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Bill 3607

                    Current Status

Bill Number:                      3607
Type of Legislation:              General Bill GB
Introducing Body:                 House
Introduced Date:                  19990224
Primary Sponsor:                  Carnell
All Sponsors:                     Carnell, Lanford, Bailey
Drafted Document Number:          l:\council\bills\psd\7238ac99.doc
Companion Bill Number:            455
Residing Body:                    House
Current Committee:                Medical, Military, Public and Municipal 
                                  Affairs Committee 27 H3M
Subject:                          Home medical equipment and services 
                                  providers, Pharmacy Board to license and 
                                  regulate; Pharmacies, Pharmacists


                        History

Body    Date      Action Description                     Com     Leg Involved
______  ________  ______________________________________ _______ ____________
House   19990224  Introduced, read first time,           27 H3M
                  referred to Committee


                             Versions of This Bill

TO AMEND TITLE 40, CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING CHAPTER 80, SO AS TO AUTHORIZE THE SOUTH CAROLINA BOARD OF PHARMACY TO LICENSE AND REGULATE HOME MEDICAL EQUIPMENT AND SERVICES PROVIDERS AND TO ESTABLISH THE HOME MEDICAL EQUIPMENT ADVISORY BOARD AND TO PROVIDE FOR ITS DUTIES.

Whereas, the South Carolina General Assembly finds that home medical equipment and services providers in this State have a significant impact on the public health, welfare, and safety of its citizens, and therefore finds the regulation and control of these providers to be in the public interest; and

Whereas, the General Assembly also finds that, as a matter of public policy, home medical equipment and services providers should merit the confidence of the public and, to this end, that only qualified entities be permitted to hold themselves out to the public as home medical equipment and services providers; and

Whereas, this act must be liberally construed to best carry out these findings.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION 1. Title 40 the 1976 Code is amended by adding:

Section 40-80-10. For purposes of this chapter:

(1) 'Advisory board' means the Home Medical Equipment and Services Advisory Board created pursuant to Section 40-80-40.

(2) 'Board' means the South Carolina Board of Pharmacy created pursuant to Section 40-43-10.

(3) 'Home medical equipment and services provider' means a legal entity engaged in the business of selling, leasing, or otherwise providing home medical equipment and services, whether directly or through a contractual arrangement, to an unrelated sick or disabled individual where that individual resides.

(4) 'Home medical equipment' means technologically sophisticated medical devices, apparatuses, machines, or other similar articles usable in a home care setting including, but not limited to:

(a) oxygen and oxygen delivery systems;

(b) ventilators;

(c) respiratory disease management devices, nebulizer compressors, C-PAP, and bi-level systems;

(d) mobility devices, seating systems, and electronic and computer driven wheelchairs, excluding scooters;

(e) recording and non-recording monitors;

(f) transcutaneous electrical nerve stimulators and muscle stimulators;

(g) low air loss, air fluidized, fluidized, pressure equalization systems, or any cutaneous pressure management device;

(h) non-segmental, segmental, or sequential compression devices;

(i) compression therapy garments;

(j) ostomy prosthetic systems;

(k) neonatal home phototherapy devices;

(l) enteral therapy pumps and supporting supplies, excluding nutrients;

(m) parenteral or infusion therapy pumps and supporting supplies, excluding medications;

(n) aspiration devices and supporting supplies;

(o) hospital beds;

(p) items that bear a label that states 'Caution: Federal law requires dispensing by or on the order of a licensed medical practitioner';

(q) other similar equipment as defined by the State Board of Pharmacy in regulation.

(5) 'Home medical equipment services' means the delivery, installation, maintenance, replacement, and repair of and instruction in the use of medical equipment, legend devices and supplies, and oxygen gas or systems by a licensed provider, used by a sick or disabled individual to allow the individual to be maintained in a non-institutional environment.

(6) 'Oxygen or oxygen system' means oxygen gas, oxygen gas system, or oxygen producing equipment used by a sick or disabled individual in a non-institutional environment on an order from a licensed medical practitioner and dispensed by a licensed home medical equipment provider.

(7) 'Order' means a prescription or order for equipment, a device, supply, or gas issued by a licensed medical practitioner authorized to issue orders or prescriptions.

Section 40-80-20. (A) The State Board of Pharmacy shall issue, deny, suspend, temporarily suspend, or revoke home medical equipment and services providers licenses to entities covered under this chapter.

(B) The board, in conjunction with the Home Medical Equipment Advisory Board created pursuant to Section 40-80-40, shall promulgate regulations to administer and enforce this chapter including, but not limited to, fees and procedures for initial licensure and renewal and restoration of licenses and standards and criteria for licensure, professional conduct, discipline, and safety. Notice of proposed regulations must be submitted by the board to the advisory board for review and recommendations. A written explanation must be given by the board to the advisory board on any recommendations not incorporated into the regulations.

(C) The board may at any time seek the advice and expertise of the advisory board on any matter relating to the administration of this chapter.

(D) The board shall report quarterly to the advisory board on the status of all complaints filed with the board relating to the home medical equipment profession.

Section 40-80-30. (A) No entity may provide home medical equipment and services or use the title 'home medical equipment and services provider' in connection with his or her profession or business without being licensed pursuant to this chapter.

(B) An entity is qualified to receive a license as a home medical equipment and services provider if the entity:

(1) complies with all federal and state licensure and regulatory requirements;

(2) maintains a physical facility and medical equipment inventory;

(3) establishes proof of commercial general liability insurance including, but not limited to, coverage for products liability and professional liability;

(4) maintains records on all patients to whom it provides home medical equipment and services;

(5) makes life supportive home medical equipment and services available twenty-four hours a day, seven days a week.

(C) The board may request a personal interview of an applicant to further evaluate the entity's qualification for licensure.

(D) Nothing in this chapter may be construed to prevent or restrict the practices, services, or activities of the following unless those practices, services, or activities include providing home medical equipment and services through a separate legal entity:

(1) a person providing medical equipment or supplies used or dispensed in the normal course of treating 'in-patients' of hospitals, nursing facilities, clinics, physicians' offices, hospice programs or rehabilitation facilities;

(2) a retail entity that does not have a Part B Medicare supplier number or that does not provide home medical equipment and services in the home;

(3) a hospital, excluding a hospital-owned and hospital-related provider of home medical equipment and services;

(4) a manufacturer or wholesale distributor of home medical equipment which does not sell directly to a patient;

(5) a health care practitioner who lawfully prescribes or orders home medical equipment and services or who uses home medical equipment and services to treat patients including, but not limited to, physicians, nurses, physical therapists, respiratory therapists, occupational therapists, speech-language pathologists, optometrists, chiropractors, and podiatrists;

(6) a pharmacist, pharmacy, or home infusion pharmacy that is not engaged in the sale or rental of home medical equipment and services;

(7) a hospice program that does not engage in the sale or rental of home medical equipment and services;

(8) a nursing home;

(9) a veterinarian;

(10) a dentist; and

(11) an emergency medical service provider.

(E) A pharmacy holding a pharmacy permit issued pursuant to Chapter 43 which also qualifies as a home medical equipment and services provider must obtain a separate home medical equipment and services provider license; however, the home medical equipment and services provider license must be issued at a reduced fee established by the board in regulation.

(F) A home medical equipment and services provider who is licensed by the board is not required to obtain a separate drug outlet permit under Chapter 43 to sell, rent, or dispense medical equipment, medical equipment services, legend devices, supplies, or oxygen.

Section 40-80-40. (A) The board shall establish a Home Medical Equipment and Services Advisory Board whose members must be appointed by the State Board of Pharmacy and to whom recommendations for appointments may be made by the South Carolina Medical Equipment Services Association. The advisory board shall consist of seven members. Four of the members must be home medical equipment and services provider representatives, and of these, two members must represent businesses grossing less than five hundred thousand dollars a year in revenue and two members must represent businesses grossing more than five hundred thousand dollars a year in revenue. The remaining three members shall include one pharmacy-based home medical equipment provider, one respiratory care practitioner, and one consumer of home medical equipment and services. The home medical equipment and services provider representatives must have provided home medical equipment and services or related home care services for at least three years before being appointed, must be currently engaged in providing home medical equipment and services in the State, and must have no record of convictions related to fraud or abuse under state or federal law. The membership of the advisory board must reasonably reflect representation from the geographic areas of this State.

(B) Members shall serve four year terms and until their successors are appointed and qualified. No member may be reappointed to the advisory board for a term that would cause continuous service on the advisory board to exceed four years. Appointments to fill vacancies must be made in same manner as the original appointment for the unexpired portion of the vacated term.

(C) The membership of the advisory board must reasonably reflect representation from the geographic areas of this State. The advisory board annually shall elect one of its members as chairperson and one as vice chairperson. Members of the advisory board must be reimbursed for authorized expenses incurred in performing the duties of the office.

(D) The administrator of the board may terminate the appointment of any member for cause which in the opinion of the administrator reasonably justifies the termination.

Section 40-80-50. (A) Application for licensure must be on forms provided by the board and must be accompanied by a nonrefundable application fee established by the board in regulation. An applicant has one year from the date of application to complete the application process. If the process has not been completed in one year, the application must be dismissed, the fee forfeited, and the applicant must reapply and meet the requirements in effect at the time of reapplication. The board may, for reasonable cause, extend the one year application process period for an additional six months.

(B) A separate license is required for each provider location which provides medical equipment, medical equipment services, legend devices or supplies, or medical gases to patients in a non-institutional environment.

(C) If a home medical equipment and services provider meets the established licensure requirements, the provider shall attest to the board that it will continue to conduct that entity in accordance with the licensure standards and promulgated by the board in regulation. The attestation shall accompany the application for licensure.

(D) If the board finds that a home medical equipment and services provider license should not be issued to an applicant, the board shall notify the applicant in writing stating the reasons for refusal to issue a license. An applicant aggrieved by this action may appeal the decision pursuant to the Administrative Procedures Act.

Section 40-80-60. (A) A home medical equipment and services provider license applicant shall designate a name and address for each location to be licensed and for the management entity which has the legal authority and responsibility for the operation of the entity. A change in name or address of a provider location must be submitted to the board within thirty days of the effective date of the change.

(B) A home medical equipment and services provider license is not transferable.

(C) An entity may renew its license by paying the required fee and by meeting the renewal requirements.

(D) An entity that advertises home medical equipment and services shall, at its place of business, display the license of the entity.

(E) No entity that provides home medical equipment and services may advertise the equipment and services unless that entity includes in the advertisement the statement 'Licensed by the State of South Carolina'.

(F) A home medical equipment and services provider, otherwise in good standing, whose license has expired may have the license restored within one year of expiration by applying to the board, paying the required fees, and filing proof acceptable to the board that the provider is in compliance with the requirements of Section 40-80-30(B).

Section 40-80-70. (A) The board may refuse to issue, renew, or restore a license or may revoke, suspend, place on probation, reprimand, impose a fine not to exceed one thousand dollars for each violation, or take other disciplinary action as the board considers proper with regard to a licensee for any one or more of the following:

(1) making a material misstatement in furnishing information to the board;

(2) negligent or intentional disregard of this chapter or regulations promulgated under this chapter;

(3) conviction of a crime under the laws of the United States or any state or territory of the United States, an essential element of which is dishonesty, or conviction of a crime that is directly related to providing home medical equipment and services;

(4) making a misrepresentation to obtain licensure or in violation of a provision of this chapter;

(5) gross negligence in practice under this chapter;

(6) engaging in a pattern of practice or other behavior that demonstrates incapacity or incompetence to practice under this chapter;

(7) aiding, assisting, or willingly permitting another person to violate a provision of this chapter or a regulation promulgated under this chapter;

(8) engaging in dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud, or harm the public;

(9) discipline by another state, the District of Columbia, a territory, or foreign nation if one or more of the grounds for the discipline is substantially equivalent to a ground set forth in this subsection;

(10) directly or indirectly giving to or receiving from a person, firm, corporation, partnership, or association a fee, commission, rebate, or other form of compensation for any services not actually or personally rendered;

(11) finding that the licensee, after having its license placed on probationary status, has violated the terms of probation;

(12) wilfully falsifying records or reports or filing false records or reports in the course of providing home medical equipment and services including, but not limited to, false records or reports filed with state agencies or departments;

(13) using words or abbreviations, figures, or letters with the intention of indicating practice as a home medical equipment and services provider without a license issued under this chapter;

(14) wilfully failing to comply with federal or state laws and regulations concerning home medical equipment and services providers;

(15) soliciting professional services using false or misleading advertising;

(16) failing to display a license in accordance with this chapter.

(B) Upon the revocation or suspension of a license, the licensee shall surrender the license immediately to the board, and if the entity fails to surrender the license, the board may seize the license.

(C) At any time after the suspension or revocation of a license, the board may restore the license upon the written recommendation of the advisory board unless, after an investigation and a hearing, the advisory board determines that restoration is not in the public interest.

Section 40-80-80. (A) If an entity violates a provision of this chapter or a regulation promulgated under this chapter, the board may petition an administrative law judge pursuant to Section 40-1-100 for an order enjoining the violation or requiring compliance with this chapter. Upon the filing of a verified petition, the administrative law judge may issue a temporary restraining order, without notice or bond, and may preliminarily and permanently enjoin the violation. If it is established that the entity has violated or is violating the injunction, the administrative law judge may punish the offender for contempt of court. Proceedings under this section are in addition to, and not in lieu of, all other remedies and penalties provided under this chapter.

(B) If an entity holds itself out as a provider of home medical equipment and services without a license issued under this chapter, an interested party or any person injured thereby, in addition to the board, may petition for relief as provided for in subsection (A).

(C) If the board has reason to believe that an applicant or entity is in violation of a provision of this chapter or a regulation promulgated under this chapter, the board may investigate the alleged violation and may issue a rule to show cause why an order to cease and desist should not be entered against the applicant or entity. The rule shall clearly set forth the grounds relied upon by the board and shall provide a period of seven days from the date of the rule to file an answer to the satisfaction of the board. Failure to answer shall cause an order to cease and desist to be issued immediately.

Section 40-80-90. An entity that practices, offers to practice, attempts to practice, or holds itself out to practice as a home medical equipment and services provider without being licensed under this chapter shall, in addition to any other penalty provided by law, pay a civil penalty to the board in an amount not to exceed five thousand dollars for each offense as determined by the board. No civil penalty may be assessed until a hearing is held in accordance with the Administrative Procedures Act. The civil penalty must be paid within sixty days after the effective date of the order imposing the penalty. The order constitutes a judgment and may be filed and executed in the same manner as any judgment from any court of record.

Section 40-80-100. The board shall inspect a licensee for compliance with the requirements of this chapter and regulations promulgated under this chapter within three years after the date of initial licensure and at least once every three years thereafter. The board shall conduct random inspections upon renewal of a license, for cause or as necessary to assure the integrity and effectiveness of the licensing process. The board may authorize qualified individuals to conduct inspections and shall establish in regulation a fee for each inspection that must be paid by the licensee. Upon notice of failure to pass inspection and pending review by the advisory board, the board may suspend or deny a license, as applicable. A provider has thirty days to appeal the inspection results. On appeal, a provider has the right to an inspection review or to a new inspection in accordance with procedures adopted by the board in regulation.

Section 40-80-110. (A) Before the board refuses to issue or renew a license or disciplines a licensee, a hearing must be conducted by the advisory board in accordance with the Administrative Procedures Act.

(B) At the conclusion of the hearing, the advisory board shall present to the board a written report of its findings and recommendations. The report shall contain a finding of whether or not the accused entity violated this chapter or a regulation promulgated under this chapter. The advisory board shall specify the nature of the violation or noncompliance and shall make its recommendations to the board. The report of findings and recommendations of the advisory board must be the basis for the board's action relative to the applicant or licensee unless the board determines that the advisory board's report is contrary to the manifest weight of the evidence, in which case the board may issue an order in contravention of the advisory board's report. Findings of the advisory board are not admissible in evidence against the entity in a criminal prosecution brought for a violation of this chapter or a regulation promulgated under this chapter, but the hearing and findings are not a bar to a criminal prosecution brought for such a violation.

(C) Notwithstanding the provisions of this section, the board temporarily may suspend the license of a home medical equipment and services provider without a hearing, pending a hearing being held pursuant to this section and in accordance with the Administrative Procedures Act, if evidence in the board's possession indicates that the home medical equipment and services provider's continuation in business would constitute an imminent danger to the public.

Section 40-80-120. (A) The board shall maintain a roster of the names and addresses of all licensees and of all entities whose licenses have been suspended or revoked within the previous year. This roster must be available upon written request and payment of a reasonable fee.

(B) In order to distribute, deliver, set-up, or instruct patients in the use of equipment, supplies, or services subject to this chapter, a home medical equipment and services provider is not required to employ as staff or as a consultant a:

(1) pharmacist unless the home medical equipment and services provider is also a pharmacy which must be licensed to dispense or compound legend drugs, medications, or pharmaceuticals pursuant to Chapter 43 or state or federal regulations;

(2) respiratory therapist, respiratory therapy technician, or respiratory care practitioner unless the home medical equipment and services provider also provides clinical respiratory assessments of patients, clinical application, and clinical monitoring of pressure adjuncts or pressure monitoring adjuncts to a patient's cardio-respiratory system which requires a medical clinician or a respiratory clinician properly trained and credentialed to perform services as may be defined in law; or

(3) physician or other medical practitioner unless the home medical equipment and services provider also provides services to patients who require a physician's or other medical practitioner's training and credentialing within the scope of their practice to perform those services.

Section 40-80-130. It is unlawful for a payor to refuse payment for equipment or services rendered to patients by home medical equipment and services providers licensed under this chapter based solely on the criteria of not being accredited by a private, for-hire accrediting entity."

SECTION 2. Of those members first appointed to the Home Medical Equipment Advisory Board pursuant to Section 40-80-40 of the 1976 Code, as added by Section 1 of this act, the consumer member must be appointed to serve for one year, two members must be appointed to serve for two years, three members must be appointed to serve for three years, and one member who is a home medical equipment and services provider must be appointed to serve for four years.

SECTION 3. A home medical equipment and services provider licensed before January 1, 2001, pursuant to Title 40, Chapter 80 of the 1976 Code, as added by Section 1 of this act, is exempt from the inspection requirements of Section 40-80-100 of the 1976 Code through December 31, 2000.

SECTION 4. If any provision of this chapter is declared unconstitutional or illegal, or the applicability of this statute to any person or entity is held invalid by a court of competent jurisdiction, the constitutionality or legality of the remaining portions of this statute and the application of the statute to other persons or entities shall remain in full force and affect.

SECTION 5. This act takes effect January 1, 2000.

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