Texas Health and Human Services Digest: June 25, 2020

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Previous meetings have made alternative arrangements like phone-in capability or have been canceled. These meetings are on the calendar as of today.

June 26, 2020

June 29, 2020

June 30, 2020

July 1, 2020

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.

No rules are presently available for public comment.

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 26, Chapter 558 Licensing Standards for Home and Community Support Services Agencies#19R069HHSC Policy, Rules, and Training6/23/207/7/20
Repeal of Title 40, Chapter 109, Subchapter C, Specialized Telecommunications Assistance Program, and new Title 26, Chapter 360, Subchapter C, Specialized Telecommunications Assistance Program#18R061Bryant Robinson6/18/207/2/20
Title 26, Chapter 744, 746, & 747 Minimum Standards for School Age and Before or After School Programs, Child-Care Centers, & Child-Care Homes#20R024HHSC Child Care Regulation6/17/207/1/20
Title 26, Chapter 742 Minimum Standards for Listed Family Homes#20R021HHSC Child Care Regulation6/15/206/29/20
Title 26, Chapter 303 Preadmission Screening and Resident Review (PASSR)#20R049Lisa Habbit6/12/206/26/20

 

Today, the Centers for Medicare & Medicaid Services (CMS) announced plans to end the emergency blanket waiver requiring all nursing homes to resume submitting staffing data through the Payroll-Based Journal (PBJ) system by August 14, 2020. The PBJ system allows CMS to collect nursing home staffing information which impacts the quality of care residents receive. The blanket waiver was intended to temporarily allow the agency to concentrate efforts on combating COVID-19 and reduce administrative burden on nursing homes so they could focus on patient health and safety during this public health emergency.

The memorandum released today also provides updates related to staffing and quality measures used on the Nursing Home Compare website and the Five Star Rating System.

To view the memorandum to states and nursing home stakeholders, visit: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/changes-staffing-information-and-quality-measures-posted-nursing-home-compare-website-and-five-star

Inpatient Rehabilitation Facility (IRF) Provider Preview Reports have been updated and are now available. The data contained within the Preview Reports is based on quality data submitted by IRFs between Quarter 1 – 2019 and Quarter 4 – 2019 and reflects what will be published on IRF Compare during the September 2020 refresh of the website. Providers have until July 18, 2020 to review their performance data. Corrections to the underlying data will not be permitted during this time; however, providers can request CMS review of their data during the preview period if they believe the quality measure scores that are displayed within their Preview Reports are inaccurate.

Beginning with the September 2020 refresh, CMS will publicly display six new measures on the IRF Compare website.  For more information: IRF Quality Public Reporting webpage, IRF Compare

Long-Term Care Hospital (LTCH) Provider Preview Reports have been updated and are now available. The data contained within the Preview Reports is based on quality data submitted by LTCHs between Quarter 1 – 2019 and Quarter 4 – 2019 and reflects what will be published on LTCH Compare during the September 2020 refresh of the website. Providers have until July 18, 2020 to review their performance data. Corrections to the underlying data will not be permitted during this time; however, providers can request CMS review of their data during the preview period if they believe the quality measure scores that are displayed within their Preview Reports are inaccurate.  Beginning with the September 2020 refresh, CMS will publicly display three new measures on the LTCH Compare website. For more information: LTCH Quality Reporting Public Reporting webpage, LTCH Compare

Feel free to contact PreclusionList@cms.hhs.gov if you have any questions or concerns.

The Centers for Medicare & Medicaid Services (CMS) today posted the 2020 Quality Measure Development Plan (MDP) Annual Report, which describes progress in developing clinician quality measures to support the Quality Payment Program. The CMS Quality Measure Development Plan (MDP) is a focused framework for developing these measures, pointing out the known measurement and performance gaps, and recommending prioritized approaches to close those gaps.

The strategic approach to measure development outlined in the MDP and additional highlights in the MDP annual reports provide information and support to key stakeholders who develop clinician quality measures for consideration for the Quality Payment Program.

For more information about the 2020 MDP Annual Report, go to the Quality Payment Program measure development page at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.

In a new study, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Pap test), the current standard for follow-up of women who test positive with primary human papillomavirus (HPV) screening. The new approach uses artificial intelligence (AI) to automate dual-stain evaluation and has clear implications for clinical care.

Findings from the study were published June 25, 2020, in the Journal of the National Cancer Institute. The algorithm was developed and the study conducted by investigators at the National Cancer Institute (NCI), part of the National Institutes of Health, in collaboration with researchers from several other institutions.

In recent years, clinicians have hoped to take advantage of advances in digital imaging and machine learning to improve cervical cancer screening. Women who test negative for HPV are at low risk for cervical cancer for the following decade, and even most cervical HPV infections—which cause positive HPV tests—will not result in precancer. The challenge is to identify which women with positive HPV test results are most likely to have precancerous changes in their cervical cells and should, therefore, have a colposcopy to examine the cervix and take samples for biopsy, or who need immediate treatment.

Currently, women with positive HPV tests may have additional HPV tests or Pap cytology tests to assess the need for colposcopy, biopsy, or treatment. Pap cytology, in which specially trained laboratory professionals (cytotechnologists) analyze stained slides to look for abnormal cells, is used to find precancers before they progress to cancer. But these approaches are not ideal. For example, Pap cytology tests are time consuming, not very sensitive, and prone to false-positive findings.

Dual-stain testing has emerged as a way to more accurately predict the chance that a woman with a positive HPV test has precancerous cervical changes. The test measures the presence of two proteins, p16 and Ki-67, in cervical samples. In two previous studies, Dr. Wentzensen and his colleagues found that women who had a negative result on a dual-stain test had a low risk of developing cervical precancer in the following five years and that fewer women test positive for dual-stain compared to Pap cytology. In March 2020, the manual dual-stain cytology test was approved by the U.S. Food and Drug Administration for women who have received a positive result on a primary HPV screening.

The manual dual-stain test has a subjective component, in that a cytotechnologist must look at the slide to determine the results. In the new study, the investigators wanted to see if a fully automated dual-stain test could match or exceed the performance of the manual approach. In collaboration with Niels Grabe, Ph.D., and Bernd Lahrmann, Ph.D., of the Steinbeis Transfer Center for Medical Systems Biology, which is associated with the University of Heidelberg, they developed a whole-slide imaging platform that, after being trained with deep learning, could determine if any cervical cells were stained for both p16 and Ki-67. They compared this method with both conventional Pap cytology and manual dual-stain testing in samples from a total of 4,253 people participating in one of three epidemiological studies of HPV-positive cervical and anal precancers at Kaiser Permanente Northern California and the University of Oklahoma.

The researchers found that the AI-based dual-stain test had a lower rate of positive tests than both Pap cytology and manual dual-stain, with better sensitivity (the ability to correctly identify precancers) and substantially higher specificity (the ability to correctly identify those without precancers) than Pap cytology. AI-based dual-stain reduced referral to colposcopy by about a third compared with Pap (approximately 42% vs. 60%). The testing method was also robust, showing comparable performance in anal cytology.

In short, the automated test surpassed the performance of the current standard, Pap cytology, reducing the number of false positive results and substantially reducing referral to unnecessary colposcopy procedures. The results also support further evaluation of the test as an option for anal cancer screening. The researchers note that their approach has clear clinical application, and through cloud-based implementation, it would be globally accessible. Other applications of the platform include assisted evaluation, second opinion, and quality control.

Because the manual dual-stain test has only recently received FDA approval for screening of women who have HPV-positive test results, its use is just getting started. Additional regulatory approval will be needed to allow for screening of HPV-positive women with a fully automated dual-stain test. The researchers say that their findings serve as an important example for introducing digital pathology and deep learning into clinical practice, and their approach has the potential to substantially improve cervical cancer screening, affecting millions of women testing HPV-positive each year.

In the largest exercise research program of its kind, researchers are poised to collect and turn data from nearly 2,600 volunteers into comprehensive maps of the molecular changes in the body due to exercise. It is well known that physical activity has substantial health benefits, but we do not fully understand why, especially at the molecular level. The National Institutes of Health-funded Molecular Transducers of Physical Activity Consortium (MoTrPAC) aims to increase our understanding by measuring molecular changes in healthy adults and children before, during, and after exercise. The large study size is meant to account for person-to-person variation, and to reveal differences based on demographics like age, race, and gender. MoTrPAC researchers published a paper(link is external) detailing their approach to this ambitious research project. They are currently reviewing lessons from an initial phase with a smaller group of adult volunteers and multiple rounds of preclinical animal model studies to optimize their protocols and prepare to scale-up for full recruitment.

The MoTrPAC clinical study pairs methods well-established in exercise research with unique study aspects to move our fundamental understanding of exercise forward. One of the most distinctive study features is its size. MoTrPAC set the ambitious goal amongst its 11 clinical sites to recruit about 2,600 healthy volunteers across a wide age range (10 to 60-plus years-old) and with balanced participation by the sexes. Part of the study will test how the response to exercise changes after generally inactive participants complete a 12-week supervised exercise regimen. Sedentary adults will be randomly assigned to an endurance training regimen (treadmill, cycling), a resistance training regimen (weightlifting), or an inactive control group. Low-activity children will be randomly assigned to an endurance training regimen, or to a control group where they pursue their normal activities. Contributing to the overall size of the study is a separate group of highly-active adults and youths who will help researchers understand what exercise looks like at the molecular level in those who have exercised vigorously and consistently over an extended period.

Another unique facet of MoTrPAC is that volunteers provide samples – or biospecimens – before, during, and after exercise that will go through a complex array of molecular assays. Adults provide blood, fat and muscle tissues, while children provide only blood samples. MoTrPAC researchers implemented an early study phase with a limited number of adult volunteers that is meant to ensure the complex study design is feasible both for the researchers and the participants before scaling up. The researchers and their data and safety monitoring board are reviewing lessons learned, so that recruitment may continue under optimized protocols. Recruitment currently is on-hold due to safety concerns over COVID-19, and will resume when it is safe to do so. To see if a MoTrPAC clinical center will be recruiting near you, visit https://motrpac.org/join/volunteerHome.cfm(link is external).

Preclinical studies in an animal model also set the stage for full-scale MoTrPAC clinical studies and enabled MoTrPAC to generate data from tissues that cannot be collected from humans, expanding the scope of the consortium. Researchers at three preclinical animal study sites conducted both a single round of exercise and an exercise training regimen in young and aged rats. Following the exercise round, or after training, 19 biospecimens were collected per animal. The number of biospecimens per animal is a powerful aspect of MoTrPAC, as it gives a nearly whole-body look at the effects of exercise, which has never been done before. The biospecimens collected from the preclinical studies were sent to MoTrPAC’s biorepository, managed by the consortium’s coordinating center. The biospecimens also provided raw material for the nine chemical analysis sites to generate data on exercise-responsive biomolecules like genes, indicators of gene activity, proteins, molecules involved in metabolism, and molecular signals in cell-to-cell communication.

Some data from the preclinical studies is available through the MoTrPAC Data Hub(link is external), and more is expected soon. MoTrPAC’s bioinformatics center is charged with data quality control, bioinformatics analysis, and making the data available through the data hub. MoTrPAC researchers alone cannot answer all our questions about the molecular basis of the health benefits of exercise. Making the data widely available brings new perspectives to the topic than would be otherwise possible. They may discover how exercise affects so many aspects of health throughout the body like metabolism, immune responses, and cardiovascular function.

Ultimately, MoTrPAC aims to have a positive impact on human health. The study and resulting data integration are an immense undertaking, and provide an unprecedented opportunity to explore the molecular basis for the benefits of exercise. The information MoTrPAC assembles about endurance and resistance exercise in a wide range of individuals and in different tissues may influence exercise guidelines, making them more tailored for specific groups of people. One day, a doctor may be able to prescribe a personalized exercise routine based on what is likely to create the best outcome for an individual. Other researchers may use the data to identify drugs that mimic the molecular signals of exercise, so-called exercise-mimetics, which could help people who are unable to exercise.

MoTrPAC is funded by the NIH Common Fund and overseen in collaboration with the National Institute on Aging , the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the National Institute of Diabetes and Digestive and Kidney Diseases. A list of funded MoTrPAC projects is at https://motrpac.org/aboutUs.cfm(link is external). MoTrPAC’s adult and pediatric clinical studies are registered with clinicaltrials.gov under NCT03960827 and NCT04151199, respectively.