87R8123 SCL-F
 
  By: Oliverson H.B. No. 1033
 
  Substitute the following for H.B. No. 1033:
 
  By:  Oliverson C.S.H.B. No. 1033
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to prescription drug price disclosure; authorizing a fee;
  providing an administrative penalty.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter A, Chapter 441, Health and Safety
  Code, is amended by adding Section 441.0003 to read as follows:
         Sec. 441.0003.  RULES. The executive commissioner may adopt
  rules to implement this chapter.
         SECTION 2.  Chapter 441, Health and Safety Code, is amended
  by adding Subchapter B, and a heading is added to that subchapter to
  read as follows:
  SUBCHAPTER B. PRESCRIPTION DRUG PRICE DISCLOSURE
         SECTION 3.  Section 441.0002, Health and Safety Code, is
  transferred to Subchapter B, Chapter 441, Health and Safety Code,
  as added by this Act, redesignated as Sections 441.0051, 441.0052,
  441.0053, and 441.0054, Health and Safety Code, and amended to read
  as follows:
         Sec. 441.0051 [441.0002].  ANNUAL REPORT [DISCLOSURE OF
  DRUG PRICING INFORMATION]. [(a)] Not later than the 15th day of
  each calendar year, a pharmaceutical drug manufacturer shall submit
  a report to the department [executive commissioner] stating the
  current wholesale acquisition cost information for the United
  States Food and Drug Administration-approved prescription drugs
  sold in or into this state by that manufacturer.
         Sec. 441.0052.  PRESCRIPTION DRUG PRICE INFORMATION
  INTERNET WEBSITE. [(b)] The department [executive commissioner]
  shall develop an Internet website to provide to the general public
  prescription drug price information submitted under Section
  441.0051 [Subsection (a)]. The Internet website shall be made
  available on the department's [Health and Human Services
  Commission's] Internet website with a dedicated link that is
  prominently displayed on the home page or by a separate easily
  identifiable Internet address.
         Sec. 441.0053.  PRESCRIPTION DRUG COST INCREASE REPORT AND
  INFORMATION. (a) [(c)] This subsection applies only to a
  prescription drug with a wholesale acquisition cost of at least
  $100 for a 30-day supply before the effective date of an increase
  described by this subsection. Not later than the 30th day after the
  effective date of an increase of 40 percent or more over the
  preceding three calendar years or 15 percent or more in the
  preceding calendar year in the wholesale acquisition cost of a
  prescription drug to which this subsection applies, a
  pharmaceutical drug manufacturer shall submit a report to the
  executive commissioner. The report must include the following
  information:
               (1)  the name of the prescription drug;
               (2)  whether the prescription drug is a brand name or
  generic;
               (3)  the effective date of the change in wholesale
  acquisition cost; and
               (4)  [aggregate, company-level research and
  development costs for the most recent year for which final audit
  data is available;
               [(5)  the name of each of the manufacturer's
  prescription drugs approved by the United States Food and Drug
  Administration in the previous three calendar years;
               [(6)  the name of each of the manufacturer's
  prescription drugs that lost patent exclusivity in the United
  States in the previous three calendar years; and
               [(7)]  a statement regarding the factor or factors that
  caused the increase in the wholesale acquisition cost and an
  explanation of the role of each factor's impact on the cost.
         (b)  If during a calendar year a prescription drug with a
  wholesale acquisition cost of at least $100 for a 30-day supply
  increases in price by 40 percent or more over the preceding three
  calendar years or 15 percent or more in the preceding calendar year
  in the wholesale acquisition cost of the prescription drug, the
  pharmaceutical drug manufacturer must include in the annual report
  submitted under Section 441.0051 the following information:
               (1)  aggregate, company-level research and development
  costs for the most recent year for which final audit data is
  available;
               (2)  the name of each of the manufacturer's
  prescription drugs approved by the United States Food and Drug
  Administration in the previous three calendar years; and
               (3)  the name of each of the manufacturer's
  prescription drugs that lost patent exclusivity in the United
  States in the previous three calendar years.
         (c) [(d)]  The quality and types of information and data that
  a pharmaceutical drug manufacturer submits to the department
  [executive commissioner] under Subsections (a) and (b) [Subsection
  (c)] must be consistent with the quality and types of information
  and data that the manufacturer includes in the manufacturer's
  annual consolidated report on Securities and Exchange Commission
  Form 10-K or any other public disclosure.
         Sec. 441.0054.  PUBLICATION OF COST INCREASE INFORMATION.
  [(e)] Not later than the 60th day after receipt of the report
  submitted under Section 441.0051 or 441.0053(a) [Subsection (c)],
  the department [executive commissioner] shall publish the cost
  increase information required by Section 441.0053 [report] on the
  department's prescription drug price information [Health and Human
  Services Commission's] Internet website [described by Subsection
  (b)].
         [(f)  The executive commissioner may adopt rules to
  implement this section.]
         SECTION 4.  Subchapter B, Chapter 441, Health and Safety
  Code, as added by this Act, is amended by adding Section 441.0055 to
  read as follows:
         Sec. 441.0055.  FEE. (a) A pharmaceutical drug
  manufacturer shall submit a fee in the amount provided by
  department rule with each report submitted under this subchapter.
         (b)  The executive commissioner by rule shall set the fee in
  the amount necessary for the department to administer this chapter,
  not to exceed $400.
         SECTION 5.  Chapter 441, Health and Safety Code, is amended
  by adding Subchapter C to read as follows:
  SUBCHAPTER C. ENFORCEMENT
         Sec. 441.0101.  RIGHT TO CORRECT. (a) If the department
  determines that a pharmaceutical drug manufacturer failed to submit
  a report or fee required under, or failed to submit the report or
  fee in the manner prescribed by, Subchapter B and the rules adopted
  under this chapter, the department shall provide written notice of
  the failure to the manufacturer.
         (b)  On receipt of notice described by Subsection (a), a
  pharmaceutical drug manufacturer shall submit, as applicable:
               (1)  a report that:
                     (A)  complies with Subchapter B and rules adopted
  under this chapter; and
                     (B)  addresses the issues raised in the notice; or
               (2)  the fee required by Section 441.0055.
         (c)  The department may not assess an administrative penalty
  under Section 441.0102 against a pharmaceutical drug manufacturer
  that submits to the department the required report or fee, as
  applicable, on or before the 45th day after the date the
  manufacturer receives notice under Subsection (a).
         Sec. 441.0102.  ADMINISTRATIVE PENALTY. (a) The department
  may assess an administrative penalty against a person who violates
  this chapter or a rule adopted under this chapter.
         (b)  In determining the amount of the penalty, the department
  shall consider:
               (1)  the person's previous violations;
               (2)  the seriousness of the violation;
               (3)  the person's demonstrated good faith; and
               (4)  any other matters as justice may require.
         (c)  The penalty may not exceed $1,000 a day for each
  violation.
         (d)  Each day a violation continues may be considered a
  separate violation.
         (e)  The enforcement of the penalty may be stayed during the
  time the order is under judicial review if the person pays the
  penalty to the clerk of the court or files a supersedeas bond with
  the court in the amount of the penalty. A person who cannot afford
  to pay the penalty or file the bond may stay the enforcement by
  filing an affidavit in the manner required by the Texas Rules of
  Civil Procedure for a party who cannot afford to file security for
  costs, subject to the right of the board to contest the affidavit as
  provided by those rules.
         (f)  The attorney general may sue to collect the penalty.
  Money collected under this section shall be deposited in the state
  treasury and may be appropriated only to the department for the
  purposes of administrating this chapter.
         Sec. 441.0103.  ADMINISTRATIVE PROCEDURE. A proceeding to
  impose an administrative penalty under Section 441.0102 is
  considered to be a contested case under Chapter 2001, Government
  Code.
         SECTION 6.  Sections 1369.502(a) and (c), Insurance Code,
  are amended to read as follows:
         (a)  Not later than March [February] 1 of each year, each
  pharmacy benefit manager shall file a report with the commissioner.  
  The report must state for the immediately preceding calendar year:
               (1)  the aggregated rebates, fees, price protection
  payments, and any other payments collected from pharmaceutical drug
  manufacturers; and
               (2)  the aggregated dollar amount of rebates, fees,
  price protection payments, and any other payments collected from
  pharmaceutical drug manufacturers that were:
                     (A)  passed to:
                           (i)  health benefit plan issuers; or
                           (ii)  enrollees at the point of sale of a
  prescription drug; or
                     (B)  retained as revenue by the pharmacy benefit
  manager.
         (c)  Not later than June [May] 1 of each year, the
  commissioner shall publish the aggregated data from all reports for
  that year required by this section in an appropriate location on the
  department's Internet website.  The combined aggregated data from
  the reports must be published in a manner that does not disclose or
  tend to disclose proprietary or confidential information of any
  pharmacy benefit manager.
         SECTION 7.  Sections 1369.503(a) and (c), Insurance Code,
  are amended to read as follows:
         (a)  Not later than March [February] 1 of each year, each
  health benefit plan issuer shall submit to the commissioner a
  report that states for the immediately preceding calendar year:
               (1)  the names of the 25 most frequently prescribed
  prescription drugs across all plans;
               (2)  the percent increase in annual net spending for
  prescription drugs across all plans;
               (3)  the percent increase in premiums that were
  attributable to prescription drugs across all plans;
               (4)  the percentage of specialty drugs with utilization
  management requirements across all plans; and
               (5)  the premium reductions that were attributable to
  specialty drug utilization management.
         (c)  Not later than June [May] 1 of each year, the
  commissioner shall publish the aggregated data from all reports for
  that year required by this section in an appropriate location on the
  department's Internet website.  The combined aggregated data from
  the reports must be published in a manner that does not disclose or
  tend to disclose proprietary or confidential information of any
  health benefit plan issuer.
         SECTION 8.  Subchapter K, Chapter 1369, Insurance Code, is
  amended by adding Section 1369.5035 to read as follows:
         Sec. 1369.5035.  CONTENT OF REPORTS. The reports required
  by Sections 1369.502 and 1369.503 must include information relating
  to private health benefit plans that cover prescription drugs and
  are regulated by the department.  The reports may not include
  information relating to:
               (1)  the child health plan program under Chapter 62,
  Health and Safety Code, or the health benefits plan for children
  under Chapter 63, Health and Safety Code; or
               (2)  the medical assistance program under Chapter 32,
  Human Resources Code.
         SECTION 9.  (a)  Subchapter C, Chapter 441, Health and Safety
  Code, as added by this Act, applies only to a violation occurring on
  or after the effective date of this Act.
         (b)  Section 1369.5035, Insurance Code, as added by this Act,
  applies only to a report submitted on or after the effective date of
  this Act.
         SECTION 10.  This Act takes effect September 1, 2021.