Regulatory Reminder: New CT Health Care Laws Effective October 1

A number of new statutes affecting hospitals and other health care providers were enacted during the past legislative session. To help remind the health care industry of the changes ahead, we’ve highlighted below some of the key pieces of legislation that are scheduled to take effect on October 1, 2018:

Urgent Care Centers (PA 18-149)

A new law changes the definition of “urgent care center.” The requirement that urgent care centers be freestanding has been eliminated, though these facilities must still be licensed by the Department of Public Health (DPH); offer services without requiring an appointment; and provide services during times when primary care provider offices are not customarily open.

The following new requirements apply to urgent care centers beginning October 1:

    • They must be distinguished from emergency department settings (as under current law), and also from “primary care settings” (this term is not defined);
    • Treatment by an urgent care center must be for “urgent care services” as defined by federal law (that is, services furnished to an individual who requires services to be furnished within 12 hours in order to avoid the likely onset of an emergency medical condition); and
    • Urgent care centers must offer, at a minimum, diagnostic imaging; administration of intravenous fluids; and the ability to employ minimal resuscitative methods.

Freestanding Emergency Departments (PA 18-149)

Current law prohibits the imposition of facility fees on certain outpatient hospital services provided at off-site hospital-based facilities, but an exemption exists for services provided at off-site hospital emergency departments. Beginning October 1, this exemption applies only to “freestanding emergency departments.” The new law defines “freestanding emergency department” as a freestanding facility that: (i) is structurally separate and distinct from a hospital; (ii) provides emergency care; (iii) is a department of a Connecticut-licensed hospital; and (iv) has received a certificate of need to operate as a freestanding emergency department. Freestanding emergency departments must also comply with new signage requirements.

Health Care Associated Infections (PA 18-168, §§12-13)

A new law changes DPH’s reporting system for health care associated infections. For example:

  • The reporting system must be based on nationally-recognized standards and must include not only health care associated infections but also antimicrobial resistance (AMR);
  • The law covers a larger range of health care facilities; and
  • The requirement that DPH report to the General Assembly on information collected through the mandatory reporting system is eliminated; instead, DPH is required to post this information online.

Biological Products (PA 18-74)

New laws governing prescriptions for biological products were enacted this year. For example, Connecticut has adopted the federal definition of “biological product” (that is, with certain specified exceptions, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or protein applicable to the prevention, treatment or cure of a disease or condition of human beings).

Beginning October 1, a practitioner must, prior to prescribing a biological product, discuss with the patient the treatment methods, alternatives to and risks associated with the use of the biological product and must document the discussion in the patient's medical record not later than 24 hours after the discussion has taken place. However, these provisions do not apply to hospital inpatients, emergency care, FDA-approved vaccines, blood or blood components.

Pharmacists may substitute a biological product for a prescribed biological product if certain conditions are met, including if the product is “interchangeable” (that is, the product has been licensed by the FDA and is determined to meet the federal standards for interchangeability; or the product is therapeutically equivalent to another biological product, as set forth in the FDA’s "Approved Drug Products with Therapeutic Equivalence Evaluations”). The pharmacist must notify the patient of the substitution within specified timeframes. In addition, the pharmacist must record the name and manufacturer of the interchangeable biological product in a way that notifies the prescribing practitioner, except: (i) when a refill prescription is not changed from the product dispensed on the prior filling of the prescription; or (ii) if the interchangeable biological product is dispensed by a pharmacy operated by a licensed hospital.

In addition, a number of the current laws governing the substitution of brand name drugs with generic drugs have been extended to apply to the substitution of biological products with interchangeable biological products, including labelling requirements; restrictions on the substitution of biological products that treat epilepsy; and the required signage that pharmacies must post.

Confidentiality of Personnel Records of Health Care Providers (PA 18-168, §§2-3)

Connecticut’s labor laws require an employer to maintain the confidentiality of its personnel records, subject to certain exceptions, including when a government agency receives personnel information during an investigation of the employer. A new law makes clear that when DPH receives personnel records during the course of an investigation of a person that it licenses, certifies or regulates or in a disciplinary hearing regarding such person, it may not disclose the records unless required by federal law. The law also provides that such records are not subject to disclosure under the state’s Freedom of Information Act.

Changing Requirements for Health Care Providers

New laws affecting some individual health care providers are effective October 1. For example:

  • Advanced practice registered nurses are given the authority to perform certain functions in connection with a patient’s terminal illness or advance directive that under current law must be performed by a physician or other specified provider. For example, current law provides that only physicians can determine if an individual is unable to make informed decisions regarding treatment. The new law also recognizes APRNs as such a provider (PA 18-168, §§35-39). In addition, for individuals with an intellectual disability placed or treated under the direction of the Connecticut Department of Developmental Services (DDS), APRNs may order the withholding of CPR, and can provide a second opinion on the terminal condition of a patient in connection with a medical order to withhold CPR, unless the individual has a legally valid advance directive (PA 18-32, §39).
  • A new law clarifies the differences in the scope of practice for licensed alcohol and drug counselors and certified alcohol and drug counselors (PA 18-168, §55).
  • The minimum education standards for art therapists have been revised to require a graduate degree (current law permits art therapists to hold a bachelor’s degree) (PA 18-168, §74)
  • The exemption from the licensure requirement for students studying licensed marital and family therapy, professional counseling or psychology will cease if the student has not successfully completed the licensing examination within two years after the completion of his or her supervised work experience (PA 18-168, §§42, 44-45).
  • A new law changes the qualification requirements for podiatrists who wish to engage in independent ankle surgery and supervised ankle surgery (PA 18-168, §§69-70).
  • The scope of practice for respiratory care therapists is expanded to include, among other things, the insertion of intravenous and intraosseous catheters in certain health care settings. Changes to the accreditation requirements have also been enacted, to allow, for example, accreditation by the Commission on the Accreditation for Respiratory Care (PA 18-168, §§75-76).

If you have any questions regarding these new laws (or any other laws enacted during this year’s legislative session), please contact Stephen M. Cowherd or Margaret A. Bartiromo.

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Alerts, commentary and insights from the attorneys of Pullman & Comley’s Health Care practice on legal developments affecting hospitals, physician groups, pharmaceutical and medical device companies as well as other health care providers and suppliers.

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