THE SCHOLASTIC INSTITUTE

Trademark of the Alumni Association Network

July 21, 2021

PROPOSED - NUTRIGENOMICS LABORATORY SCREENING ACT OF 2021/2022 - HOME-BASED GENETICS TESTS - IN THE HANDS OF EVERY AMERICAN CITIZEN - INTRODUCED BY THE ALUMNI ASSOCIATION NETWORK (AAN)

LET'S TALK ABOUT UNIVERSAL HEALTHCARE!
Text - H.R.1976 - 117th Congress (2021-2022): Medicare for All Act of 2021 | Congress.gov | Library of Congress
 

I. When the U.S. Supreme Court rejected the GOP's challenge to Obamacare, I began to think about the letter I sent to the White House in 2020 to President Donald J. Trump. A brief overview of the letter is provided here for the public: TheFirm_ProvisionsACA_SampleLtr_2020.pdf (brigettes.com) . In 2021, CareTUG (TM) emerged as a concept to expand the roles of Caregivers.

CareTUG by Brigette's Technology Consulting and Research Firm (brigettes.com)
VA Caregiver Support Program Home
Caregiving | Division of Aging Services | Georgia Department of Human Services

II. Over the course of the last year after being declined by Optum [Veterans Administration (VA)], Medicare, Cigna, Anthem and so forth to practice as a Natural Healthcare Provider, I decided to pursue CLIA-Waived Laboratory Screening/Research.

III. Because many rare diseases lack appropriate attention, I, hereby, will advocate that private and public insurance and payment solution providers relax high-deductibles terms for all rare diseases genetic lab testing similar to the policies associated with COVID testing.

NIH funding bolsters rare diseases research collaborations | National Institutes of Health (NIH) 
IRS Relaxes High-Deductible Terms for COVID-19 Testing and Treatment (shrm.org)
Out-of-Pocket Maximums and Deductible Limits For 2021 (obamacarefacts.com)
Does Medicare Cover Genetic Testing? | Medicare & Medicare Advantage Info, Help and Enrollment

IV. All billings associated with home testing kits for rare diseases/disorders should follow the same protocol as the following: Medi-Cal NewsFlash: CPT Code for COVID-19 Testing Now a CLIA-Waived Test

V. Medicare-Only/HMO and Medicaid participants are covered for any forms of genetic testing, to include nutrition genetics testing and home-based nutrition genetics testing..

VI. With the number of VA Medical Centers emerging, I further advocate that veterans who file VA benefits claims submit a genetic test(s) as a requirement, NOT to disqualify based on a pre-existing condition, but to qualify based on how military services may have "worsen" the condition(s): Genomics (va.gov) / Timeline of the Genetic Information Nondiscrimination Act (GINA) (genome.gov)

VII. Further authorizing CLIA-Waived Laboratory Directors who are Natural Healthcare Doctors (NDs) under CLIA-Waived guidelines (a) to perform PGx sample collections without having to apply to become a Medicare (PECOS) provider and (b) to have natural prescribing authority in all 50 U.S. states and territories; however, such screeners who collect such samples via swabs, saliva, urine, blood pricks and so forth., could only prescribe naturals based on the results from home-based ordered "natural" genetic tests derived from analytical laboratories that require a DEA number. [See XIII]

VIII. Add Naturopathy/Holistic Doctor as a subspecialty to the Medicare/Medicaid application under the Non-Physician Specialty category, further indicating if Licensed or Unlicensed/But Certified via CLIA
Medical Nutrition Therapy Act (eatrightpro.org)

XI. Add CLIA-Waived Laboratories as a subspecialty under the Medicare/Medicaid application under the Non-Physician Specialty category

X: In the PECOS Medicare system, add an option to clarify: In Person, Telehealth, Both: Read: CMS Confirms Provider’s Home Acceptable for Distant Site Telehealth Services | Hall Render

XI. The CAQH system and VA Community Care networks would need to align with Medicare Regional and Availity Technical Solutions by having CLIA-Waived Laboratory listed as a Primary Type or Primary Specialty and/or a subspecialty under Naturopathy. Availity, however, does lists Screening Laboratory under Service Information. 

XII. Ensure all public and private insurance companies are updated on the appropriate CPT codes to apply the aforementioned services.  According to Aetna's website, the Government Accountability Office (GAO) only investigated limited samples of direct-to-consumer genetic tests companies: 23andMe, deCode Genetics, Navigenics, and Paythway Genomics; however, in another breath, entities such as the FDA, USDA, and VA are also calling to advance telehealth solutions.  The GAO and FDA, thus, would need to test a larger sample size to acquire a fairer assessment. See: With Increased Funding, AHRQ To Explore Scope and Causes of Diagnostic Errors | Agency for Healthcare Research and Quality. Findings, thus, should consider who performed the tests and their skillsets and knowledge base (ability to read and follow manufacturers' instructions are essential to eliminate/reduce errors) and if the right home test was selected; as different companies uses different analytical methods. The results of the GAO's assessments should also include a peer debrief or opinions from various Genetic Counselors or Genetic Advisors.  As We are all aware, all medical technologies have side effects and errors: Johnson & Johnson Vaccine Error Affects 15 Million Doses | Time / Johnson & Johnson vaccine and Guillain-Barré: FDA adds new warning related to rare autoimmune disorder - The Washington Post

XIII. Last, an accreditation and a designation and licensing criteria for Clinical Research Nutrigenetics Advisors (C*RNA) offered through the Alumni Association Network (AAN) can certify such natural healthcare professionals: Alumni Association Network Scholastic Research Institute (SRI): Nutrigenomics Research Network and Advisors (N*RNA). Upon passage of the Bill, entities would update the State and Insurance applications, License Verification Forms, and so forth; all of which should be electronic.  I would advocate that the Drug Enforcement Agency (DEA) establishes another Category VI and DEA Form 230 to embody such natural researchers who are also practitioners.

In closing, I believe such measures are efficient means to enhance the tele-health/tele-mental/clinical point-of-care health industries!
 

Brenda Nelson-Porter, ND, DM, MIT, BAS, CLIA-Certified Waived Laboratory Director, Founder
Brigette's Natural Healthcare Research and Laboratory Division
Brigette's Technology Consulting and Research Firm
Alumni Association Network (AAN)

Newnan, GA  30263 USA
770-365-7577

 

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