Texas 2017 - 85th Regular

Texas Senate Bill SB1922 Compare Versions

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1-85R28848 JG-D
21 By: Schwertner S.B. No. 1922
3- (Raymond)
4- Substitute the following for S.B. No. 1922: No.
52
63
74 A BILL TO BE ENTITLED
85 AN ACT
9- relating to contract requirements for prescription drug benefits
10- provided by Medicaid managed care organizations and a study
11- regarding Medicaid prior authorization requirements for certain
12- prescription drugs.
6+ relating to prescription drug benefits in the Medicaid managed care
7+ program.
138 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
14- SECTION 1. Section 531.073, Government Code, is amended by
15- adding Subsection (a-3) to read as follows:
16- (a-3) Once every 10 years, the commission shall conduct a
9+ SECTION 1. (a) Section 533.005(a), Government Code, is
10+ amended to read as follows:
11+ (a) A contract between a managed care organization and the
12+ commission for the organization to provide health care services to
13+ recipients must contain:
14+ (1) procedures to ensure accountability to the state
15+ for the provision of health care services, including procedures for
16+ financial reporting, quality assurance, utilization review, and
17+ assurance of contract and subcontract compliance;
18+ (2) capitation rates that ensure the cost-effective
19+ provision of quality health care;
20+ (3) a requirement that the managed care organization
21+ provide ready access to a person who assists recipients in
22+ resolving issues relating to enrollment, plan administration,
23+ education and training, access to services, and grievance
24+ procedures;
25+ (4) a requirement that the managed care organization
26+ provide ready access to a person who assists providers in resolving
27+ issues relating to payment, plan administration, education and
28+ training, and grievance procedures;
29+ (5) a requirement that the managed care organization
30+ provide information and referral about the availability of
31+ educational, social, and other community services that could
32+ benefit a recipient;
33+ (6) procedures for recipient outreach and education;
34+ (7) a requirement that the managed care organization
35+ make payment to a physician or provider for health care services
36+ rendered to a recipient under a managed care plan on any claim for
37+ payment that is received with documentation reasonably necessary
38+ for the managed care organization to process the claim:
39+ (A) not later than:
40+ (i) the 10th day after the date the claim is
41+ received if the claim relates to services provided by a nursing
42+ facility, intermediate care facility, or group home;
43+ (ii) the 30th day after the date the claim
44+ is received if the claim relates to the provision of long-term
45+ services and supports not subject to Subparagraph (i); and
46+ (iii) the 45th day after the date the claim
47+ is received if the claim is not subject to Subparagraph (i) or (ii);
48+ or
49+ (B) within a period, not to exceed 60 days,
50+ specified by a written agreement between the physician or provider
51+ and the managed care organization;
52+ (7-a) a requirement that the managed care organization
53+ demonstrate to the commission that the organization pays claims
54+ described by Subdivision (7)(A)(ii) on average not later than the
55+ 21st day after the date the claim is received by the organization;
56+ (8) a requirement that the commission, on the date of a
57+ recipient's enrollment in a managed care plan issued by the managed
58+ care organization, inform the organization of the recipient's
59+ Medicaid certification date;
60+ (9) a requirement that the managed care organization
61+ comply with Section 533.006 as a condition of contract retention
62+ and renewal;
63+ (10) a requirement that the managed care organization
64+ provide the information required by Section 533.012 and otherwise
65+ comply and cooperate with the commission's office of inspector
66+ general and the office of the attorney general;
67+ (11) a requirement that the managed care
68+ organization's usages of out-of-network providers or groups of
69+ out-of-network providers may not exceed limits for those usages
70+ relating to total inpatient admissions, total outpatient services,
71+ and emergency room admissions determined by the commission;
72+ (12) if the commission finds that a managed care
73+ organization has violated Subdivision (11), a requirement that the
74+ managed care organization reimburse an out-of-network provider for
75+ health care services at a rate that is equal to the allowable rate
76+ for those services, as determined under Sections 32.028 and
77+ 32.0281, Human Resources Code;
78+ (13) a requirement that, notwithstanding any other
79+ law, including Sections 843.312 and 1301.052, Insurance Code, the
80+ organization:
81+ (A) use advanced practice registered nurses and
82+ physician assistants in addition to physicians as primary care
83+ providers to increase the availability of primary care providers in
84+ the organization's provider network; and
85+ (B) treat advanced practice registered nurses
86+ and physician assistants in the same manner as primary care
87+ physicians with regard to:
88+ (i) selection and assignment as primary
89+ care providers;
90+ (ii) inclusion as primary care providers in
91+ the organization's provider network; and
92+ (iii) inclusion as primary care providers
93+ in any provider network directory maintained by the organization;
94+ (14) a requirement that the managed care organization
95+ reimburse a federally qualified health center or rural health
96+ clinic for health care services provided to a recipient outside of
97+ regular business hours, including on a weekend day or holiday, at a
98+ rate that is equal to the allowable rate for those services as
99+ determined under Section 32.028, Human Resources Code, if the
100+ recipient does not have a referral from the recipient's primary
101+ care physician;
102+ (15) a requirement that the managed care organization
103+ develop, implement, and maintain a system for tracking and
104+ resolving all provider appeals related to claims payment, including
105+ a process that will require:
106+ (A) a tracking mechanism to document the status
107+ and final disposition of each provider's claims payment appeal;
108+ (B) the contracting with physicians who are not
109+ network providers and who are of the same or related specialty as
110+ the appealing physician to resolve claims disputes related to
111+ denial on the basis of medical necessity that remain unresolved
112+ subsequent to a provider appeal;
113+ (C) the determination of the physician resolving
114+ the dispute to be binding on the managed care organization and
115+ provider; and
116+ (D) the managed care organization to allow a
117+ provider with a claim that has not been paid before the time
118+ prescribed by Subdivision (7)(A)(ii) to initiate an appeal of that
119+ claim;
120+ (16) a requirement that a medical director who is
121+ authorized to make medical necessity determinations is available to
122+ the region where the managed care organization provides health care
123+ services;
124+ (17) a requirement that the managed care organization
125+ ensure that a medical director and patient care coordinators and
126+ provider and recipient support services personnel are located in
127+ the South Texas service region, if the managed care organization
128+ provides a managed care plan in that region;
129+ (18) a requirement that the managed care organization
130+ provide special programs and materials for recipients with limited
131+ English proficiency or low literacy skills;
132+ (19) a requirement that the managed care organization
133+ develop and establish a process for responding to provider appeals
134+ in the region where the organization provides health care services;
135+ (20) a requirement that the managed care organization:
136+ (A) develop and submit to the commission, before
137+ the organization begins to provide health care services to
138+ recipients, a comprehensive plan that describes how the
139+ organization's provider network complies with the provider access
140+ standards established under Section 533.0061, as added by Chapter
141+ 1272 (S.B. 760), Acts of the 84th Legislature, Regular Session,
142+ 2015;
143+ (B) as a condition of contract retention and
144+ renewal:
145+ (i) continue to comply with the provider
146+ access standards established under Section 533.0061, as added by
147+ Chapter 1272 (S.B. 760), Acts of the 84th Legislature, Regular
148+ Session, 2015; and
149+ (ii) make substantial efforts, as
150+ determined by the commission, to mitigate or remedy any
151+ noncompliance with the provider access standards established under
152+ Section 533.0061, as added by Chapter 1272 (S.B. 760), Acts of the
153+ 84th Legislature, Regular Session, 2015;
154+ (C) pay liquidated damages for each failure, as
155+ determined by the commission, to comply with the provider access
156+ standards established under Section 533.0061, as added by Chapter
157+ 1272 (S.B. 760), Acts of the 84th Legislature, Regular Session,
158+ 2015, in amounts that are reasonably related to the noncompliance;
159+ and
160+ (D) regularly, as determined by the commission,
161+ submit to the commission and make available to the public a report
162+ containing data on the sufficiency of the organization's provider
163+ network with regard to providing the care and services described
164+ under Section 533.0061(a), as added by Chapter 1272 (S.B. 760),
165+ Acts of the 84th Legislature, Regular Session, 2015, and specific
166+ data with respect to access to primary care, specialty care,
167+ long-term services and supports, nursing services, and therapy
168+ services on the average length of time between:
169+ (i) the date a provider requests prior
170+ authorization for the care or service and the date the organization
171+ approves or denies the request; and
172+ (ii) the date the organization approves a
173+ request for prior authorization for the care or service and the date
174+ the care or service is initiated;
175+ (21) a requirement that the managed care organization
176+ demonstrate to the commission, before the organization begins to
177+ provide health care services to recipients, that, subject to the
178+ provider access standards established under Section 533.0061, as
179+ added by Chapter 1272 (S.B. 760), Acts of the 84th Legislature,
180+ Regular Session, 2015:
181+ (A) the organization's provider network has the
182+ capacity to serve the number of recipients expected to enroll in a
183+ managed care plan offered by the organization;
184+ (B) the organization's provider network
185+ includes:
186+ (i) a sufficient number of primary care
187+ providers;
188+ (ii) a sufficient variety of provider
189+ types;
190+ (iii) a sufficient number of providers of
191+ long-term services and supports and specialty pediatric care
192+ providers of home and community-based services; and
193+ (iv) providers located throughout the
194+ region where the organization will provide health care services;
195+ and
196+ (C) health care services will be accessible to
197+ recipients through the organization's provider network to a
198+ comparable extent that health care services would be available to
199+ recipients under a fee-for-service or primary care case management
200+ model of Medicaid managed care;
201+ (22) a requirement that the managed care organization
202+ develop a monitoring program for measuring the quality of the
203+ health care services provided by the organization's provider
204+ network that:
205+ (A) incorporates the National Committee for
206+ Quality Assurance's Healthcare Effectiveness Data and Information
207+ Set (HEDIS) measures;
208+ (B) focuses on measuring outcomes; and
209+ (C) includes the collection and analysis of
210+ clinical data relating to prenatal care, preventive care, mental
211+ health care, and the treatment of acute and chronic health
212+ conditions and substance abuse;
213+ (23) subject to Subsection (a-1), a requirement that
214+ the managed care organization develop, implement, and maintain an
215+ outpatient pharmacy benefit plan for its enrolled recipients:
216+ (A) that exclusively employs the vendor drug
217+ program formulary and preserves the state's ability to reduce
218+ waste, fraud, and abuse under Medicaid;
219+ (B) that adheres to the applicable preferred drug
220+ list adopted by the commission under Section 531.072;
221+ (C) that includes the prior authorization
222+ procedures and requirements prescribed by or implemented under
223+ Sections 531.073(b), (c), and (g) for the vendor drug program;
224+ (D) for purposes of which the managed care
225+ organization:
226+ (i) may [not] negotiate with and [or]
227+ collect rebates from labelers and manufacturers, as those terms are
228+ defined by Section 531.070, that are associated with pharmacy
229+ products on the managed care organization's [vendor drug program]
230+ formulary; and
231+ (ii) may not receive drug rebate or pricing
232+ information that is confidential under Section 531.071;
233+ (E) that complies with the prohibition under
234+ Section 531.089;
235+ (F) under which the managed care organization may
236+ not prohibit, limit, or interfere with a recipient's selection of a
237+ pharmacy or pharmacist of the recipient's choice for the provision
238+ of pharmaceutical services under the plan through the imposition of
239+ different copayments;
240+ (G) that allows the managed care organization or
241+ any subcontracted pharmacy benefit manager to contract with a
242+ pharmacist or pharmacy providers separately for specialty pharmacy
243+ services, except that:
244+ (i) the managed care organization and
245+ pharmacy benefit manager are prohibited from allowing exclusive
246+ contracts with a specialty pharmacy owned wholly or partly by the
247+ pharmacy benefit manager responsible for the administration of the
248+ pharmacy benefit program; and
249+ (ii) the managed care organization and
250+ pharmacy benefit manager must adopt policies and procedures for
251+ reclassifying prescription drugs from retail to specialty drugs,
252+ and those policies and procedures must be consistent with rules
253+ adopted by the executive commissioner and include notice to network
254+ pharmacy providers from the managed care organization;
255+ (H) under which the managed care organization may
256+ not prevent a pharmacy or pharmacist from participating as a
257+ provider if the pharmacy or pharmacist agrees to comply with the
258+ financial terms and conditions of the contract as well as other
259+ reasonable administrative and professional terms and conditions of
260+ the contract;
261+ (I) under which the managed care organization may
262+ include mail-order pharmacies in its networks, but may not require
263+ enrolled recipients to use those pharmacies, and may not charge an
264+ enrolled recipient who opts to use this service a fee, including
265+ postage and handling fees;
266+ (J) under which the managed care organization or
267+ pharmacy benefit manager, as applicable, must pay claims in
268+ accordance with Section 843.339, Insurance Code; and
269+ (K) under which the managed care organization or
270+ pharmacy benefit manager, as applicable:
271+ (i) to place a drug on a maximum allowable
272+ cost list, must ensure that:
273+ (a) the drug is listed as "A" or "B"
274+ rated in the most recent version of the United States Food and Drug
275+ Administration's Approved Drug Products with Therapeutic
276+ Equivalence Evaluations, also known as the Orange Book, has an "NR"
277+ or "NA" rating or a similar rating by a nationally recognized
278+ reference; and
279+ (b) the drug is generally available
280+ for purchase by pharmacies in the state from national or regional
281+ wholesalers and is not obsolete;
282+ (ii) must provide to a network pharmacy
283+ provider, at the time a contract is entered into or renewed with the
284+ network pharmacy provider, the sources used to determine the
285+ maximum allowable cost pricing for the maximum allowable cost list
286+ specific to that provider;
287+ (iii) must review and update maximum
288+ allowable cost price information at least once every seven days to
289+ reflect any modification of maximum allowable cost pricing;
290+ (iv) must, in formulating the maximum
291+ allowable cost price for a drug, use only the price of the drug and
292+ drugs listed as therapeutically equivalent in the most recent
293+ version of the United States Food and Drug Administration's
294+ Approved Drug Products with Therapeutic Equivalence Evaluations,
295+ also known as the Orange Book;
296+ (v) must establish a process for
297+ eliminating products from the maximum allowable cost list or
298+ modifying maximum allowable cost prices in a timely manner to
299+ remain consistent with pricing changes and product availability in
300+ the marketplace;
301+ (vi) must:
302+ (a) provide a procedure under which a
303+ network pharmacy provider may challenge a listed maximum allowable
304+ cost price for a drug;
305+ (b) respond to a challenge not later
306+ than the 15th day after the date the challenge is made;
307+ (c) if the challenge is successful,
308+ make an adjustment in the drug price effective on the date the
309+ challenge is resolved, and make the adjustment applicable to all
310+ similarly situated network pharmacy providers, as determined by the
311+ managed care organization or pharmacy benefit manager, as
312+ appropriate;
313+ (d) if the challenge is denied,
314+ provide the reason for the denial; and
315+ (e) report to the commission every 90
316+ days the total number of challenges that were made and denied in the
317+ preceding 90-day period for each maximum allowable cost list drug
318+ for which a challenge was denied during the period;
319+ (vii) must notify the commission not later
320+ than the 21st day after implementing a practice of using a maximum
321+ allowable cost list for drugs dispensed at retail but not by mail;
322+ and
323+ (viii) must provide a process for each of
324+ its network pharmacy providers to readily access the maximum
325+ allowable cost list specific to that provider;
326+ (24) a requirement that the managed care organization
327+ and any entity with which the managed care organization contracts
328+ for the performance of services under a managed care plan disclose,
329+ at no cost, to the commission and, on request, the office of the
330+ attorney general all discounts, incentives, rebates, fees, free
331+ goods, bundling arrangements, and other agreements affecting the
332+ net cost of goods or services provided under the plan;
333+ (25) a requirement that the managed care organization
334+ not implement significant, nonnegotiated, across-the-board
335+ provider reimbursement rate reductions unless:
336+ (A) subject to Subsection (a-3), the
337+ organization has the prior approval of the commission to make the
338+ reduction; or
339+ (B) the rate reductions are based on changes to
340+ the Medicaid fee schedule or cost containment initiatives
341+ implemented by the commission; and
342+ (26) a requirement that the managed care organization
343+ make initial and subsequent primary care provider assignments and
344+ changes.
345+ (b) This section takes effect September 1, 2018.
346+ SECTION 2. Chapter 533, Government Code, is amended by
347+ adding Subchapter B to read as follows:
348+ SUBCHAPTER B. PRESCRIPTION DRUG BENEFITS
349+ Sec. 533.051. DEFINITIONS. In this subchapter:
350+ (1) "Labeler" and "manufacturer" have the meanings
351+ assigned by Section 531.070.
352+ (2) "Recipient" means a Medicaid recipient.
353+ (3) "Step therapy protocol" means a protocol that
354+ requires a recipient to use a prescription drug or sequence of
355+ prescription drugs other than the drug that the recipient's
356+ physician recommends for the recipient's treatment before a managed
357+ care organization provides coverage for the recommended drug.
358+ Sec. 533.052. APPLICABILITY OF SUBCHAPTER. (a) This
359+ subchapter applies to an outpatient pharmacy benefit plan
360+ implemented by a managed care organization that contracts with the
361+ commission to provide health care benefits to recipients.
362+ (b) To the extent of a conflict between the requirements for
363+ an outpatient pharmacy benefit plan for a managed care
364+ organization's enrolled recipients specified by Sections
365+ 533.005(a)(23)(A), (B), and (C) and the requirements for that plan
366+ specified by this subchapter, the requirements specified by
367+ Sections 533.005(a)(23)(A), (B), and (C) prevail. This subsection
368+ expires August 31, 2018.
369+ Sec. 533.053. STEP THERAPY PROTOCOL EXCEPTION REQUESTS.
370+ (a) A managed care organization shall establish a process in a
371+ user-friendly format through which an exception request under this
372+ section may be submitted by a prescribing provider. The process
373+ must be readily accessible to:
374+ (1) a recipient who enrolls in a managed care plan
375+ offered by the managed care organization or transfers to a managed
376+ care plan offered by the managed care organization from a managed
377+ care plan offered by another managed care organization; and
378+ (2) the provider.
379+ (b) A prescribing provider on behalf of a recipient may
380+ submit in written or electronic form or by telephone to the
381+ recipient's managed care organization an exception request for a
382+ step therapy protocol required by the recipient's managed care
383+ organization.
384+ (c) A managed care organization shall review and, if
385+ clinically appropriate, grant an exception request under
386+ Subsection (b) if the request includes a statement by the
387+ prescribing provider stating that:
388+ (1) the drug required under the step therapy protocol:
389+ (A) is contraindicated;
390+ (B) will likely cause an adverse reaction in or
391+ physical or mental harm to the recipient; or
392+ (C) is expected to be ineffective based on the
393+ known clinical characteristics of the recipient and the known
394+ characteristics of the prescription drug regimen;
395+ (2) the recipient previously discontinued taking the
396+ drug required under the step therapy protocol:
397+ (A) while enrolled in a managed care plan offered
398+ by the recipient's current managed care organization or while
399+ enrolled in a managed care plan offered by another managed care
400+ organization; and
401+ (B) because the drug was not effective or had a
402+ diminished effect or because of an adverse event;
403+ (3) the drug required under the step therapy protocol
404+ is not in the best interest of the recipient, based on clinical
405+ appropriateness, because the recipient's use of the drug is
406+ expected to:
407+ (A) cause a significant barrier to the
408+ recipient's adherence to or compliance with the recipient's plan of
409+ care;
410+ (B) worsen a comorbid condition of the recipient;
411+ or
412+ (C) decrease the recipient's ability to achieve
413+ or maintain reasonable functional ability in performing daily
414+ activities; or
415+ (4) the drug that is subject to the step therapy
416+ protocol was prescribed for the recipient's condition while
417+ enrolled in a managed care plan offered by the recipient's current
418+ managed care organization or while enrolled in a managed care plan
419+ offered by a previous managed care organization and the recipient
420+ is stable on the drug.
421+ (d) Except as provided by Subsection (e), if a managed care
422+ organization does not deny an exception request under Subsection
423+ (b) before 72 hours after the managed care organization receives
424+ the request, the request is considered granted.
425+ (e) If a statement described by Subsection (c) also states
426+ that the prescribing provider reasonably believes that denial of
427+ the exception request makes the death of or serious harm to the
428+ recipient probable, the request is considered granted if the
429+ managed care organization does not deny the request before 24 hours
430+ after the managed care organization receives the request.
431+ (f) A managed care organization may not require a
432+ prescribing provider to submit a subsequent exception request under
433+ Subsection (b) for a drug for treatment of a recipient's condition
434+ for which the managed care organization has already granted an
435+ exception to a step therapy protocol for the recipient unless the
436+ managed care organization's medical director determines that the
437+ drug for treatment under the previously granted exception request
438+ will likely cause physical or mental harm to the recipient.
439+ Sec. 533.054. CONTINUITY OF CARE. (a) A managed care
440+ organization shall provide coverage to a recipient who enrolls in a
441+ managed care plan offered by the managed care organization or
442+ transfers to a managed care plan offered by the managed care
443+ organization from a managed care plan offered by another managed
444+ care organization for a prescription drug prescribed for the
445+ recipient before the enrollment or transfer for a 90-day period
446+ following the date of the enrollment or transfer, regardless of
447+ whether the prescription drug is on the managed care organization's
448+ preferred drug list.
449+ (b) To promote continuity of care for recipients who
450+ transfer to a managed care plan offered by a managed care
451+ organization from a managed care plan offered by another managed
452+ care organization, the executive commissioner by rule or the
453+ commission in its contracts with managed care organizations shall:
454+ (1) require a managed care organization that offers
455+ the managed care plan from which a recipient transfers enrollment
456+ to provide to the managed care organization that offers the managed
457+ care plan to which the recipient transfers enrollment the
458+ prescription drug information necessary to promote the recipient's
459+ continuity of care to the extent allowed by law; and
460+ (2) establish an electronic process that facilitates
461+ the transfer of the information described by Subdivision (1)
462+ between managed care organizations.
463+ Sec. 533.055. ACCESS TO INFORMATION REGARDING PRESCRIPTION
464+ DRUG REBATES, PRICING, AND NEGOTIATIONS. (a) The commission may
465+ require the submission of and review information obtained or
466+ maintained by a managed care organization regarding prescription
467+ drug rebate negotiations or a supplemental Medicaid or other rebate
468+ agreement, including the rebate amount, rebate percentage, and
469+ manufacturer or labeler pricing.
470+ (b) Subject to Subsections (c), (d), and (e), information
471+ described by Subsection (a) that a managed care organization
472+ submits to the commission as required by the commission is
473+ confidential and not subject to disclosure under Chapter 552.
474+ (c) Subsection (b) does not:
475+ (1) authorize the commission to withhold from
476+ individual members, agencies, or committees of the legislature for
477+ use for legislative purposes information described by Subsection
478+ (a) that a managed care organization submits to the commission; or
479+ (2) affect the applicability of Section 552.008.
480+ (d) The commission may not release information that is
481+ confidential under 42 U.S.C. Section 1396r-8(b)(3)(D) unless the
482+ legislative request for information is accompanied by a written
483+ affidavit from the requestor providing a detailed description of
484+ the legislative purpose for the request and describing how the
485+ request is within the exception to confidentiality described by 42
486+ U.S.C. Section 1396r-8(b)(3)(D)(iv).
487+ (e) The commission may not disclose information described
488+ by Subsection (a) until each legislative recipient of the
489+ information signs a nondisclosure agreement acknowledging that the
490+ information is subject to, and the recipient agrees to comply with,
491+ the confidentiality provisions in 42 U.S.C. Section
492+ 1396r-8(b)(3)(D) and Section 531.071. The nondisclosure agreement
493+ must also contain an acknowledgement of applicable civil and
494+ criminal penalties for improper disclosure.
495+ Sec. 533.056. PREFERRED DRUG LIST; SEARCHABLE DATABASE OF
496+ PREFERRED DRUGS AND RESTRICTIONS. (a) A managed care organization
497+ shall provide for the distribution of current copies of the managed
498+ care organization's preferred drug list by posting the list on the
499+ managed care organization's Internet website.
500+ (b) A managed care organization shall maintain on the
501+ managed care organization's Internet website a searchable database
502+ to allow a provider to search the managed care organization's
503+ preferred drug list and easily determine whether a prescription
504+ drug or drug class is subject to any prior authorization
505+ requirements, clinical edits, or other clinical restrictions. A
506+ managed care organization shall make reasonable efforts to ensure
507+ that the database contains current information.
508+ Sec. 533.057. PRIOR AUTHORIZATION AND STEP THERAPY
509+ PROTOCOLS FOR CERTAIN PRESCRIPTION DRUGS. (a) Except as provided
510+ by Subsection (b), a managed care organization may not require
511+ prior authorization or a step therapy protocol for prescription
512+ drugs that, as determined by the executive commissioner by rule or
513+ by the commission in a contract with a managed care organization,
514+ are used to treat patients with illnesses that:
515+ (1) are life-threatening;
516+ (2) are chronic; and
517+ (3) require complex medical management strategies.
518+ (b) Subsection (a) applies only to a drug that is prescribed
519+ for a use approved by the United States Food and Drug
520+ Administration. A managed care organization may require prior
521+ authorization for a drug prescribed for a use that is not approved
522+ by the United States Food and Drug Administration, provided that
523+ the prior authorization requirement is not solely based on the drug
524+ manufacturer's package insert.
525+ (c) Once every 10 years, the commission shall conduct a
17526 study to evaluate and determine the classes of prescription drugs
18- described by Subsection (a-1) for which prior authorizations are
19- required.
20- SECTION 2. Section 533.005(a-1), Government Code, is
21- amended to read as follows:
22- (a-1) The requirements imposed by Subsections (a)(23)(A),
23- (B), and (C) do not apply, and may not be enforced, on and after
24- August 31, 2023 [2018].
527+ for which prior authorizations or step therapy protocols are
528+ prohibited under Subsection (a).
529+ (d) A managed care organization shall ensure that a drug
530+ prescribed before the managed care organization implements a prior
531+ authorization requirement or step therapy protocol for that drug is
532+ not subject to the prior authorization requirement or step therapy
533+ protocol until the expiration of a period of at least 90 days
534+ beginning on the date the prior authorization requirement or step
535+ therapy protocol is implemented, as specified by the managed care
536+ organization.
537+ (e) Notwithstanding Subsection (a), a managed care
538+ organization may require prior authorization for a prescription
539+ drug for patient safety purposes, including a drug that is
540+ clinically contraindicated.
541+ Sec. 533.058. PRIOR AUTHORIZATION PROCEDURES. Each managed
542+ care organization shall establish a procedure for prior
543+ authorizations, including step therapy protocols, to ensure
544+ compliance with 42 U.S.C. Section 1396r-8(d)(5). The procedure
545+ must ensure that:
546+ (1) a prior authorization requirement for a drug is
547+ not imposed before the drug has been submitted for review to the
548+ managed care organization's drug utilization review board or
549+ pharmacy and therapeutics committee;
550+ (2) a response to a request for prior authorization
551+ will be provided by telephone or other telecommunications device
552+ not later than 24 hours after the request is made; and
553+ (3) a 72-hour supply of a covered prescribed drug will
554+ be provided in an emergency or if a response is not provided within
555+ the period required by Subdivision (2).
556+ Sec. 533.059. REDUCING ADMINISTRATIVE BURDENS ASSOCIATED
557+ WITH NATIONAL DRUG CODES. (a) A managed care organization shall
558+ ensure that a prescribing provider is not required to provide the
559+ national drug code number on a prescription for a generic
560+ equivalent of a prescribed drug, except as required by federal law.
561+ (b) As soon as practicable after receiving notice from the
562+ Centers for Medicare and Medicaid Services that a national drug
563+ code number for a rebate-eligible prescription drug has been
564+ changed or newly added to a list of rebate-eligible prescription
565+ drugs maintained by the Centers for Medicare and Medicaid Services
566+ or a prescription drug has been removed from that list, the
567+ commission and each managed care organization shall provide notice
568+ of the change, addition, or removal to providers by updating the
569+ commission's or managed care organization's electronic database of
570+ national drug code numbers for rebate-eligible prescription drugs,
571+ as applicable.
572+ Sec. 533.060. ANNUAL REPORT. Each managed care
573+ organization shall annually report to the commission:
574+ (1) the total number of prescriptions dispensed to
575+ recipients enrolled in a managed care plan offered by the managed
576+ care organization;
577+ (2) the percentage of prescription drugs described by
578+ Subdivision (1) for which prior authorization was required;
579+ (3) the percentage of prescription drugs described by
580+ Subdivision (1) for which a step therapy protocol was required; and
581+ (4) the number of exceptions and appeals sought and
582+ granted for prior authorizations, step therapy protocols, and other
583+ formulary requests.
25584 SECTION 3. Not later than September 1, 2018, the Health and
26585 Human Services Commission shall conduct the initial study required
27- by Section 531.073(a-3), Government Code, as added by this Act. The
28- commission may not change a prior authorization requirement for a
29- prescription drug to which that subsection applies until the
586+ by Section 533.057(c), Government Code, as added by this Act. The
587+ commission or a managed care organization may not change a prior
588+ authorization requirement or step therapy protocol for a
589+ prescription drug to which that section applies until the
30590 commission has completed the study.
31591 SECTION 4. If before implementing any provision of this Act
32592 a state agency determines that a waiver or authorization from a
33593 federal agency is necessary for implementation of that provision,
34594 the agency affected by the provision shall request the waiver or
35595 authorization and may delay implementing that provision until the
36596 waiver or authorization is granted.
37- SECTION 5. This Act takes effect immediately if it receives
38- a vote of two-thirds of all the members elected to each house, as
39- provided by Section 39, Article III, Texas Constitution. If this
40- Act does not receive the vote necessary for immediate effect, this
597+ SECTION 5. Except as otherwise provided by this Act, this
41598 Act takes effect September 1, 2017.