Alliance of Independent Pharmacists of Texas

Former State Representative Capelo Joins Alliance Legislative Affairs Team December 1

The Alliance of Independent Pharmacists (Alliance) is pleased to announce the addition of the Hon. Jaime Capelo to its legislative affairs team Friday, December 1. He will consult with the Alliance on legislative and regulatory initiatives, while aggressively advancing the Alliance's legislative policies and goals.

Capelo has a proven track record of a successful lobbyist who possesses intimate knowledge of the legislative process, fundamental knowledge of healthcare issues and works to build strong personal relationships with legislators. He represents a broad range of client interests, giving him an in-depth understanding of the healthcare delivery system.

We are excited Jaime has agreed to join the Alliance's legislative efforts, said Audra Conwell, CAE. "We feel confident his years of healthcare legislative and regulatory experience and his influence will help us achieve the goals and directives of the Alliance Board of Directors and its members."

He is a native of Corpus Christi where he served on the Corpus Christi City Council before serving as the Texas House Representative from District 34 for four terms, 1998-2004. Representative Capelo served on the House Public Health Committee while in the Texas House, and was ultimately appointed Chair of the House Public Health Committee in his last term.

During the 78th Legislature, Representative Capelo not only chaired the Public Health Committee he also was the author of SB 803 that authorized a compounding pharmacy to advertise nonsterile prescription compounding services that the pharmacy provided and specific compounded drug products the pharmacist dispensed or delivered.

Capelo will coordinate the Alliance's advocacy efforts with our current Medicaid Consultant, Brittani Bilse, at the direction of the Board and CEO.

 

PBM and Managed Care Compliance Concerns

Formal complaints are the most effective way to push compliance issues to the appropriate level of enforcement at the Texas Department of Insurance (TDI). TDI has created a pharmacy-based complaint process to allow for better oversight of PBM and other health insurer pharmacy benefit coverage compliance issues. There are several specific items that have to be documented before a formal complaint is initiated. As you become aware of health insurer or PBM compliance issues, please document the specific circumstances of the issue (audit, contracting, billing, reimbursement, coverage of benefits, patient out-of-pocket costs, etc.), and send your documented formal complaint to Audra Conwell at aconwell@aiptexas.org

Specific items of interest are as follows:

  • pharmacist/pharmacy contact information;
  • name of the health plan and/or PBM involved in the complaint;
  • the nature of the complaint; and
  • patient group and ID number(s), and date(s) of service

See additional information on the TDI Pharmacy Resource Page.

The Alliance will follow-up on your complaint-based enforcement questions with the appropriate staff at TDI. We will organize complaints according to their level of non-compliance and ask TDI to review their enforcement actions as necessary.

 

End of Session Report

The 85th Regular Session adjorned Sine Die Memorial Day, May 29. The fate of the Alliance priority legislative issues that passed are now in the hands of the Governor. We have worked on several issues that directly impact your profession and small business. The Alliance will provide a final report in the weeks to come and again after the Governor's veto period ends in June, until then, the following important pharmacy issues have been sent to the Governor's office as follows: {Download print version}

PBM Reform

HB 3218, regulates the mysterious middlemen of prescription drug benefits (PBMs), regulating PBMs that contract with HMOs by requiring them to disclose their business practices, including Department of Insurance (TDI) jurisdiction and oversight into complaints, payment to pharmacies, prior authorization processes, credentialing, contracts, and other administrative duties.

HB 3218, an Alliance priority, requires PBMs that contract with pharmacies to comply with all laws and rules that apply to HMOs and requires PBMs to register as "delegated entities." Signed by the Governor Thursday, June 1 and is effective September 1, 2017.

Mandatory HHSC Audits of PBMs in the Medicaid Program

SB 894 requires statewide audits of Medicaid PBMs to comply with all laws, rules, and contract requirements of MCOs, including oversight of payment and benefits administration. This legislation requires MCO PBMs to be audited by a third party every two years.

Management of the Medicaid Drug Formulary

HB 1917 continues the administration of a statewide formulary, preferred drug list, and adherence to prior authorization procedures and requirements of the Health and Human Services Commission, Vendor Drug Program. 
The measure allows pharmacy to continue to advocate for a single statewide PBM or pharmacy benefits administrator for the Medicaid program with adequate reimbursement guidelines.

Read more...
 

Congress Preserves Access to Office-Use Compounding to Patients


International Academy of Compounding Pharmacists (IACP) reported yesterday the President has signed the Consolidated Appropriations of 2017 (H.R. 244). The bill supported by numerous national and state pharmacy organizations including the Alliance, provides funding for the federal government through September 30, 2017, and includes language that addresses the Memorandum of Understanding (MOU) for office-use and pharmacy inspections.

This bipartisan legislation includes critical language which clarifies congressional intent on several compounding regulations implementing the Drug Quality and Security Act (DQSA) of 2013.

The language calls on FDA to do the following:

  • Draft a new MOU that does not include "dispensing" of compounded prescriptions across state lines. Congress expressed concern that the FDA draft MOU includes both "dispensing" and "distribution" of compounded medications. Congress made clear in the language that FDA does not possess this authority and specifically stated, "Congress only allowed the FDA to regulate distribution" under the MOU and "Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU."
  • Release new guidance to allow 503A pharmacists to compound for "office-use" for prescribers, hospitals, and other health systems. Congress expressed concern that patient access is decreasing to compounded medications, due to FDA's implementation actions of prohibiting all office-use compounding even where "this practice is authorized in the vast majority of states and was intended to be allowable under DQSA." 
  • Cease inspecting state-licensed 503A pharmacies under current Good Manufacturing Practices (cGMPs). Congress instructed FDA to inspect 503A pharmacies under USP standards or other applicably pharmacy inspection standards adopted by state law or regulation. Congress also stated it "reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations." Congress further stated, "compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed."

We are pleased Congress has preserved patient access to compounded medications from their local independent community pharmacists.

 

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