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FDA & CMS Partnering To Promote Accurate and Reliable Diagnostic Tests

January 18, 2024

The Food and Drug Administration (“FDA” and Centers for Medicare and Medicaid Services (“CMS”) are joining forces to heighten scrutiny of diagnostic testing. As part of these efforts, the agencies are working together to expand FDA oversight of testing facilities to increase FDA regulation and oversight of tests run within a single laboratory, known as laboratory, developed tests or LDTs. The agencies claim this will promote more reliable and accurate diagnostic tests.

LDTs Defined

LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements. Specifically, such laboratory must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet the regulatory requirements under CLIA to perform high complexity testing.

IVDs are intended for use in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva, or tissue. LDTs, like other IVDs, can be used to measure or detect a wide variety of substances, analytes, or markers in the human body, such as proteins, glucose, cholesterol, or DNA, to provide information about a patient’s health, including to diagnose, monitor, or determine treatment for diseases and conditions.

FDA Steps Up LDT Oversight

While LDTs generally are covered by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and required to meet the regulatory requirements under CLIA to perform high complexity testing, the FDA since the 1970s has not enforced applicable requirements with respect to most LDTs.

The FDA now is making clear LDTs are covered by the CLiA and the FDA now will require LDT CLIA compliance in response to their increasing use and the greater risks associated with most modern LDTs compared to those associated with LDTs used decades ago.

In furtherance of this effort, on September 29, 2023, the FDA announced a proposed rule aimed at helping to ensure the safety and effectiveness of these tests. The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs through a phaseout of its general enforcement discretion approach for most LDTs.

Today, the FDA announced it is moving forward to phase out its CLIA non enforcement policy for LDTs to provide increased FDA oversight of LDTs on January 18, 2024. See Laboratory Developed Tests (January 18, 2024).

Along with this announcement, the FDA and CNS also released the following joint statement released on January 18, 2024, attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Dora Hughes, M.D., M.P.H., acting chief medical officer and acting director of the Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)

Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according to the Centers for Disease Control and Prevention (CDC). For example, results from laboratory tests can be the sole determinant of whether a patient with cancer gets a particular therapy, potentially risking the patient’s life with an inaccurate test result. Because of the important role of laboratory tests in healthcare decisions, it is essential to ensure these tests work.

While the U.S Food and Drug Administration (FDA) actively oversees tests made outside laboratories by test manufacturers, tests m and run within a single laboratory, known as laboratory, developed tests or LDTs, are often used without such oversight. The FDA’s approach was developed half a century ago when tests made and used in single labs were generally simple, often made to address local individual needs, and mostly manufactured in small volumes. Therefore, the FDA, as a policy approach, generally did not enforce requirements for LDTs. However, since then, LDTs have evolved. Due to the increased risk to patients, it is time to reconsider this approach.

In recent decades, the FDA has identified concerns with a number of LDTs. For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism and Alzheimer’s Disease.^1,2Other evidence, including published literature^3,4,5,6,7,8 and the FDA’s experience with tests to diagnose COVID-19,⁹ suggests that the situation is getting worse. Therefore, in October of this year, the FDA issued a notice of proposed rulemaking to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs would generally fall under the same enforcement approach as other tests. The Centers for Medicare & Medicaid Services (CMS) supports the FDA’s proposal.

Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. The FDA and CMS both provide oversight to help assure the accuracy of test results, however, they have different roles. CMS regulates laboratories that perform testing on individuals in the U.S. through the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by establishing quality standards for all laboratory testing to help ensure the accuracy, reliability and timeliness of patient test results. In 2013, CMS published a fact sheet on LDTs, outlining each agency’s authority and the complementary roles of the two regulatory schemes. That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight.

Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony, CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.

The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs. LDTs play an important role in healthcare, but when they perform poorly or are not supported by science, they put patients at risk. The current approach has enabled some tests to enter the market with unfounded claims of innovation. These claims can mislead the public, undermine legitimate competition and disincentivize responsible, science-based innovation. Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.

We are now emerging from a global pandemic that has underscored the importance of accurate and reliable tests. Patients and providers need to have confidence that laboratory tests work. We believe the complementary FDA and CMS frameworks are both critical to assuring patients can rely on the clinical accuracy of their test results. “
See: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made (January 18, 2024).

Affected LDT facilities and other interested parties should follow these efforts closely for relevant developments and opportunities for comment and other input. Additionally, LDTs should move quickly to come into compliance with all applicable CLIA requirements.

For More Information

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.

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¹ See pages 68010- 68012 of FDA’s Notice of Proposed Rulemaking.

² See “Memorandum to File – Examples of IVDs Offered as LDTs that Raise Public Health Concerns RE: Medical Devices; Laboratory Developed Tests”

³ Pfeifer, J.D., R. Loberg, C. Lofton-Day, et al., “Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics,” American Journal of Clinical Pathology, 157(4):628-638, 2022 External Link Disclaimer.

⁴Quy, P.N., K. Fukuyama, M. Kanai, et al., “Inter-Assay Variability of Next-Generation Sequencing-Based Gene Panels,” BMC Medical Genomics, 15: 86, 2022 External Link Disclaimer.

⁵ Vega, D.M., L.M. Yee, L.M. McShane, et al., “Aligning Tumor Mutational Burden (TMB) Quantification Across Diagnostic Platforms: Phase II of the Friends of Cancer Research TMB Harmonization Project,” Annals of Oncology, 32(12):1626-1636, 2021 External Link Disclaimer.

⁶ Offit, K., C.M. Sharkey, D. Green, et al., “Regulation of Laboratory-Developed Tests in Preventive Oncology: Emerging Needs and Opportunities,” Journal of Clinical Oncology, 41(1): 11-21, 2023 External Link Disclaimer.

⁷Coffey, D., “Blood Test Positive for Cancer, but Is There Really a Tumor?” Medscape, February 17, 2023 External Link Disclaimer.

⁸ Manrai, A.K., B.H. Funke, H.L. Rehm, et al., “Genetic Misdiagnoses and the Potential for Health Disparities,” New England Journal of Medicine, 375(7):655-665, 2016 External Link Disclaimer.

⁹ See “Memorandum from Elizabeth Hillebrenner to FDA CDRH”

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Posted by Cynthia Marcotte Stamer

Participate In October 8 Free Kickin’ COVID-19: Reopening Texas Summit On Facebook Live

October 2, 2020

A Virtual Summit For Texas Families & Business, Community and Government Leaders On Safely Keeping Texas Working During COVID-19 And Other Pandemics

Presented Via Facebook Live

October 8, 2020

11:00 a.m. – 1:30 p.m. Central Daylight Time

Supercharge your ability to get back to business safely during the COVID-19 and other pandemic health care emergencies by joining other business, community and government leaders online at the Kickin’ COVID-19: Reopening Texas Summit, a free virtual event scheduled on Thursday October 8, 2020 from 11:00 a.m. to 1:30 p.m. Central Daylight Time on Facebook Live.

Solutions Law Press, Inc. PROJECT COPE: COALITION ON PATIENT EMPOWERMENT is happy to join in presenting the Kickin’ COVID-19: Reopening Texas Summit on October 8, 2020 on Facebook Live from 11:00 a.m.-1:30 p.m. Central Time, a free virtual Summit to discuss and share critical tools, information and perspectives to help American citizens, businesses, schools, health care providers, government organizations and leaders and communities better understand options to safely and responsibly do business and get on with life during the COVID-19 and other pandemic outbreaks.

ABOUT THE SUMMIT

Scheduled to be broadcast live on Facebook Live at from 11:30 a.m. to 1:30 p.m. Central Time, the Summit and its resources are designed to empower and inform individuals and families, businesses, schools, churches and other communities and our government leaders about options to continue safe and responsible reopening of Texas and America.

The Summit provides a uniquely valuable opportunity to hear a panel a leading biomedical expert and a panel of other business, community and government leaders share how the COVID-19 health care emergency is affecting their operations, their experiences and strategies reopening in response to these challenges, and their perceptions about the other tools and actions that their organizations for their operations and Texas to reopen and operate safely during the COVID-19 or other pandemic outbreaks. Participants will:

Hear leading biomedical expert James Burgess objectively explain the science of COVID-19 and other pandemic risks and their management;
Hear a panel of key business, community and government leaders discuss how COVID-19 impacts their operations, their response, and their thoughts about what their organizations and Texas need to safely resume operations; and
View and explore a portable pandemic containment unit and other exhibits demonstrating science based pandemic prevention and management tools promoting safe resumption of operations;
Join the fireside chat between the panel and live audience of business, community and government leaders discuss practical challenges and opportunities for business, community and government leaders separately or collaboratively can help expedite and support the recovery of their own and other businesses, communities, people and economy from the COVID-19 and future pandemics; and
Collaborate with other business, government and community leaders on reopening and keeping our businesses, governments, communities and economies open and thriving despite the COVID-19 or another pandemic.

Confirmed panelists include:

Biomedical engineer James Burgess, Chief Executive Officer, American Biomedical Group, Inc.

Susan Fletcher, Collin County Commissioner, Precinct 1; Gubernatorial Appointee TCDRS

George C. Fuller, Owner The Guitar Center and The Sanctuary Music & Events Center; Mayor of McKinney, Texas

Traci Mayer, Executive Director, Hotel Association of North Texas

Pam Minick, Executive Vice President of Marketing, Billy Bob’s Texas

Michael Simmons, CISSP, CISM, CISA, CRISC, Managing Director – Technology, Chief Information Security Officer, Southwest Airlines

Cynthia Marcotte Stamer, Executive Director, Project COPE Coalition; Managing Shareholder, Cynthia Marcotte Stamer, P.C.; Vice Chair, American Bar Association International Section Life Sciences & Health Committee and Tort & Insurance Practice Section Medicine & Law Committee

Sean Terry, Chief Operating Officer, Centurion American Development Group; Mayor, City of Celina, Texas; past president of the North Texas Mayors Association

TOUR PANDEMIC MANAGEMENT RESOURCES IN VIRTUAL EXHIBIT HALL

Along with this valuable opportunity to participate in the Summit, participants also can tour the Summit’s Virtual Event Hall of information and exhibits collected as resources for helping to cope with COVID-19 and prepare for future pandemic threats.

The Summit has been organized through a collaboration of business, community and government leaders, who are volunteering their time and resources to share information and discussions they hope will support the continued responsible and safe reopening and continued resumption of operations and life in Texas and across the Nation despite the continued COVID-19 or other pandemic outbreaks. The Solutions Law Press, Inc. is proud to support this effort as part of its PROJECT COPE: Coalition on Patient Empowerment initiatives.

Join the Summit during the live broadcast or in replay at http://www.pandemicresourcegroup.com/pandemic/reopen-texas-summit!

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Posted by Cynthia Marcotte Stamer

CME Credit Offered For Providers Completing Online Replay Of 4/16 CDC Training On Certifying COVID-19 Deaths

April 16, 2020

Healthcare providers, the Centers for Disease Control and Prevention (“CDC”) can get continuing education credit for completing free heath care provider training available online on “Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19)” originally presented by CDC live on April 16, 2020.

In addition to providing training about proper classification of COVID-19 related deaths on death certificates, health care providers participating in the call may qualify for continuing education credit.

About CDC’s 4/16 COVID-19 Death Reporting Training

The training covers updated rules on completing death certificates for patients believed to have died when infected with COVID-19 published April 2. Monitoring the emergence of Coronavirus Disease 2019 (COVID-19) and guiding public health response requires accurate and timely mortality data. As death certificates are one of the few sources of health-related data that are comparable for small geographic areas and are available over a long time period in the United States, mortality data from the National Vital Statistics System (NVSS) derived from information reported on death certificates to monitor deaths due to COVID-19 versus other causes of death.

During this COCA Call, the following presenters from the CDC provide an overview of the importance of mortality data, discuss the NCHS publication and the guidance it provides to clinicians who may need to certify a death involving COVID-19, and present a summary of COVID-19 surveillance through the NVSS.

Robert N. Anderson, PhD, Chief, Mortality Statistics Branch, National Center for Health Statistics;
Margaret Warner, PhD, Injury Epidemiologist, National Center for Health Statistics;
Lee Anne Flagg, PhD, Statistician (Health), National Center for Health Statistics; and
Farida Ahmad, MPH, Mortality Surveillance Lead, National Center for Health Statistics.

An advance copy of the program Slides is currently available on the CDC website and CDC plans to post a transcript of the program following the presentation.

Continuing Education Credit

Health care providers participating in today’s training may be able to qualify for continuing education credit. CDC says that health care providers wishing to receive continuing education for participation should complete the online between May 19, 2020, and May 19, 2022, and use course code WD2922. The access code is COCA041620. Continuing education certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CEs obtained through the CDC Training & Continuing Education Online System will be maintained for each user.

Interested providers and others can learn mre at this CDC Clinician Outreach and Communication Activity (COCA) here.

More Information

We hope this update is helpful. In addition to this update, the author of this article also is extensively published and frequent speaker on HIPAA and other medical privacy and security, pandemic and other infectious disease, and other health industry crisis preparedness and response, regulatory compliance, risk management and operations, public policy and other concerns. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297. Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

About the Author

Cynthia Marcotte Stamer is a practicing attorney, management and regulatory affairs consultant, author and lecturer, who has worked extensively on pandemic and other crisis planning, preparedness and response and other business change, risk, compliance and operation management throughout her 30 plus year career.

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is most widely recognized for her career long pragmatic, leading edge work, scholarship and thought leadership domestic and international, public and private sector health care and managed care, workforce and employee benefits, insurance and financial services, their technology, data, and other service providers and advisors, and governments domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; creditation, peer review and quality committees and organizations; health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers, and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and the author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans and a multitude of other publications and workshops on health and other disaster and other crisis preparedness, risk management and response, as well as a multitude of other health care, workforce and other management and regulatory affairs publications and presentations, Ms. Stamer also shares her thoughtleadership through her extensive and diverse involvement in a broad range of other professional and civic organizations. Examples of these involvements include her service as the current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former JCEB Council Representative; past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; former ABA RPTE Employee Benefits & Other Compensation Group Chair and Past Chair and current Co-Chair of its Welfare Benefits Committee; former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas; former technical advisor to the National Physicians Council on Health Care Policy; former member of the Stem Cell Advisory Committee; and in a multitude of other professional, trade, civic and community service organizations . For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.

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Posted by Cynthia Marcotte Stamer

4/15 ONC Briefing Covers New Health IT Funding Opportunities

April 14, 2020

Working or interested in working on the development and testing of data sharing functionalities to support clinical care, research, and improved health care outcomes? Listen in tomorrow (April 15, 2020) at 1:30 p.m. Eastern, 12:30 p.m. Central time to an informational briefing about newly announced funding opportunities issued by the Office of the National Coordinator for Health Information Technology under its Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT) whose specific aims address one of the following areas:

Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem
Cutting Edge Health IT Tools for Scaling Research
Integrating Health Care and Human Services Data to Support Improved Outcomes

The new funding opportunities are part of efforts to promote the interoperability of heath care data to enhance health care quality and affordability that continues to be a top ONC priority since ONC released its 2018 Report to Congress: Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information (“Report”).

Under the 21st Century Cures Act, Congress gave ONC authority to enhance innovation, scientific discovery, and expand the access and use of health information through provisions related to:

The development and use of upgraded health IT capabilities;
Transparent expectations for data sharing, including through open application programming interfaces (APIs); and
Improvement of the health IT end user experience, including by reducing administrative burden.

The Report describes barriers, actions taken, and recommendations as well as ONC’s path forward to implement the 21st Century Cures Act and to increase nationwide interoperability of health information and reduce clinician burden.

ONC’s resulting emphasis on health data interoperability raises new business and compliance planning opportunities and challenges for health care providers, health insurers and other payers, health data and information technology (IT) providers and others. The new funding opportunities are intended to produce new capabilities for achieving these objectives.

For more information, visit LEAP in Health IT.

More Information

About the Author

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.

Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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Posted by Cynthia Marcotte Stamer

OCR Adds HIPAA Privacy Rule Enforcement Relief For Community-Based COVID-19 Testing Sites; Updated HIPAA Risk Assessments Advisable For COVID-19 Impacted Operational Changes

April 9, 2020

All Health Care Providers & Business Associates Reminded To Conduct Documented Risk Assessments In Response To COVID-19 Operational Changes

The U.S Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced Health Insurance Portability & Accountability Act Privacy Rule 2019 Novel Coronavirus (COVID-19) emergency enforcement relief for certain covered health care providers and their business associates participating in the operation of mobile, drive-through, or walk-up COVID-19 specimen collection and testing sites that only provide COVID-19 specimen collection or testing services to the public (Community-Based Testing Sites, or CBTS). The Notification of Enforcement Discretion ON CBTS During The COVID-19 Nationwide Public Health Emergency (“Notice”) expands upon the series of HIPAA enforcement relief and other flexibility OCR has granted to health care providers and other HIPAA-covered entities and business associates when dealing with the COVID-19 National Health Emergency declared by President Trump on March 13, 2020.

While welcome relief for those health care providers and business associates that qualify for this relief, it is critical that all health care providers, health plans, health care clearinghouses and their business associates do not overlook the importance of ensuring their HIPAA obligations are fulfilled amid the frenzy of coping with the ongoing COVID-19 crisis. Like OCR’s previously announced March 30, 2020 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Telehealth Relief”) and the COVID-19 related flexibilities granted by OCR in its February 2020 Office for Civil Rights, U.S. Department of Health and Human Services BULLETIN: HIPAA Privacy and Novel Coronavirus (“OCR COVID-19 HIPAA Bulletin”), the CBTS Notice provides valuable flexibility and relief for HIPAA covered entities and business associates that qualify for the granted relief. While welcoming this relief, all covered entities and business associates need to keep in mind that the shifting of care locations, systems, affiliations and other arrangements to deal with the COVID-19 national health emergency generally are accompanied by changes in the collection, use, access, disclosure, storage and transmission of protected health information generally and electronic protected health information and its associated devices and systems. Except to the extent protected by COVID-19 or other specific disaster relief from OCR, covered entities and business associates need to use care to conduct appropriately documented risk assessments and take other necessary steps to maintain HIPAA compliance in these operations and systems throughout the emergency. See also COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released; OCR Grants HIPAA Telemedic ine Relief During COVID-19 Crisis.

April 9 HIPAA Enforcement Relief For Certain COVID-19 Testing Related Activities

According to Director Roger Severino, the limited enforcement relief in the Notice is intended “to encourage the growth of mobile testing sites so more people can get tested quickly and safely.” Under the April 9, 2020 Notice, OCR will not impose penalties for violations of HIPAA regulatory requirements committed by covered entities or business associates in connection with their good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. The enforcement relief provided by the s retroactive to violations committed on or after March 13, 2020 even though just announced on April 9.

The enforcement relief applies to all HIPAA covered health care providers and their business associates when such entities are, in good faith, participating in the operation of a CBTS. According to the Notice, operation of a CBTS includes all activities that support the collection of specimens from individuals for COVID-19 testing. Covered entities and business associates intending to rely upon the enforcement relief need to understand its limited scope. The relief only applies to health care providers or their business associates when participating in CBTS related activities. It does not apply to non-CBTS related activities of health care providers or their business associates including the handling of PHI outside of the operation of a CBTS or to health plans, health care clearinghouses, or their business associates performing health plan and clearinghouse functions. To the extent that an entity performs both plan and provider functions, the Notice says the relief only applies to the entity in its role as a covered health care provider and only to the extent that it participates in a CBTS. Covered entities and business associates not covered by the CBTS relief provided by the Notice generally remain subject to all otherwise applicable HIPAA requirements except as otherwise provided in the Telehealth Relief or other COVID-19 related flexibilities granted by OCR in the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies,

While committing that OCR will not take HIPAA enforcement action against covered entities or business associates for violating HIPAA’s regulatory requirements during the COVID-19 emergency, the Notice nevertheless encourages covered entities and business associates participating in the good faith operation of a CBTS to implement reasonable safeguards to protect the privacy and security of individuals’ PHI including:

Using and disclosing only the minimum PHI necessary except when disclosing PHI for treatment.
Setting up canopies or similar opaque barriers at a CBTS to provide some privacy to individuals during the collection of samples.
Controlling foot and car traffic to create adequate distancing at the point of service to minimize the ability of persons to see or overhear screening interactions at a CBTS. (A six foot distance would serve this purpose as well as supporting recommended social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a “buffer zone” to prevent members of the media or public from observing or filming individuals who approach a CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit electronic PHI.
Posting a Notice of Privacy Practices (NPP), or information about how to find the NPP online, if applicable, in a place that is readily viewable by individuals who approach a CBTS.

While OCR says the Notice’s enforcement relief for CBTS related activity is not conditional upon adherence to these recommendations, CBTS involved covered entities and business associations should keep in mind that the OCR relief does not necessarily affect their otherwise applicable requirements, if any, to comply to these and other health or medical privacy, data security, confidentiality or other similar requirements applicable under otherwise applicable state statutory or common laws, regulations, accreditation or credentialing, contractual or other legally relevant requirements or standards.

Covered Entities & Business Associates Should Conduct Documented Risk Assessment To Verify Compliance Taking Into Account COVID-19 Operational Changes & Relief

Health care providers, health plans, health care clearinghouses and their business associates hoping to rely upon the relief in the CBTS Notice, the Telehealth Relief, the OCR COVID-19 HIPAA Bulletin or other previously issued HIPAA guidance for dealing with public emergencies, need to verify their qualification and compliance with that guidance. In the meantime, all HIPAA covered entities and business associates also should be cognizant of the advisability of also conducting timely, documented risk assessments and taking other necessary steps to ensure that they can demonstrate that their ongoing operations, taking into account any COVID-19 specific changes in operations, systems, locations, business associates or other HIPAA relevant arrangements or operations, comply with all remaining relevant requirements of HIPAA or other relevant federal or state statutory, regulatory, common law, ethical, contractual or other requirements. This is particularly important with respect to modification locations, equipment, or other COVID-19 related changes may impact or disrupt usual operations or involve the use, access, disclosure, retention or transmission of protected health information or other sensitive data outside of processes, systems or location previously subject to a risk assessment to confirm and document adequate compliance with HIPAA or other relevant requirements. To the extent that any deficiencies may have occurred, timely action should be taken to conduct an appropriate documented investigation and risk assessment, and provide any necessary breach notification or other corrective action necessary to correct or mitigate those events. Because of the potential sensitivity of these activities, health care providers, health plans, health care clearinghouses and their business associations should consider contacting experienced legal counsel to arrange for those activities to be structured to preserve the possibility of using attorney-client privilege or other legal privileges to help defend sensitive communications or evaluations against discovery in the event of a future litigation or administrative investigation.

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About the Author

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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Posted by Cynthia Marcotte Stamer

6/16 Feedback Deadline For CDC Legal Epidemiology Competency Model; Other Legal Epidemiology Resources

June 1, 2017

Public health and other health care, employer and other business, education, community services, law enforcement and other government and community leaders and their legal and other advisers should check out and provide feedback to the Centers for Disease Control (CDC) on the new draft Legal Epidemiology Competency Model (LECM) and other CDC resources designed to help the U.S., its organizations, communities and people prepare for and respond to epidemic and other public health and disease concerns.

National and international concern about the outbreak and management of deadly Ebola and other pandemics, bioterrorism and other terrorism attacks, national disasters and other public health risks have sensitized Americans and their business, community and governmental leaders to the potential community wide risks of these and other public health events, the legal and operational challenges that often arise in the course of responding to these risks, and the helpfulness if not necessity of community-wide involvement, preparation and collaboration to the effectiveness of efforts to prepare for and respond to these occurrences.

In recognition of these realities, the CDC is stepping up its efforts both to understand better, and to to educate and support relevant components of U.S. communities, their advisers, researchers and leaders about these public health challenges including the relationships and influences between the occurrence and management of these public health events and the law (“legal epidemiology.”)

Widespread public and private concern and coverage of terrorism attacks and pandemic outbreaks have reinvigorated CDC’s emphasis and efforts to outreach to health care providers, public health, school, and other community organizations, employers and other business leaders and others. In response to government and public Ebola and other epidemic and pandemic out breaks, for instance, the CDC in recent years has stepped up both its public communications about epidemic and other public health risks and its emphasis upon understanding and developing legal epidemiology practices and resources. For instance, the death of an Ebola patient in Dallas and subsequent diagnosis of various other victims of Ebola and other pandemic diseases within or potentially traveling to the United States, reinvigorated the emphasis and efforts of the CDC and other federal and state agencies and other public and private organizations and groups to help law and policy makers prepare for and respond to pandemic and other public health concerns.

While much of the increased or updated CDC knowledge and guidance focuses on improving understanding and communications targeting a specific public health risk or situation, such as the updated State Ebola Protocols Table specifically to support preparedness for and responsiveness Ebola-related situations, the CDC also now recognizes the need to understand and address more generally the emerging area of legal epidemiology.

As part of its efforts to promote better understanding and resources to address legal epidemiology challenges, CDC recently released and now is inviting input on a new draft LECM developed by the CDC in collaboration with a “multidisciplinary expert review workgroup” as a resource to provide helpful information and support to lawyers, researchers, and others whose work explores how laws can play a role in the cause, distribution, and prevention of disease and injury or otherwise engaged in projects focused at the intersection of law and epidemiology, referred to as “legal epidemiology.”

Recognizing the growing importance of legal epidemiology, the CDC now is inviting input from the broad public health community, as well as from those engaged directly in legal epidemiology work to help CDC further refine the LECM. While the CDC is inviting interested persons to review the draft LECM and share thoughts on any aspect of the model, CDC has indicated that CDC particularly is interested in reactions and suggestions related to any of the following questions:

Does the LECM reflect the requirements for truly effective performance of legal epidemiology?
Are there concepts that should be added or removed?
Are the behavioral statements in the draft LECM representative of how legal epidemiologists demonstrate competency in their work?
Does the draft LECM accurately reflect the knowledge, skills, and abilities that legal epidemiologists must demonstrate in your organization?
How might you use the LECM in your work?

Parties wishing to provide feedback should submit their feedback by Friday, June 16, 2017 in accordance with the instructions shared here or by email to Janelle Nichols at jnichols@phf.org.

Coincident with CDC’s release of the draft LECM for public comment, the CDC PHLP is working to expand awareness and understanding of the emerging field of legal epidemiology.

As part of these efforts, CDC recently released an updated version of its Criminal and Epidemiological Investigations Handbook. Offered in English, Spanish and French, this latest version provides an overview of criminal and epidemiological investigation procedures involving interactions between law enforcement and public health. It is designed to help teach public health and law enforcement how to work together to identify the biological agent, prevent the spread of the disease, avoid public panic, and apprehend those responsible.

CDC also is offering in collaboration with the National Environmental Health Association, a series of webinars on legal epidemiology. The second webinar in a three-part series of free programs on legal epidemiology titled “Legal Epidemiology, Part 2: A Tool for Evaluating the Impact of Environmental Public Health Laws,” scheduled to take place on June 14, 2017, 1:00–2:30 pm (EDT) will feature speakers from PHLP, highlight variations in state law provisions related to environmental public health issues, and describe related legal epidemiology methods. It will also offer abbreviated training in the principles of legal epidemiology, give examples of its application to environmental public health law, and allow participants to ask questions. For more details about the program or participation, see here.

About The Author

Ms. Stamer works domestically and internationally with health, insurance and financial services, data and technology, services and consulting, energy, retail, hospitality and other businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. Her day-to-day work encompasses both labor and employment issues, as well as independent contractor, outsourcing, employee leasing, management services and other nontraditional service relationships. She supports her clients both on a real-time, “on demand” basis and with longer term basis to deal with all aspects for workforce and human resources management, including, recruitment, hiring, firing, compensation and benefits, promotion, discipline, compliance, trade secret and confidentiality, noncompetition, privacy and data security, safety, daily performance and operations management, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Well-known for her extensive work with health, insurance, financial services, technology, energy, manufacturing, retail, hospitality and governmental employers, her nearly 30 years’ of experience encompasses domestic and international businesses of all types and sizes.A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association; Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children; former Gulf Coast TEGE Council Exempt Organization Coordinator; a founding Board Member and past President of the Alliance for Healthcare Excellence; former board member and Vice President of the Managed Care Association; past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; a member and advisor to the National Physicians’ Council for Healthcare Policy; current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee; current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section; Past Chair of the ABA Health Law Section Managed Care & Insurance Section; a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group; immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council; past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a former member of the Board of Directors, Treasurer, Member and Continuing Education Chair of the Southwest Benefits Association and others.

Author of “Privacy & Pandemic: A Workshop & Materials” presented to the ASTHO and a multitude of other pandemic, occupational health and other public health law and management matters, Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health care, privacy, human resources, labor and employment, employee benefits, compensation, occupational safety and health, and other regulatory and operational risk management for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clients on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications.

Want to know more? See here for details about the author of this update, attorney Cynthia Marcotte Stamer, e-mail her here or telephone Ms. Stamer at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at www.SolutionsLawPress.com.

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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The publisher and the author expressly disclaim all liability for this content and any responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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Posted by Cynthia Marcotte Stamer

HHS, Sesame Workshop, & Ad Council National Ad Campaign Reminds Americans Of Need to Continue To Protect Against H1N1 (Swine Flu) Virus

June 3, 2009

Declining press attention on the H1N1 flu virus (swine flu) pandemic does not mean the need for precautions is over for Americans, their employers, schools and other community organizations.

The Department of Health and Human Services (HHS),the Ad Council and Sesame Workshop, the nonprofit educational organization behind Sesame Street, recently launched a national public service advertising campaign designed to encourage American families and children to take steps to protect themselves from the 2009 H1N1 flu virus (swine flu) and continue to practice healthy habits. The announcement of the campaign signals continuing concerns by government and other health experts that the swine flu pandemic may continue to circulate or even worsen unless proper precautions are taken.

The 2009 H1N1 flu virus is a new flu virus of swine origin that was first detected in April 2009. While press attention has died down in recent weeks, the virus is spreading from person-to-person, sparking a growing outbreak of illness in the U.S. and internationally. To date, over 5,700 cases have been reported in the United States and there are nine deaths associated with the novel H1N1 infection. Experts believe that the 2009 H1N1 flu spreads in the same way that seasonal influenza viruses spread — primarily through the coughs and sneezes of people who are sick with the virus.

HHS Secretary Kathleen Sebelius unveiled the campaign at the HHS/Department of Education Childcare Center in Washington, D.C. The PSAs will be distributed nationwide and will be supported in airtime donated by television stations.

The new PSA campaign focuses on the importance of providing parents, teachers and children with accurate information about how to practice healthy habits, highlighting proper hand-washing and simple everyday actions that lead to staying healthy and keeping germs away. Created by Sesame Workshop, the television PSAs encourage audiences to visit http://www.cdc.gov to get more information on how to stay healthy. The PSAs are an extension of Sesame’s Healthy Habits for Life initiative, which helps young children and their caregivers establish an early foundation of healthy habits. As part of HHS/Ad Council campaign, Sesame Workshop produced a television PSA featuring Sesame Street’s Elmo and Gordon explaining the importance of healthy habits such as washing your hands, avoid touching your eyes, nose and mouth and sneezing into the bend of your arm.

The PSAs are part of an initiative to provide practical steps recommended by HHS’ Centers for Disease Control and Prevention (CDC) to help prevent the spread of the flu virus and other infectious disease, including:

Avoid close contact with people who are sick.

Keep your distance from others if you are sick.

When possible, stay home from work, school, and errands when you are sick, and don’t send your children to childcare or school if they are sick.

Cover your mouth and nose when coughing or sneezing.

Wash your hands often with soap and water, especially after coughing and sneezing.

Avoid touching your eyes, nose and mouth.

Cynthia Marcotte Stamer and other attorneys practicing with Curran Tomko Tarski LLP are experienced advising and representing health industry clients, community organizations and others about federal and state regulatory, reimbursement, grant, enforcement and other health industry risk management and compliance concerns. If you have questions about these matters, please contact Ms. Stamer at 214.270.2402.

For More Information

We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com.

You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at Health Care Update Blog. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

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Posted by Cynthia Marcotte Stamer

HHS, Sesame Workshop, and the Ad Council Launch National Campaign to Protect Families from H1N1 (Swine Flu) Virus and Stay Healthy

June 3, 2009

Avoid close contact with people who are sick.
Keep your distance from others if you are sick.
When possible, stay home from work, school, and errands when you are sick, and don’t send your children to childcare or school if they are sick.
Cover your mouth and nose when coughing or sneezing.
Wash your hands often with soap and water, especially after coughing and sneezing.
Avoid touching your eyes, nose and mouth.

Cynthia Marcotte Stamer and other attorneys practicing with Curran Tomko Tarski LLP are experienced advising and representing health industry clients, community organizations and others about pandemic planning and other disease management and health industry risk management and compliance concerns. If you have questions about these matters, please contact Ms. Stamer at 214.270.2402.

For More Information

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Posted by Cynthia Marcotte Stamer

Swine Flu Treatment & Pandemic Response Information Updated

April 30, 2009

With U.S. officials confirming the first swine flu attributed death in the U.S. yesterday and the number of U.S. reported cases expected to top 100 today, health care providers and organizations are initiating their pandemic response plans to help their organizations, people, patients and communities respond to the rapidly spreading epidemic.

Whether or not the swine flu outbreak reaches the level of an official pandemic, official reports reflect a legitimate need for concern. According to officials from the Centers for Disease Control and Prevention (CDC), victims of the swine influenza A (H1N1) virus infection already have been reported in 10 states, and the number of people known to be infected with the 2009 H1N1 influenza strain grew to 91 in the U.S. as of Wednesday. That number includes the first U.S. swine flu fatality: a 22-month-old child from Mexico who died of the illness Monday at a Houston, Texas hospital while visiting the United States. While swine flu victims have been reported in more than 11 countries, the majority of the incidents of the disease and deaths as of Wednesday morning had occurred in Mexico. Alarm that the outbreak will reach pandemic proportions continues to grow.

In response to the expanding crisis, the CDC yesterday released updated interim guidance on the use of antiviral agents for treatment and chemoprophylaxis of patients with confirmed, probable or suspected swine influenza virus infection and their close contacts. This guidance is only part of a host of growing resources for health care providers and other parties posted at http://www.pandemicflu.gov, the website founded by the U.S government to provide one-stop access to U.S. Government swine, avian and pandemic flu information. The website links to a growing list of special guidance provided by the CDC and other organizations for health care organizations and providers, public officials, schools, businesses, the public and others. Health care providers and other concerned parties should check this site regularly for updates about the latest guidance for responding to and treating swine flu.

Health care providers, schools, government agencies and others concerned about preparing to cope with pandemic or other infectious disease challenges also may want to review the guidance for health care providers and public health officials as health care providers, employers, and public entities contained in the pandemic and privacy planning workshop materials “Planning for the Pandemic” authored by Curran Tomko Tarski LLP partner Cynthia Marcotte Stamer available at http://www.cynthiastamer.com/documents/speeches/20070530%20Pan%20Flu%20Workplace%20Privacy%20Issues%20Final%20Merged.pdf.

Health care providers also should educate employees, patients and the public about the steps they should take to help minimize their risk of contracting the disease. While the CDC says getting employees and their families to get a flu shot remains the best defense against a flu outbreak, it also says getting individuals to consistently practice good health habits like covering a cough and washing hands also is another important key to prevent the spread of germs and prevent the spread of respiratory illnesses like the flu. Health care providers, employers, public officials and others should encourage patients, employees and their families and others to take the following steps and to coach others they know to do so as well:

Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick too.
Stay home when you are sick to help prevent others from catching your illness. Cover your mouth and nose.
Cover your mouth and nose with a tissue when coughing or sneezing. It may prevent those around you from getting sick.
Clean your hands to protect yourself from germs.
Avoid touching your eyes, nose or mouth.
Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.
Practice other good health habits. Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.

To help promote this message, health care providers, public officials and businesses may want to download and circulate some of the many free resources published by the CDC at http://www.cdc.gov/flu/protect/habits.htm.

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting health care providers, public agencies, schools, businesses and others employers with these and other health care, workforce, crisis preparedness and response and related matters. If your organization needs assistance with assessing, , please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402. For additional information about the experience and services of Ms. Stamer and to access some of her publications, see www.cynthiastamer.com or www.cttlegal.com.

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Posted by Cynthia Marcotte Stamer

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