| 1 | The Health Care Regulation Committee recommends the following: |
| 2 |
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| 3 | Council/Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to home medical equipment providers; |
| 7 | amending s. 400.925, F.S.; revising and providing |
| 8 | definitions; amending s. 400.931, F.S.; including |
| 9 | additional categories of equipment in a report required by |
| 10 | applicants for licensure; increasing the amount of |
| 11 | liability insurance required of home medical equipment |
| 12 | providers; providing for issuance of temporary licenses; |
| 13 | amending s. 400.933, F.S.; revising requirements for |
| 14 | licensure inspections and investigations; providing for |
| 15 | assessment of fees to conduct complaint investigations; |
| 16 | amending s. 400.934, F.S.; revising minimum standards |
| 17 | required for licensure; amending s. 400.935, F.S.; |
| 18 | requiring the Agency for Health Care Administration to |
| 19 | provide additional regulatory standards by rule; creating |
| 20 | s. 400.936, F.S.; requiring proof of accreditation as a |
| 21 | prerequisite for licensure or license renewal; providing |
| 22 | for temporary licensure; providing for rules relating to |
| 23 | designation of accrediting organizations; amending s. |
| 24 | 400.95, F.S.; providing for notice of toll-free telephone |
| 25 | number to report fraud and abuse by providers; providing |
| 26 | an effective date. |
| 27 |
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| 28 | Be It Enacted by the Legislature of the State of Florida: |
| 29 |
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| 30 | Section 1. Subsection (1) of section 400.925, Florida |
| 31 | Statutes, is amended, and subsections (17), (18), (19), and (20) |
| 32 | are added to said section, to read: |
| 33 | 400.925 Definitions.--As used in this part, the term: |
| 34 | (1) "Accrediting organizations" means the Joint Commission |
| 35 | on Accreditation of Healthcare Organizations, the Community |
| 36 | Health Accreditation Program (CHAP), the Accreditation |
| 37 | Commission for Health Care, Inc. (ACHC), or other national |
| 38 | accreditation agencies whose standards for accreditation are |
| 39 | comparable to those required by this part for licensure. |
| 40 | (17) "High-tech medical equipment provider" means any home |
| 41 | medical equipment company that provides life-sustaining |
| 42 | equipment, technologically advanced equipment, or any other |
| 43 | similar equipment or product to any patient. |
| 44 | (18) "Life-sustaining equipment" means mechanical |
| 45 | ventilators or other equipment that is essential to the |
| 46 | restoration or continuation of a bodily function important to |
| 47 | the continuation of human life. |
| 48 | (19) "Technologically advanced equipment" means equipment |
| 49 | of such complexity that a licensed respiratory therapist or |
| 50 | registered nurse must set it up and train the patient in its |
| 51 | use. |
| 52 | (20) "From its own inventory" means to provide the items |
| 53 | or services directly to the patient. |
| 54 | Section 2. Paragraph (a) of subsection (2) and subsections |
| 55 | (6), (7), (9), and (17) of section 400.931, Florida Statutes, |
| 56 | are amended to read: |
| 57 | 400.931 Application for license; fee; temporary |
| 58 | provisional license; temporary permit.-- |
| 59 | (2) The applicant must file with the application |
| 60 | satisfactory proof that the home medical equipment provider is |
| 61 | in compliance with this part and applicable rules, including: |
| 62 | (a) A report, by category, of the equipment to be |
| 63 | provided, indicating those offered either directly by the |
| 64 | applicant or through contractual arrangements with existing |
| 65 | providers. Categories of equipment include: |
| 66 | 1. Respiratory modalities. |
| 67 | 2. Ambulation aids. |
| 68 | 3. Mobility aids. |
| 69 | 4. Sickroom setup. |
| 70 | 5. Disposables. |
| 71 | 6. Life-sustaining equipment. |
| 72 | 7. Technologically advanced equipment. |
| 73 | (6) The home medical equipment provider must also obtain |
| 74 | and maintain professional and commercial liability insurance. |
| 75 | Proof of liability insurance, as defined in s. 624.605, must be |
| 76 | submitted with the application. The agency shall set the |
| 77 | required amounts of liability insurance by rule, but the |
| 78 | required amount must not be less than $300,000 $250,000 per |
| 79 | claim. In the case of contracted services, it is required that |
| 80 | the contractor have liability insurance not less than $300,000 |
| 81 | $250,000 per claim. |
| 82 | (7) A provisional license shall be issued to an approved |
| 83 | applicant for initial licensure for a period of 90 days, during |
| 84 | which time a survey must be conducted demonstrating substantial |
| 85 | compliance with this section. A temporary provisional license |
| 86 | shall also be issued pending the results of an applicant's |
| 87 | Federal Bureau of Investigation report of background screening |
| 88 | confirming that all standards have been met. If substantial |
| 89 | compliance is demonstrated, a standard license shall be issued |
| 90 | to expire 2 years after the effective date of the temporary |
| 91 | provisional license. |
| 92 | (9) When a change of ownership of a home medical equipment |
| 93 | provider occurs, the prospective owner must submit an initial |
| 94 | application for a license at least 15 days before the effective |
| 95 | date of the change of ownership. An application for change of |
| 96 | ownership of a license is required when ownership, a majority of |
| 97 | the ownership, or controlling interest of a licensed home |
| 98 | medical equipment provider is transferred or assigned and when a |
| 99 | licensee agrees to undertake or provide services to the extent |
| 100 | that legal liability for operation of the home medical equipment |
| 101 | provider rests with the licensee. A temporary provisional |
| 102 | license shall be issued to the new owner for a period of 90 |
| 103 | days, during which time all required documentation must be |
| 104 | submitted and a survey must be conducted demonstrating |
| 105 | substantial compliance with this section. If substantial |
| 106 | compliance is demonstrated, a standard license shall be issued |
| 107 | to expire 2 years after the issuance of the temporary |
| 108 | provisional license. |
| 109 | (17) A home medical equipment provider against whom a |
| 110 | proceeding for revocation or suspension, or for denial of a |
| 111 | renewal application, is pending at the time of license renewal |
| 112 | may be issued a temporary provisional license effective until |
| 113 | final disposition by the agency of such proceedings. If judicial |
| 114 | relief is sought from the final disposition, the court that has |
| 115 | jurisdiction may issue a temporary permit for the duration of |
| 116 | the judicial proceeding. |
| 117 | Section 3. Subsection (2) of section 400.933, Florida |
| 118 | Statutes, is amended, and subsection (3) is added to said |
| 119 | section, to read: |
| 120 | 400.933 Licensure inspections and investigations.-- |
| 121 | (2) The agency shall accept, in lieu of its own periodic |
| 122 | inspections for licensure, submission of the following: |
| 123 | (a) the survey or inspection of an accrediting |
| 124 | organization, provided the accreditation of the licensed home |
| 125 | medical equipment provider is not provisional and provided the |
| 126 | licensed home medical equipment provider authorizes release of, |
| 127 | and the agency receives the report of, the accrediting |
| 128 | organization; or |
| 129 | (b) A copy of a valid medical oxygen retail establishment |
| 130 | permit issued by the Department of Health, pursuant to chapter |
| 131 | 499. |
| 132 | (3) In addition to any administrative fines imposed, the |
| 133 | agency may assess a survey fee of $500 to cover the cost of |
| 134 | conducting complaint investigations that result in the finding |
| 135 | of a violation that was the subject of the complaint and any |
| 136 | followup visits conducted to verify the correction of the |
| 137 | violations found in complaints. |
| 138 | Section 4. Subsections (3), (4), and (18) of section |
| 139 | 400.934, Florida Statutes, are amended, and subsection (20) is |
| 140 | added to said section, to read: |
| 141 | 400.934 Minimum standards.--As a requirement of licensure, |
| 142 | home medical equipment providers shall: |
| 143 | (3) Respond to orders received for other equipment by |
| 144 | filling those orders from its own inventory or inventory from |
| 145 | other companies with which it has contracted to fill such |
| 146 | orders; or by customizing or fitting items for sale from |
| 147 | supplies purchased under contract, except that high-tech medical |
| 148 | equipment providers shall fill all orders for technologically |
| 149 | advanced equipment directly from its own inventory and shall not |
| 150 | contract with any entity for the delivery of such orders unless |
| 151 | such entity is also licensed and accredited pursuant to this |
| 152 | part. |
| 153 | (4) Maintain trained personnel to coordinate order |
| 154 | fulfillment and schedule timely equipment and service delivery. |
| 155 | High-tech medical equipment providers shall have on staff, at a |
| 156 | minimum, one licensed respiratory therapist, who is either a |
| 157 | certified respiratory therapist (CRT) or a registered |
| 158 | respiratory therapist (RRT), or a registered nurse. |
| 159 | (18) Maintain safe premises that are fully accessible to |
| 160 | all patients between the hours of 9 a.m. and 5 p.m. |
| 161 | (20) Provide consumers with after-hours emergency service |
| 162 | appropriately staffed by personnel equipped to offer necessary |
| 163 | services to the public. High-tech medical equipment providers |
| 164 | shall have on call, at a minimum, one licensed respiratory |
| 165 | therapist, who is either a certified respiratory therapist (CRT) |
| 166 | or a registered respiratory therapist (RRT), or a registered |
| 167 | nurse. |
| 168 | Section 5. Subsections (11) and (12) are added to section |
| 169 | 400.935, Florida Statutes, to read: |
| 170 | 400.935 Rules establishing minimum standards.--The agency |
| 171 | shall adopt, publish, and enforce rules to implement this part, |
| 172 | which must provide reasonable and fair minimum standards |
| 173 | relating to: |
| 174 | (11) The designation of equipment as life sustaining or |
| 175 | technologically advanced. |
| 176 | (12) The designation of appropriate accrediting |
| 177 | organizations. |
| 178 | Section 6. Section 400.936, Florida Statutes, is created |
| 179 | to read: |
| 180 | 400.936 Mandatory accreditation.-- |
| 181 | (1) Effective January 1, 2006, all home medical equipment |
| 182 | providers licensed pursuant to this part shall submit to the |
| 183 | agency proof of accreditation as a prerequisite for licensure or |
| 184 | license renewal. Any provider that does not submit proof of |
| 185 | accreditation shall be issued a temporary license and shall have |
| 186 | 60 days to submit proof of application to an accrediting |
| 187 | organization. Such provider shall submit proof of accreditation |
| 188 | within 180 days after submitting an application in order to |
| 189 | receive a permanent license. Any home medical equipment provider |
| 190 | licensed as of January 1, 2006, shall have a reasonable period |
| 191 | of time, not to exceed the next licensure renewal date for the |
| 192 | provider, to comply with the accreditation requirement. |
| 193 | Applicants that submit proof of accreditation, a completed |
| 194 | licensure application, and the required fee may receive a |
| 195 | temporary license until completion of the review of |
| 196 | accreditation. |
| 197 | (2) The agency shall adopt rules designating appropriate |
| 198 | accrediting organizations whose standards for accreditation are |
| 199 | comparable to those required by this part for licensure. |
| 200 | Section 7. Section 400.95, Florida Statutes, is amended to |
| 201 | read: |
| 202 | 400.95 Notice of toll-free telephone number for central |
| 203 | fraud and abuse hotline.--On or before the first day home |
| 204 | medical equipment is delivered to the patient's home, any home |
| 205 | medical equipment provider licensed under this part must inform |
| 206 | the consumer and his or her immediate family, if appropriate, of |
| 207 | the right to report fraudulent, abusive, neglectful, or |
| 208 | exploitative practices. The statewide toll-free telephone number |
| 209 | for the central fraud and abuse hotline must be provided to |
| 210 | consumers in a manner that is clearly legible and must include |
| 211 | the words: "To report fraud, abuse, neglect, or exploitation, |
| 212 | please call toll-free 1-800-962-2873." Home medical equipment |
| 213 | providers shall establish appropriate policies and procedures |
| 214 | for providing such notice to consumers. |
| 215 | Section 8. This act shall take effect July 1, 2005. |