PA 10-117—sSB 428

Public Health Committee

Appropriations Committee

AN ACT CONCERNING REVISIONS TO PUBLIC HEALTH RELATED STATUTES AND THE ESTABLISHMENT OF THE HEALTH INFORMATION TECHNOLOGY EXCHANGE OF CONNECTICUT

SUMMARY: This act makes numerous substantive and minor changes to laws governing Department of Public Health (DPH) programs and health professional licensing and certification. The DPH program changes relate to:

1. access to patient medical records,

2. the Advisory Committee on Healthcare Associated Infections,

3. nursing home and nursing facility management certificate holder oversight,

4. the transfer of the Drinking Water State Revolving Fund administration to DPH,

5. Stem Cell Research Advisory Committee reporting requirements,

6. municipal and district health director qualifications,

7. funeral home practices,

8. chronic disease hospital emergency psychiatric admissions,

9. medical foundation providers,

10. regional emergency medical services (EMS) advisory board and regional councils,

11. designation of regional EMS coordinators as state employees,

12. Office of Oral Health director qualifications,

13. nursing home temperature levels and meals,

14. use of circulating nurses in certain operating rooms,

15. childhood immunizations,

16. oxygen-related patient care activities in hospitals, and

17. a new DPH laboratory in Rocky Hill.

The professional licensing and certification changes affect home health care agencies, long-term care facilities, homemaker-home health aide agencies, dentists, chiropractors, barbers, acupuncturists, nursing home administrators, registered nurses, licensed practical nurses, emergency medical technicians, mobile field hospitals, optometrists, foreign surgeons and physicians, radiologist assistants, child day care centers, group day care homes, marital and family therapists, paramedics, substance abuse counselors, and professional counselors.

The act also contains provisions relating to:

1. organ donation information on state tax form instructions,

2. the administration of feeding tubes by unlicensed assistive personnel in certain settings under the Department of Developmental Services' jurisdiction,

3. an exemption to the pharmaceutical wholesaler licensure requirements,

4. establishment of the “Health Information Technology Exchange of Connecticut” as a quasi-public agency for health information technology (HIT) and health information exchange (HIE) in the state,

5. collaborative drug therapy management agreements, and

6. pharmaceutical and medical device manufacturing company codes of conduct concerning interactions with health care professionals.

EFFECTIVE DATE: October 1, 2010 except as noted below.

1 — HOME HEALTH AGENCY AND NURSING HOME LICENSE RENEWALS

The act requires DPH to issue a license to a Medicare-certified home health care agency every three years, rather than biennially. This aligns Medicare's certification process, which requires triennial inspections (conducted by DPH) with license renewals.

The act also removes DPH's authority to waive licensure renewal inspection and investigation requirements for residential care homes, nursing homes, or rest homes certified by Medicare or Medicaid in the preceding year.

Finally, the act removes the DPH commissioner's authority to grant a provisional one-year license prior to an applicant's initial licensure as a home health care agency, homemaker-home health aide service, or homemaker-home health aide agency.

2-3 — ADVISORY COMMITTEE ON HEALTHCARE ASSOCIATED INFECTIONS

The act renames the Committee on Healthcare Associated Infections the Advisory Committee on Healthcare Associated Infections and makes technical revisions to reflect this change.

The act requires DPH to consider, rather than implement within available appropriations, the committee's recommendations concerning the creation of a mandatory reporting system for healthcare associated infections. It specifies that this mandatory reporting system must be designed to prevent healthcare associated infections. It also removes the requirement that these recommendations include standardized data reporting measures.

Starting in 2011, the act changes from October 1st to May 1st the annual deadline by which DPH must report to the Public Health Committee on the information it collects through the mandatory reporting system. The report must be posted on DPH's website and be available to the public.

4, 5, 20, & 65 — PATIENT MEDICAL RECORDS

Medical Records of a Healthcare Institution Ceasing Operations

By law, each licensed healthcare institution ceasing operations must give DPH, at the time it turns over its license to the department, a certified document specifying where patient records will be stored and how patients, former patients, and authorized representatives can access them. The act requires this certified document to also include provisions (1) concerning storage if the storage location closes or changes ownership and (2) granting DPH authority to enforce the certified document's provisions if the storage location closes or changes ownership.

The act imposes a civil penalty of up to $100 for each day an institution fails to comply with the terms of the certified document.

Medical Records of Retired, Deceased, or Other Providers

The act prohibits a healthcare provider from refusing to return to a patient, original or copied medical records from another provider. When returning these records, the provider may keep copies for the patient's file as long as the provider does not charge the patient for the cost of copying the records.

It also prohibits a provider who purchases or otherwise assumes a retiring or deceased provider's practice from refusing to return original or copied medical records to a patient who decides not to continue receiving care from that practice. It prohibits the successor provider from charging the patient for the cost of copying the records of the retired or deceased provider.

If a provider abandons his or her practice, the act allows the DPH commissioner to appoint a licensed healthcare provider to keep the abandoned provider's patient records and disburse them to patients upon their request.

Medical Records Related to a Provider Investigation or Disciplinary Proceeding

The act gives DPH and the professional licensing boards under its jurisdiction access to copies of patient records relating to any investigation or disciplinary proceeding of a person DPH licenses, certifies, or regulates. Except as required by federal law, the act specifies that DPH and the boards must not (1) be denied access to these records on the grounds that they are privileged or confidential and (2) further disclose these records. It also provides that these records are not subject to disclosure under the Freedom of Information Act.

Nursing Home Medical Records

The act requires a chronic and convalescent nursing home or a rest home with nursing supervision to preserve all patient medical records, regardless of whether they are in printed or electronic format, for at least seven years after the patient's (1) death at the facility or (2) discharge from the facility. Facilities may maintain all or part of these records electronically in a format that complies with accepted professional standards. It also requires the DPH commissioner to amend the Public Health Code to comply with this provision.

EFFECTIVE DATE: July 1, 2010

6-7 — DPH AND DEPARTMENT OF SOCIAL SERVICES (DSS) HEALTHCARE INSTITUTION INVESTIGATIONS

The act allows the DPH commissioner, when conducting an inquiry or investigation involving any healthcare institution, to (1) issue subpoenas and (2) order the production of books, records, and documents. The law already allows the commissioner to do this when conducting a hearing. The law also allows him to inspect facilities, administer oaths, and take testimony under oath.

The act allows the DSS commissioner, or his designee, to examine or audit the financial records of a nursing facility management certificate holder. The law already allows this for a nursing home. The act also extends to nursing facility management certificate holders the requirement to maintain (1) all financial information, data, and records of operation for at least 10 years and (2) all financial information, data, and records relating to any real estate transactions affecting its operation for at least 25 years.

When conducting an inquiry, examination, or investigation of a nursing home or nursing facility management services certificate holder, the act allows the DSS commissioner, or his designee, to (1) issue subpoenas; (2) order the production of books, records, or documents; (3) administer oaths; and (4) take testimony under oath. The commissioner may also ask the attorney general to petition the Superior Court to enforce any subpoena order. The law allows the commissioner to petition the court directly.

8 — NURSING HOME ACQUISITIONS

Prior law prohibited a nursing home operator who violated nursing home laws or had problems related to Medicare or Medicaid from acquiring a nursing home for five years. It applied to an operator with any civil penalties for nursing home violations imposed by DPH or another state over two years.

The act limits the prohibition (1) for civil penalties, to three or more imposed during the immediate two years before submitting the application, rather than any two-year period and (2) for Medicare and Medicaid sanctions, to those civil penalties over $20,000. Prior law imposed the acquisition prohibition for any intermediate Medicare or Medicaid sanctions. The application must also include any additional information the DPH commissioner deems necessary. Under the act, if any of these conditions is present, the five-year prohibition on further acquisition continues to apply.

Notwithstanding these limitations, the law allows the DPH commissioner, for good cause, to approve a potential licensee's or owner's application to acquire a nursing home before the five-year period expires.

7 & 9 — NURSING FACILITY MANAGEMENT SERVICES CERTIFICATION

The act adds to the required information an applicant must submit to DPH to obtain a nursing facility management services certificate. It defines a “nursing facility management services certificate holder” as an individual or entity DPH certifies to provide nursing facility management services. The law defines “nursing facility management services” as services provided in a nursing home to manage the home's operations, including the provision of care and services.

By law, a “nursing home facility,” is a nursing home, residential care home, or rest home with 24-hour nursing supervision (CGS 19a-521). But nursing facility management services do not serve residential care homes, thus it appears this section does not apply to these facilities.

Contact Information

The act requires an applicant, if a partnership, corporation or other legal entity, to provide the names of (1) its officers, directors, trustees, or managing and general partners and (2) anyone having 10% or more beneficial ownership interest in the applicant and a description of the person's relationship to the applicant. If the applicant is an out-of state corporation or provides nursing facility management services in another state, it must also provide a certificate of good standing from the agencies in that state that oversee corporations and public health licensing, respectively.

Prior law required an applicant to provide only its name and business address and indicate whether it is an individual, partnership, corporation, or other legal entity.

Affidavits

The act requires that each individual listed above, not just the applicants, sign the affidavits that the law requires applicants to submit disclosing the following:

1. any matter in which the person was convicted of or pleaded nolo contendere to a felony charge, or was held liable or enjoined in a civil action, if the felony or civil action involved fraud, embezzlement, fraudulent conversion, or misappropriation of property or

2. whether the person (a) has, within the past five years, had any state or federal license or permit suspended or revoked as a result of a government action related to heath care or business activity, including actions affecting the operation of a nursing, continuing care, or residential care home in Connecticut or elsewhere or (b) is subject to a current injunction, restriction, or remedial court order at the time of the application.

Disclosure of Additional Nursing Homes

The act explicitly requires an applicant to disclose the location and description of any out-of-state nursing home in which it currently provides management services or provided such services in the past five years.

Certification Determinations

The act adds a condition under which DPH may wholly or partially refuse to issue or renew a certificate. It can deny certification to provide services at one or more facilities to an applicant that (1) is an out-of state corporation or provides services in an out-of state-nursing home and (2) failed to provide a certificate of good standing from the agencies in that state that oversee corporations and public health licensing, respectively. The law already permits such denial for substantial noncompliance with the Public Health Code at a facility.

The act requires applicants to submit information in their renewal applications showing that the homes they serve comply with certification requirements and any other applicable state laws and regulations.

Investigations

The act allows DPH to conduct an inquiry or investigation concerning the issuance or renewal of a nursing facility management services certificate.

It also permits DPH, when the attorney general advises it, to conduct an investigation and seek an injunction or other action against an uncertified provider of nursing facility management services. The law already allows this for unlicensed health care institutions.

Penalties

The act allows the DPH commissioner to impose a civil penalty of up to $1,000 per day against an individual or entity operating without a nursing facility management services certificate.

10 — NURSING HOME FACILITY MAINTENANCE AND REPAIRS

By law, nursing home, residential care home, or rest home property or building owners that are not the facility's license holder must submit a copy of the lease agreement to DPH indicating the person or entity responsible for maintenance and repair. The lease must be submitted whenever the facility's license is renewed and whenever the property owner changes.

If a DPH investigation reveals any Public Health Code violations, the law allows the commissioner to require the owner to sign a consent order to bring the facility into compliance. The act allows the commissioner, alternatively, to impose a civil penalty of up to $1,000 for each day the owner violates the code or the consent order. It also permits the consent order to include the appointment of a temporary manager to complete any required improvements or repairs. It allows the attorney general, at the DPH commissioner's request, to petition the Superior Court for equitable and injunctive relief to ensure compliance with the consent order.

11 — DENTAL COMMISSION DISCIPLINARY ACTION

The act allows the Dental Commission to take disciplinary action (e. g. license suspension or revocation, censure, probation, or letter of reprimand) against a dentist for failure to maintain professional liability insurance or other indemnity against professional malpractice liability. By law, dentists providing direct patient care services must have coverage amounts of at least $500,000 per incident per individual and $1. 5 million in the aggregate.

12 — BOARD OF CHIROPRACTIC EXAMINERS DISCIPLINARY ACTION

The act allows the Board of Chiropractic Examiners to take disciplinary action against a chiropractor for failing to comply with continuing education requirements for state licensure renewal.

13 & 62 — CHIROPRACTIC LICENSURE

Licensure Without Examination

The act allows DPH to grant a license to a chiropractor without a written or practical examination if the chiropractor (1) holds a current valid license in good standing after examination by another state or territory with licensure standards comparable to Connecticut's, except for the examination and (2) has worked continuously as a licensed chiropractor in an academic or clinical setting for at least five years immediately prior to applying for licensure without examination.

Licensure Without Examination Exception

The act allows DPH to issue a chiropractor license to a person with a current, inactive chiropractor license in good standing from another state or territory. The inactive license must have been initially issued before August 1, 1995 on the basis of passing a (1) three-part clinical competency examination, (2) two-part x-ray examination, and (3) jurisprudence examination administered by the state's or territory's licensing authority. DPH may only issue such a license within 30 days of the act's effective date.

14 & 47 — ACUPUNCTURIST LICENSURE

Licensure By Endorsement

By law, an applicant seeking an acupuncturist license by endorsement must provide evidence to DPH of licensure or certification in another state or jurisdiction as an acupuncturist or as a person entitled to perform services similar to those of an acupuncturist but under a different designation. (Endorsement basically means that a licensee from another state may be eligible for licensure, without examination, in this state provided that the applicant has credentials and qualifications substantially equivalent to Connecticut's licensure requirements. )

Under the act, the other state's requirements must be equivalent to or higher than Connecticut's. Prior law required that they be only substantially similar to or higher than Connecticut's. The act retains the existing requirement that applicants have no disciplinary actions or unresolved complaints pending.

Licensure Exception

The act, notwithstanding licensure requirements, allows DPH within 30 days of the act's effective date, to issue an acupuncturist license to an applicant who presents satisfactory evidence that he or she (1) is a current licensed acupuncturist in good standing in another state, (2) was issued a license prior to September 5, 1990, (3) has a diploma from the National Board of Acupuncture Orthopedics, and (4) passed the acupuncture comprehensive exam and clean needle technique course portions of the National Certification Commission For Acupuncture and Oriental Medicine acupuncture exam.

15, 16, 52, 64, & 76 — BARBERS, HAIRDRESSERS, AND COSMETICIANS

Barber Licensure Requirements

Starting October 1, 2011, the act reduces from 1,500 to 1,000, the minimum number of hours of study an applicant must complete to obtain a barber license. These hours must be completed in an approved school, or if trained out-of-state, in a barber school or college whose requirements are equivalent to Connecticut's. The act specifies that any DPH-issued barber license is non-transferable.

Licensure Without Examination

The act removes the requirement that applicants currently licensed as either a (1) barber or (2) hairdresser and cosmetician in another state complete at least 1,500 hours of formal education and training in (1) barbering or (2) hairdressing and cosmetology respectively, in order to obtain a Connecticut license. It instead requires these applicants to have successfully completed a (1) barber education and training program or (2) hairdressing and cosmetician education and training program. It retains the existing requirement that applicants also successfully pass a written examination in the state in which they are currently licensed.

It also removes the requirement that DPH annually inform the Connecticut Examining Board for Barbers, Hairdressers, and Cosmeticians of the number of applications for hairdresser and cosmetician licenses without examination.

Exception to Barber Licensure Requirements

The act allows DPH, notwithstanding the above licensure requirements, to issue a barber license until October 1, 2011 to an applicant who (1) completed an approved 1,500 hour course in a barber or hairdressing and cosmetology school and (2) passed the written examination. This provision takes effect upon passage.

Displaying Barber Licenses

The act requires all barber shops and barber schools to post in a conspicuous place, the license of any person practicing barbering in that shop or school. It allows any local or district health director DPH authorizes to conduct inspections to assess a civil penalty of up to $100 against any school or shop owner that fails to comply with this provision.

Barber, Hairdressing, and Cosmetology Regulations

The act requires the DPH commissioner, in consultation with the Connecticut Examining Board for Barbers, Hairdressers and Cosmeticians, to adopt regulations prescribing minimum curriculum requirements for (1) barber schools and (2) hairdressing and cosmetology schools. It allows him to consult with the board and adopt a curriculum and procedures for the approval of these schools while in the process of adopting the regulations. The commissioner must publish notice of intent to adopt regulations in the Connecticut Law Journal within 30 days of implementation. The curriculum and procedures are valid until the final regulations are adopted.

17 & 71 — NURSING HOME ADMINISTRATORS

Licensure by Endorsement

The act makes both technical and substantive changes to the requirements for licensure by endorsement for nursing home administrators. By law, an applicant must hold a nursing home administrator license in another state. The act specifies that this license must be (1) in current and good standing and (2) issued based on the licensee having at least a baccalaureate degree and passing that state's licensure examination.

It also removes the requirement that an applicant be a currently practicing competent practitioner in a state with licensure requirements substantially similar to or higher than Connecticut's. It instead requires an applicant to have practiced as a nursing home administrator in another state for at least one year within the two year period preceding the application date.

In-Service Training

The act requires a nursing home administrator to ensure that all nursing home staff receive annual in-service training in an area specific to the needs of the home's patient population. The administrator must ensure that any person conducting the training is familiar with that home's patient population provided the training does not have to be conducted by a qualified social worker or qualified social worker consultant. It requires the DPH commissioner to amend the Public Health Code to reflect this.

EFFECTIVE DATE: July 1, 2010

18 — REGISTERED NURSES

The act allows a registered nurse to execute orders issued by a licensed physician assistant, podiatrist, or optometrist as long as the orders do not exceed the scope of practice of the nurse or ordering practitioner.

The law allows a registered nurse to provide medical care under the direction of a licensed physician, dentist, or advanced practice registered nurse.

19 — DPH LICENSURE REQUIREMENTS

The act prohibits DPH from issuing any license to an applicant (1) with pending professional disciplinary actions or (2) who is the subject of an unresolved complaint with a professional licensing authority in another state. It appears to apply to any health care profession under the department's regulatory jurisdiction.

21 — CONTINUING EDUCATION FOR DENTISTS

Starting October 1, 2010, the act requires the DPH commissioner, in consultation with the Dental Commission, to biennially issue a list of up to five mandatory topics for continuing education activities licensed dentists must complete during the following two-year registration period. The list applies to registration periods beginning on and after October 1, 2011.

Under prior law, continuing education topics were limited to (1) infectious diseases, including AIDS and HIV; (2) access to care; (3) risk management; (4) special needs patient care; and (5) domestic violence. Licensees were required to complete at least one hour of continuing education in each of these topics within the two-year registration period. The law, unchanged by the act, requires licensees to complete at least 25 hours of qualifying continuing education every two years.

22-25 & 29 — EMERGENCY MEDICAL SERVICES

Definitions

The act substitutes the terms (1) “emergency medical technician” for “emergency medical technician-intermediate” and (2) “emergency medical responder” for “medical response technician” in the definition of “emergency medical technician. ” It also adds the following definitions into the EMS laws:

1. “advanced emergency medical technician” means a person who is certified as such by DPH;

2. “emergency medical responder” means a person who is certified as such by DPH;

3. “medical oversight” means active surveillance by mobile intensive care physicians sufficient to assess overall practice levels defined by statewide protocols;

4. “mobile intensive care” means pre-hospital care involving invasive or definitive skills, equipment, procedures, and other therapies;

5. “Office of Emergency Medical Services” (OEMS) means the office established by law within DPH; and

6. “sponsor hospital” means a hospital that has (1) agreed to maintain staff to provide medical oversight, supervision, and direction to an emergency medical services organization and its personnel and (2) been approved by OEMS for such activity.

It also makes other technical and conforming changes.

Policies and Procedures

The act allows the DPH commissioner to implement policies and procedures concerning training, recertification, and licensure or certification reinstatement of (1) emergency medical responders, (2) emergency medical technicians, (3) advanced emergency medical technicians, and (4) paramedics while in the process of adopting them in regulation. The commissioner must publish notice of intent to adopt regulations in the Connecticut Law Journal within 30 days of implementation. These policies are valid until the final regulations are adopted.

The commissioner may implement these policies and procedures notwithstanding (1) the department's existing regulatory requirements and (2) EMS laws regarding reinstatement of expired certificates.

EFFECTIVE DATE: Upon passage, except for the new definitions which take effect October 1, 2010.

26-27 — RADIOLOGIST ASSISTANTS

The act removes the requirement that a radiologist assistant perform (1) contrast media administration and (2) needle or catheter placement under the personal supervision of a supervising radiologist. (Personal supervision means a supervising radiologist must be in the room during the procedure. )

Starting July 1, 2011, the law creates a new license category for radiologist assistants, but only if DPH has appropriations to implement it. If this licensure goes forward, the act applies the same supervision criteria to radiologist assistants.

EFFECTIVE DATE: Upon passage except for the provision pertaining to licensure which takes effect July 1, 2011.

28 & 67 — MARITAL AND FAMILY THERAPISTS

Definition

The act expands the statutory definition of “martial and family therapy” to include the diagnosis and treatment of emotional disorders within the context of marriage and family systems. Under prior law, such therapy included only the evaluation, assessment, counseling, and management of these disorders.

Licensure Without Examination

The act extends licensure without examination to marital and family therapists licensed or certified in another territory or commonwealth. Those licensed in other states can already obtain a license without examination. Under the act, an applicant can obtain a license this way if these jurisdictions' licensing standards are equivalent to or greater than Connecticut's. Prior law required that they only be substantially similar to or higher than Connecticut's. The act retains the existing requirement that applicants have no disciplinary actions or unresolved complaints pending.

Notwithstanding these requirements, the act allows an applicant currently licensed or certified in another state, territory, or commonwealth, whose standards are not equivalent to or higher than Connecticut's to substitute five years of licensed or certified work experience in lieu of Connecticut's clinical training requirements.

30 & 75 — CHILD DAY CARE LICENSING

Licenses Non-Transferable

The act makes a DPH-issued child day care center or group day care home license non-transferable. By law, these licenses are issued for four-year terms and renewable upon payment of the licensing fees.

Exemption

The act exempts DSS-contracted teen pregnancy prevention programs providing services to children ages 10 to 19 from day care licensing requirements.

EFFECTIVE DATE: Upon passage

31 — PARAMEDIC LICENSURE

The act allows a paramedic currently licensed by a state with licensing requirements equal to or higher than those in Connecticut to be eligible for licensure as a paramedic in Connecticut.

32-33 & 60 — MOBILE FIELD HOSPITALS

The act makes technical and conforming changes to relocate the definition of a mobile field hospital from the statute concerning the licensing of institutions to the statute concerning the DPH mobile field hospital board. Removing the definition from the institutional licensing statute means the state does not have to license these hospitals.

34-41 — CLEAN WATER FUND

Drinking Water State Revolving Fund Management

The act makes several changes, primarily technical, to transfer the primary responsibility for management and administration of the Clean Water Fund's Drinking Water State Revolving Fund from the Department of Environmental Protection (DEP) to DPH, codifying current practice. (The fund consists of federal revolving loan and state accounts. )

By law, the fund may be used in specific ways to provide financial assistance for the construction of eligible DPH-approved drinking water projects, administration and management of drinking water programs, and for other federally authorized purposes. The act allows the DPH commissioner to administer this financial assistance including loans, grants, principal forgiveness, negative interest loans, or combinations of these, if permitted by federal law and made according to a legally authorized project funding agreement.

If permitted by federal law, the DEP commissioner could previously issue project loans to disadvantaged communities under different terms, such as reduced interest rates or extended repayment. The act instead allows the DPH commissioner to do this for any project, not just those in disadvantaged communities, in conjunction with the state treasurer.

In transferring the fund's management to DPH, the act requires the department to assume responsibilities such as administering the fund's subaccounts, funding studies and surveys to assess drinking water needs and priorities, maintaining a priority list for project selection, and representing the state in funding agreements with eligible projects. It also requires DPH to consult with the state treasurer, in addition to the Office of Policy and Management secretary, before paying the fund's administrative and management costs.

The act allows drinking water state account funds to be used by the state treasurer to pay debt service on bonds the state issued to fund drinking water programs under the Clean Water Fund at any time. Prior law allowed the funds to be used in this manner only if they were not required for the fund's purposes.

Regulations

The act requires DPH to adopt regulations pertaining to the Clean Water Fund's drinking water federal revolving and state accounts and eligible drinking water projects. Prior law required DPH to adopt such regulations jointly with DEP.

Definitions

The act makes technical changes to several definitions pertaining to the Clean Water Fund to reflect the administrative transfer of the Drinking Water State Revolving Fund to DPH. It also changes the definition of “eligible project costs” to specify that if the eligible drinking water project recipient is a water company, the DPH commissioner must determine the project's total costs in consultation with the Department of Public Utility Control.

The act also makes technical and conforming changes.

42 — UNLICENSED ASSISTIVE PERSONNEL

The act permits unlicensed assistive personnel to administer jejunostomy and gastrojejunal tube feedings to people who attend day programs or respite centers, reside in residential facilities, or receive support under the Department of Developmental Services' (DDS) jurisdiction. These feedings must be performed by trained, unlicensed personnel under the written order of either a (1) physician, (2) advanced practice registered nurse, or (3) physician assistant, who is licensed to prescribe.

43 — STEM CELL RESEARCH ADVISORY COMMITTEE

The act removes the requirement that the Stem Cell Research Advisory Committee annually report, until June 30, 2015, to the governor and the General Assembly on (1) the amount of grants awarded from the Stem Cell Research Fund to eligible institutions, (2) grant recipients, and (3) the current status of stem cell research in the state.

44 — MANAGED RESIDENTIAL COMMUNITY REGULATIONS

The act deletes the requirement that the DPH commissioner adopt regulations concerning managed residential communities.

45-46 — LOCAL HEALTH DIRECTORS

Starting October 1, 2010, the act requires any municipal or district health director nominee to (1) be a licensed physician and hold a public health degree from an accredited school, college, university or institution or (2) hold a graduate public health degree from an accredited school, college, or institution. It exempts from these educational requirements any municipal or district health director nominated or appointed prior to October 1, 2010.

Prior law required a municipal health director nominee to be either (1) a licensed physician or (2) hold a graduate public health degree. This degree must have resulted from at least one year of training, including at least 60 hours in local public health administration in a recognized public health school. Prior law allowed the DPH commissioner to approve a combination of training and experience in lieu of this educational requirement.

Prior law required district health nominees to be either (1) a doctor of medicine with a public health degree resulting from at least one year of special public health training (or that meets qualifications prescribed by the DPH commissioner) or (2) trained in public health and hold a public health master's degree.

48 — FUNERAL HOME PRACTICES

The law requires placing any body entombed in a crypt or mausoleum in a zinc-lined or plastic container (made of acrylonitrile butadiene styrene (ABS)) or, if the cemetery permits, a non-rusting or ABS sheeting tray. The act requires the use of a nationally-accepted composite instead of ABS. The use of zinc-lined containers remains unchanged under the act.

49 — SUBSTANCE ABUSE COUNSELORS

The act requires any state-employed alcohol and drug counselor to be licensed or certified unless he or she is, on October 1, 2010, a rehabilitation counselor acting in the capacity of an alcohol and drug counselor.

Prior law exempted all state-employed alcohol and drug counselors from licensure and certification requirements except for Department of Correction substance abuse counselors or supervisors.

50 — DEFINITION OF PROFESSIONAL COUNSELING

The law defines professional counseling as the application, by those trained in counseling, of established principles of psycho-social development and behavioral science to evaluate, assess, analyze, and treat emotional, behavioral, or interpersonal dysfunction or difficulties interfering with mental health and human development. The act expands this definition to include the diagnosis of such dysfunction or difficulties.

51 — COMMITMENT TO A CHRONIC DISEASE HOSPITAL

The law prohibits emergency psychiatric admission to a chronic disease hospital if the placing physician believes the person is suicidal or homicidal. The act allows such an admission if the hospital is certified under Medicare as an acute care hospital with an inpatient prospective payment system excluded psychiatric unit.

EFFECTIVE DATE: Upon passage

53 — OPTOMETRISTS AS MEDICAL FOUNDATION PROVIDERS

The act allows optometrists to provide health care services as part of a medical foundation. The law already allows licensed physicians, chiropractors, or podiatrists to do this.

The law allows any hospital or health system to organize and become a member of a medical foundation to practice medicine and provide health care services as a medical foundation through its employees or agents who are licensed physicians and through other providers.

54-58 & 95 — REGIONAL EMERGENCY MEDICAL SERVICES

Regional EMS Coordinators Now State Employees

The act repeals the requirement that regional EMS councils, or in regions without a council the DPH commissioner, appoint a regional EMS coordinator. It instead requires any regional EMS coordinator or assistant regional EMS coordinator employed on June 30, 2010 to be offered an unclassified durational position within DPH from July 1, 2010 to June 30, 2011. It limits the number of these positions to five and allows them to extend beyond June 30, 2011 only if appropriations are available.

The act requires the administrative services commissioner to establish job classifications and salaries for these positions, which must be located at DPH offices. It exempts the positions from collective bargaining requirements and provides that these employees do not (1) have reemployment or any other rights extended to unclassified employees under a State Employee's Bargaining Agent Coalition (SEBAC) agreement or (2) receive credit for any purpose for services performed prior to July 1, 2010.

It requires the Tobacco and Health Trust Fund to transfer any available FY 2011 funds for regional EMS councils to DPH to establish these positions.

Emergency Medical Services (EMS) Advisory Board

The act removes the EMS Advisory Board's 41 member limit and adds to its membership the state's five appointed regional medical services coordinators (see above). The board (1) advises DPH on EMS; (2) coordinates EMS efforts;  (3) makes legislative recommendations; and (4) reviews EMS regulations, guidelines, and policies.

Regional EMS Councils

The act changes the role of regional EMS councils from area-wide EMS planning and coordinating agencies to advisory councils to the DPH commissioner on EMS planning and coordination for each region.

The act requires regional EMS coordinators, in consultation with the commissioner, to assist these councils in developing the regional EMS delivery plan required by existing law. Councils must submit this plan every five years to OEMS and submit annual updates detailing their progress.

It also requires each regional EMS coordinator, as directed by the DPH commissioner, to facilitate the work of its respective regional EMS council including, representing DPH at any Council Regional Chairpersons meetings.

It also makes technical changes.

EFFECTIVE DATE: July 1, 2010

59 — OFFICE OF ORAL PUBLIC HEALTH

The act requires the director of the DPH Office of Oral Public Health to (1) be a licensed dentist or dental hygienist and (2) have a graduate public health degree. Prior law required the director to be an experienced licensed public health dentist.

61 — FOREIGN PHYSICIANS AND SURGEONS LICENSURE EXEMPTION

The act exempts a foreign physician or surgeon from state licensure requirements if he or she is participating in supervised clinical training under the direct supervision and control of a licensed physician at either a (1) Connecticut licensed hospital with an Accreditation Council for Graduate Medical Education-accredited residency program or (2) Connecticut primary affiliated teaching hospital of a medical school accredited by the Liaison Committee on Medical Education. The act requires the hospital to verify that the foreign physician or surgeon holds a current, valid license in another country.

EFFECTIVE DATE: Upon passage

63 & 77-78 — NURSING HOMES

Temperature Levels

The act allows a chronic and convalescent nursing home or a rest home with nursing supervision to maintain temperatures in resident rooms and other areas residents use that are lower than Public Health Code minimum standards if they comply with federal “comfortable and safe” temperature standards. (Federal regulations require nursing homes initially certified after October 1, 1990 to maintain a temperature range of 71-81 degrees Fahrenheit (42 CFR 483. 15(h)(6)). ) It also requires the DPH commissioner to amend the Public Health Code to conform to this provision.

The act removes the requirement that DPH (1) adopt recommendations for temperature levels in nursing homes; (2) make them available to nursing homes, rest homes, and the public; and (3) post them on its website.

Meals

The act allows a nursing home to extend from 14 to 16 hours, the maximum time span between the patient's evening meal and breakfast the following day if such an extension complies with federal law. (Federal regulations allow the extension if the residents agree to this time span and the home serves a bedtime snack (42 CFR 483. 35(f)(4))).

The act allows a home, when providing a bed-time snack to patients required under the Public Health Code, to verbally offer the snack and to not serve it to patients who decline. It also requires the DPH commissioner to amend the Public Health Code to conform to this provision.

EFFECTIVE DATE: July 1, 2010

Stretchers

The act allows a nursing home to provide one stretcher per floor regardless of whether the floor contains multiple nursing units. It also requires the DPH commissioner to amend the Public Health Code to conform to this provision.

EFFECTIVE DATE: July 1, 2010

66 — OPTOMETRIST CONTINUING EDUCATION

The act requires the Connecticut Board of Examiners for Optometrists to approve all optometrist continuing education courses. By law, licensed optometrists must complete at least 20 hours of continuing education during each registration period (the 12-month period for which a license has been renewed) based on DPH regulations.

68-70 — LICENSED PRACTICAL NURSES

Licensure Without Examination

The act allows DPH to issue a licensed practical nurse (LPN) license without examination to an individual licensed in another state, commonwealth, territory, or the District of Columbia whose licensure requirements are equivalent to or higher than Connecticut's. Prior law required that they only be substantially similar to or higher than Connecticut's.

If an applicant obtained a license in another state, district, territory, or commonwealth by either (1) partially completing a registered nursing education program or (2) completing a practical nursing education program shorter than Connecticut's minimum requirements, he or she may substitute licensed clinical work experience. This experience must (1) be performed under the supervision of a licensed registered nurse, (2) occur after completion of a nursing education program, and (3) when combined with the applicant's educational program, equal or exceed the minimum program length for approved LPN education programs in Connecticut.

Licensure Exception

Under the act, a person is eligible for licensure as a LPN if he or she successfully completes by December 31, 2010 (1) at least 1,500 education and training hours in a registered nursing education program approved by the Connecticut Board of Examiners for Nursing and (2) the state licensure examination.

EFFECTIVE DATE: Upon passage

Licensure Reinstatement

Notwithstanding state law, the act allows any person previously licensed as an RN or LPN whose license became void solely because he or she failed to pay the 2007 supplemental annual professional services fee to apply to the DPH commissioner for license reinstatement. The commissioner must reinstate the license without imposing any requirements or conditions on the applicant other than filing the application and paying the current fee. A person may apply for license reinstatement in this manner until December 31, 2010.

EFFECTIVE DATE: Upon passage

72 — PHARMACEUTICAL WHOLESALERS

The act exempts from the pharmaceutical wholesaler licensure requirements, a pharmacy within a licensed hospital that contains another hospital wholly within its physical structure and supplies the contained hospital with either (1) noncontrolled drugs or (2) schedule II, III, IV, or V controlled substances it normally stocks. The hospital must stock these drugs to meet the needs of the contained hospital's patients receiving inpatient care as indicated by an authorized practitioner's prescription or medication order.

The law already exempts from the licensure requirements a retail pharmacy or pharmacy within a licensed hospital that supplies another pharmacy with noncontrolled drugs or schedule III, IV, or V controlled substances normally stocked to provide for immediate patient needs according to an authorized practitioner's prescription or medication order. The act extends the exemption to such pharmacies that supply schedule II controlled substances (e. g. methadone, morphine, oxycodone).

73 — CIRCULATING NURSES

The act requires any hospital or outpatient surgical facility to ensure that a circulating nurse is assigned to, and present for the duration of, each surgical procedure performed in its operating room.

It prohibits the hospital or facility from assigning a circulating nurse to concurrent or overlapping surgical procedures. A circulating nurse assigned to a surgical procedure must be present for its duration unless it is necessary for the nurse to leave the operating room as part of the procedure or the nurse is relieved by another circulating nurse.

Under the act, a “circulating nurse” is a licensed registered nurse who is (1) educated, trained, or experienced in perioperative nursing and (2) responsible for coordinating the nursing care and safety needs of a patient in an operating room. Perioperative nursing means nursing services provided to patients before, during, and immediately after a surgical procedure.

74 — NEW DPH LABORATORY

The act requires DPH to ensure that the new state public health laboratory in Rocky Hill will be constructed and operated according to all applicable biosafety level criteria prescribed by the National Centers for Disease Control and Prevention Office of Health and Safety. The laboratory's construction must enable its operation and administration to conform to biosafety level (BSL) 3 criteria as prescribed by the national centers. Its design or construction cannot include any component that would allow BSL 4 activities at the laboratory. The act also prohibits (1) activities at the new laboratory that exceed BSL 3 and (2) any person, entity, or state agency from applying for or seeking permission to convert the laboratory into one conducting BSL 4 activities (see BACKGROUND).

79 — CHILDHOOD IMMUNIZATIONS

The act requires the DPH commissioner to determine the standard of care for childhood immunizations in Connecticut based on the recommended schedules of the (1) National Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, (2) American Academy of Pediatrics, and (3) American Academy of Family Physicians.

Prior law required the standard of care to be the recommended immunization schedule of either the (1) American Academy of Pediatrics' Committee on Infectious Diseases or (2) National Immunization Practices Advisory Committee, as determined by the DPH commissioner.

80 — OXYGEN-RELATED PATIENT CARE ACTIVITIES IN HOSPITALS

The act allows a hospital to designate any licensed healthcare provider and any certified ultrasound or nuclear medicine technician to perform the following oxygen-related patient care activities in hospitals: (1) connecting or disconnecting oxygen supply; (2) transporting a portable oxygen source; (3) connecting, disconnecting, or adjusting the mask, tubes, and other patient oxygen delivery apparatus; and (4) adjusting the oxygen rate or flow consistent with a medical order.

Under the act, a designated provider or technician may perform these activities only to the extent permitted by hospital policies and procedures, including applicable bylaws, rules, and regulations. The hospital must document that each designee is property trained, either through (1) his or her professional education or (2) training provided by the hospital. It must also require each designee to complete annual competency testing.

It specifies that the act does not apply to any type of (1) ventilator, (2) continuous positive airway pressure or bi-level positive airway pressure unit, or (3) any other noninvasive positive pressure ventilation.

81 — ORGAN DONATION ON STATE TAX FORM INSTRUCTIONS

In order to help taxpayers to become registered organ donors, the act requires the revenue services commissioner to include in state tax return form instructions, information that (1) indicates how a taxpayer may contact an organ donor registry organization or (2) provides electronic links to appropriate organ donor registry organizations.

82-90 & 96 — HEALTH INFORMATION TECHNOLOGY

The act establishes the “Health Information Technology Exchange of Connecticut” as a quasi-public agency for health information technology (HIT) and health information exchange (HIE) in the state. (The act refers to this entity as the “authority” throughout. ) It designates the authority as the lead HIE organization for the state beginning January 1, 2011. Under prior law, DPH was the designated lead HIE organization for the state.

Under the act, the authority takes over DPH's responsibilities for the implementation and periodic review of the HIT plan. This includes the implementation of an integrated statewide electronic health information infrastructure for sharing electronic health information among health care facilities, health care professionals, public and private payors, and patients. The authority, instead of DPH, must also develop standards and protocols for privacy in sharing electronic health information.

Prior law also established a Health Information Technology and Exchange (HITE) Advisory Committee. The act replaces the HITE advisory committee with an authority board of directors. Board members are appointed by the governor and legislative leaders. The board also includes the lieutenant governor and the DPH commissioner who is the chairperson. Other executive branch officials serve as ex-officio, nonvoting members.

The act allows the authority to establish or designate subsidiaries to create, develop, coordinate, and operate a statewide health information exchange or for other approved purposes.

Health Information Technology Exchange of Connecticut

Creation and Purposes. The act creates the exchange (authority) as a quasi-public agency and adds the authority to the statutes governing quasi-public agencies. The purposes of the authority include promoting, planning, designing, developing, assisting, acquiring, constructing, maintaining, equipping, reconstructing, and improving health care information technology. Public funds may be spent to carry out these purposes. The authority is not a state department, institution, or agency.

Under the act, the authority can:

1. establish a state office;

2. employ assistants, agents, and other employees as necessary who are exempt from the classified service and not employees as defined in the collective bargaining law;

3. establish all necessary or appropriate personnel practices and policies concerning hiring, promotion, compensation, retirement, and collective bargaining, which do not have to follow the existing state law on collective bargaining for state employees (the authority is not an employer as defined under that law);

4. use consultants, attorneys, and other experts as necessary;

5. acquire, lease, purchase, own, manage, hold, and dispose of personal property and lease, convey, deal, or enter into agreements concerning such property on any terms necessary to carry out these purposes;

6. obtain insurance against loss concerning its property and other assets;

7. enter into necessary contracts or agreements to perform its duties and such contracts are not subject to approval by any other state department or agency, but copies must be kept by the authority as public records subject to the proprietary rights of the parties;

8. consent to termination, modification, forgiveness, or other change in contract rights, payments, royalties, contracts, or agreements that the authority is a party to, to the extent allowed under contracts with others;

9. receive and accept aid or contributions from any source;

10. invest any funds not needed for immediate use or disbursement;

11. account for and audit authority funds and funds of any recipients of authority funds;

12. sue and be sued, plead and be impleaded, and adopt and alter a seal;

13. adopt regular procedures for exercising its powers that do not conflict with other statutes; and

14. do all acts necessary and convenient to carry out its purposes.

Board of Directors Members and Appointing Authorities. Under the act, the authority is managed by a 20-member board of directors. Members are:

1. the lieutenant governor;

2. the DPH, DSS, and Department of Consumer Protection (DCP) commissioners and Department of Information Technology's (DOIT)'s chief information officer;

3. three members appointed by the governor, one who is a representative of a medical research organization, one an insurer or representative of a health plan, and one an attorney with experience in privacy, health care data security, or patient rights;

4. three appointed by the Senate president pro tempore, one with background in a private-sector health information exchange or HIT entity; one with public health expertise; and one who is a licensed physician in a practice of no more than ten physicians and not employed by a hospital, health network, health plan, health system, or academic institution or university;

5. three appointed by the House speaker, one a representative of hospitals, an integrated delivery network, or hospital association; one with expertise with federally qualified health centers; and one a consumer or consumer advocate;

6. a primary care physician whose practice uses electronic health records, appointed by the Senate majority leader;

7. a consumer or consumer advocate, appointed by the House majority leader;

8. a pharmacist or other health care provider that uses health information exchange, appointed by the Senate minority leader; and

9. a large employer or representative of a business group, appointed by the House minority leader.

The OPM secretary and the healthcare advocate, or their designees, are ex-officio, nonvoting members. The DPH commissioner is the board's chairperson.

Board membership and the respective appointing authorities are basically the same as for the existing HITE committee. (The chairperson of the HITE committee is chosen by its members, while the act designates the DPH commissioner as the chairperson).

Board members are not compensated, but can receive actual and necessary expenses incurred in performing official duties. The board must employ a chief executive officer (CEO) responsible for administering the authority's programs and activities according to the board's established policies and objectives. The CEO serves at the board's pleasure which determines his or her compensation. The CEO can employ others as designated by the board and must attend all board meetings, keep records, and maintain and keep all books and documents filed with the authority.

Board Members' Terms. Initial board appointments must be made by October 1, 2010, with the initial term for the governor-appointed members being four years. For members appointed by the House speaker the term is three years, for those appointed by the House and Senate minority leaders, two years. The initial term for the members appointed by the Senate president and majority leader is one year. Terms expire on September 30 of each year. Vacancies must be filled by the appointing authority for the rest of the term. Other than the initial term, a member serves for four years. No board member can serve more than two terms. Members can be removed by the appointing authority for misfeasance, malfeasance, or willful neglect of duty.

The first board meeting must be held by November 1, 2010. A member failing to attend three consecutive meetings or 50% of all meetings during a calendar year is deemed to have resigned.

Conflicts of Interest, Ethics. The act provides that it is not a conflict of interest for a trustee, director, partner, officer, stockholder, proprietor, counsel, or employee of any person, firm, or corporation to serve as a board member, provided the individual abstains from deliberation, action, or vote by the board in specific respect to such person, firm, or corporation. All members are considered public officials and must follow the code of ethics for public officials.

Board Direction. The board must direct the authority concerning: (1) implementation and periodic revisions of the HIT plan submitted as required by law, including implementation of an integrated statewide electronic health information infrastructure for sharing electronic health information among health care facilities, health care professionals, public and private payors, state and federal agencies, and patients; (2) appropriate protocols for health information exchange; and (3) electronic data standards to assist the development of a statewide, integrated electronic health information system for use by health care providers and institutions that receive state funding.

The electronic data standards must:

1. include provisions on security, privacy, data content, structures, format, vocabulary, and transmission protocols;

2. limit the use and dissemination of an individual's social security number (SSN) and require its encryption;

3. require privacy standards no less stringent than the “Standards for Privacy of Individually Identifiable Health Information” established under the federal Health Insurance Portability and Accountability Act (HIPAA);

4. require that individually identifiable health information be secure with access to it traceable by an electronic audit trail; and

5. be compatible with any national data standards to allow for interstate interoperability, permit collection of health information in a standard electronic format, and be compatible with the requirements for an electronic health information system as these terms and requirements are defined under existing law (CGS 19a-25d).

The board can consult with public or private parties as it finds desirable in exercising its duties.

Grants. Applications for grants from the authority must be made on a board-prescribed form. The board must review applications and decide whether to make an award. The board may consider as a condition for receiving a grant, the applicant's financial participation and any other factors considered relevant.

Reports. By February 1, 2011 and annually until February 1, 2016, the authority's CEO must report to the governor and the General Assembly on (1) any private or federal funds received during the preceding year and how they were spent, (2) grant recipients and amounts, and (3) the current status of HIE and HIT in the state.

Previously, the DPH commissioner and the HITE Advisory Committee had to make these reports from 2010 to 2015.

Contracts. Under the act, the state pledges and agrees with any person the authority contracts with that it will not limit or alter the rights vested in the authority until such contracts and obligations are fully met and performed by the authority. But nothing precludes limitation or alteration if adequate provision is made by law to protect those entering into contracts with the authority.

Taxes. Under the act, the authority is exempt from all state or local franchise, corporate business, property, and income taxes. But it is not exempt from taxes levied concerning the manufacture or sale of any products which are the subject of an agreement made by the authority.

Subsidiaries. The act authorizes the authority to establish or designate one or more subsidiaries (1) to create, develop, coordinate, and operate a statewide health information exchange or (2) for other purposes prescribed by board resolution, which must be consistent with the authority's purposes. Each subsidiary is a quasi-public agency for statutory purposes.

The act allows the authority to transfer to a subsidiary any money and real or personal property. A subsidiary has all the privileges, immunities, tax exemptions, and other exemptions of the authority. An authority resolution must prescribe the purposes for forming a subsidiary.

Each subsidiary can sue and be sued, provided the liability of each subsidiary is limited solely to its assets, revenues, and resources and without recourse to the general funds, revenues, resources, or any other assets of the authority or any other subsidiary.

Each subsidiary has the power to do all acts and things necessary or convenient to carry out its purposes including: (1) solicit, receive and accept aid, grants, or contributions from any source of money, property, labor, or other things of value, subject to the conditions upon which such grants and contributions are made, including gifts, grants, or loans from any department, agency, or quasi-public agency of the United States or the state, or from any organization recognized as a nonprofit organization; (2) enter into agreements on terms and conditions consistent with the purposes of the subsidiary; and (3) acquire, lease, manage, hold and dispose of real and personal property and lease, convey, or deal in or enter into agreements with respect to such property.

Each subsidiary must act through its board of directors, not less than 50% of whom must be members of the board of directors of the authority or their designees.

Officers, directors, designees, or employees appointed as a member, director or officer of a subsidiary are not personally liable for the debts, obligations, or liabilities of the subsidiary as provided by law. Each subsidiary must, and the authority may, provide for the indemnification to protect, save harmless, and indemnify such officer, director, designee, or employee as provided by law.

The authority or any subsidiary may take actions necessary to comply with the provisions of the Internal Revenue Code to qualify and maintain the subsidiary as a tax exempt corporation.

The authority may make loans or grants to, and may guarantee specified obligations of, any subsidiary, following standard authority procedures, from the authority's assets and the proceeds of its bonds, notes and other obligations. The source and security, if any, for the repayment of any such loans or guarantees must be derived from the subsidiary's assets, revenues, and resources.

Lead Health Information Exchange (HIE) Organization

Prior law designated DPH as the state's lead HIE organization and required the department to seek private and federal funds, including those available under the federal American Recovery and Reinvestment Act (ARRA) for the initial development of a statewide HIE. DPH can use any private or federal funds it receives to establish HIT pilot programs and grant programs.

The act designates DPH as the state's lead HIE organization until December 31, 2010. It eliminates the pilot and grant program language. Beginning January 1, 2011, the act designates the Health Information Technology Exchange of Connecticut as the lead HIE organization for the state. It must continue to seek private and federal funds for the initial development of a statewide HIE. DPH may contract with the authority to transfer unexpended ARRA funds it received for the initial development of a statewide HIE. Within available resources, the authority can provide grants for the advancement of HIT and HIE.

Prior law required DPH to (1) assist with implementation and periodic revisions of the HIT plan after its initial submittal, including implementing an integrated statewide infrastructure for sharing electronic health information among health care facilities, health care professionals, public and private payors, and patients. The act adds sharing the information among state and federal agencies as well. The act specifies that DPH is responsible for these activities until December 31, 2010. After that time, the exchange (authority) is responsible for the implementation and periodic revisions of the HIT plan. Other DPH duties concerning developing privacy standards and protocols for sharing HIE become the responsibility of the authority as described above.

Bonding and Other Financial Incentives

The act extends to the authority requirements already applicable to several other quasi-public authorities. These are that it obtain the state treasurer's or deputy treasurer's approval before:

1. borrowing money or issuing bonds or notes backed by either a state guarantee or any kind of capital reserve fund that includes a state contribution or guarantee or

2. entering into any agreement or contract to moderate interest rate fluctuations or concerning interest rates, currency, cash flow, or similar issues that subjects any state-guaranteed or state-funded capital reserve fund to potential liability.

By law, the state treasurer's approval, in the first case, must be based on the authority's documenting that it has enough revenue to (1) pay off the bond or note principal and interest; (2) establish and maintain advisable reserves to secure the payment of principal and interest; (3) if applicable, pay the cost of maintaining, servicing, and insuring the purpose for which the bonds or notes are issued; and (4) pay other required costs. In the second case, the authority must demonstrate that its revenue is sufficient to meet the agreement's financial obligations.

The borrowing and interest rate agreement approval requirements already apply to the Connecticut Development Authority, Connecticut Health and Educational Facilities Authority, Connecticut Higher Education Supplemental Loan Authority, Connecticut Housing Finance Authority, the Connecticut Housing Authority, Connecticut Resources Recovery Authority, and Capitol City Economic Development Authority.

The act also authorizes the indemnification of the authority's directors, officers, and employees from personal liability in performing their duties.

EFFECTIVE DATE: Upon passage, except for the provision repealing the existing HITE Advisory Committee which takes effect January 1, 2011.

91-92 — COLLABORATIVE DRUG THERAPY MANAGEMENT AGREEMENTS

The act allows physicians and pharmacists to enter into written collaborative drug therapy management agreements without regard to the health care practice setting or the condition being treated. The law already allows (1) physicians and hospital pharmacists and (2) physicians and pharmacists working in nursing homes to enter into such agreements.

As under existing law, these collaborative agreements must be governed by patient-specific written protocols established by the treating physician in consultation with the pharmacist. These agreements can authorize a pharmacist to implement, modify, or discontinue a drug therapy that the physician prescribes; order associated lab tests; and administer drugs.

Under the act, a pharmacist may enter into a collaborative agreement if determined competent according to regulations adopted by the DCP. Under the law, a pharmacist's competency is determined by the hospital or nursing home facility employing the pharmacist.

The act specifies that existing collaborative drug therapy provisions in effect on September 30, 2010 apply to any written protocol-based collaborative drug therapy management agreement entered into before October 1, 2010.

Expansion of Collaborative Agreement Opportunities

By law, physicians and hospital pharmacists, as well as physicians and pharmacists working in nursing homes, can enter into collaborative drug therapy management agreements. The hospital-based agreements can be for individuals receiving inpatient services as well as for certain outpatient drug therapies. The law allows hospital pharmacists to enter into agreements with physicians to manage the drug therapy of patients receiving outpatient care for diabetes, asthma, hypertension, hyperlipidemia, osteoporosis, congestive heart failure, or smoking cessation. Patients include those who qualify as targeted beneficiaries under the Medicare Part D prescription drug benefit. Protocols for both inpatient and outpatient care must be patient-specific and established by the treating physician with the pharmacist.

The act eliminates references to specific health settings where, and conditions for which, collaborative drug therapy management agreements may be implemented. Instead, the act allows them in all settings and without reference to specific health conditions or diseases. The agreements must continue to be based on written protocols.

Physician-Patient Relationship

The act specifies that in order to enter into a written protocol-based collaborative drug therapy management agreement, the physician must have a physician-patient relationship with the patient who will receive such therapy. The act defines a “physician-patient relationship” as one based on (1) the patient making a medical complaint, providing a medical history, and receiving a physical examination and (2) a logical connection between the complaint, history, examination, and any drug prescribed.

Competency Determination Regulations

By law, a pharmacist's eligibility to enter into a collaborative agreement is based on a determination of competency by the hospital or nursing home employing the pharmacist. A copy of the criteria used to determine competency must be filed with the Commission on Pharmacy. The act instead requires DCP, in consultation with DPH, to adopt regulations on competency requirements for participation in collaborative agreements. Previously, DPH, in consultation with DCP, could adopt regulations addressing the minimum content of these agreements and the written protocols necessary. The act requires adoption of the regulations described above.

93-94 — PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURING COMPANIES

The act requires pharmaceutical and medical device manufacturing companies to adopt (1) codes of conduct concerning interactions with health care professionals consistent with existing industry codes and (2) a comprehensive compliance program. It authorizes the DCP commissioner to impose civil penalties for noncompliance.

Definitions

Biologic. A “biologic” is a biological product, as defined in federal law, that is regulated as a drug under the federal Food, Drug, and Cosmetic Act.

Medical Device. “Medical device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:

1. recognized in the official National Formulary, the United States Pharmacopeia, or any of their supplements;

2. intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in people or animals; or

3. intended to affect human or animal body structure or function through primary means other than chemical reaction and is not dependent upon being metabolized to achieve its primary intended purposes.

Pharmaceutical or Medical Device Manufacturing Company. The act defines “pharmaceutical or medical device manufacturing company” as an entity (1) engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, biologics, or medical devices, either directly or indirectly, by extraction from natural substances, chemical synthesis, or a combination or these means or (2) directly engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs, biologics, or medical devices. The definition does not include a health care provider; physician practice; home health agency; or a Connecticut-licensed hospital, wholesale drug distributor, or retail pharmacy.

Adoption of Code and Compliance Program

By January 1, 2011, the act requires each pharmaceutical or medical device manufacturing company to adopt and implement a code consistent with and minimally containing all of the requirements of the Pharmaceutical Research and Manufacturers of America's (PhRMA) “Code on Interaction with Healthcare Professionals” or AdvaMed's “Code of Ethics on Interactions with Healthcare Professionals” as these codes were in effect on January 1, 2010 (see BACKGROUND).

The act also requires each such company to adopt a comprehensive compliance program according to the guidelines of the “Compliance Program Guidance for Pharmaceutical Manufacturers” dated April 2003 and issued by the federal Department of Health and Human Services Office of Inspector General.

Penalties

Upon complaint, the act authorizes DCP to investigate an alleged (1) violation of the code adoption requirement or (2) failure to conduct any training program or regular audit for compliance with the adopted code. It allows the commissioner to impose a civil penalty of up to $5,000 for any violation of these provisions.

BACKGROUND

Pharmaceutical or Medical Device Manufacturing Company Codes

The Advanced Medical Technology Association (AdvaMed) represents companies that produce medical devices, diagnostic products, and health information systems. Their voluntary code addresses third-party educational conferences; consulting arrangements; sales, promotional and other business meetings; entertainment and recreational prohibitions; meals; educational items; gift prohibitions; reimbursements; and research and educational grants.

PhRMA represents the country's pharmaceutical research and biotechnology companies. Its voluntary code on interactions with health care professionals addresses similar issues and topics.

Laboratory Biosafety Levels (BSL)

BSL 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure by inhalation. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents and are supervised by scientists who are experienced with these agents. All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment. The laboratory has special engineering and design features.

BSL 4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available (e. g. Ebola; smallpox), and other various hemorrhagic diseases. When dealing with biological hazards at this level, the use of a Hazmat suit and a self-contained oxygen supply is mandatory. The entrance and exit of a Level 4 lab will contain multiple showers, a vacuum room, an ultraviolet light room, and other safety precautions designed to destroy all traces of the biohazard. Multiple airlocks are used. Members of the laboratory staff have specific training in handling extremely hazardous infectious agents, with an understanding of primary and secondary containment functions of standard and special practices, containment equipment, and lab design characteristics. The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building. Within work areas of the facility, all activities are confined to Class III biological safety cabinets or Class II biological safety cabinets used with one piece positive pressure personnel ventilated by a life support system. The BSL 4 lab has special engineering and design features to prevent microorganisms from being disseminated into the environment. The laboratory is kept at negative air pressure, so that air flows into the room if the barrier is penetrated or breached. Also, an airlock is used during personnel entry and exit.

OLR Tracking: ND: KM: CR: DF