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 literature3,4,5,6,7,8 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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.

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About the Author

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, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

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, 2022External Link Disclaimer

Quy, P.N., K. Fukuyama, M. Kanai, et al., “Inter-Assay Variability of Next-Generation Sequencing-Based Gene Panels,” BMC Medical Genomics, 15: 86, 2022External 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, 2021External 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, 2023External Link Disclaimer

Coffey, D., “Blood Test Positive for Cancer, but Is There Really a Tumor?” Medscape, February 17, 2023External 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, 2016External Link Disclaimer.

9 See “Memorandum from Elizabeth Hillebrenner to FDA CDRH”


Stamer To Speak 8/20 On “Sex, Drugs & Rock ‘N Role: Managing Physician Conduct In Health Care”

August 15, 2013

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONALS ASSOCIATION

Invites Members and Guests to Our Next Group Luncheon

SEX, DRUGS & ROCK ‘N ROLE:

MANAGING PHYSICIAN CONDUCT IN HEALTH CARE

Featuring

Cynthia Marcotte Stamer, J.D.

Managing Shareholder, Cynthia Marcotte Stamer, P.C. & NTHCPA Vice-President

Tuesday, August 20, 2013

11:30 a.m. to 1:30 p.m.

Dallas Ft. Worth Hospital Council Offices

250 Decker Drive, Irving, TX 75062-2706

RSVP here by Noon on August 19, 2013

Register Early As Space Is Limited

Stay In Touch. Check Out Our New Newsletter, the NTHCPA News, here!

Whether false claims and other aggressive billing, referral or treatment practices, chemical dependency or other impairment, medical staff or other rule breaking, harassing or other disruptive conduct or a host of other personal behavioral or performance concerns, preventing and addressing personal misconduct and other risky behaviors by physicians on the staff or team of a hospital, medical practice personal misconduct often present major legal, quality, financial, political and operational challenges and risks for health care compliance, medical staff, risk management and other leaders. Alternatively, properly directed physicians can significantly help the operation and performance of health care organizations in many critical ways.

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals faced with these and other challenges to join us on Tuesday, August 20, 2013 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring attorney Cynthia Marcotte Stamer speaking on “Sex Drugs & Rock ‘N Role: Managing Physician Conduct in Health Care.”

While physician involvement remains an operational necessity for most hospitals, group practices and other health care organizations, these and other health care organizations and other members of their team often face significant legal, financial, reputational and operational risks when a physician becomes impaired by chemical dependency, mental illness, stress, personal tragedy or other personal impairment; is disruptive; or engages in sexual or other harassment of staff or patients, billing, treatment, referral, anticompetitive or other illegal conduct, medical board or facility rule violations, or other acts of personal or professional misconduct. While these behaviors often create major risks for health care organizations and others, successful redress of these or other physician performance or misconduct concerns often depends upon the ability to successfully negotiate a complex minefield of due process and other procedural, legal, political, operational and other challenges.

Attorney Cynthia Marcotte Stamer will use lead participants in a workshop examining these challenges and discussion of strategies to help health care organizations and their compliance officers can use to help their organization prevent, investigate and redress these and other physician performance and misconduct concerns while managing HCQIA and other peer review, licensing board, contractual, defamation and other legal, professional and operational traps that often arise out of physician discipline or other corrective actions. On the other hand, well-motivated and properly focused physicians play a key role in leading quality, financial, compliance and other improvements in health care organizations and practices.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on August 20, 2013 at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706 will feature a complimentary luncheon for those who timely R.S.V.P. Networking and lunch service will begin at 11:30 a.m.. Our program will begin at Noon.

There is no charge to participate in the meeting. However space is limited and available only on a first come, first serve basis. To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on August 19, 2013. Walk in guests will be accommodated on a space-available basis only.

About The Speaker, Cynthia Marcotte Stamer, J.D.

Attorney, author and health care change leader Cynthia Marcotte Stamer, J.D. is nationally and internationally recognized for her more than 25 years of health policy and legal work, process improvement and reengineering, publications and programs, and advocacy. Ms. Stamer works extensively with public and private health care organizations, managed care and health insurance organizations, governments and community leaders and others health industry compliance, risk management, quality, staffing, workforce, patient, quality and performance management, operations, governance, compensation, reimbursement and financing, regulatory and public policy, process improvement and reengineering and other health industry legal and operational concerns.

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Vice-President of the North Texas Health Care Compliance Professionals Association, past Board Compliance Chair of the National Kidney Foundation of North Texas, Past President of Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, combines her health industry operations compliance, and risk management experience with an in-depth knowledge of federal and state healthcare, workforce, governance, internal controls, enforcement and other operational issues to help health industry clients to support legal and operational risk and performance management. Her experience includes advising public and private health care systems, hospitals, managed care organizations and physician management organizations, physicians and physician practice groups, skilled nursing, home health, rehabilitation, pharmacy, and other health industry clients domestically and internationally on a wide range of matters including physician and other staffing, credentialing and peer review, gainsharing and other performance management, compliance, enforcement, and a wide range of other matters matters. A widely recognized health industry thought leader, advocate, author and speaker, Ms. Stamer’s insights are sought out by government and business leaders, and quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications. She also conducts continuing board, medical education, workforce and other health industry compliance and risk management training for many organizations on a wide range of topics. She also regularly represents health care organizations and other health industry clients before peer review and other disciplinary bodies, federal and state regulators, investigators, Congress and state legislatures, licensing and credentialing and other governmental and regulatory authorities.

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

Would you or someone you know like to join the NTHCPA, get notice of upcoming meetings or events and network on relevant professional developments with other health care professionals? Stay on top of information about upcoming meetings and share and dialogue with other NTHCPA members about health care compliance challenges and developments by participating in our meetings and events, joining our Linked In Group here and checking out the NTHCPA News here. To be added to our invitation list, we also encourage interested persons to make sure we have your current contact information by registering for the meeting or sending your current contact information including name, title, company, preferred mailing address, e-mail, and telephone number to Vice-President Cynthia Marcotte Stamer here.

Thanks To Solutions Law Press, Inc.

The NTHCPA thanks Solutions Law Press, Incâ„¢. and its Coalition for Responsible Health Policy and Project COPE: the Coalition on Patient Empowerment, for its generous underwriting support of the August 20, 2013 luncheon.

Solutions Law Press, Inc.â„¢ publishes the Health Care Update and other resources, as well as provides health care risk management, legal compliance, management effectiveness and other briefings, training, policy and operational consulting, and other resources and services on health care, human resources, employee benefits, compensation, data security and privacy, insurance, and other key compliance, risk management, internal controls and other key operational concerns. To review or receive the Health Care Update, participate in discussions in the Solutions Law Press, Inc.â„¢ Linkedin Group or for other information about Solutions Law Press, Inc. resources and services, see http://www.SolutionsLawPress.com.

Sponsorship and Other Involvement Opportunities

Would you like to show your support for the NTHCPA by sponsoring the luncheon or hosting a social hour? Want to help plan upcoming meetings? Suggest a speaker or topic? Help with the newsletter or website? Serve on the steering committee or get more involved in other ways? Get more information about membership or involvement with the NTHCPA? Send your inquiry by e-mail here.

This communication may be considered marketing purposes. If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading here.

Please share this invitation with others who might be interested in this topic or other NTHCPA events!


100,000+ Primary Care Providers Signed Up To Get EHRs Regional Extension Centers

November 17, 2011

The HHS Office for the National Coordinator for Health Information Technology announced today that nearly one-third of all primary care providers -plan to work with their Regional Extension Center (REC) to participate in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs as a way to transition from paper records to certified EHRs. 

Designed to jump start EHR adoption, the Health Information Technology Economic and Clinical Health (HITECH) Act of 2009, part of the Recovery Act, created a nationwide network of RECs comprised of local nonprofits, to provide guidance and resources to help eligible professionals make the transition from paper records to certified EHRs.  Eligible providers that meet meaningful use of certified EHRs criteria may be eligible for incentive payments under the Recovery Act.

The 62 RECs focus on assisting primary care providers and those providers serving traditionally medically underserved populations as they take part in the Medicare and Medicaid EHR Incentive Programs and meaningfully use EHRs in ways that can reduce health care costs, increase patient safety, and improve the overall quality of patient care.  These providers face challenges in EHR adoption including tight budgets, over-stretched health information technology staff, and limited broadband access.

One-half of the providers committed to making the transition to certified EHRs are in small group practices or consortia of small group practices.  The remaining providers focus on the underserved with 18 percent in community health centers, 11 percent in public hospitals, and 21 percent in other underserved settings, such as critical access hospitals, rural health clinics, and practices in medically underserved areas.

RECs serve the majority of primary care providers in small practices in rural areas.  Today’s figures include over half of the targeted 1,776 critical access and rural hospitals in 41 states and throughout Indian Country.

A complete listing of REC grant recipients and additional information about Regional Extension Centers may be found at http://www.HealthIT.hhs.gov/REC/.

For information about the Medicare and Medicaid EHR Incentive Programs, see http://www.cms.gov/EHRIncentivePrograms.

For information about HHS Recovery Act health IT programs, see http://www.hhs.gov/recovery/announcements/by_topic.html#hit.

For Help With Compliance, Investigations Or Other Needs

If you need assistance understanding, managing or defending licensing board, peer review or other requirements or actions, providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others..   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

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

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

 

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

 


TMP Reminds Texas Doctors To Register To Electronically File Death Certificates; Enforcement Grace Period Ends 6/1

May 17, 2011

Texas physicians that anticipate being called upon to sign a death certificate should register to file the the certificate electronically ahead of time.   

Texas law now requires electronic filing of death certifications and advance registration is required to use this process. 

According to the Texas Medical Board, more than 100 physicians faced disciplinary action from the Texas Medical Board for failing to complete death certificates electronically, as required by Texas law.  In response to requests of members of the Texas Legislature, the Texas Medical Board gave physicians a grace period until June 1 to allow them more time to register and has refunded fines and dismissed pending disciplinary actions. As it prepares to resume enforcement when the grace period ends June 1, 2011, the Texas Medical Board is reminding physicians of the need to register as soon as possible by visiting here.

For Help With Compliance, Investigations Or Other Needs

If you need assistance understanding, managing or defending licensing board, peer review or other requirements or actions, providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others..   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

 

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

 


Sexual Misconduct Investigation Prompts Medical Board Suspension of Texas Doctor

March 16, 2011

Personal Misconduct By Physicians Or Other Health Care Workers Common Trigger for Disciplinary Action Or  Other Liability

On March 14, 2011, a disciplinary panel of the Texas Medical Board temporarily suspended, with notice, the medical license of Ramon A. Cruz, M.D., of Denton, based on allegations of inappropriate sexual behavior with several patients.  According to the Texas Medical Board, the panel found that Dr. Cruz, Lic. No. K3703, engaged in sexually inappropriate behavior with several patients. Four incidents, including an alleged sexual assault, were reported by patients to Denton Police.  The panel found that Dr. Cruz’s actions demonstrate a pattern of inappropriate behavior, which is a continuing threat to public health and safety justifying the suspension of his license.  The suspension remains in effect until the Board takes further action.

Unprofessional personal misconduct presenting a right to public health and safety is a common trigger for discipline by the Texas Medical Board and other licensing boards.  See, e.g. Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians. Although complaints based on sexual misconduct occur much less frequently than substance abuse or other types of personal misconduct, the Texas Medical Board and other medical licensing bodies view sexual misconduct as among the most serious types of violations.  The prevalence rate of sexual misconduct in physicians is estimated at 6-10 percent but this phenomenon is likely under-reported in physician surveys and by patients. It is believed that the number of false claims made by patients is very low. A 1992 study indicates that only 4-8 percent of patients report a doctor’s sexual misconduct.  Physicians found guilty of engaging in prohibited sexual misconduct typically are male, have a mean age of 53, practice in private practice, and have a history of substance abuse, are in the midst of a divorce, separation or other life crisis and tend to engage in higher than typical nonsexual patient touch with patients.

Because of their special role and responsibility with respect to patients and the community, the law, the profession and the public impose high expectations upon physicians and other health care professionals in relation to their sexual conduct toward patients and others.  State medical practices and other medical licensure bodies, the American Medical Association Code of Conduct, the Joint Commission, peer review and other disciplinary boards and other regulatory and administrative policies and bodies generally prohibit both sexual assault, sexual harassment, and a broad range of other conduct of a sexual nature considered to be inconsistent with the special relationship of trust occupied by the health care professional. 

Sexual misconduct charges that can result in discipline can include clear atrocities such as rape or other sexual assaults, as well as engagement in inappropriate sexual relationships or overtures to current or former patients, as well as sexual harassment and certain other types of sexual relationships or conduct involving staff or others.  See, e.g., Ringer v. Texas State Bd. of Med. Examiners, 1999 Tex. App. LEXIS 8214 (Tex. App. 1999); Texas State Board of Medical Examiners v. Haynes, 388 S.W.2d 258, 261 (Tex. App. 1965); Texas State Board of Medical Examiners v. Koepsel, 159 Tex. 479 (Tex. 1959).  In addition discipline by the Board of Medicine, physicians or other health care providers typically also face other consequences such as medical malpractice, sexual harassment or other similar claims or charges, peer review discipline, data bank reports, employment termination or discipline, practice expulsion, and criminal prosecution.  Even if a physician or other heath care provider dodges formal discipline, accusations of sexual misconduct by a physician or other health care provider tends to permanently damage the practice and reputation of the health care.

Sexual misconduct by a physician or other health care provider or workforce member also can create significant exposures for hospitals, clinics, affiliated physicians and health care professionals associated with a physician or health care provider found to have engaged in sexual misconduct. Among other things, the failure of these third parties to take adequate steps to prevent, investigate, report or redress another health care provider’s sexual misconduct or harassment may result in malpractice or other civil litigation, licensure or other professional investigation or discipline, reputational damages and other consequences.

To guard against these exposures, physicians and other health care providers should exercise care to avoid engaging in actions that might expose them to charges of sexual assault, harassment or other inappropriate sexual conduct and should adopt policies, adopt procedures and practices to prohibit and provide training and other oversight to encourage other health care providers and staff to avoid such conduct. If a physician or other health care provider or organization observes, receives a report or charge or otherwise becomes aware of information indicating that a potential sexual assault or other inappropriate sexual conduct may have occurred, it should act promptly and appropriately to investigate and redress the conduct or suspected conduct in a manner designed to strengthen their defenses against possible disciplinary action or other liabilities and risks.   Because of the legal sensitivity and risk associated with the allegations of sexual misconduct and the investigation of those charges, physicians and other health care providers and organizations involved in these concerns generally should engage competent legal counsel as soon as possible when these concerns come to light for assistance in responding to the concerns, as well as the ability to use attorney-client privilege and work product, peer review, quality, and other legal privileges and other legal rules and safeguards to help promote confidentiality and defensibility of sensitive communications and conduct in connection with the investigation and response to these concerns.

For Help With Compliance, Investigations Or Other Needs

If you need assistance providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others..   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

 


CMS Physician Compare Tool Gives Patients New Info On Physicians & Other Providers

January 4, 2011

The Centers for Medicare & Medicaid Services (CMS) is giving patients and their families new resources to learn about physicians and certain other health care providers.  On December 30, 2010, CMS added a new “Physician Compare” feature to the CMS Healthcare Provider Directory.  While the information provided currently is relatively limited, CMS plans to expand the data to help Medicare and non-Medicare patients and their families find and assess the quality of providers.   While these and other similar resources can provide valuable information for patients and their families, like all provider directories, patients and their families should be cautioned to properly understand the benefits and limitations of the resource.  Accordingly, physicians and other providers covered by the new tool should be aware of the tool and prepare to respond to questions and concerns that it may prompt.  Physicians and other providers also should monitor proposed future expansions of this resource and provide input about the proposed content, format and presentation of such information.

Required by the Patient Protection & Affordable Care Act (“Affordable Care Act”), the Physician Compare tool located here has information about Doctors of Medicine, Osteopathy, Optometry, Podiatric Medicine, and Chiropractic and certain other types of health care professionals participating in the Medicare Program, who routinely care for Medicare beneficiaries.

According to CMS, the Physician Compare Web Site is designed to be consumer friendly and help all patients—whether on Medicare or not—locate health professionals in their communities. The information on the site includes contact and address information for offices, the professional’s medical specialty, where the professional completed his or her degree as well as residency or other clinical training, whether the professional speaks a foreign language, and the professional’s gender.  The tool can also help Medicare beneficiaries find out which physicians that see Medicare patients.

In addition to information about the physician’s practice, Physician Compare also shows consumers whether the practice reported certain data to CMS through the Physician Quality Reporting System, formerly known as the Physician Quality Reporting Initiative (PQRI). Currently, the PQRI reporting system is a voluntary reporting program that rewards physicians and other eligible healthcare professionals for reporting data on quality measures related to services furnished to Medicare beneficiaries.  These quality measures are based on the best available medical evidence and designed to help professionals improve care for patients. In 2009, over 200,000 professionals reported data to CMS through the Physician Quality Reporting System.

According to CMS, it plans a second phase of the Web site which will indicate whether professionals chose to participate in a voluntary effort with the Agency to encourage doctors to prescribe medicines electronically, rather than through traditional paper-based prescription methods later in 2011.

In future years, the Physician Compare Web site will be expanded with information about the quality of care Medicare beneficiaries receive from physicians and the other healthcare professionals profiled on the site.  The expansion will include information on quality of care and patient experience that can help consumers learn more about the care provided by Medicare-participating physicians.  CMS is required by the Affordable Care Act to develop a plan to implement this expansion by 2013.

The new Physician Compare resource supplements a broad range of resources that patients and their families can use to gather information about an existing or proposed health care provider.  Like all directories, however, patients and their families should keep in mind that no single resource or directory provides complete information about any one provider or should be used as a sole basis for selecting or assessing the quality or credentials of any health care provider.

Help patients and their families to constructively use these and other tools by managing your reputation and sharing information with patients and their families about how to properly use and understand the information provided.  You also can share your input about how patients and their families should use these and other similar resources and other insights to help other patients and their families better prepare to manage and assist in their own health care and health benefit management by participating in Project COPE: Coalition for Patient Empowerment here

For More Information Or Assistance

If you need assistance reviewing or responding to the DEA prescribing guidance contained in the Statement or addressing other health care related risk management or compliance concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solutions Law Press publications authored by Ms. Stamer including:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872 or via e-mail here.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. 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 e-mailing this information here.

©2011 Cynthia Marcotte Stamer.  Limited right to republish granted to Solutions Law Press.  All other rights reserved.


Stamer Speaks On “Sex, Drugs & Rock ‘N Role: Personal Misconduct In Health Care” July 21, 2010 In Dallas

July 5, 2010

From substance abuse to stress, medical staff and other health care workforce personal misconduct creates major liability and management challenges for health care organizations and their licensed providers. Cynthia Marcotte Stamer will speak about “Sex Drugs & Rock ‘N Role: Personal Misconduct in Health Care” at the Wednesday, July 21, 2010 monthly meeting of the Dallas Bar Association Health Law Section. 

Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, attorney and author Cynthia Marcotte Stamer is nationally and internationally recognized for her legal work, publications and programs, and advocacy on health industry performance management and other health industry matters.  Ms. Stamer works extensively with health care organizations, managed care and health insurance organizations, governments and others to manage performance and legal risks.  Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer combines her more than 23 years of health industry regulatory and risk management experience with an in-depth knowledge of workforce management and regulation to help clients manage performance and legal and operational risks.  Her experience includes advising public and private health industry clients domestically and internationally on a wide range of matters.  A widely published author and popular speaker, Ms. Stamer’s insights on health industry matters also are quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications.  She also conducts continuing medical education and other health industry compliance and risk management training for many organizations on a wide range of topics.

The program will be held from Noon to 1:00 p.m. Central Time at the Dallas Bar Association Belo Mansion located at 2101 Ross Avenue, Dallas Texas.  For additional information, visit www.dallasbar.org.

For additional information, call the Dallas Bar Association at 214-220-7400 or see http://www.dallasbar.org.

Other Recent Developments

If you are interested in this health industry development, you also may be interested in reviewing some of our other recent updates available at https://slphealthcareupdate.wordpress.com including:

For More Information

We hope that this information is useful to you. If you need assistance with medical staff credentialing or discipline, employment, benefits and compensation, reimbursement, health care fraud or other health care compliance, risk management, transaction or operations concerns, please contact Cynthia Marcotte Stamer at (469) 767-8872 or via e-mail to here.

You can review other recent health care and internal controls resources and get additional information about the health industry and other experience of Cynthia Marcotte Stamer, P.C. here. If you or someone else you know would like to receive future updates about developments on these and other concerns, register or update your profile – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to here.


Joint Commission Revises Medical Staff Bylaw Standard

March 25, 2010

On Monday, March 15, 2010, the Joint Commission announced revisions to Medical Staff Standard MS.01.01.01 relating to medical staff governance and accountability to the governing body for patient care quality and safety.  Hospitals and their medical staff have until March 31, 2010 to comply with the revised standard. The revised standard is available for review here.

Standard MS.01.01.01 addresses the medical staff’s self-governance and its accountability to the governing body for the quality and safety of patient care. Intended by the Joint Commission to promote patient safety and quality of care through the support of a well-functioning, positive relationship between a hospital’s medical staff and governing body, the Standard recognizes that a hospital’s governing body is ultimately responsible for the quality and safety of care, but that collaboration among a hospital’s governing body, medical staff and administration.

Focusing on the key role that the definition of the medical staff’s organizational responsibilities and how the medical staff and governing body will work together in the medical staff bylaws, that Standard MS.01.01.01 outlines a detailed framework for constructing, writing and implementing bylaws that the Joint Commission believes best supports appropriate collaboration between the medical staff, the governing body and the administration to promote the safety and quality of care.  These Standard address the allocation of responsibilities between the medical staff and the governing body for the development and adoption of medical staff bylaws, processes to be utilized to develop and implement bylaws and a detailed list of elements that medical staff bylaws are required to address to meet the Standard.

The new Medical Staff standard is only one of an expanding series of Joint Commission Standards focusing on medical staff regulation and performance to help promote quality that facilities and their medical staff must address to maintain accreditation.   In addition to the revised Medical Staff Standard, for instance, health care facilities and their medical staffs also generally are working to address the Joint Commission’s Standards to Ongoing Professional Practice Evaluation, credentialing, peer review and disruptive conduct standards. 

About The Author

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@cttlegal.com or 214.270.2402. 

Nationally and internationally recognized for more than 22 years of work with health industry and other organizations, publications, workshops and presentations and leadership Cynthia Marcotte Stamer has worked extensively with medical staffs, hospitals and other health care facilities, physician organizations and others on these and other medical staff bylaws and management, physician and other health industry staffing and credentialing, performance management and discipline, peer review; regulatory compliance and internal controls; risk management; quality assurance; operations; tax; reimbursement; public policy and other matters. The publisher of the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update and a former legal columnist for MD News, and Board Certified in Labor and Employment Law, Ms. Stamer also is a popular speaker and author of these and other health industry topics.  She regularly speaks and conducts training for the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, Harris County Medical Society, the Medical Group Management Association, SHRM, Southwest Benefits Association and many other organizations.  Her many publications and programs regularly include “Monitoring & Managing Physician Performance, Standards For Ongoing Professional Practice Evaluation and Beyond,” “Sex, Drugs & Rock ‘n Role in Medicine,” “Medical Staff Bylaws That Help Medical Staff’s Work,” “Payment or Not For Never Events” “Physician Survival Training,” and a host of other continuing medical education and other health industry compliance, operations and risk management topics.  Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others.  You can review other highlights of Ms. Stamer’s health care experience here, and employment experience hereHer insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More Information

We hope that this information is useful to you.  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 e-mailing this information here. To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.