Texas Health and Human Digest: September 14, 2020

  • Twitter
  • Facebook
  • Google+
  • Linkedin

Upcoming Public Meetings

Previous meetings have made alternative arrangements like phone capability or have been cancelled. These meetings are on the Calendar as of today.

September 14, 2020

September 15, 2020

September 16, 2020

September 23, 2020

September 24, 2020

HHSC has the Following Rules Available for Comment

The Administrative Procedure Act (Texas Government Code, Chapter 2001(link is external)) 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.

The Administrative Procedure Act (Texas Government Code, Chapter 2001(link is external)) 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.

TitleProject No., DescriptionContactComment End Date
Title 25, Chapter 1, Subchapter V, Adult Stem Cells#20R014: Informed Consent for Investigational Stem Cell TreatmentHHS Rules Coordination Office10/12/20
Title 25, Chapter 97, Subchapter A, Control of Communicable Diseases#20R059: Notifiable ConditionsHHS Rules Coordination Office10/12/20
Title 40, Chapter 9, Sections 9.153 and 9.553; Chapter 42, Section 42.103; Chapter 45, Section 45.103; and Chapter 49, Sections 49.102, 49.208 – 49.210, 49.532, 49.551, 49.601, 49.702, and new Section 49.561#20R048: Convert Open-Ended Contracts to Term ContractsHHS Rules Coordination Office10/12/20
Title 25, Chapter 37, Maternal and Infant Health(link is external)#19R012: Texas School Health Advisory CommitteeDSHS School Health9/28/20
Title 25, Chapter 85, Local Public Health(link is external)#20R003: Data Request Process for Public Health Practice PurposesDSHS Center for Health Policy and Performance9/28/20
Title 25, Chapter 221, Meat Safety Assurance(link is external)#20R013: Low-Volume Livestock Processing EstablishmentsDSHS PSQA Meat Compliance Unit9/28/20
Title 1, Chapter 355, Reimbursement Rates(link is external)#20R054: HCS and TxHmL Respite and Day Habilitation ReimbursementHHS Rate Analysis Department9/21/20
Title 26, Part 1, Chapter 370, Human Trafficking Resource Center(link is external)#20R034: Human Trafficking Prevention Training RequirementsHHS Rules Coordination Office9/14/20

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.
Title Project No. Contact Comment Start Date Comment End Date
Title 25, Chapter 228, Retail Food, concerning Texas Food Establishments#20R023DSHS Consumer Protection Division9/8/209/30/20
Title 40, Chapter 85, Subchapter A, Section 85.2, Definitions, and Subchapter D, Section 85.302, Nutrition Services#20R031HHS Rules Coordination Office9/4/209/18/20
Title 1, Chapter 393, Section 393.1, Section 393.2, and new Section 393.3#20R093Allison Levee9/8/209/15/20

HHSC: EVV Requirements for in -Home Day Habilitation in the HCS Program

HHSC is issuing this guidance from CMS to Home and Community-based Services program providers. It clarifies electronic visit verification requirements for in-home day habilitation.

All service events occurring on or after Dec. 1, 2020, for an EVV-required service, must be captured in the EVV system and accepted into the EVV Aggregator.

EVV is not required for In-Home Day Habilitation provided to someone in a:

  • Three or four-person home
  • Host home
  • Companion care residential setting

EVV is only required for the following services:

  • Community First Choice Personal Assistance Services/Habilitation
  • In-Home Day Habilitation in own home or family home settings
  • In-Home Respite in own home or family home settings

See IL 20-07 Electronic Visit Verification in the HCS and TxHmL Program (PDF) for information about EVV requirements.

Additional Guidance on Day Habilitation Services

Program providers billing claims for In-Home Day Habilitation services requiring EVV will continue to use the current claims procedure code, T2020. The EVV Service Bill Codes Table lists this code on the HHS EVV website.

HHSC is developing separate bill codes for Out-of-Home Day Habilitation and will provide guidance before implementing the new codes.

CMS: HQRP COVID-19 Tip Sheet is Available

The HQRP COVID-19 PR Tip Sheet is now available. The purpose of this Tip Sheet is to help providers understand CMS’ public reporting strategy for the PAC QRP in the midst of the COVID-19 public health emergency (PHE).  This Tip Sheet explains the CMS strategy to account for CMS quality data, which were exempted from public reporting due to COVID-19 and the impact on CMS’ Hospice Compare website refreshes. Please navigate to the HQRP Requirements and Best Practices page to download this document.

NIH: NIH augments large scale study of Alzheimer’s disease biomarkers

To meet the pressing need to better understand the prevalence, progression, and clinical impact of Alzheimer’s disease among Mexican Americans, the National Institutes of Health has added funding for more biomarker measures, including positron emission tomography (PET) imaging, to the ongoing Health and Aging Brain Among Latino Elders (HABLE) Study. NIH’s National Institute on Aging (NIA) awarded new support that is expected to total $45.5 million over five years to the University of North Texas Health Science Center (HSC) at Fort Worth for the Health and Aging Brain Among Latino Elders-Amyloid, Tau, and Neurodegeneration (HABLE-AT(N)) Study. This combined investment and effort will help researchers better understand the health disparities of brain aging and Alzheimer’s between Mexican Americans and non-Latino whites.

Developing a better understanding of how and why many diseases affect diverse communities in different ways is paramount in the search for treatments and prevention for Alzheimer’s, the most common form of dementia. While studies suggest that dementia prevalence rates appear to be declining, most of this evidence is based on studies in non-Latino whites; it is largely unknown whether these trends extend to under-represented populations.

Launched in September 2017, the HABLE study has nearly completed recruitment of 1,000 Mexican Americans and 1,000 non-Latino whites, age 50 years and older, in the Fort Worth area. HABLE participants receive a functional exam, clinical labs, neuropsychological testing, bloodwork, and an MRI of the brain. The added funding for HABLE-AT(N) significantly expands the neuroimaging component of the study to include amyloid and tau PET. The researchers also plan to determine if traces of amyloid peptides (Aβ40 and Aβ42), tau, and neurofilament light (NfL) — as well as exosomes in the blood — can be used to screen across the spectrum of Alzheimer’s, from asymptomatic to mild cognitive impairment and advanced stages of the disease.

An additional benefit of HABLE and HABLE AT(N) will be the ability to better classify/categorize participants into groups by type of dementia and stage of the disease. This will help facilitate potential enrollment in future studies.

The research teams for HABLE and HABLE-AT(N) consist of leading experts in Mexican American cognitive aging, neuroimaging, blood-based biomarkers, as well as advanced statistical modeling. Sid O’Bryant, Ph.D., professor and executive director of the HSC Institute for Translational Research, and professor in HSC’s Pharmacology & Neuroscience unit, is the principal investigator for both efforts.

Projections from the U.S. Census Bureau(link is external) show that the number of Latinos age 65 and older is expected to nearly quadruple by 2060, whereas, for the same age range, the number of non-Hispanic whites is expected to increase by about 23% and the number of Blacks will more than double. Because aging is the greatest risk factor for Alzheimer’s, this means Latinos will face the largest increase in Alzheimer’s cases of any racial/ethnic group nationwide — about 3.5 million by 2060. Mexican Americans are the largest segment of the U.S. Latino population.

NIA is committed to supporting studies on risk factors related to health disparities. A key part of the HABLE-AT(N) study is its alignment with the NIA-Alzheimer’s Association Research Framework. This biological construct is based on three general groups of biomarkers: beta-amyloid (A), tau (T), and neurodegeneration or neuronal injury (N). Also referred to as the AT(N) research framework, it is designed to facilitate better understanding of the disease process and the sequence of events that lead to cognitive impairment and dementia. HABLE and HABLE-AT(N) are also responsive to the NIA Health Disparities Research Framework.

The new study is instrumental in making sure Alzheimer’s biomarker studies are increasingly representative of the population. HABLE-AT(N) will provide a variety of biological, behavioral, environmental, and sociocultural data to examine the big picture of how Alzheimer’s affects people throughout their lives. There will also be data to determine whether Mexican Americans experience the same Alzheimer’s biomarker trajectory reported in past studies.

HSC’s Institute for Translational Research(link is external) will also make the HABLE and HABLE-AT(N) data available to the scientific community to facilitate rapid scientific advancements, thereby meeting an NIA goal of open access to research data.

The HABLE-AT(N) Study is funded by NIH grant R01AG058533-01A1. The HABLE Study is funded by NIH grant R01AG054073.

NIA leads NIH’s systematic planning, development, and implementation of research milestones to achieve the goal of effectively treating and preventing Alzheimer’s and related dementias. HABLE and HABLE-AT(N) demonstrate efforts toward the following milestones:

  • Clarify the epidemiology of health disparities in Alzheimer’s disease and related dementias (AD/ADRD) prevalence and incidence by documenting and monitoring trends in health disparities in AD/ADRD prevalence and incidence over time.
  • Initiate studies to link peripheral blood-based molecular signatures and central imaging and CSF biomarkers.
  • Expand existing large scale, open-science molecular profiling efforts.

NIA recently updated its website with a new Spanish-language health information landing page: www.nia.nih.gov/espanol. Current information is available on subjects such as Alzheimer’s disease and related dementias, as well as clinical trials and other aging-related health topics.

Información de salud — www.nia.nih.gov/espanol

NIH: Substance use disorders linked to COVID-19 susceptibility

A National Institutes of Health-funded study found that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. The research, published today in Molecular Psychiatry, was co-authored by Nora D. Volkow, M.D., director of the National Institute on Drug Abuse (NIDA). The findings suggest that health care providers should closely monitor patients with SUDs and develop action plans to help shield them from infection and severe outcomes.

By analyzing the non-identifiable electronic health records (EHR) of millions of patients in the United States, the team of investigators revealed that while individuals with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The analysis revealed that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death), than people without an SUD.

NIDA’s Dr. Volkow and Rong Xu, Ph.D., of Case Western Reserve University in Cleveland, Ohio, analyzed EHR data collected until June 15, 2020, from 360 hospitals nationwide. The EHRs were de-identified to ensure privacy.

The study population consisted of over 73 million patients, of which over 7.5 million had been diagnosed with an SUD at some point in their lives. Slightly more than 12,000 were diagnosed with COVID-19, and about 1,880 had both an SUD and a COVID-19 diagnosis on record. The types of SUDs investigated in the study were tobacco, alcohol, opioid, cannabis, and cocaine.

The complicating effects of SUD were visible in increased adverse consequences of COVID-19. Hospitalizations and death rates of COVID-19 patients were all elevated in people with recorded SUDs compared to those without (41.0% versus 30.1% and 9.6% versus 6.6%, respectively).

Additionally, African Americans with a recent opioid use disorder diagnosis were over four times more likely to develop COVID-19, compared to whites. Results showed that hypertension, diabetes, cardiovascular diseases, and renal diseases, which are risk factors for COVID-19, were more prevalent among African Americans than whites with opioid use disorder.

According to the authors, the study findings underscore the need to screen for, and treat, SUDs as part of the strategy for controlling the pandemic. Additional research needs to be done to better understand how best to treat those with SUDs who are at risk for COVID-19 and counsel on how to avoid the risk of infection.

*This research was funded by NIDA, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute on Aging, all parts of NIH, as well as the American Cancer Society and The Clinical and Translational Science Collaborative of Cleveland.

CMS: Release of State Payment of Medicare Premiums Manual

On September 8, CMS released the updated Manual for State Payment of Medicare Premiums (formerly called “State Buy-in Manual”). The manual updates information and instructions to states on federal policy, operations, and systems concerning the payment of Medicare Parts A and B premiums (or buy-in) for individuals dually eligible for Medicare and Medicaid. The update to the manual is part of CMS’ Better Care for Dually Eligible Individuals Strategic Initiative aimed at improving quality, reducing costs, and improving customer experiences.

States pay Medicare Part B premiums each month for over 10 million individuals and Part A premiums for over 700,000 individuals. This process promotes access to Medicare coverage for low-income older adults and people with disabilities, and it helps states ensure that Medicare is the first and primary payer for Medicare covered services for dually eligible beneficiaries.

The prior version of this manual had not been fully updated since the 1990s. The new manual released today clarifies various provisions of statute, regulation, and operations that have evolved over time. We also redesigned the manual content to make it (1) easier for states to discern federal requirements and find information, (2) compliant with federal accessibility standards and (3) available online for the first time. The new manual also addresses multiple comments from states and other partners on the draft released in December 2019.

The manual is available at: https://www.cms.gov/medicare-medicaid-coordination/medicare-medicaid-coordination-office/state-payment-medicare-premiums. We will be posting on this site various opportunities for training and technical assistance for our state and other partners.

The Centers for Medicare & Medicaid Services (CMS) Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) is seeking input from the public as part of the measure development process. CMS has posted Draft Measure Specifications: SNF Healthcare-Associated Infections Requiring Hospitalizations for the SNF QRP (SNF HAI measure).  This document contains conceptual and technical measure information and provides a link to the Final Technical Expert Panel Summary Report: Development of a Healthcare-Associated Infections Quality Measure for the SNF QRP for the public’s review.  Please review both of these documents and give us your feedback via the email:  SNFQualityQuestions@cms.hhs.gov.

CMS would also like to announce the SNF HAI measure will be a part of the Measures Under Consideration list later this year and it is our intention to present this measure for pre-rulemaking review at the Measure Applications Partnership Post-Acute Care/Long-Term Care Workgroup meeting in December.  CMS will be providing Confidential Dry Run Reports to alert each SNF of their SNF HAI performance score based on these draft measure specifications later this summer.

The full Draft Measure Specification documents is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/PC-Currently-Accepting-Comments