Texas Health and Human Services Digest: September 9, 2020

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HHSC has the Following Rules Available for Comment
Proposed Rules
Formal Comments via the Texas Register
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.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.,
Description
ContactComment End Date
Title 25, Chapter 37, Maternal and Infant Health#19R012: Texas School Health Advisory CommitteeDSHS School Health9/28/20
Title 25, Chapter 85, Local Public Health#20R003: Data Request Process for Public Health Practice PurposesDSHS Center for Health Policy and Performance9/28/20
Title 25, Chapter 221, Meat Safety Assurance#20R013: Low-Volume Livestock Processing EstablishmentsDSHS PSQA Meat Compliance Unit9/28/20
Title 1, Chapter 355, Reimbursement Rates#20R054: HCS and TxHmL Respite and Day Habilitation ReimbursementHHS Rate Analysis Department9/21/20
Title 26, Part 1, Chapter 370, Human Trafficking Resource Center#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.
TitleProject No.ContactComment Start DateComment Start 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
Probiotic skin therapy improves eczema in children, NIH study suggests
Atopic dermatitis, commonly called eczema, is a chronic inflammatory skin disease characterized by dry, itchy skin and rashes. The disease is most common in children and is linked to an increased risk of developing asthma, hay fever and food allergy. While available treatments can help manage eczema symptoms, current options can be costly, and many require multiple daily applications.

The experimental therapy contains strains of live Roseomonas mucosa—a bacterium naturally present on the skin—originally isolated from healthy volunteers and grown under carefully controlled laboratory conditions. For four months, clinical trial participants or their caregivers periodically applied this probiotic therapy to areas of skin affected by eczema.

Numerous genetic and environmental factors contribute to eczema, and scientists are learning more about the role that the skin’s microbiome plays in this condition. In 2016, NIAID researchers reported that R. mucosa strains isolated from healthy human skin improved outcomes in cell culture and mouse models of eczema.

To build on these preclinical findings, NIAID launched a Phase 1/2 clinical trial at the NIH Clinical Center in Bethesda, Maryland, to assess the safety and potential benefit of R. mucosa therapy in people with eczema. Interim results reported in 2018 for 10 adults and five children aged 9 to 14 years indicated that the treatment was safe and associated with reduced eczema severity. Since then, the trial has enrolled an additional 15 children, for a total of 20 children with mild to severe eczema ranging in age from 3 to 16 years.

Twice weekly for three months and every other day for an additional month, children or their caregivers sprayed a solution of sugar water containing live R. mucosa onto areas of skin with eczema. For the first 15 children enrolled in the study, the dose of live R. mucosa was gradually increased each month. The last five children to enroll received the same dose throughout the four-month treatment period. Regardless of dosing strategy, no serious adverse events were attributed to the therapy.

Seventeen of the 20 children experienced a greater than 50% improvement in eczema severity following treatment. Improvement occurred on all treated skin sites, including the inner elbows, inner knees, hands, trunk and neck. The scientists also observed increases in the skin’s barrier function—its ability to seal in moisture and keep out allergens. Additionally, most children needed fewer corticosteroids to manage their eczema, experienced less itching, and reported a better quality of life following the therapy. These benefits persisted after treatment ended, and the therapeutic R. mucosa strains remained on the skin for up to eight months.

The NIAID researchers next set out to better understand how R. mucosa therapy improves eczema symptoms. They found that treated skin had increased microbial diversity and reduced levels of Staphylococcus aureus—a bacterium known to exacerbate eczema.

In addition to imbalances in the microbiome, the skin of people with eczema is deficient in certain lipids, or oils. By conducting experiments in cell and animal models of eczema, the NIAID scientists found that a specific set of lipids produced by R. mucosa strains isolated from healthy skin can induce skin repair processes and promote turnover of skin tissue. Study participants had increased levels of these lipids on their skin after treatment with R. mucosa.

The researchers emphasize that additional studies are needed to further elucidate the mechanism of R. mucosa therapy and to explore whether genetic or other factors may explain why some participants did not benefit from the experimental treatment.
For more information about the completed Phase 1/2 study Beginning Assessment of Cutaneous Treatment Efficacy for Roseomonas in Atopic Dermatitis (BACTERiAD), see ClinicalTrials.gov using identifier NCT03018275.

NIH has exclusively licensed the R. mucosa therapy to Forte Biosciences to advance this potential treatment through further clinical development, and the company plans to begin enrollment in a Phase 2 placebo-controlled trial later this month. For more information about this study, Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis, see ClinicalTrials.gov using identifier NCT04504279.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

Study shows decline in awareness, treatment and control of high blood pressure
The trend could threaten decades of public health work against heart disease.

After nearly 15 years on an upward trend, awareness among Americans about high blood pressure and how to control and treat it is now on the decline, according to a new study. Even with the help of blood pressure medications, some groups, including older adults, are less likely than they were in earlier years to adequately control their blood pressure, the research found.

The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, appears online on Sept. 9 in JAMA(link is external). The authors say the trend could make longstanding efforts to fight heart disease and stroke—leading causes of death in the United States—even more challenging. High blood pressure, also called hypertension, is a major risk factor for heart disease. According to the Centers for Disease Control and Prevention (CDC), nearly 108 million Americans have hypertension, with a blood pressure reading of 130/80 millimeters of mercury (mm Hg) or higher or are taking medication for their blood pressure, but only 27 million are considered to have their blood pressure under control, despite it being a condition that can be managed.

The study included 18,262 U.S. adults age 18 and older, with high blood pressure. The definition of hypertension at the time of the study was defined by a blood pressure reading of 140/90 mm Hg or higher or by treating the condition with blood pressure medications. Participants with a blood pressure reading of less than 140/90 mm Hg were categorized as having controlled blood pressure.

With data from the National Health and Nutrition Examination Survey (NHANES) taken between1999 and 2018, the study authors looked at 20-year trends in high blood pressure awareness and treatment and blood pressure control. The CDC’s National Center for Health Statistics conducts NHANES.
At the beginning of the survey, participants had their blood pressure measured three times, then averaged. Participants answered yes or no when asked if their doctors told them they had high blood pressure and if they currently took prescribed medication for high blood pressure.

The authors found that in 1999-2000, just 70% of participants showed an awareness of their condition. That number increased steadily to 85% in 2013-2014, but declined to 77% in 2017-2018. Of those “aware” adults, the number who also were taking blood pressure medications remained relatively
consistent—85% in 1999-2000, 89% in 2013-2014, and 88% in 2017-2018.

Of all adults with high blood pressure, the number who managed to control their condition increased from 32% in 1999-2000 to 54% in 2013-2014, but then declined to 44% in 2017-2018. Of those adults with controlled blood pressure, the number taking blood pressure medication increased from 53% in 1999-2000 to 72% in 2013-2014, then declined to 65% in 2017-2018.
These observations, Muntner said, underscore the importance of continuity of care, including having a usual source of care and regularly scheduled healthcare visits that could increase high blood pressure awareness and treatment and blood pressure control among adults.

Between 2015 to 2018, adults age 60 and older, as well as Black Americans as a group, were less likely than adults ages 18 to 44 and whites as a group to have controlled blood pressure. But participants with Medicaid as their health insurance were more likely to have their blood pressure under control than those without health insurance.

NIH: Testimony on Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health
Witness appearing before the Senate Health, Education, Labor and Pensions Committee
Francis S. Collins, M.D., Ph.D. Director, National Institutes of HealthChairman Alexander, Ranking Member Murray and distinguished members of this committee thank you for inviting me to discuss the Department of Health and Human Services’ (HHS) Operation Warp Speed (OWS) efforts and the importance of vaccination. I am grateful for this opportunity to address how the National Institutes of Health (NIH) is working tirelessly with other parts of the government, and with industry partners, to prevent, diagnose, and treat the novel coronavirus SARS-CoV-2. We thank Congress for your continual partnership in response to COVID-19.I am also pleased to be here today to reinforce the importance vaccines play in protecting public health from childhood immunizations to the annual flu and pneumonia vaccines in keeping Americans safe and healthy. While our immediate focus has been on the development of a COVID-19 vaccine, we can’t lose sight of the need to encourage the continued uptake of all vaccines by the American people.

To accelerate the development and subsequent production of a vaccine for COVID-19, in mid-May, President Trump announced Operation Warp Speed (OWS). OWS aims to deliver up to 300 million doses of a safe and effective vaccine for COVID-19 in early 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as medical countermeasures). OWS is a partnership among components of HHS, including NIH, Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), and Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD), with the aim of a unified government approach to respond to the pandemic. OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. OWS coordinates with existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and research activities by the National Institute of Allergy and Infectious Diseases (NIAID).

NIH is the HHS agency leading the biomedical research response to COVID-19 and the novel coronavirus that causes the disease, SARS-CoV-2. We have done everything possible to unleash the most rapid and innovative approaches to address this global pandemic. The importance of studying the safety and efficacy of vaccine and therapeutic candidates during the critical clinical trial phases is now NIH’s top priority. OWS has been selecting the most promising countermeasure candidates and providing coordinated government support. Protocols for the demonstration of safety and efficacy are being aligned, which allows the trials to proceed more quickly. The protocols for the trials are being overseen by the Federal Government, in contrast to traditional public-private partnerships, in which pharmaceutical companies are solely responsible for design and implementation of their own protocols. Rather than eliminating steps from traditional development timelines, steps are proceeding simultaneously. That includes starting manufacturing of a vaccine candidate at industrial scale well before the demonstration of vaccine efficacy and safety, as happens normally. This increases the financial risk in the event of non-optimal product performance, but not the product risk.

It is important to highlight that none of the safety and efficacy assessments will be skipped or abbreviated. Efforts to shorten the timeline from bench to bedside, but still achieve a safe and effective vaccine, have been accomplished by eliminating down times and assuming the costs of at-risk manufacturing. Throughout the clinical trials, an independent data and safety monitoring board (DSMB) continues to monitor ongoing results to ensure study participant well- being and safety as well as study integrity. The critical final steps in clinical trials will be well-coordinated and done in parallel with manufacturing, but with NIH and industry providing the FDA with all of the critical safety and efficacy data necessary for sound scientific decision- making.

NIH is deeply engaged in the vaccine trial program. NIAID recently established the COVID-19 Prevention Network (CoVPN) by leveraging four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group (ACTG), in partnership with the DoD. The CoVPN is engaged in assisting enrollment of tens of thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines, monoclonal antibodies (mAb), and drugs intended to treat and protect people from COVID-19. The CoVPN is a functional unit of the OWS partnership led by HHS to invest in and coordinate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The CoVPN is participating in harmonized protocols, developed in collaboration with the ACTIV public-private partnership, vaccine manufacturers, and BARDA. The network will participate in numerous trials at more than 100 clinical trial sites across the United States and internationally. The CoVPN has developed an extensive community engagement framework to reach out to the diverse communities most affected by COVID-19; understand interest in, and concerns about, research participation; and partner with them to ensure their input is reflected in study implementation. The CoVPN plans to evaluate both therapeutic and vaccine candidates. While the long-term goal is to have a safe and effective vaccine, NIH is continuing its vital work on researching and evaluating all potential therapeutic approached against SARS-CoV-2.

Identifying Therapeutics to Treat COVID-19
NIH, in collaboration with the Foundation for the NIH, launched an innovative public- private partnership to speed up the development of COVID-19 therapeutics and vaccines. The ACTIV public-private partnership brings together stakeholders from across the U.S. government, industry, and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic. The ACTIV public-private partnership is led by an Executive Committee co-chaired by me and Dr. Paul Stoffels of Johnson & Johnson, and has engaged more than 100 experts from both sectors in a 24/7 effort to prioritize therapeutic options. ACTIV has designed five adaptive master protocols for ACTIV clinical trials. These master protocols provide an efficient and coordinated evaluation of multiple investigational agents as they become available within the same clinical trial structure and across multiple study sites. Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to identify rapidly drug candidates that work, and quickly move additional experimental agents into the trial.

Effective therapeutics for COVID-19 are critically needed to treat patients who have been infected with SARS-CoV-2. NIH was engaged in this effort from the very beginning of the pandemic. On February 21, 2020, NIAID launched a multicenter, randomized placebo-controlled clinical trial, the Adaptive COVID-19 Treatment Trial (ACTT), to evaluate the safety and efficacy of therapeutics for COVID-19, initially examining the antiviral drug remdesivir for treatment of severe COVID-19 in hospitalized adults (ACTT-1). An analysis of preliminary data from ACTT-1 indicated that those who received remdesivir had a 32 percent faster time to recovery, a median of 11 days compared with 15 days for those who received placebo. These initial findings were published on May 22, 2020, in the New England Journal of Medicine. The adaptive design of this trial will enable the evaluation over time of additional promising therapies, such as the anti-inflammatory drug baricitinib. This drug was added to the second iteration of the study (ACTT-2); enrollment for ACTT-2 is now complete. The third iteration of the study (ACTT-3), announced by NIH on August 6, 2020, is a randomized, controlled clinical trial to study the use of interferon beta-1a, which is typically used to treat individuals with multiple sclerosis.

Monoclonal antibodies (mAbs) are another promising approach for the treatment of COVID-19. At least 21 companies are developing mAbs that target SARS-CoV-2 and several of them are already being studied in clinical trials. On August 4, 2020, NIH launched two clinical trials under the ACTIV-2 and ACTIV-3 master protocols. ACTIV-2, a Phase 2/3 clinical trial, will evaluate potential therapeutics in study participants with mild to moderate COVID-19 who do not require hospitalization. The first stage of ACTIV-2 is looking at the potential of synthetic mAbs to treat the disease. The trial may also investigate other experimental therapeutics later under the same trial protocol. Another Phase 2/3 randomized, controlled trial known as ACTIV-3 will test mAb treatments in hospitalized patients. The initial stage of the ACTIV-3 clinical trial plans to enroll approximately 300 volunteers who have been hospitalized with mild to moderate COVID-19. ACTIV-3 will initially study the investigational mAb from Lilly, LY-CoV555, discovered by Abcellera Biologics in collaboration with NIAID’s Vaccine Research Center (VRC).
Developing Vaccines to Prevent SARS-CoV-2 Infection and/or COVID-19 Disease
A safe and effective vaccine for SARS-CoV-2 will be essential to stopping the spread of infection, reducing rates of morbidity and mortality, and preventing future outbreaks. It is among our best hopes for getting our country back to normal.

NIAID has been supporting development of several SARS-CoV-2 vaccine candidates, including vaccines based on platform technologies that have shown promise against coronaviruses that cause SARS and MERS. As part of a longstanding collaboration, the NIAID VRC worked with biotechnology company Moderna, Inc., to develop a vaccine candidate using a messenger RNA (mRNA) vaccine platform expressing the SARS-CoV-2 spike protein. On July 14, 2020, encouraging interim findings from the Phase 1 clinical trial were published in the New England Journal of Medicine. The investigational mRNA-1273 vaccine was generally well tolerated and induced robust neutralizing antibody responses in healthy adults in this interim analysis of data from the ongoing trial. On May 29, 2020, a Phase 2 clinical trial, sponsored by Moderna, was initiated to further study the safety and immune response to the experimental mRNA vaccine. The Phase 2 study closed to enrollment on July 30, 2020, and is now in follow up – no safety concerns have been identified. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacture of the vaccine candidate for the Phase 1 trial, and BARDA is supporting advanced development of the candidate.
Scientists at NIAID’s Rocky Mountain Laboratories (RML) in Hamilton, Montana, are collaborating with University of Oxford researchers to develop the SARS-CoV-2 chimpanzee adenovirus-vectored vaccine candidate AZD1222, formerly known as ChAdOx1. The University of Oxford has partnered with the pharmaceutical company AstraZeneca on this vaccine candidate, now in a Phase 3 clinical trial in the U.S. supported by NIAID and BARDA. BARDA has announced plans to support advanced development and production of AZD1222.

In July, OWS committed to working with Novavax on their new COVID-19 vaccine candidate after Phase 1 trials of this vaccine were done in Australia with promising results. A Phase 3 trial is expected to begin in the U.S. by the end of September. Janssen Pharmaceutical Companies of Johnson & Johnson have a viral vector COVID-19 vaccine candidate that has demonstrated protection in nonhuman primate models. OWS is working with this company and Phase 1 trials began on July 27, 2020, in the U.S. Depending on results from the early trials, a Phase 3 clinical trial is expected to begin this month. Additionally, Sanofi working with GSK developed a protein-based vaccine candidate that is currently in preclinical development. A Phase 1 trial is expected to begin this month with a goal of entering Phase 3 by the end of 2020.

Lastly, Pfizer working with BioNTech developed an RNA vaccine candidate for COVID-19. Phase 3 trials for this vaccine began on July 27, 2020. The RNA vaccines, developed by Pfizer in partnership with BioNTech, and by Moderna in partnership with NIAID, have already begun large scale manufacturing in order to be ready to distribute if the Phase 3 trials show promising results on the safety and efficacy of the vaccine candidates. OWS is working to refurbish manufacturing sites to scale up manufacturing for the other COVID-19 vaccine candidates in testing. The CoVPN at NIH is currently working to enroll thousands of volunteers in the clinical trials for vaccine candidates and preventive interventions. We continue to prioritize enrollment of racial and ethnic populations impacted disproportionately by this disease. It is critical that we continue to engage all communities in this effort with transparency and the highest standards of safety and ethics.

The CoVPN developed a community engagement framework to assist researchers in reaching out to communities, and potential research volunteers. In order to have the trust of the community, NIH has prioritized open and transparent communication with participants, sharing the specific details involved in participating in the clinical trials for COVID-19 vaccine candidates or therapeutics and using their feedback to improve the trial designs. To facilitate outreach to key communities, the CoVPN established expert panels of 10-15 scientific experts from within those respective communities. NIH believes that by engaging communities early we can address any concerns about the treatments and vaccines in advance of potential distribution of FDA-approved/licensed vaccines.
COVID-19 and Seasonal Influenza

The fight against the COVID-19 pandemic may become more difficult as we enter the fall and winter “flu season”. Each year influenza causes a surge in hospitalizations. This expected surge, in combination with COVID-19, is a serious concern for healthcare systems across the U.S. In addition to the expected surge in patient numbers, the clinical symptoms for influenza and SARS-CoV-2 can overlap, and an increase in influenza infections will require testing for SARS-CoV-2 in order to determine if the patient has COVID-19 or influenza. NIAID is currently supporting studies investigating the impact of seasonal influenza co-circulation with SARS-CoV-2, and coinfections have already been observed in the Southern hemisphere. An increase in the vaccination rate for influenza will help to safeguard our healthcare systems against this surge, by reducing flu morbidity, to allow for COVID-19 surge capacity in hospitals and reducing the number of sick individuals presenting to outpatient clinics. During the 2018- 2019 fall and winter, the influenza vaccination rate for adults was 45.3 percent. It is imperative that we increase this vaccination rate to protect our healthcare systems. Lastly, it is important to remind the public that childhood vaccinations are another way we can protect our communities and healthcare systems from avoidable illnesses and deaths.

Conclusion
The rigorous clinical testing required to establish vaccine safety and efficacy means that it may take some time for a licensed SARS-CoV-2 vaccine to be available to the general public, but there is growing optimism that one or more of these vaccine candidates will prove safe and effective by late 2020 or early 2021.

The NIH is the world’s largest biomedical research funder, but we are also America’s research engine. Right now, our funded scientists are working around the clock to find the best ways to diagnose, prevent, and treat COVID-19. We won’t rest until this job is done.

CMS: Reminder: 2020 Cost Measure Field Testing Period Ends on Sept 18th
As a reminder, CMS and its contractor, Acumen, LLC, are conducting field testing until September 18, 2020 for 5 episode-based cost measures before consideration of their potential use in the Cost performance category of the Merit-based Incentive Payment System (MIPS). During field testing, all stakeholders are invited to provide feedback on the draft measure specifications. Participation is voluntary.
The following measures are being field tested:

  1. Asthma/Chronic Obstructive Pulmonary Disease (COPD)
  2. Colon and Rectal Resection
  3. Diabetes
  4. Melanoma Resection
  5. Sepsis

Field Test Reports are available for download from the Quality Payment Program website. The draft measures specifications for the 5 episode-based cost measures are on the MACRA Feedback Page.

You may provide feedback through this online survey by 11:59 p.m. Eastern Time on September 18, 2020. A document containing specific questions about the measures for stakeholders to reference while reviewing the materials is available on the MACRA Feedback Page.

CMS Reminder: Submit Comments on the 2021 Proposed Rule for the Quality Payment Program by October 5.
On August 3, the Centers for Medicare & Medicaid Services (CMS) released its proposed policies for the 2021 performance year of the Quality Payment Program via the Medicare Physician Fee Schedule (PFS) Notice of Proposed Rulemaking (NPRM).

Note: In recognition of the 2019 Novel Coronavirus (COVID-19) public health emergency, CMS has limited annual rulemaking required by statute to focus primarily on essential policies including Medicare payment to providers.  

Submit a Formal Comment by Monday, October 5
CMS is seeking comment on a variety of proposals in the NPRM. Comments are due no later than 5 p.m. EDT, on Monday, October 5.

You must officially submit your comments in one of the following ways:

  • Electronically, through Regulations.gov
  • Regular mail
  • Express or overnight mail

More Information on the Quality Payment Program Policies Proposed in the 2021 PFS NPRM
Key proposals for the Quality Payment Program include:

  • Increasing the complex patient bonus to a 10-point maximum for the 2020 performance year due to COVID-19
  • Postponing the implementation of the Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) until 2022 instead of 2021
  • Introducing the Alternative Payment Model (APM) Performance Pathway (APP) for participants in MIPS APMs beginning in 2021
  • Increasing the performance threshold to 50 points for the 2021 performance year (10 points less than the 60-point threshold finalized for 2021 in the CY 2020 PFS Rule)
  • Decreasing the performance category weight for Quality to 40% and increasing Cost to 20%
  • Removing the CMS Web Interface as collection and submission types for reporting MIPS quality measures beginning with the 2021 performance period
  • Sunsetting the APM Scoring Standard and allowing MIPS eligible clinicians to participate in MIPS under an APM Entity beginning in 2021

For More Information
To learn more about the PFS NPRM and the Quality Payment Program proposals, review the following resources:

  • Fact Sheet – Offers an overview of the QPP proposed policies for 2021 and compares these policies to the current 2020 requirements
  • Webinar Recording – Details the QPP proposed policies for 2021, answers questions from webinar attendees, and shares information on how to comment
  • QPP COVID-19 Response Webpage – Shares information on the proposed complex patient bonus change and other flexibilities implemented in response to the public health emergency

To learn more about the Quality Payment Program, visit the Quality Payment Program website.

Questions?
Contact the Quality Payment Program at 1-866-288-8292 or by e-mail at: QPP@cms.hhs.gov. To receive assistance more quickly, please consider calling during non-peak hours—before 10:00 a.m. and after 2:00 p.m. ET.

Customers who are hearing impaired can dial 711 to be connected to a TRS Communications Assistant.

DSHS: GETAC Committee applications accepted until October 9th
Applications for GETAC committee appointments are now being accepted. If you are interested in serving on a committee, go to the application page for details.
Submit your application by 11:59 pm, October 9.NOTE: If your appointment to a committee expires in 2020, you MUST reapply to be considered for re-appointment.For information, email Robert Friedrich at robert.friedrich@dshs.texas.gov or call 512-484-8113.
HHSC Publishes COVID-19 Response Plan for Day Activity and Health Services Providers
HHSC LTCR has published the COVID-19 Response Plan for DAHS Providers. The document provides guidance to prevent the spread of COVID-19 in DAHS facilities and with response actions in the event of a case of COVID-19 in staff or clients served by the facility.

The document can be found on the DAHS provider portal website under the COVID-19 Resources accordion.

Texas HHSC: Rural Hospital Proposed Standard Dollar Amounts Realignment.
Senate Bill 170, 86th Legislature, Regular Session, 2019, required the Health and Human Services Commission (HHSC) to calculate a prospective reimbursement methodology for the payment of inpatient services to rural hospitals participating in Medicaid using the hospitals’ most recent cost information. This proposed realignment of rural hospital inpatient Standard Dollar Amounts is published for public comment on September 1, 2020 for proposed rates to be effective on September 1, 2021.

Written comments regarding the proposed rates will be accepted until 5 p.m. November 30, 2020. Written comments may be sent by U.S. mail to the Texas Health and Human Services Commission, Attention: Provider Finance, Mail Code H-400, P.O. Box 149030, Austin, Texas 78714-9030; by fax to Rate Analysis at (512) 730-7475; or by e-mail to program staff.

In addition, written comments will be accepted by overnight mail or hand delivery to Texas Health and Human Services Commission, Attention: Provider Finance, Mail Code H-400, Brown-Heatly Building, 4900 North Lamar, Austin, Texas 78751. The realignment plan is available for viewing on the Provider Finance Department website.

Texas DFPS
See the latest children who were added to or updated in the Texas Adoption Resource Exchange (TARE).
WHO: COVID-19 could reverse decades of progress toward eliminating preventable child deaths, agencies warn
With the number of under-five deaths at an all-time recorded low of 5.2 million in 2019, disruptions in child and maternal health services due to the COVID-19 pandemic are putting millions of additional lives at stake

The number of global under-five deaths dropped to its lowest point on record in 2019 – down to 5.2 million from 12.5 million in 1990, according to new mortality estimates released by UNICEF, the World Health Organization (WHO), the Population Division of the United Nations Department of Economic and Social Affairs and the World Bank Group.

Since then, however, surveys by UNICEF and WHO reveal that the COVID-19 pandemic has resulted in major disruptions to health services that threaten to undo decades of hard-won progress.
“The global community has come too far towards eliminating preventable child deaths to allow the COVID-19 pandemic to stop us in our tracks,” said Henrietta Fore, UNICEF Executive Director. “When children are denied access to health services because the system is overrun, and when women are afraid to give birth at the hospital for fear of infection, they, too, may become casualties of COVID-19. Without urgent investments to re-start disrupted health systems and services, millions of children under five, especially newborns, could die.”

Over the past 30 years, health services to prevent or treat causes of child death such as preterm, low birthweight, complications during birth, neonatal sepsis, pneumonia, diarrhea and malaria, as well as vaccination, have played a large role in saving millions of lives.
Now countries worldwide are experiencing disruptions in child and maternal health services, such as health checkups, vaccinations and prenatal and post-natal care, due to resource constraints and a general uneasiness with using health services due to a fear of getting COVID-19.

UNICEF survey conducted over the summer across 77 countries found that almost 68 per cent of countries reported at least some disruption in health checks for children and immunization services. In addition, 63 per cent of countries reported disruptions in antenatal checkups and 59 per cent in post-natal care.

recent WHO survey based on responses from 105 countries revealed that 52 per cent of countries reported disruptions in health services for sick children and 51 per cent in services for management of malnutrition.

Health interventions such as these are critical for stopping preventable newborn and child deaths. For example, women who receive care by professional midwives trained according  to internationals standards are 16 per cent less likely to lose their baby and 24 per cent less likely to experience pre-term birth, according to WHO.

“The fact that today more children live to see their first birthday than any time in history is a true mark of what can be achieved when the world puts health and well-being at the centre of our response,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “Now, we must not let the COVID-19 pandemic turn back remarkable progress for our children and future generations. Rather, it’s time to use what we know works to save lives, and keep investing in stronger, resilient health systems.”
Based on the responses from countries that participated in the UNICEF and WHO surveys, the most commonly cited reasons for health service disruptions included parents avoiding health centers for fear of infection; transport restrictions; suspension or closure of services and facilities; fewer healthcare workers due to diversions or fear of infection due to shortages in personal protective equipment such as masks and gloves; and greater financial difficulties. Afghanistan, Bolivia, Cameroon, the Central African Republic, Libya, Madagascar, Pakistan, Sudan and Yemen are among the hardest hit countries.

Seven of the nine countries had high child mortality rates of more than 50 deaths per 1000 live births among children under five in 2019. In Afghanistan, where 1 in 17 children died before reaching age 5 in 2019, the Ministry of Health reported a significant reduction in visits to health facilities. Out of fear of contracting the COVID-19 virus, families are de-prioritizing pre- and post-natal care, adding to the risk faced by pregnant women and newborn babies.

Even before COVID-19, newborns were at highest risk of death. In 2019, a newborn baby died every 13 seconds. Moreover, 47 per cent of all under-five deaths occurred in the neonatal period, up from 40 per cent in 1990. With severe disruptions in essential health services, newborn babies could be at much higher risk of dying. For example, in Cameroon, where 1 out of every 38 newborns died in 2019, the UNICEF survey reported an estimated 75 per cent disruptions in services for essential newborn care, antenatal check-ups, obstetric care and post-natal care.

In May, initial modelling by Johns Hopkins University showed that almost 6,000 additional children could die per day due to disruptions due to COVID-19.

These reports and surveys highlight the need for urgent action to restore and improve childbirth services and antenatal and postnatal care for mothers and babies, including having skilled health workers to care for them at birth. Working with parents to assuage their fears and reassure them is also important.

“The COVID-19 pandemic has put years of global progress to end preventable child deaths in serious jeopardy,” said Muhammad Ali Pate, Global Director for Health, Nutrition and Population at the World Bank. “It is essential to protect life-saving services which have been key to reducing child mortality. We will continue to work with governments and partners to reinforce healthcare systems to ensure mothers and children get the services they need.”

“The new report demonstrates the ongoing progress worldwide in reducing child mortality,” said John Wilmoth, Director of the Population Division of the United Nations Department of Economic and Social Affairs. “While the report highlights the negative effects of the COVID-19 pandemic on interventions that are critical for children’s health, it also draws attention to the need to redress the vast inequities in a child’s prospects for survival and good health.”