A. The Opioid Epidemic
Tackling the state’s opioid crisis was a leading concern for the Governor and General Assembly this year. One new law requires health care providers to prescribe the lowest effective dose of an opioid for treating pain, based on the clinical judgment of the provider.
Among its many provisions, the Heroin and Opioid Prevention Effort (HOPE) and Treatment Act requires hospitals, federal qualified health centers, outpatient mental health clinics, outpatient or residential addiction treatment providers and local health departments to make health care providers available who are trained and authorized under federal law to prescribe opioid addiction treatment medications. The law also requires hospitals to develop and report certain discharge protocols.
Beginning June 1, 2017, health care practitioners will be exempt from the state prohibition against self-referral when they have a compensation arrangement with a health care entity, and that arrangement is funded under a Medicare Shared Savings Program accountable care organization (ACO) or a payment model approved by the federal Centers for Medicare and Medicaid Services (CMS).
The Maryland State Board of Physicians will be required, starting October 1, 2017, to include information on each physician’s practitioner profile page on the Board’s website as to whether or not a physician has professional liability insurance. If a licensed physician does not carry professional liability insurance, the physician must conspicuously post that information at his or her practice, and must notify patients in writing. Physicians must also notify patients if his or her insurance coverage has lapsed for any period of time and has not been renewed.
C. Pharmacies and Pharmaceuticals
Maryland is the first state to pass a law giving its attorney general the power to take action against pharmaceutical “price gouging.” Starting October 1, 2017, manufacturers or wholesale distributers will be prohibited from engaging in price gouging in the sale of essential off-patent or generic drugs. The Attorney General may petition a circuit court to issue an order that compels manufacturers or distributers to provide records, pay restitution, and/or impose a civil penalty of up to $10,000 per violation.
Manufacturers of investigational drugs, biological products or devices will be able to provide that drug, product or device directly to eligible patients, such as ones with a terminal illness, as of October 1, 2017, as long as the manufacturer does not profit from the transaction. The Attorney General is required to develop a relevant informed consent form that includes instructions for the physician or patient.
Beginning October 1, 2017, pharmacists will be able to substitute an interchangeable biological product of the same dosage and strength for any brand name drug, provided that the prescriber does not explicitly state that the prescription must be dispersed as directed, and provided that the consumer is charged less for the interchangeable biological product than the brand name drug.
Additionally, pharmacists who meet specified requirements will be able to prescribe and dispense contraceptives, pursuant to regulations to be drafted by the State Board of Pharmacy. These regulations must be adopted by September 1, 2018. Still, it may be a while before pharmacists’ roles include this practice; the law requires forthcoming regulations to prohibit a pharmacist from prescribing contraceptives before January 1, 2019.
D. Prior Authorization, Step-Therapy, First-Fail Protocols
The HOPE and Treatment Act, mentioned above, limits prior authorization requirements for an opioid antagonist, including naloxone hydrochloride. Health insurance carriers that provide coverage for prescription drugs may apply prior authorization requirements for an opioid antagonist only if the carrier provides coverage for at least one formulation of the opioid antagonist without a prior authorization requirement. Additionally, these health insurance carriers are now prohibited from applying a preauthorization requirement for a prescription drug that is used for treatment of an opioid use disorder and contains methadone, buprenorphine or naltrexone.
As of October 1, 2017, carriers are also prohibited from imposing a step-therapy or first-fail protocol if a prescription drug is used to treat an insured or enrollee’s stage four advanced metastatic cancer, and the drug use is consistent with the FDA-approved indication or the National Comprehensive Cancer Network Drugs and Biologics Compendium indication for the treatment of stage four metastatic cancer.
E. Mandated Coverage
Maryland’s health insurance mandate for the coverage of breast cancer screenings now includes coverage for digital tomosynthesis, a radiologic procedure that produces cross-sectional digital three-dimensional images.
Additionally, as of January 1, 2018, carriers will be prohibited from imposing a deductible, copayment or coinsurance requirement on diabetes test strips. High-deductible plans, though, may subject diabetes test strips to the plan’s deductible requirement.
F. Affordable Care Act
The General Assembly established the Maryland Health Insurance Coverage Protection Commission, effective June 1, 2017, to monitor potential and actual federal changes to health care programs, such as the Affordable Care Act (ACA), and to provide recommendations to both state and local agencies.
Since the ACA remains on the books, lawmakers continued to pass legislation that complies with and implements the federal law. For example, the Maryland Insurance Administration will now be able to enforce ACA requirements for preventive and wellness services, as well as chronic disease management. On and after June 1, 2017, if an individual is renewing coverage under a policy or insurance contract, carriers will be prohibited from cancelling or refusing to renew the individual’s health benefit plan because they are entitled to enroll, or are enrolled, in Medicare.
Licensed health care practitioners who provide behavioral health services will be able to use telehealth to deliver that care—a service known as “teletherapy”—starting October 1, 2018. Telehealth involves the use of interactive audio, video or other telecommunications to deliver a health service; it does not include an audio-only telephone conversation, an e-mail or a fax. The state boards of Nursing, Physicians, Professional Counselors and Therapists, Psychologists, and Social Workers must adopt regulations for the use of teletherapy by April 1, 2018.
On or after October 1, 2017, mandated health insurance coverage for telehealth services must also include coverage of counseling for substance abuse disorders.
H. Medical Records
The General Assembly addressed disclosure of directory information, such as the presence and general health condition of a patient in a health care facility. On or after October 1, 2017, health care providers may disclose directory information to an individual who asks for a patient by name; however, the provider must inform patients of this potential disclosure, and provide them with the opportunity to restrict or prohibit the disclosure.
I. New Name
As of July 1, 2017, the Department of Health and Mental Hygiene will simply be the Maryland Department of Health, and the Secretary of Health and Mental Hygiene will be known as the Secretary of Health.
Sara J. Witman, Paralegal
410-576-4010 • email@example.com