Texas Health and Human Services Digest: September 11, 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.

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.

CMS: Community Health Access and Rural Transformation Model

The CMS Innovation Center announced the Community Health Access and Rural Transformation (CHART)Model.

The approximately 57 million Americans living in rural communities, including millions of Medicare and Medicaid beneficiaries, face unique challenges when seeking health care services, such as limited transportation options, shortages of health care services, and an inability to fully benefit from technological and care-delivery innovations.

Current regulations and volume-based payment structures perpetuate these challenges, with unsustainable financial models leading to over 130 rural hospitals closing since 2010. The constellation of reduced access to care and patients not seeking or delaying care leads to rural Americans facing worse health outcomes and having higher rates of preventable diseases than those living in urban areas.
CMS remains focused on the transformation of rural health care delivery and enabling local community collaboration to redesign their systems of care and align across providers and payers based on their unique needs. As part of that rural transformation, including transforming a system built on fee-for-service and volume to one based on value, CMS is testing the CHART Model.

Through the Model, CMS is directly providing a pool of $75M in upfront, seed funding, with 15 rural communities applying for up to $5M to develop local transformation plans. With this upfront seed funding, CMS is also providing regulatory and operational flexibility for updated service delivery models as well as changing how participating hospitals in these communities are paid, from a system based on volume to stable, monthly payments. In additional to supporting these 15 rural communities, CMS is also looking for 20 rural Accountable Care Organizations (ACOs) to participate in the model, paying shared savings upfront so that ACOs have infrastructure funding to be successful on the move towards achieving better outcomes. Taken together, these are substantial and tangible actions to support health care in our rural communities.
Specifically, the CHART Model will:

  • Increase financial stability for rural health care providers through multiple new funding approaches, including the use of up-front investments and predictable, capitated payments that pay for quality and patient outcomes over volume
  • Provide the necessary operational and regulatory flexibilities to allow health care providers and CMS to test the Model in their local communities and successfully transform themselves
  • Support local rural communities’ transformation efforts by being directly engaged at CMS, offering real-time technical expertise and other learning when needed to foster success

If successful, beneficiaries’ access to health care services should be improved, rural provider’s financial sustainability should increase for years to come, and communities can align with payers and other stakeholders to address both their health care service delivery ecosystem and the necessary social support structures, such as food and housing, to deliver improved health. Ultimately, the CHART Model aims to improve quality and health, while reducing Medicare and Medicaid expenditures, in rural communities over the long-term.

CMS is providing funding, regulatory and operational flexibilities, and technical assistance for rural communities to transform their systems of care through a Community Transformation Track. Further,

CMS is enabling providers to participate in value-based payment models where they are paid for quality and outcomes, instead of volume, through an ACO Transformation Track.

CMS anticipates the Notice of Funding Opportunity for the Community Transformation Track will be available in September on the Model website. The Request for Application for the ACO Transformation Track will be available in early 2021 on the CHART Model website.
See the full text of this excerpted CMS Fact Sheet

HHSC: Practice Period Update and Important Dates

From July 1 to Nov. 30, the EVV practice period allows program providers, FMSAs, and CDS employers to practice the EVV process. During the practice period, claims for services included in the Cures Act EVV Expansion will not be denied for an EVV mismatch.

Practice Period Update
Approximately 1,000 program providers and FMSAs delivering or supporting services included in the Cures Act EVV Expansion can participate in the practice period. All numbers are approximate.
As of Sept. 1:
EVV Vendor Onboarding
Of the 1,000 Cures Act program providers and FMSAs able to participate in the practice period:

  • 50% have completed the onboarding process with their EVV vendor.
  • 30% are currently in progress.
  • 20% have not started.

EVV System Usage
Of the 50% of Cures Act program providers and FMSAs identified above who have completed the onboarding process:

  • 16% have used the EVV system to capture at least one visit when delivering services.

Managed Care EVV Claims Submission Setup to TMHP
A total of 280 program providers and FMSAs must setup managed care EVV claims submission to TMHP by Oct. 1, for EVV claims matching.

  • 47% have completed the setup process and are submitting EVV claims to TMHP.

EVV Claims Matching

  • 52% of claims have received an informational EVV claims match result of EVV01 during the practice period.
  • The majority of the remaining 48% of claims did not match because the EVV system was not used to capture the visit when delivering services.

How to Participate in the Practice Period

  1. Complete the onboarding process with your EVV vendor. Contact your vendor or payer for more information. CDS employers should contact their FMSA (the person they submit their timesheets to) for more information.
  2. Complete required EVV training. See the Cures Act EVV: Training Requirements Checklists (PDF) for information about who must take training and the different ways to complete it.
  3. Start practicing with the EVV system. Attendants and CDS employees should start clocking in and clocking out of the system when delivering services to create visits in the system.
  4. Start practicing with the EVV Portal. Program providers and FMSAs will use the EVV Portal to confirm accepted EVV visit transactions before billing and review EVV claims matching results.

See TMHP’s article The EVV Practice Period Begins July 1 (PDF) for more information.
Important Dates
Oct. 1: All managed care EVV claims for dates of service on and after Oct. 1 must be submitted to TMHP and will be denied or rejected if submitted directly to an MCO.

Dec. 1: EVV claims matching with denials begins.

  • All EVV-required service visits must be captured in the EVV system.
  • Claims without a matching EVV visit transaction accepted into the EVV Portal will be denied for payment.

Resources

Questions

  • EVV vendor onboarding: contact your vendor or payer
  • Claims submission: email TMHP
  • EVV policy and training: email HHSC EVV

HHSC: Vendor Drug Program Updates

Epidiolex and Diacomit Clinical Prior Authorization Criteria Updates
VDP regularly updates clinical prior authorization criteria. These updates help align VDP drug policies and prior authorization approval criteria with the latest information available on drug information packets, the federal or state regulations. Recent changes include:

  • On Oct. 1, 2020, ICD-10 code G40.83 becomes available for Dravet Syndrome.
  • On July 31, 2020, the FDA approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients one year of age and older.

Updates to clinical prior authorization criteria documents were made to reflect these changes. To learn more, visit the VDP website.

Non-Preferred Status Updates
VDP published the following notices Aug. 25 to reflect changes effective Sept. 18. The list of affected drugs in each notice was updated Sept. 9:

Reminders

CMS: News and Events Updates

News

Events

MLN Matters® Articles

Publications

Multimedia

NIH ACTIV initiative launches adaptive clinical trials of blood-clotting treatments for COVID-19

The National Institutes of Health has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, these trials will be conducted at more than 100 sites around the world and will involve patients in various clinical settings — those who have not been hospitalized, those currently hospitalized and those discharged after hospitalization for moderate to severe disease.

Collectively known as ACTIV-4 Antithrombotics, the trials will provide critical insights that could help guide the care of patients with COVID-19, particularly those who suffer from life-threatening blood clots. The trial for hospitalized COVID-19 patients and the trial for patients with COVID-19 who have not been hospitalized are now underway. A third trial to start later will focus on patients discharged after hospitalization for moderate to severe COVID-19 disease. All three clinical trials will be coordinated and overseen by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, and funded through Operation Warp Speed(link is external).

Researchers have noted that many patients who have died from COVID-19 — the deadly disease caused by SARS-CoV-2 — had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting, one of many life-threatening effects of the disease, has caused multiple health complications, from organ damage to heart attack, stroke and pulmonary embolism.

ACTIV-4 Antithrombotics will be recruiting at sites with significant COVID-19 burden and are interested in enrolling patients in studies testing potential treatments to prevent or reduce the formation of blood clots. The adaptive design of the protocol allows different blood thinners to be started, stopped or combined during the study in response to emerging trial data. This approach accelerates the timeline for testing different agents without compromising safety.
Antithrombotics, also known as blood thinners or anticoagulants, keep blood protein and platelets from turning into clumps or sticking to each other, but doctors have not yet figured out if, and at what point during the course of the disease, blood thinners might be effective at treating patients with COVID-19.

ACTIV-4 Antithrombotics Inpatient will investigate the safety and effectiveness of using varying doses of the blood thinner heparin to prevent clotting events and improve outcomes in hospitalized COVID-19 patients. Patients will be assigned to either a low or high dose of heparin, and as the trial progresses, additional antithrombotics may be tested, depending on the trial results. All participants in the study will continue to receive clinical care as indicated for their condition.

ACTIV-4-Antithrombotics Outpatient will investigate whether anticoagulants or antithrombotic therapy can reduce life-threatening cardiovascular or pulmonary complications in newly diagnosed COVID-19 patients who do not require hospital admission. Researchers will also collect patient data and blood samples to help identify new drug targets and biomarkers that may help identify a patient’s risk of developing complications related to COVID-19. Participants will be assigned to take either a placebo, aspirin or a low or therapeutic dose of the blood thinner apixaban.

Trial planning and development work is being done through a collaborative effort with a number of universities, including the University of Pittsburgh; University of Michigan, Ann Arbor; New York University, New York City; Brigham and Women’s Hospital, Boston; University of Illinois at Chicago; University of North Carolina at Chapel Hill; and The University of Vermont, Burlington.

NIH announced the ACTIV public-private partnership in April 2020 to develop a coordinated national research response to speed COVID-19 treatment and vaccine options. As part of this partnership, Bristol-Myers Squibb/Pfizer have agreed to donate the treatments for the trials for patients with COVID-19 who have not been hospitalized. Managed by the Foundation for the National Institutes of Health, ACTIV brings together multiple partners from government, industry, academia and non-profit organizations. For more information about this and other ACTIV therapeutic trials, visit the ACTIV Therapeutics page.

CMS: Guidance for Representing Telehealth Encounters in QRDA I Format for eCQMS

The Centers for Medicare & Medicaid Services (CMS) has posted additional guidance for using the Quality Reporting Document Architecture I (QRDA I) format to represent telehealth encounters for the Eligible Professional and Eligible Clinician electronic clinical quality measures (eCQMs) used in CMS quality reporting programs for the 2020 and 2021 performance periods. There is no change to the original guidance provided by CMS in July 2020.

Representing Telehealth Encounters in QRDA I format by using the Qualifier attribute:
To represent “telehealth-eligible” Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes for eCQMs in QRDA I, submitters should use the optional qualifier attribute of the encounter code element to send the telehealth modifier code in addition to the primary “telehealth-eligible” CPT or HCPCS encounter code from the eCQM-specified value sets.
The qualifier attribute name is set to a fixed code virtual “VR” selected from the HL7 ActCode code system. The applicable telehealth modifier, such as modifier 95, will be in qualifier attribute value. The updated guidance provides an example xml.
The updated guidance is available on the Electronic Clinical Quality Improvement (eCQI) Resource Center.

The Cypress Validation Utility + Calculation Check (CVU+) is being updated to follow this guidance to filter out telehealth encounters when calculating eCQMs not eligible for telehealth encounters, which are listed in Table 2 referenced in the 2020 and 2021 reporting guidance. This update will be made available in Cypress scheduled for release in Fall 2020.

Additional Resources: To find out more about eCQMs, visit the eCQI Resource Center. To report questions or comments on the eCQM specifications, visit the eCQM Issue Tracker. Note that an ONC Project Tracking System (Jira) account is required to ask a question or comment

Governor Abbott Appoints Three to Nursing Facility Administrators Advisory Committee

Governor Greg Abbott has appointed Melinda Mitchell Jones, Hari Namboodiri, and Cathy Wilson to the Nursing Facility Administrators Advisory Committee for terms set to expire on February 1, 2025. The committee provides the Texas Department of Aging and Disability Services with recommendations for licensure sanctions and rule changes for the Nursing Facility Administrator Licensing Program.

Melinda Mitchell Jones of Lubbock is a Distinguished Professor at Texas Tech University Health Sciences Center’s School of Nursing. She is a member of the bar of the U.S. Supreme Court, the Texas State Bar, Lubbock Bar Association, Texas Chapter of the American Association for Nurse Attorneys, the National League of Nursing, and Sigma Theta Tau Honor Society. In addition, she is chairman of the Board for Girl Scouts Texas Oklahoma Plains Council and a member of the Board for Legal Aid Society of Lubbock. Jones received a Bachelor of Science in Nursing from Baylor University, a Master of Science in Nursing with a focus on administration from the University of North Carolina at Greensboro, and a Juris Doctor degree from Texas Tech University School of Law.

Hari Namboodiri of McAllen is the executive director of Las Palmas Health Care Center. He is a member of the American College of Health Care Executives and the American Health Care Association. In addition, he is the president of the India Association of Rio Grande Valley and serves on the Senior Citizen’s Advisory Board for the City of McAllen. Namboodiri received a Bachelor of Education from the University of Kerala, Master of Arts in Education from the University of Calicut, Master of Social Work from the University of Kerala, and a Bachelor of Law from Government Law College.

Cathy Wilson of Austin is a Culture and Logistics Manager for Holtzman Partners. She is a past board member and treasurer of the Junior League of Austin. She has served in a variety of volunteer positions with the Parent Teacher Association and the Oak Hill Youth Sports Association. Wilson received a Bachelor of Journalism from The University of Texas at Austin.

HHSC Publishes PL 20-37 – COVID-19 and Death Reporting Guidance for Long-term Care Providers

HHSC Long-term Care Regulation has published Provider Letter 20-37 Reporting Guidance for Long-term Care ProvidersThe PL outlines provider reporting responsibilities related to COVID-19 and deaths (COVID-19 and non-COVID-19 related). This letter and attachment consolidate reporting requirements in a more user-friendly manner.
The PL is addressed to:

  • nursing facilities;
  • assisted living facilities; and
  • intermediate care facilities for individuals with an intellectual disability or related conditions.

NIH: Miglustat improves swallowing in children and adolescents with Niemann-Pick type C1 disease

NIH observational study suggests that the drug may decrease risk of pneumonia and death in this population.

The drug miglustat appears to stabilize the swallowing problems that occur in children and adolescents with Niemann-Pick type C1 (NPC1), a rare and ultimately fatal neurological disease, according to a study by researchers at the National Institutes of Health. The authors conclude that the drug could slow the deterioration of swallowing function in NPC1 cases and decrease the risk of pneumonia resulting from aspiration, or inhaling food or drink. Aspiration pneumonia accounts for roughly 2 out of 3 deaths in people with NPC1.

The study was conducted by Forbes D. Porter, M.D., Ph.D., of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and colleague in the NIH Clinical Center. It appears in the JAMA Neurology.

NPC1 is a rare genetic disorder that causes a progressive decline in neurological and cognitive functions. Although miglustat is not approved by the Food and Drug Administration to treat NPC1, the drug is thought to stabilize the neurological deterioration seen in the disease and is frequently prescribed to treat it. Previous studies have suggested that by slowing this neurological deterioration, miglustat can stabilize swallowing ability. However, these studies have not documented any specific swallowing improvements for patients.

In the current study, researchers used video fluoroscopy — an X-ray scan of the throat — to evaluate swallowing function in 120 NPC1 patients. They ranked each of the scans based on the need for feeding tubes and other interventions to assist swallowing and on the likelihood and extent of food and drink entering the airway. On average, patients were evaluated once a year for three years. Of these, 36 had been prescribed miglustat and 24 had not. The researchers found that, compared to those not taking miglustat, those who took the drug had a 91% lower risk for deterioration in swallowing and a 72% lower risk for getting food or drink in the airway.