Friday, June 30, 2017
TAC Chapter 134
CHAPTER 134: BENEFITS – GUIDELINES FOR MEDICAL SERVICES,
CHARGES, AND PAYMENTS
Title
28 Texas Administrative Code (TAC) § 134.500, § 134.530 and § 134.540
§134.500. Definitions.
(a) The following words and terms, when used in
this subchapter, have the following meanings, unless the context clearly
indicates otherwise:
(1) Brand name drug--A drug marketed under a proprietary,
trademark-protected name.
(2) Certified workers' compensation health care network (certified
network)--An organization that is certified in accordance with Insurance Code
Chapter 1305 and department rules.
(3) Closed formulary--All available Food and Drug Administration (FDA)
approved prescription and nonprescription drugs prescribed and dispensed for
outpatient use, but excludes:
(A) drugs identified with a status of "N" in the current
edition of the Official Disability Guidelines Treatment in Workers' Comp (ODG)
/ Appendix A, ODG Workers' Compensation Drug Formulary, and any updates;
(B) any prescription drug created through compounding [any
compound that contains a drug identified with a status of "N" in the
current edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG
Workers' Compensation Drug Formulary, and any updates]; and
(C) any investigational or experimental drug for which there is early,
developing scientific or clinical evidence demonstrating the potential efficacy
of the treatment, but which is not yet broadly accepted as the prevailing
standard of care as defined in Labor Code §413.014(a).
(4) Compounding--As defined under Occupations Code §551.003(9), the
preparation, mixing, assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription drug order based on
the practitioner-patient-pharmacist relationship in the course of professional
practice;
(B) for administration to a patient by a practitioner as the result of
a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C) in anticipation of a prescription drug order based on a routine,
regularly observed prescribing pattern; or
(D) for or as an incident to research, teaching, or chemical analysis
and not for selling or dispensing, except as allowed under Occupations Code
§562.154 or Occupations Code Chapter 563.
(5) Generic--See generically equivalent in definition of paragraph (6)
of this section.
(6) Generically equivalent--As defined under Occupations Code §562.001,
a drug that, when compared to the prescribed drug, is:
(A) pharmaceutically equivalent--Drug products that have identical
amounts of the same active chemical ingredients in the same dosage form and
that meet the identical compendia or other applicable standards of strength,
quality, and purity according to the United States Pharmacopoeia or another
nationally recognized compendium; and
(B) therapeutically equivalent--Pharmaceutically equivalent drug
products that, if administered in the same amounts, will provide the same
therapeutic effect, identical in duration and intensity.
(7) Medical emergency--The sudden onset of a medical condition
manifested by acute symptoms of sufficient severity, including severe pain that
in the absence of immediate medical attention could reasonably be expected to
result in:
(A) placing the patient's health or bodily functions in serious
jeopardy; or
(B) serious dysfunction of any body organ or part.
(8) Nonprescription drug or over-the-counter medication--A non-narcotic
drug that may be sold without a prescription and that is labeled and packaged
in compliance with state or federal law.
(9) Open formulary--Includes all available Food and Drug Administration
(FDA) approved prescription and nonprescription drugs prescribed and dispensed
for outpatient use, but does not include drugs that lack FDA approval, or
non-drug items.
(10) Prescribing doctor--A physician or dentist who prescribes
prescription drugs or over the counter medications in accordance with the physician's
or dentist's license and state and federal laws and rules. For purposes of this
chapter, prescribing doctor includes an advanced practice nurse or physician
assistant to whom a physician has delegated the authority to carry out or sign
prescription drug orders, under Occupations Code Chapter 157, who prescribes
prescription drugs or over the counter medication under the physician's
supervision and in accordance with the health care practitioner's license and
state and federal laws and rules.
(11) Prescription--An order for a prescription or nonprescription drug
to be dispensed.
(12) Prescription drug--
(A) A substance for which federal or state law requires a prescription
before the substance may be legally dispensed to the public;
(B) A drug that under federal law is required, before being dispensed
or delivered, to be labeled with the statement: "Caution: federal law
prohibits dispensing without prescription;" "Rx only;" or
another legend that complies with federal law; or
(C) A drug that is required by federal or state statute or regulation
to be dispensed on prescription or that is restricted to use by a prescribing
doctor only.
(13) Statement of medical necessity--A written statement from the
prescribing doctor to establish the need for treatments or services, or
prescriptions, including the need for a brand name drug where applicable. A
statement of medical necessity shall include:
(A) the injured employee's full name;
(B) date of injury;
(C) social security number;
(D) diagnosis code(s);
(E) whether the drug has previously been prescribed and dispensed, if
known, and whether the inability to obtain the drug poses an unreasonable risk
of a medical emergency; and
(F) how the prescription treats the diagnosis, promotes recovery, or
enhances the ability of the injured employee to return to or retain employment.
(14) Substitution--As defined under Occupations Code §551.003(41), the
dispensing of a drug or a brand of drug other than the drug or brand of drug
ordered or prescribed.
(b) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule amendment
is finally adopted).
§134.530. Requirements for Use of the Closed Formulary for Claims Not Subject to
Certified Networks.
(a) Applicability.
The closed formulary applies to all drugs that are prescribed and dispensed for
outpatient use for claims not subject to a certified network on or after
September 1, 2011 when the date of injury occurred on or after September 1,
2011.
(b) Preauthorization
for claims subject to the Division's closed formulary.
(1) Preauthorization is only required for:
(A) drugs identified with a status of "N" in the current
edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers'
Compensation Drug Formulary, and any updates;
(B) any prescription drug created through compounding [any
compound that contains a drug identified with a status of "N" in the
current edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG
Workers' Compensation Drug Formulary, and any updates]; and
(C) any investigational or experimental drug for which there is early,
developing scientific or clinical evidence demonstrating the potential efficacy
of the treatment, but which is not yet broadly accepted as the prevailing
standard of care as defined in Labor Code §413.014(a).
(2) When §134.600(p)(12) of this title (relating to Preauthorization,
Concurrent Review, and Voluntary Certification of Health Care) conflicts with
this section, this section prevails.
(c) Preauthorization
of intrathecal drug delivery systems.
(1) An intrathecal drug delivery system requires preauthorization in
accordance with §134.600 of this title and the preauthorization request must
include the prescribing doctor's drug regime plan of care, and the anticipated
dosage or range of dosages for the administration of pain medication.
(2) Refills of an intrathecal drug delivery system with drugs excluded
from the closed formulary, which are billed using Healthcare Common Procedure
Coding System (HCPCS) Level II J codes, and submitted on a CMS-1500 or UB-04
billing form, require preauthorization on an annual basis. Preauthorization for
these refills is also required whenever:
(A) the medications, dosage or range of dosages, or the drug regime
proposed by the prescribing doctor differs from the medications, dosage or
range of dosages, or drug regime previously preauthorized by that prescribing
doctor; or
(B) there is a change in prescribing doctor.
(d) Treatment
guidelines. Except as provided by this subsection, the prescribing of drugs
shall be in accordance with §137.100 of this title (relating to Treatment
Guidelines), the division's adopted treatment guidelines.
(1) Prescription and nonprescription drugs included in the division's
closed formulary and recommended by the division's adopted treatment guidelines
may be prescribed and dispensed without preauthorization.
(2) Prescription and nonprescription drugs included in the division's
closed formulary that exceed or are not addressed by the division's adopted
treatment guidelines may be prescribed and dispensed without preauthorization.
(3) Drugs included in the closed formulary that are prescribed and
dispensed without preauthorization are subject to retrospective review of
medical necessity and reasonableness of health care by the insurance carrier in
accordance with subsection (g) of this section.
(e) Appeals process
for drugs excluded from the closed formulary.
(1) For situations in which the prescribing doctor determines and
documents that a drug excluded from the closed formulary is necessary to treat
an injured employee's compensable injury and has prescribed the drug, the
prescribing doctor, other requestor, or injured employee must request approval
of the drug by requesting preauthorization, including reconsideration, in
accordance with §134.600 of this title and applicable provisions of Chapter 19
of this title (relating to Agents' Licensing).
(2) If preauthorization is being requested by an injured employee or a
requestor other than the prescribing doctor, and the injured employee or other
requestor requests a statement of medical necessity, the prescribing doctor
shall provide a statement of medical necessity to facilitate the
preauthorization submission as set forth in §134.502 of this title (relating to
Pharmaceutical Services).
(3) If preauthorization for a drug excluded from the closed formulary
is denied, the requestor may submit a request for medical dispute resolution in
accordance with §133.308 of this title (relating to MDR by Independent Review
Organizations).
(4) In the event of an unreasonable risk of a medical emergency, an
interlocutory order may be obtained in accordance with §133.306 of this title
(relating to Interlocutory Orders for Medical Benefits) or §134.550 of this title
(relating to Medical Interlocutory Order).
(f) Initial
pharmaceutical coverage.
(1) Drugs included in the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are not subject to retrospective
review of medical necessity.
(2) Drugs excluded from the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization, except as referenced in subsection (b)(1)(C)
of this section, and are subject to retrospective review of medical necessity.
(g) Retrospective
review. Except as provided in subsection (f)(1) of this section, drugs that do
not require preauthorization are subject to retrospective review for medical
necessity in accordance with §133.230 of this title (relating to Insurance
Carrier Audit of a Medical Bill) and §133.240 of this title (relating to
Medical Payments and Denials), and applicable provisions of Chapter 19 of this
title.
(1) Health care, including a prescription for a drug, provided in
accordance with §137.100 of this title is presumed reasonable as specified in
Labor Code §413.017, and is also presumed to be health care reasonably required
as defined by Labor Code §401.011(22-a).
(2) In order for an insurance carrier to deny payment subject to a
retrospective review for pharmaceutical services that are recommended by the
division's adopted treatment guidelines, §137.100 of this title, the denial
must be supported by documentation of evidence-based medicine that outweighs
the presumption of reasonableness established under Labor Code §413.017.
(3) A prescribing doctor who prescribes pharmaceutical services that
exceed, are not recommended, or are not addressed by §137.100 of this title, is
required to provide documentation upon request in accordance with §134.500(13)
of this title (relating to Definitions) and §134.502(e) and (f) of this title.
(h) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule
amendment is finally adopted).
§134.540. Requirements for Use of the Closed Formulary for Claims Subject to
Certified Networks.
(a) Applicability.
The closed formulary applies to all drugs that are prescribed and dispensed for
outpatient use for claims subject to a certified network on or after September
1, 2011 when the date of injury occurred on or after September 1, 2011.
(b) Preauthorization
for claims subject to the Division's closed formulary. Preauthorization is only
required for:
(1) drugs identified with a status of "N" in the current
edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers'
Compensation Drug Formulary, and any updates;
(2) any prescription drug created through compounding [any
compound that contains a drug identified with a status of "N" in the
current edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG
Workers' Compensation Drug Formulary, and any updates]; and
(3) any investigational or experimental drug for which there is early,
developing scientific or clinical evidence demonstrating the potential efficacy
of the treatment, but which is not yet broadly accepted as the prevailing
standard of care as defined in Labor Code §413.014(a).
(c) Preauthorization
of intrathecal drug delivery systems.
(1) An intrathecal drug delivery system requires preauthorization in
accordance with the certified network's treatment guidelines and
preauthorization requirements pursuant to Insurance Code Chapter 1305 and
Chapter 10 of this title (relating to Workers' Compensation Health Care
Networks).
(2) Refills of an intrathecal drug delivery system with drugs excluded
from the closed formulary, which are billed using Healthcare Common Procedure
Coding System (HCPCS) Level II J codes, and submitted on a CMS-1500 or UB-04
billing form, require preauthorization on an annual basis. Preauthorization for
these refills is also required whenever:
(A) the medications, dosage or range of dosages, or the drug regime
proposed by the prescribing doctor differs from the medications dosage or range
of dosages, or drug regime previously preauthorized by that prescribing doctor;
or
(B) there is a change prescribing doctor.
(d) Treatment
guidelines. The prescribing of drugs shall be in accordance with the certified
network's treatment guidelines and preauthorization requirements pursuant to
Insurance Code Chapter 1305 and Chapter 10 of this title. Drugs included in the
closed formulary that are prescribed and dispensed without preauthorization are
subject to retrospective review of medical necessity and reasonableness of
health care by the insurance carrier in accordance with subsection (f) of this section.
(e) Appeals process
for drugs excluded from the closed formulary.
(1) For situations in which the prescribing doctor determines and
documents that a drug excluded from the closed formulary is necessary to treat
an injured employee's compensable injury and has prescribed the drug, the
prescribing doctor, other requestor, or injured employee must request approval
of the drug in a specific instance by requesting preauthorization in accordance
with the certified network's preauthorization process established pursuant to
Chapter 10, Subchapter F of this title (relating to Utilization Review and
Retrospective Review) and applicable provisions of Chapter 19 of this title (relating
to Agents' Licensing).
(2) If preauthorization is pursued by an injured employee or requestor
other than the prescribing doctor, and the injured employee or other requestor
requests a statement of medical necessity, the prescribing doctor shall provide
a statement of medical necessity to facilitate the preauthorization submission
as set forth in §134.502 of this title (relating to Pharmaceutical Services).
(3) If preauthorization for a drug excluded from the closed formulary
is denied, the requestor may submit a request for medical dispute resolution in
accordance with §133.308 of this title (relating to MDR by Independent Review
Organizations).
(4) In the event of an unreasonable risk of a medical emergency, an
interlocutory order may be obtained in accordance with §133.306 of this title
(relating to Interlocutory Orders for Medical Benefits) or §134.550 of this title
(relating to Medical Interlocutory Order).
(f) Initial
pharmaceutical coverage.
(1) Drugs included in the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are not subject to retrospective
review of medical necessity.
(2) Drugs excluded from the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are subject to retrospective review
of medical necessity.
(g) Retrospective
review. Except as provided in subsection (f)(1) of this section, drugs that do
not require preauthorization are subject to retrospective review for medical
necessity in accordance with §133.230 of this title (relating to Insurance
Carrier Audit of a Medical Bill), §133.240 of this title (relating to Medical
Payments and Denials), the Insurance Code, Chapter 1305, applicable provisions
of Chapters 10 and 19 of this title.
(1) In order for an insurance carrier to deny payment subject to a
retrospective review for pharmaceutical services that fall within the treatment
parameters of the certified network's treatment guidelines, the denial must be
supported by documentation of evidence-based medicine that outweighs the
evidence-basis of the certified network's treatment guidelines.
(2) A prescribing doctor who prescribes pharmaceutical services that
exceed, are not recommended, or are not addressed by the certified network's
treatment guidelines, is required to provide documentation upon request in
accordance with §134.500(13) of this title (relating to Definitions) and
§134.502(e) and(f) of this title.
(h) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule
amendment is finally adopted).
Thursday, June 15, 2017
The Health Cell - June 20
|
Monday, June 5, 2017
Charles R. "Chuck" Bauer, MD
It is with a sad heart that we inform you that
Charles R. “Chuck” Bauer, MD passed away Sunday, June 4, 2017. Dr. Bauer was
loved and admired for all his service to the United States, Texas and to San
Antonio.
Dr. Bauer graduated from Marquette University School of
Medicine in 1958 and completed a rotating internship at St. Mary's Hospital. He
entered the US Air Force and spent 3 years as a flight surgeon at Tinker AFB,
Oklahoma. From 1962-1967 he completed four years of general surgery residency
and an additional year in Plastic and Reconstructive Surgery and Thoracic and
Cardiovascular Surgery at the University of Florida, Gainesville, Florida. From
1967-1970 he was stationed at Tachikawa Air Base, Japan caring for Vietnam war
casualties. Dr. Bauer was Commander, 659th Air Transportable Hospital, USAF
Hospital Luke, and USAF Kessler Medical Center (Brig. General position). He
retired in 1982 as a Colonel with Chief Physician and Chief Flight Surgeon
ratings and was awarded the Legion of Merit with 2 oak leaf clusters.
After being out of uniform for 22 years Colonel Bauer was one
of the first physicians recruited into the Texas Medical Brigade (then known as
the Texas Medical Rangers) during the initial organization of the Brigade.
During his tenure in the Medical Brigade, Colonel Dr. Bauer held almost every
important position appropriate for a physician. He responded as the Chief
Medical Officer to Hurricanes Katrina, Rita, Dean, Dolly, Ike, and Gustav.
Upon retirement from the Air Force, Dr. Bauer joined the
faculty at the University of Texas Health Science Center San Antonio as a
general and trauma surgeon and as the Assistant Dean for Ambulatory and
Emergency Services. He was instrumental in the founding of the Division of
Trauma and Emergency Surgery, the Division of Emergency Medicine. He is a
founding member of the Department of Emergency Medicine. Doctor Bauer served
until his death as an Adjunct Professor of Emergency Medicine.
He was board certified in general surgery, emergency medicine
and medical management. The American College of Physician Executives recognized
him as a Certified Physician Executive (CPE). He continued clinical practice in
emergency medicine and trauma surgery resuscitation at University Hospital.
Dr. Bauer was interested in Disaster Response and
Preparedness after arriving in San Antonio. He was the founding Chair of the
Southwest Texas Regional Advisory Council (STRAC) and which he continued as the
Chair Emeritus. He chaired the Bexar County Medical Society Emergency and
Disaster Preparedness Committee from 1985–2006. He was nationally recognized
for his contributions to medical preparedness and training for disasters by
FEMA and by the Medial Reserve Corps Program of the US Department of Health and
Humans Services.
Dr. Bauer developed the South Texas Poison Center located at
the UT Health Science Center and was instrumental in the establishment of the
Texas Poison Center Network. He retired as a Colonel from the Texas State
Guard, and served as the Commander of the Alamo Group, Texas Medical Rangers.
Dr. Bauer was recognized by the San Antonio Business Journal with a Life Time
Achievement Award for his community and medical services to San Antonio and Texas
and has also received the 2009 Governor’s Lonestar Achievement Award.
He completed numerous courses and taught on the subjects of
HazMat, Biological, Chemical, Nuclear and Radiation, Disaster Response, and
Hospital Emergency Incident Command. He had been the course director for close
to 100 Advanced Trauma Life Support Courses and also taught Advanced Cardiac
Life Support, Pediatric Life Support, Advanced HazMat Life Support and Advanced
Pediatric Life Support.
Dr. Charles R. Bauer dedicated his life to
medicine, to serving the citizens of the United States of America and the State
of Texas. There is no one that had done more for our community with such grace
and humility. He has a heart of gold and was earlier this year awarded the
Bexar County Medical Society’s highest honor, the Golden Aesculapius Award.
He will be truly missed!
Melody
Newsom
Chief Operating Officer
Bexar County Medical Society
4334 North Loop 1604 West Ste 200
San Antonio, TX 78249
Rosary for Dr.
Charles Bauer will be held at 7pm, June 15th, 2017 at Porter Loring
Funeral Home, located at 1101 McCullough, San Antonio, TX 78212.
Services will be
at 11:30am, June 16th, 2017 at Porter Loring Main Chapel, with
burial to follow at Ft Sam at 1:15pm
Thursday, June 1, 2017
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