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To amend sections 1739.05 and 1751.01 and to enact | 1 |
section 3923.80 of the Revised Code to prohibit | 2 |
insurers, public employee benefit plans, and | 3 |
multiple employer welfare arrangements from | 4 |
excluding coverage for routine patient care | 5 |
administered as part of a cancer clinical trial. | 6 |
Section 1. That sections 1739.05 and 1751.01 be amended and | 7 |
section 3923.80 of the Revised Code be enacted to read as follows: | 8 |
Sec. 1739.05. (A) A multiple employer welfare arrangement | 9 |
that is created pursuant to sections 1739.01 to 1739.22 of the | 10 |
Revised Code and that operates a group self-insurance program may | 11 |
be established only if any of the following applies: | 12 |
(1) The arrangement has and maintains a minimum enrollment of | 13 |
three hundred employees of two or more employers. | 14 |
(2) The arrangement has and maintains a minimum enrollment of | 15 |
three hundred self-employed individuals. | 16 |
(3) The arrangement has and maintains a minimum enrollment of | 17 |
three hundred employees or self-employed individuals in any | 18 |
combination of divisions (A)(1) and (2) of this section. | 19 |
(B) A multiple employer welfare arrangement that is created | 20 |
pursuant to sections 1739.01 to 1739.22 of the Revised Code and | 21 |
that operates a group self-insurance program shall comply with all | 22 |
laws applicable to self-funded programs in this state, including | 23 |
sections 3901.04, 3901.041, 3901.19 to 3901.26, 3901.38, 3901.381 | 24 |
to 3901.3814, 3901.40, 3901.45, 3901.46, 3902.01 to 3902.14, | 25 |
3923.282, 3923.30, 3923.301, 3923.38, 3923.581, 3923.63, 3923.80, | 26 |
3924.031, 3924.032, and 3924.27 of the Revised Code. | 27 |
(C) A multiple employer welfare arrangement created pursuant | 28 |
to sections 1739.01 to 1739.22 of the Revised Code shall solicit | 29 |
enrollments only through agents or solicitors licensed pursuant to | 30 |
Chapter 3905. of the Revised Code to sell or solicit sickness and | 31 |
accident insurance. | 32 |
(D) A multiple employer welfare arrangement created pursuant | 33 |
to sections 1739.01 to 1739.22 of the Revised Code shall provide | 34 |
benefits only to individuals who are members, employees of | 35 |
members, or the dependents of members or employees, or are | 36 |
eligible for continuation of coverage under section 1751.53 or | 37 |
3923.38 of the Revised Code or under Title X of the "Consolidated | 38 |
Omnibus Budget Reconciliation Act of 1985," 100 Stat. 227, 29 | 39 |
U.S.C.A. 1161, as amended. | 40 |
Sec. 1751.01. As used in this chapter: | 41 |
(A)(1) "Basic health care services" means the following | 42 |
services when medically necessary: | 43 |
(a) Physician's services, except when such services are | 44 |
supplemental under division (B) of this section; | 45 |
(b) Inpatient hospital services; | 46 |
(c) Outpatient medical services; | 47 |
(d) Emergency health services; | 48 |
(e) Urgent care services; | 49 |
(f) Diagnostic laboratory services and diagnostic and | 50 |
therapeutic radiologic services; | 51 |
(g) Diagnostic and treatment services, other than | 52 |
prescription drug services, for biologically based mental | 53 |
illnesses; | 54 |
(h) Preventive health care services, including, but not | 55 |
limited to, voluntary family planning services, infertility | 56 |
services, periodic physical examinations, prenatal obstetrical | 57 |
care, and well-child care; | 58 |
(i) Routine patient care for patients enrolled in an eligible | 59 |
cancer clinical trial pursuant to section 3923.80 of the Revised | 60 |
Code. | 61 |
"Basic health care services" does not include experimental | 62 |
procedures. | 63 |
Except as provided by divisions (A)(2) and (3) of this | 64 |
section in connection with the offering of coverage for diagnostic | 65 |
and treatment services for biologically based mental illnesses, a | 66 |
health insuring corporation shall not offer coverage for a health | 67 |
care service, defined as a basic health care service by this | 68 |
division, unless it offers coverage for all listed basic health | 69 |
care services. However, this requirement does not apply to the | 70 |
coverage of beneficiaries enrolled in Title XVIII of the "Social | 71 |
Security Act," 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended, | 72 |
pursuant to a medicare contract, or to the coverage of | 73 |
beneficiaries enrolled in the federal employee health benefits | 74 |
program pursuant to 5 U.S.C.A. 8905, or to the coverage of | 75 |
beneficiaries enrolled in Title XIX of the "Social Security Act," | 76 |
49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended, known as the | 77 |
medical assistance program or medicaid, provided by the department | 78 |
of job and family services under Chapter 5111. of the Revised | 79 |
Code, or to the coverage of beneficiaries under any federal health | 80 |
care program regulated by a federal regulatory body, or to the | 81 |
coverage of beneficiaries under any contract covering officers or | 82 |
employees of the state that has been entered into by the | 83 |
department of administrative services. | 84 |
(2) A health insuring corporation may offer coverage for | 85 |
diagnostic and treatment services for biologically based mental | 86 |
illnesses without offering coverage for all other basic health | 87 |
care services. A health insuring corporation may offer coverage | 88 |
for diagnostic and treatment services for biologically based | 89 |
mental illnesses alone or in combination with one or more | 90 |
supplemental health care services. However, a health insuring | 91 |
corporation that offers coverage for any other basic health care | 92 |
service shall offer coverage for diagnostic and treatment services | 93 |
for biologically based mental illnesses in combination with the | 94 |
offer of coverage for all other listed basic health care services. | 95 |
(3) A health insuring corporation that offers coverage for | 96 |
basic health care services is not required to offer coverage for | 97 |
diagnostic and treatment services for biologically based mental | 98 |
illnesses in combination with the offer of coverage for all other | 99 |
listed basic health care services if all of the following apply: | 100 |
(a) The health insuring corporation submits documentation | 101 |
certified by an independent member of the American academy of | 102 |
actuaries to the superintendent of insurance showing that incurred | 103 |
claims for diagnostic and treatment services for biologically | 104 |
based mental illnesses for a period of at least six months | 105 |
independently caused the health insuring corporation's costs for | 106 |
claims and administrative expenses for the coverage of basic | 107 |
health care services to increase by more than one per cent per | 108 |
year. | 109 |
(b) The health insuring corporation submits a signed letter | 110 |
from an independent member of the American academy of actuaries to | 111 |
the superintendent of insurance opining that the increase in costs | 112 |
described in division (A)(3)(a) of this section could reasonably | 113 |
justify an increase of more than one per cent in the annual | 114 |
premiums or rates charged by the health insuring corporation for | 115 |
the coverage of basic health care services. | 116 |
(c) The superintendent of insurance makes the following | 117 |
determinations from the documentation and opinion submitted | 118 |
pursuant to divisions (A)(3)(a) and (b) of this section: | 119 |
(i) Incurred claims for diagnostic and treatment services for | 120 |
biologically based mental illnesses for a period of at least six | 121 |
months independently caused the health insuring corporation's | 122 |
costs for claims and administrative expenses for the coverage of | 123 |
basic health care services to increase by more than one per cent | 124 |
per year. | 125 |
(ii) The increase in costs reasonably justifies an increase | 126 |
of more than one per cent in the annual premiums or rates charged | 127 |
by the health insuring corporation for the coverage of basic | 128 |
health care services. | 129 |
Any determination made by the superintendent under this | 130 |
division is subject to Chapter 119. of the Revised Code. | 131 |
(B)(1) "Supplemental health care services" means any health | 132 |
care services other than basic health care services that a health | 133 |
insuring corporation may offer, alone or in combination with | 134 |
either basic health care services or other supplemental health | 135 |
care services, and includes: | 136 |
(a) Services of facilities for intermediate or long-term | 137 |
care, or both; | 138 |
(b) Dental care services; | 139 |
(c) Vision care and optometric services including lenses and | 140 |
frames; | 141 |
(d) Podiatric care or foot care services; | 142 |
(e) Mental health services, excluding diagnostic and | 143 |
treatment services for biologically based mental illnesses; | 144 |
(f) Short-term outpatient evaluative and crisis-intervention | 145 |
mental health services; | 146 |
(g) Medical or psychological treatment and referral services | 147 |
for alcohol and drug abuse or addiction; | 148 |
(h) Home health services; | 149 |
(i) Prescription drug services; | 150 |
(j) Nursing services; | 151 |
(k) Services of a dietitian licensed under Chapter 4759. of | 152 |
the Revised Code; | 153 |
(l) Physical therapy services; | 154 |
(m) Chiropractic services; | 155 |
(n) Any other category of services approved by the | 156 |
superintendent of insurance. | 157 |
(2) If a health insuring corporation offers prescription drug | 158 |
services under this division, the coverage shall include | 159 |
prescription drug services for the treatment of biologically based | 160 |
mental illnesses on the same terms and conditions as other | 161 |
physical diseases and disorders. | 162 |
(C) "Specialty health care services" means one of the | 163 |
supplemental health care services listed in division (B) of this | 164 |
section, when provided by a health insuring corporation on an | 165 |
outpatient-only basis and not in combination with other | 166 |
supplemental health care services. | 167 |
(D) "Biologically based mental illnesses" means | 168 |
schizophrenia, schizoaffective disorder, major depressive | 169 |
disorder, bipolar disorder, paranoia and other psychotic | 170 |
disorders, obsessive-compulsive disorder, and panic disorder, as | 171 |
these terms are defined in the most recent edition of the | 172 |
diagnostic and statistical manual of mental disorders published by | 173 |
the American psychiatric association. | 174 |
(E) "Closed panel plan" means a health care plan that | 175 |
requires enrollees to use participating providers. | 176 |
(F) "Compensation" means remuneration for the provision of | 177 |
health care services, determined on other than a fee-for-service | 178 |
or discounted-fee-for-service basis. | 179 |
(G) "Contractual periodic prepayment" means the formula for | 180 |
determining the premium rate for all subscribers of a health | 181 |
insuring corporation. | 182 |
(H) "Corporation" means a corporation formed under Chapter | 183 |
1701. or 1702. of the Revised Code or the similar laws of another | 184 |
state. | 185 |
(I) "Emergency health services" means those health care | 186 |
services that must be available on a seven-days-per-week, | 187 |
twenty-four-hours-per-day basis in order to prevent jeopardy to an | 188 |
enrollee's health status that would occur if such services were | 189 |
not received as soon as possible, and includes, where appropriate, | 190 |
provisions for transportation and indemnity payments or service | 191 |
agreements for out-of-area coverage. | 192 |
(J) "Enrollee" means any natural person who is entitled to | 193 |
receive health care benefits provided by a health insuring | 194 |
corporation. | 195 |
(K) "Evidence of coverage" means any certificate, agreement, | 196 |
policy, or contract issued to a subscriber that sets out the | 197 |
coverage and other rights to which such person is entitled under a | 198 |
health care plan. | 199 |
(L) "Health care facility" means any facility, except a | 200 |
health care practitioner's office, that provides preventive, | 201 |
diagnostic, therapeutic, acute convalescent, rehabilitation, | 202 |
mental health, mental retardation, intermediate care, or skilled | 203 |
nursing services. | 204 |
(M) "Health care services" means basic, supplemental, and | 205 |
specialty health care services. | 206 |
(N) "Health delivery network" means any group of providers or | 207 |
health care facilities, or both, or any representative thereof, | 208 |
that have entered into an agreement to offer health care services | 209 |
in a panel rather than on an individual basis. | 210 |
(O) "Health insuring corporation" means a corporation, as | 211 |
defined in division (H) of this section, that, pursuant to a | 212 |
policy, contract, certificate, or agreement, pays for, reimburses, | 213 |
or provides, delivers, arranges for, or otherwise makes available, | 214 |
basic health care services, supplemental health care services, or | 215 |
specialty health care services, or a combination of basic health | 216 |
care services and either supplemental health care services or | 217 |
specialty health care services, through either an open panel plan | 218 |
or a closed panel plan. | 219 |
"Health insuring corporation" does not include a limited | 220 |
liability company formed pursuant to Chapter 1705. of the Revised | 221 |
Code, an insurer licensed under Title XXXIX of the Revised Code if | 222 |
that insurer offers only open panel plans under which all | 223 |
providers and health care facilities participating receive their | 224 |
compensation directly from the insurer, a corporation formed by or | 225 |
on behalf of a political subdivision or a department, office, or | 226 |
institution of the state, or a public entity formed by or on | 227 |
behalf of a board of county commissioners, a county board of | 228 |
mental retardation and developmental disabilities, an alcohol and | 229 |
drug addiction services board, a board of alcohol, drug addiction, | 230 |
and mental health services, or a community mental health board, as | 231 |
those terms are used in Chapters 340. and 5126. of the Revised | 232 |
Code. Except as provided by division (D) of section 1751.02 of | 233 |
the Revised Code, or as otherwise provided by law, no board, | 234 |
commission, agency, or other entity under the control of a | 235 |
political subdivision may accept insurance risk in providing for | 236 |
health care services. However, nothing in this division shall be | 237 |
construed as prohibiting such entities from purchasing the | 238 |
services of a health insuring corporation or a third-party | 239 |
administrator licensed under Chapter 3959. of the Revised Code. | 240 |
(P) "Intermediary organization" means a health delivery | 241 |
network or other entity that contracts with licensed health | 242 |
insuring corporations or self-insured employers, or both, to | 243 |
provide health care services, and that enters into contractual | 244 |
arrangements with other entities for the provision of health care | 245 |
services for the purpose of fulfilling the terms of its contracts | 246 |
with the health insuring corporations and self-insured employers. | 247 |
(Q) "Intermediate care" means residential care above the | 248 |
level of room and board for patients who require personal | 249 |
assistance and health-related services, but who do not require | 250 |
skilled nursing care. | 251 |
(R) "Medical record" means the personal information that | 252 |
relates to an individual's physical or mental condition, medical | 253 |
history, or medical treatment. | 254 |
(S)(1) "Open panel plan" means a health care plan that | 255 |
provides incentives for enrollees to use participating providers | 256 |
and that also allows enrollees to use providers that are not | 257 |
participating providers. | 258 |
(2) No health insuring corporation may offer an open panel | 259 |
plan, unless the health insuring corporation is also licensed as | 260 |
an insurer under Title XXXIX of the Revised Code, the health | 261 |
insuring corporation, on June 4, 1997, holds a certificate of | 262 |
authority or license to operate under Chapter 1736. or 1740. of | 263 |
the Revised Code, or an insurer licensed under Title XXXIX of the | 264 |
Revised Code is responsible for the out-of-network risk as | 265 |
evidenced by both an evidence of coverage filing under section | 266 |
1751.11 of the Revised Code and a policy and certificate filing | 267 |
under section 3923.02 of the Revised Code. | 268 |
(T) "Panel" means a group of providers or health care | 269 |
facilities that have joined together to deliver health care | 270 |
services through a contractual arrangement with a health insuring | 271 |
corporation, employer group, or other payor. | 272 |
(U) "Person" has the same meaning as in section 1.59 of the | 273 |
Revised Code, and, unless the context otherwise requires, includes | 274 |
any insurance company holding a certificate of authority under | 275 |
Title XXXIX of the Revised Code, any subsidiary and affiliate of | 276 |
an insurance company, and any government agency. | 277 |
(V) "Premium rate" means any set fee regularly paid by a | 278 |
subscriber to a health insuring corporation. A "premium rate" does | 279 |
not include a one-time membership fee, an annual administrative | 280 |
fee, or a nominal access fee, paid to a managed health care system | 281 |
under which the recipient of health care services remains solely | 282 |
responsible for any charges accessed for those services by the | 283 |
provider or health care facility. | 284 |
(W) "Primary care provider" means a provider that is | 285 |
designated by a health insuring corporation to supervise, | 286 |
coordinate, or provide initial care or continuing care to an | 287 |
enrollee, and that may be required by the health insuring | 288 |
corporation to initiate a referral for specialty care and to | 289 |
maintain supervision of the health care services rendered to the | 290 |
enrollee. | 291 |
(X) "Provider" means any natural person or partnership of | 292 |
natural persons who are licensed, certified, accredited, or | 293 |
otherwise authorized in this state to furnish health care | 294 |
services, or any professional association organized under Chapter | 295 |
1785. of the Revised Code, provided that nothing in this chapter | 296 |
or other provisions of law shall be construed to preclude a health | 297 |
insuring corporation, health care practitioner, or organized | 298 |
health care group associated with a health insuring corporation | 299 |
from employing certified nurse practitioners, certified nurse | 300 |
anesthetists, clinical nurse specialists, certified nurse | 301 |
midwives, dietitians, physician assistants, dental assistants, | 302 |
dental hygienists, optometric technicians, or other allied health | 303 |
personnel who are licensed, certified, accredited, or otherwise | 304 |
authorized in this state to furnish health care services. | 305 |
(Y) "Provider sponsored organization" means a corporation, as | 306 |
defined in division (H) of this section, that is at least eighty | 307 |
per cent owned or controlled by one or more hospitals, as defined | 308 |
in section 3727.01 of the Revised Code, or one or more physicians | 309 |
licensed to practice medicine or surgery or osteopathic medicine | 310 |
and surgery under Chapter 4731. of the Revised Code, or any | 311 |
combination of such physicians and hospitals. Such control is | 312 |
presumed to exist if at least eighty per cent of the voting rights | 313 |
or governance rights of a provider sponsored organization are | 314 |
directly or indirectly owned, controlled, or otherwise held by any | 315 |
combination of the physicians and hospitals described in this | 316 |
division. | 317 |
(Z) "Solicitation document" means the written materials | 318 |
provided to prospective subscribers or enrollees, or both, and | 319 |
used for advertising and marketing to induce enrollment in the | 320 |
health care plans of a health insuring corporation. | 321 |
(AA) "Subscriber" means a person who is responsible for | 322 |
making payments to a health insuring corporation for participation | 323 |
in a health care plan, or an enrollee whose employment or other | 324 |
status is the basis of eligibility for enrollment in a health | 325 |
insuring corporation. | 326 |
(BB) "Urgent care services" means those health care services | 327 |
that are appropriately provided for an unforeseen condition of a | 328 |
kind that usually requires medical attention without delay but | 329 |
that does not pose a threat to the life, limb, or permanent health | 330 |
of the injured or ill person, and may include such health care | 331 |
services provided out of the health insuring corporation's | 332 |
approved service area pursuant to indemnity payments or service | 333 |
agreements. | 334 |
Sec. 3923.80. (A) No plan of health coverage shall deny | 335 |
coverage for the costs of any routine patient care administered to | 336 |
an insured participating in any stage of an eligible cancer | 337 |
clinical trial, if that coverage exists under the plan for | 338 |
patients who are not participating in a clinical trial. | 339 |
(B) The coverage that may not be excluded under division (A) | 340 |
of this section is subject to all terms, conditions, restrictions, | 341 |
exclusions, and limitations that apply to any other coverage under | 342 |
the plan, policy, or arrangement for services performed by | 343 |
participating and nonparticipating providers. Nothing in this | 344 |
section shall be construed as requiring reimbursement to a | 345 |
provider or facility providing the routine care that does not have | 346 |
a health care contract with the entity issuing the plan of health | 347 |
care coverage, or as prohibiting a plan of health care coverage | 348 |
that does not have a health care contract with the provider or | 349 |
facility providing the routine care from negotiating a single case | 350 |
or other agreement for coverage. | 351 |
(C) As used in this section: | 352 |
(1) "Eligible cancer clinical trial" means a cancer clinical | 353 |
trial that meets the following criteria: | 354 |
(a) A purpose of the trial is to test whether the | 355 |
intervention potentially improves the trial participant's health | 356 |
outcomes. | 357 |
(b) The treatment provided as part of the trial is given with | 358 |
the intention of improving the trial participant's health | 359 |
outcomes. | 360 |
(c) The trial has a therapeutic intent and is not designed | 361 |
exclusively to test toxicity or disease pathophysiology. | 362 |
(d) The trial does one of the following: | 363 |
(i) Tests how to administer a health care service, item, or | 364 |
drug for the treatment of cancer; | 365 |
(ii) Tests responses to a health care service, item, or drug | 366 |
for the treatment of cancer; | 367 |
(iii) Compares the effectiveness of a health care service, | 368 |
item, or drug for the treatment of cancer with that of other | 369 |
health care services, items, or drugs for the treatment of cancer; | 370 |
(iv) Studies new uses of a health care service, item, or drug | 371 |
for the treatment of cancer. | 372 |
(e) The trial is approved by one of the following entities: | 373 |
(i) The national institutes of health or one of its | 374 |
cooperative groups or centers under the United States department | 375 |
of health and human services; | 376 |
(ii) The United States food and drug administration; | 377 |
(iii) The United States department of defense; | 378 |
(iv) The United States department of veterans' affairs. | 379 |
(2) "Subject of a cancer clinical trial" means the health | 380 |
care service, item, or drug that is being evaluated in the | 381 |
clinical trial and that is not routine patient care. | 382 |
(3) "Plan of health coverage" means any of the following when | 383 |
the contract, policy, or plan provides payment or reimbursement | 384 |
for the costs of health care services other than for specific | 385 |
diseases or accidents only: | 386 |
(a) An individual or group policy of sickness and accident | 387 |
insurance; | 388 |
(b) An individual or group contract of a health insuring | 389 |
corporation; | 390 |
(c) A public employee benefit plan; | 391 |
(d) A multiple employer welfare arrangement as defined in | 392 |
section 1739.01 of the Revised Code. | 393 |
(4) "Routine patient care" means all health care services | 394 |
consistent with the coverage provided in the plan of health | 395 |
coverage or arrangement for the treatment of cancer, including | 396 |
the type and frequency of any diagnostic modality, that is | 397 |
typically covered for a cancer patient who is not enrolled in a | 398 |
cancer clinical trial, and that was not necessitated solely | 399 |
because of the trial. | 400 |
(5) For purposes of this section, a plan of health coverage | 401 |
may exclude coverage for: | 402 |
(a) A health care service, item, or drug that is the subject | 403 |
of the cancer clinical trial; | 404 |
(b) A health care service, item, or drug provided solely to | 405 |
satisfy data collection and analysis needs for the cancer clinical | 406 |
trial that is not used in the direct clinical management of the | 407 |
patient; | 408 |
(c) An investigational or experimental drug or device that | 409 |
has not been approved for market by the United States food and | 410 |
drug administration; | 411 |
(d) Transportation, lodging, food, or other expenses for the | 412 |
patient, or a family member or companion of the patient, that are | 413 |
associated with the travel to or from a facility providing the | 414 |
cancer clinical trial; | 415 |
(e) An item or drug provided by the cancer clinical trial | 416 |
sponsors free of charge for any patient; | 417 |
(f) A service, item, or drug that is eligible for | 418 |
reimbursement by a person other than the insurer, including the | 419 |
sponsor of the cancer clinical trial. | 420 |
Section 2. That existing sections 1739.05 and 1751.01 of the | 421 |
Revised Code are hereby repealed. | 422 |
Section 3. Section 3923.80 of the Revised Code, as enacted by | 423 |
this act, shall apply to plans of health coverage that are | 424 |
delivered, issued for delivery, or renewed in this state on or | 425 |
after the effective date of this act. | 426 |