Access to Innovation

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Throughout the 86th Texas Legislature, THBI fought to preserve and continue our state's access to innovation. It is critical that all patients fighting diseases have access to needed treatments and cures that allow patients to live longer, healthier, and more productive lives.

THBI is committed to safeguarding and preserving timely patient access to new medicines while maintaining the integrity of those who utilize the latest innovations in creating these products. We worked hard to preserve and foster Texas' investments to continue to grow a productive infrastructure in our state.

Below you'll find a comprehensive overview of the successes our industry had during the legislative session as it relates to access to innovation.

Budget Initiatives

THBI and several member companies worked diligently through the budget process in the 86th Session to have two riders (extensions of the budget) adopted that would clarify the process and timeframe in which the Health and Human Services Commission includes prescription drugs on the Texas Drug Code Index and provides notification of Medicaid Coverage and expenditures on Orphan Drugs - drugs which treat life-threatening, rare diseases.

The Clear Process for Including Prescription Drugs on the Texas Drug Code Index Rider can be located on page II-103 of the newly adopted state budget and the Orphan Drug Rider can found in Article II, Special Provisions, Section 14(b) on page II-112.

Clear Process

The budget includes a rider for the development of a clear process for including prescription medications on the Texas Drug Code Index requiring HHSC to clarify their process for the inclusion of prescription drugs in both Medicaid and CHIP.

The Health and Human Services Commission (HHSC) shall make clear their process for the inclusion of prescription drugs in the Medicaid and Children's Health Insurance Programs. In maintaining the prescription drug inclusion process, HHSC shall ensure that the timeline for review, including initiation of drug review, clinical evaluation, rate setting, Legislative Budget Board notification, and making the product available, does not extend past the 90th day of receipt of the completed application for coverage on the Texas Drug Code Index. After the applicable Drug Utilization Review Board meeting and approval by the HHSC Executive Commissioner, HHSC will complete the public posting of medical policies associated with the product.

Orphan Drug Notification

The budget includes a provision of notification related to orphan drug rates and rate increases (Article II Special Provisions, Section 14.b.). An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition.

The rider provides that HHSC shall provide notification of a new or increased rate for an orphan drug within 60 calendar days following expenditures for this purpose if managed care capitation rates are to be adjusted or the annual fiscal impact to fee-for-service expenditures is expected to exceed $500,000 in General Revenue Funds. An orphan drug must meet criteria specified in the federal Orphan Drug Act and regulations at 21 C.F.R. §316 and be required to be covered by the Medicaid program under federal law. With the notification, HHSC shall provide the fiscal impact including the amount of General Revenue Funds, and All Funds, by fiscal year; the number of drug rebates projected; and an estimate of the population to be served

Legislative Initiatives

Biosimilars

In 2015, legislation was passed that allowed interchangeable biological products to be substituted for brand-name biological products under certain circumstances. A “biosimilar” is a biological product that is highly similar to another biological product apart from minor differences in clinically inactive components and that has no clinically meaningful differences between the safety, purity, and potency of the two products.

HB 1264 removes the expiration on the requirement for a pharmacist to communicate to a prescribing practitioner within three business days certain information about a biological product dispensed to a patient.

Newborn Screening

Throughout the 86th session, THBI and several member companies and other organizations were involved in a newborn screening working group with the goal of adding additional core newborn conditions recommended by the Recommended Uniform Screening Panel (RUSP) added to the Texas panel for screening.

SB 748 establishes the Newborn Screening Preservation Account as a dedicated account in general revenue to be administered by the Department of State Health Services (DSHS). The bill would require the Comptroller to transfer unexpended and unencumbered funds from Medicaid reimbursements collected by the agency for newborn screening services to the new account. The account will be composed of grants, gifts, donations, legislative appropriations, and interest earned on the investment of money in the account. Money in the account can only be appropriated to DSHS and only for the purposes of carrying out the newborn screening program, performing additional newborn screening tests, or for certain capital expenditures. The bill takes effect September 1, 2019.

Insurance

HB 1584 amends the Insurance Code relating to health benefit plan coverage of prescription drugs for stage-four advanced, metastatic cancer and applies only to a health benefit plan that is delivered, issued for delivery or renewed on or after January 1, 2020. The bill takes effect on September 1, 2019.

General Healthcare

HB 2425 relates to the authority of physicians to delegate to certain pharmacists the implementation and modification of a patient’s drug therapy. It has been noted that a physician is already allowed to delegate to a pharmacist the ability to implement or modify a patient's drug therapy under a protocol if the pharmacist practices in certain health care facilities. This bill allows a physician to delegate this same authority to pharmacists working in federally qualified health centers.

The Texas Diabetes Council was established by the legislature in 1983 and addresses issues affecting people with diabetes in Texas. SB 2151 by Senator Kolkhorst updates the council's statute to reflect its functions, purview, and composition.

Drug Pricing and Transparency

HB 2536 requires pharmaceutical drug manufacturers (PDMs) to annually report to the Health and Human Services Commission (HHSC) on the current wholesale acquisition costs of certain FDA-approved drugs sold in the state. HHSC would be required to develop a website to provide this information to the public. The bill would also require PDMs to report information on certain drug price increases with HHSC publishing this information online. The bill further requires pharmacy benefit managers and health benefit plan issuers to submit reports to the Insurance Commissioner, who would be required to publish the combined aggregated data from those reports online.