S 1051 Session 112 (1997-1998)
S 1051 General Bill, By Giese
A 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.
02/19/98 Senate Introduced and read first time SJ-2
02/19/98 Senate Referred to Committee on Medical Affairs SJ-2
A 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:
"CHAPTER 80
Home Medical Equipment and Services
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 administrator of 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 $500,000 a year in revenue and two members must
represent businesses grossing more than $500,000 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 denied, 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 or assignable without the express written permission of
the board.
(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 whose
license has expired may have the license restored by applying to the
board, paying the required fees, and filing proof acceptable to the
board as established by the board in regulation.
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 $1,000 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 $5,000 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 clinician, or other medical
clinician 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) a 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, 2000, 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, 1999.
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, 1999.
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