Texas Health and Human Services Digest: November 9, 2020

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From HHSC: While every effort has been made to offer an accurate and current listing of meeting agendas and events on this calendar, the information has been compiled from a variety of sources and is subject to change without notice to the user.

November 9, 2020

November 10, 2020

November 12, 2020

November 13, 2020

November 16, 2020

November 17, 2020

November 18, 2020

November 19, 2020

November 30, 2020

December 11, 2020

Proposed Rules
Formal Comments via the Texas Register
To let the public know about a rulemaking action – such as new, amended or repealed rules – HHS publishes a notice in the Texas Register, a publication of the Texas Secretary of State. Interested parties then can review and comment on the proposed rule. The Secretary of State publishes a new issue of the Texas Register each Friday.

The Administrative Procedure Act (Texas Government Code, Chapter 2001) requires the notice published in the Texas Register to include a brief explanation of the proposed rule and a request for comments from any interested person. The notice also includes instructions for submitting comments regarding the rule to the agency, including the date by which comments must be submitted. Agencies must give interested persons “a reasonable opportunity” to submit comments. The public comment period begins on the day after the notice of a proposed rule is published in the Texas Register and lasts for a minimum of 30 calendar days.

Below is a list of proposed rules that have been published in the Texas Register. The proposed rules that are published in the Texas Register are open for public comment until the end of the comment period.

TitleProject No., DescriptionContactComment End Date
Title 1, Chapter 355, Subchapter J, Division 11, Section 355.8201, Waiver Payments to Hospitals for Uncompensated Care#21R012: Uncompensated Care Secondary Reconciliation for DYs 6-8HHSC12/7/20
Repeal of Title 25, Chapter 415, Subchapter C, Use and Maintenance of Department of State Health Services/Department of Aging and Disability Services Drug Formulary#19R052: HHSC Psychiatric Drug FormularyHHS Health and Specialty Care11/23/20
Repeal of Title 40, Chapter 5, Subchapter C, Use and Maintenance of Drug Formulary#19R052: HHSC Psychiatric Drug FormularyHHS Health and Specialty Care11/23/20
New Title 26, Chapter 306, Subchapter G, Use and Maintenance of the Health and Human Services Commission Psychiatric Drug Formulary, Sections 306.351 – 306.360#19R052: HHSC Psychiatric Drug FormularyHHS Health and Specialty Care11/23/20
Title 1, Chapter 355, Subchapter B, Establishment and Adjustment of Reimbursement Rates for Medicaid, Section 355.205#21R015: Rate Increase Attestation Process COVID-19HHS Provider Finance Department11/23/20
Repeal of Title 1, Chapter 383, Interstate Compact on Mental Health and Mental Retardation#19R065: Interstate Compact CoordinationHHS Health and Specialty Care11/16/20
New Title 26, Chapter 903, Interstate Compact on Mental Health and Intellectual and Developmental Disabilities#19R065: Interstate Compact CoordinationHHS Health and Specialty Care11/16/20
Title 1, Chapter 354, Subchapter A, Division 1, Section 354.1003, Time Limits for Submitted Claims#20R006: Claims Payment Deadlines ExceptionsHHS Rules Coordination Office11/16/20
Title 25, Chapter 40, Subchapter D, concerning Maintenance and Administration of Asthma Medication#20R019: Asthma MedicationDSHS School Health Program11/16/20
Title 25, Chapter 40, Subchapters B and C, concerning Epinephrine Auto-Injector Policies in Certain Entities and Youth Facilities#20R018: Epinephrine Policies in Certain Entities and Youth FacilitiesDSHS School Health Program11/16/20

Draft Rules Informal Comments

Informal opportunities to comment occur before a rule is published in the Texas Register. HHS staff may solicit informal public and stakeholder input by:

  • inviting stakeholders to submit comments on potential rule changes during rule development.
  • sharing a draft rule with stakeholders for review.
  • using existing HHS advisory committees to comment on rules.

The following are draft rules on which HHS is accepting informal public or stakeholder input. All rules are posted in MS Word format unless otherwise noted.

TitleProject No.ContactComment Start DateComment End Date
Title 1, Chapter 351, Section 351.805, State Medicaid Managed Care Advisory Committee#20R108HHS Medicaid/CHIP Services11/5/2011/19/20
Title 1, Chapter 354, Subchapter F, Division 8, Drug Utilization Review Board#21R007John Pepin10/30/2011/13/20
Title 26, Chapter 561, Employee Misconduct Registry (EMR)#19R045HHS Policy, Rules and Training10/30/2011/13/20

The following Limited Data Set (LDS) file is now available to request:

  • 2021 End-Stage Renal Disease (ESRD) Final

To request this file, please see the instructions on the CMS Data Use Agreement (DUA) website.

For more information about CMS LDS files, please see the LDS File Listing website.

CMS to Host Benefits Coordination & Recovery Center Non-Group Health Plan Beneficiary Recovery Process Webinar. CMS will be hosting a Benefits Coordination & Recovery Center Non-Group Health Plan Beneficiary Recovery Process webinar on December 9, 2020.  Complete webinar information is available in the announcement in the Downloads section of the Attorney Services What’s New page on CMS.gov.

Trump Administration Announces Medicaid and CHIP Managed Care Final Rule, Continues Commitment to Transform Medicaid by Delivering Greater Flexibility to States. The Centers for Medicare & Medicaid Services (CMS) released the 2020 Medicaid and Children’s Health Insurance Program (CHIP) Managed Care final rule. The final rule fulfills one of the Trump Administration’s earliest commitment to states by reducing unnecessary administrative burden and federal regulatory barriers. The purpose of the rule is to ensure state Medicaid and CHIP agencies are able to work effectively to develop and implement managed care programs that better serve each state’s growing number of Medicaid and CHIP beneficiaries.

Today’s final rule was designed to improve federal oversight and state flexibility while maintaining beneficiary protections and providing high quality of care for the 55 million beneficiaries who are enrolled in Medicaid managed care plans. This also includes the 79 percent of CHIP children in 32 states who enrolled in CHIP managed care plans.

The rule fosters accountability by ensuring CMS issues guidance to help states more quickly complete the federal rate review process, while preserving the requirement for states to implement a Quality Rating System (QRS) for the managed care plans they contract with, so beneficiaries can have information about their plan and make informed decisions about their healthcare. The rule also reinforces CMS’s commitment to providing access and quality care to beneficiaries living in rural America by changing the minimum standards states must use in developing network adequacy requirements in a way that supports state facilitation for telehealth options.

In 2016, CMS issued a Medicaid & CHIP Managed Care Final Rule to update the regulations governing Medicaid and CHIP managed care programs. However, numerous stakeholders complained that the 2016 regulations were overly prescriptive and burdensome. As a result, CMS formed a working group with the National Association of Medicaid Directors (NAMD) and State Medicaid Directors to review and prioritize areas of concern within the managed care regulations. The recommendations from this group culminated in the proposals that CMS put forward for comment in November 2018.

This final rule strengthens provisions in the 2016 rule taking into consideration the comments the agency received, giving states greater flexibility to establish appropriate payment for Medicaid and CHIP services and to set standards that effectively address the healthcare needs specific to their state, while ensuring appropriate beneficiary protections.

The majority of provisions will be effective thirty days after issuance of the Final Rule. There are two provisions that will be effective with contract rating periods starting on or after July 1, 2021 and two provisions that states will be required to come into compliance with for certain reports and quality strategies submitted on or after July 1, 2021.

For more information, please visit: https://www.federalregister.gov/public-inspection/2020-24758/medicaid-program-medicaid-and-childrens-health-insurance-program-managed-care

For a fact sheet on the CHIP Managed Care final rule, please visit: https://www.cms.gov/newsroom/fact-sheets/medicaid-childrens-health-insurance-program-chip-managed-care-final-rule-cms-2408-f

9/8-9/9 ICD-10 Coordination and Maintenance Committee Meeting Updates

Reminder: 
Today, November 9, 2020, is the deadline for receipt of public comments on proposed new codes and revisions being considered for implementation on October 1, 2021.

 

NIH study finds long-acting injectable drug prevents HIV acquisition in cisgender women. A pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form of the HIV drug cabotegravir injected once every eight weeks was safe and more effective than a daily oral PrEP regimen at preventing HIV acquisition among a group of cisgender women. The women, from southern and east Africa, are enrolled in a clinical trial sponsored by the National Institutes of Health. This finding, from a planned interim analysis of study data, marks the first time a large-scale clinical trial has shown a long-acting injectable form of HIV prevention to be highly effective for cisgender women.

Read the full release.

Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application3 or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

This guidance considers both demographic characteristics of study populations (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics of populations (e.g., patients with organ dysfunction, comorbid conditions, disabilities, those at the extremes of the weight range, and populations with diseases or conditions with low prevalence). Enrolling participants5 with a wide range of baseline characteristics may create a study population that more accurately reflects the patients likely to take the drug if it is approved and allow assessment of the impact of those characteristics on the safety and effectiveness of the study drug. In issuing this guidance, FDA is satisfying the mandate under section 610(a)(3) of the FDA Reauthorization Act of 2017 (FDARA) (21 U.S.C. 360bbb note).

Consistent with the FDARA mandate, this guidance discusses (1) broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials; (2) developing eligibility criteria and improving trial recruitment so that the participants enrolled in trials will better reflect the population most likely to use the drug, if the drug is approved, while maintaining safety and effectiveness standards; and (3) applying the recommendations for broadening eligibility criteria to clinical trials of drugs intended to treat rare diseases or conditions.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Download the final guidance document.

Behavioral Health Conference on Dec. 9, 2020. The Texas Health and Human Services Commission (HHSC) will be hosting a free virtual conference focusing on key behavioral health initiatives, innovations, obstacles, and opportunities.

All Texas Access Conference
Dec. 9, 2020
10 a.m. – 5 p.m. Central Time

Featured at the conference will be the All Texas Access Report (Senate Bill 633, 86th Legislature, Regular Session, 2019) and behavioral health innovations throughout the state. Many of these innovations improve access to behavioral health services, particularly for Texans living in rural communities. Attendees will leave the conference with a better understanding of how the behavioral health field is improving and becoming more accessible to all Texans.

Register for the Conference: Registration is limited to a first come first serve basis. To register for the conference, click on the following link:

Behavioral Health Conference registration
If you have any questions or concerns, please email alltexasaccess@hhsc.state.tx.us.

STAR Health Pre-Solicitation Vendor Meetings. In anticipation of the upcoming solicitation and resulting contract for STAR Health, HHSC invites vendors to participate in a pre-solicitation meeting with Medicaid program, legal, and procurement staff.

Virtual meetings will be scheduled November 12 – 20, 2020. For more information and to register, read the news article.

Shopping for a health plan? How to spot problems. With Healthcare.gov and Medicare open enrollments in swing, many Texans are shopping for health plans. The Texas Department of Insurance has tips to help consumers avoid scams and guard against deceptive marketing. Consumer alert