined as a standard of care by which a clinical pharmacist assesses each of a patient’s medications, including prescription and nonprescription medications, vitamins, and nutritional supplements, to determine that each is appropriate, effective, and safe, given the patient’s medical conditions, comorbidities, and other medications. Comprehensive medication management services are provided by a clinical pharmacist as part of a patient’s health care team.

The bill defines a “clinical pharmacist” as a licensed pharmacist who has completed a clinical residency to acquire expertise in the therapeutic use of medications to ensure optimal patient health outcomes. Clinical pharmacists work as part of a patient’s team of healthcare professionals to provide medication therapy evaluations and recommendations to patients and healthcare providers.

CMM services for which a clinical pharmacist would receive NJ FamilyCare reimbursement will include:

1. comprehensive reviews of a pediatric patient’s prescription medications, over-the-counter medications, vitamins, and nutritional supplements;

2. development and implementation of patient-specific medication action plans;

3. ongoing monitoring of patient adherence to the patient-specific medication action plan;

4. follow-up consultations and services necessary to ensure the efficacy and safety of the patient-specific medication action plan; and

5. any other CMM services deemed necessary by the Division of Medical Assistance and Health Services (the division) in the Department of Human Services and the Board of Pharmacy for the appropriate care of a medically complex pediatric patient.

The bill directs the division to enter into value-based contracts with licensed clinical pharmacists in order to reimburse for CMM services provided for medically complex pediatric patients. The division also will establish a quality assurance program in order to monitor and evaluate the outcomes and efficacy of the CMM services provided, and ensure that these services align with the division’s value-based payment strategies.

The division and the New Jersey State Board of Pharmacy in the Division of Consumer Affairs will designate the educational, training, and credentialing requirements for licensed clinical pharmacists to provide CMM services.

The bill also amends “The New Jersey Pharmacy Practice Act,” P.L.2003, c.280 (C.45:14-40 et seq.), to specify that a licensed clinical pharmacist who satisfies the credentialing requirements for the provision of CMM services will not be required to enter into a written agreement with a licensed physician in order to provide CMM services. The bill further amends section 25 of P.L.2003, c.280 to provide that the statutory provisions regulating collaborative drug therapy management will not apply to the provision of CMM services, as provided by a licensed clinical pharmacist.