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Trump Executive Order Calls For PBM ERISA Fee Disclosure Rules and Other Prescription Drug Reforms

April 17, 2025

Creating greater transparency of the compensation of prescription benefit management (“PBM”) arrangements used in group health plans covered by the Employee Retirement Income Security Act of 1974 (“ERISA”) is one of many new policy directives President Trump directs federal agencies to pursue to promote lower cost access to prescription drugs under his Executive Order on Lowering Drug Prices By Once Again Putting Americans First (the “Executive Order”) signed April 15, 2025. Employer and union-sponsored health plans, their sponsors, fiduciaries and service providers should carefully track and provide appropriate input to the Department of Labor and other federal agencies charged with implementing the new ERISA transparency requirement and other policy changes directed in the Executive Order.

ERISA PMB Transparency Requirements

To improve the transparency of compensation received by PBMs working with ERISA-covered group health plnas, the Executive Order directs the Department of Labor (“DOL”) to propose regulations to make the fee disclosure requirements of ERISA section 408(b)(2)(B) applicable to PBMs by October 12, 2025.

The Executive Order’s directive to the DOL contemplates that DOL will revise its existing regulations under Section 408(b)(2) to prohibit group health plan fiduciaries from allowing PBMs to directly or indirectly receive compensation for their PBM services unless the PBM discloses its compensation from the arrangement in accordace with the fee disclosure requirements that the Executive Order contemplates DOL will add to ERISA section 408(b)(2).

While DOL regulations have required since 2012 that pension plan service providers to disclose direct or indirect compensation under arrangements with ERISA-covered pension plans in order for the service provider compensation to be allowed “reasonable compensation” under ERISA section 408(b)(2), the fee disclosure requirement currently does not apply to PBMs or other service providers to group health plans or other welfare benefit plan arrangements.

Across the intervening years, concern that the lack of transparency and disclosure allows PBMs to receive excessive compensation and engage in conflicts of interest has led employee benefit industry watchdogs, employer and other plan sponsors, plan members, health care providers and others increasingly to urge the DOL to impose fee disclosure requirements on PBMs and other health and welfare benefit plan service providers. The Executive Order yields to these demands by calling upon the DOL to deem a group health plan’s compensation arrangements with PBMs reasonable only where PBMs disclose direct and indirect compensation, including compensation paid among related parties such as subcontractors, in a manner consistent with current Section 408(b )(2) Regulations.

Other Prescription Drug Reforms

The Executive Order also includes numerous other reform directives beyond calling for DOL to make PBMs subject to ERISA’s fee disclosure rules. These included several directives to HHS and certain other agencies that President Trump intends to lower the cost of prescription drugs within and outside the Medicare program.

Medicare & Other Drug Pricing and Coverage Related Prescription Drug Reforms

Many of the policy directives in the Executive Order seek to reform Medicare and other prescription drug cost and coverage.

By April 15, 2026, for instance, the Executive Order directs HHS to develop a better payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products covered by Medicare, including those not subject to the Medicare Drug Price Negotiation Program.

In addition, the Executive Order:

Directs HHS to work with the Congress to modify the Medicare Drug Price Negotiation Program to align the treatment of small molecule prescription drugs with that of biological products so as to end the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries;
By June 14, 2025,
- Requires HHS to propose changes to the Medicare Drug Price Negotiation Program regulations for the initial price applicability year 2028 and manufacturer implementation of maximum fair price under such program in 2026, 2027, and 2028 to improve the transparency of the Medicare Drug Price Negotiation Program, prioritize the selection of prescription drugs with high costs to the Medicare program, and minimize any negative impacts of the maximum fair price on pharmaceutical innovation within the United States; andRequires HHS to require health centers receiving Public Health Service Act Section 330(e) grants to establish practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to low income individuals who have a high cost-sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or have no healthcare insurance.Requires the Assistant to the President for Domestic Policy (“APDP”) in coordination with the Secretary, the Director of the Office of Management and Budget (“OMB Director”), and the Assistant to the President for Economic Policy (“APECP”), to provide recommendations to the President on how best to stabilize and reduce Medicare Part D premiums;Requires the HHS Secretary to publish a plan to conduct a survey under the Site-of-Service Price Transparency rules of Social Security Act Section 1833(t)(14)(D)(ii) to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments and propose appropriate adjustments to align Medicare payment with the cost of acquisition, consistent with the budget neutrality requirements; and
- Requires HHS to evaluate and propose regulations to ensure that payment within the Medicare program is not encouraging a shift in drug administration volume away from less costly physician office settings to more expensive hospital outpatient departments.

Other Prescription Drug Reforms

In addition to these predominantly Medicare-focused programs, the Executive Order also orders federal agencies to

Requires the Secretary of Labor to propose regulations pursuant to section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers by October 12, 2025;
Requires the APDP, in coordination with the HHS Secretary, the OMB Director, and the APECP, to provide recommendations to the President on how best to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices for Americans by June 14, 2025;
Requires the Food and Drug Administration to streamline and improve the Importation Program under the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality;
Requires the OMB Director, the APDP, and the Assistant to the President for Economic Policy )”APECP, and HHS Secretary to provide joint recommendations on how best to ensure that manufacturers pay accurate Medicaid drug rebates consistent with section 1927 of the Social Security Act, promote innovation in Medicaid drug payment methodologies, link payments for drugs to the value obtained, and support States in managing drug spending;
Requires the HHS Secretary, through the Commissioner of Food and Drugs, to issue a report providing administrative and legislative recommendations to accelerate approval of generics, biosimilars, combination products, and second-in-class brand name medications; and improve the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter;
Requires HHS, the Department of Justice, the Department of Commerce, and the Federal Trade Commission to conduct listening sessions and issue a report with recommendations to reduce anti-competitive behavior from pharmaceutical manufacturers.

Health plans, their sponsoring employers or unions, fiduciaries, PBM and other service providers, brokers, insurers, auditors, and others involved in the design or oversight of PBM and other group health plan arrangements should monitor closely the DOL and other agency responses to the Executive Order to anticipate and prepare for required changes, as well as to be prepared to identify and timely provide input about proposed rules or other actions to DOL or the otherwise applicable regulatory agency before finalized.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, with decades of experience advising employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, PBMs, health and other insurers, third party administrators, managed care organizations, health plan technology, and other businesses about health plan design, administration, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.

For More Information

We hope this update is helpful. For more information about these or other health or other employee benefits, human resources, or health care developments, please contact the author, Cynthia Marcotte Stamer, via e-mail or 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, the American Bar Foundation and the Texas Bar Foundation; Cynthia Marcotte Stamer is an attorney board certified in labor and employment law by the Texas Board of Legal Specialization, management consultant, author, public policy advocate and lecturer sought out by clients and industry and government leaders for her more than 35 years of health, insurance, employment and employee benefits and other industry management work, thought leadership, public policy and regulatory affairs advocacy, coaching, teaching, and publications on health and other employee benefits, health care, insurance, workforce and other risk management and compliance.

Along with her decades of legal and strategic consulting experience, Ms. Stamer also contributes her leadership and experience to many professional, civic and community organizations. Along with currently serving as Co-Chair of the ABA Real Property Trusts and Estates (“RPTE”) Section Welfare Plan Committee, Co-Chair of the ABA International Section International Employment Law Committee and its Annual Meeting Program Planning Committee, Chair Emeritus and Vice Chair of the ABA Tort Trial and Insurance (“TIPS”) Section Medicine and Law Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, her previous ABA leadership roles include more than a decade of service as a Scribe for the Joint Committee on Employee Benefits (“JCEB”) annual agency meetings with the Department of Health and Human Services and JCEB Council Representative, International Section Life Sciences Committee Chair, RPTE Section Employee Benefits Group Chair and a Substantive Groups Committee Member, Health Law Section Managed Care & Insurance Interest Group Chair, as TIPS Section Medicine and Law Committee Chair and Employee Benefits Committee and Workers Compensation Committee Vice Chair, Tax Section Fringe Benefit Committee Chair, and in various other ABA leadership capacities. Ms. Stamer also is a former Southwest Benefits Association Board Member and Continuing Education Chair, SHRM National Consultant Board Chair and Region IV Chair, Dallas Bar Association Employee Benefits Committee Chair, former Texas Association of Business State, Regional and Dallas Chapter Chair, a founding board member and Past President of the Alliance for Healthcare Excellence, as well as in the leadership of many other professional, civic and community organizations. She also is recognized for her contributions to strengthening health care policy and charitable and community service resolving health care challenges performed under PROJECT COPE Coalition For Patient Empowerment initiative and many other pro bono service involvements locally, nationally and internationally.

Ms. Stamer is the author of many highly regarded works published by leading professional and business publishers, the ABA, the American Health Lawyers Association, and others. Ms. Stamer also frequently speaks and serves on the faculty and steering committee for many ABA and other professional and industry conferences and conducts leadership and industry training for a wide range of organizations.

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

About Solutions Law Press™

Solutions Law Press™ provides health care, insurance, human resources and employee benefit, data and technology, regulatory and operational performance, and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education. These include extensive resources 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™ resources or training.

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.

NOTICE: These statements and materials are for general information and 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 considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or an admission. Solutions Law Press and its authors 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 constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. Solutions Law Press and its authors disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, 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.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department 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.

©2025 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press.™ For information about licensing for republication, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

$200,000 OCR Penalty Shows Health Care Providers & Other HIPAA Entities Risks Of Late Record Access

March 7, 2025

The $200,000 civil monetary penalty [paid by Oregon Health & Science University (“OHSU”) for failing to provide requested medical records shows health care providers, health plans and insurers, and health care clearinghouses (“covered entities”) the perils of violating an individual’s Health Insurance Portability & Accountability Act of 1996 (“HIPAA”) right to timely access. As the 53^rd Department of Health and Human Services Office of Civil Rights (“OCR”) announced HIPAA right of action enforcement action, the penalty reaffirms OCR’s continued strong commitment to the enforcement of HIPAA rights of access against covered entities and demonstrates the potential high cost covered entities can face for noncompliance with these requirements. Like the 52 prior enforcement actions, the OHSU penalty warns health plans and other covered entities to confirm their compliance to avoid incurring similar liabilities.

Thie HIPAA Privacy Rule’s ”Right of Access” provisions require covered entities give requesting individuals or their personal representatives with timely access to requested protected health information. Generally, this means the covered entity must provide protected health information access within 30 days, with the possibility of one 30-day extension if certain requirements are met. HIPAA also prohibits covered entities from charging more than a reasonable, cost-based fee for this record access. This requirement is in addition to any otherwise applicable duty to provide timely access to records imposed by otherwise applicable laws such as rules applicable to health plans and health insurers covered by the adverse benefit determination rules of the Patient Protection and Affordable Care Act (“ACA”) or the Employee Retirement Income Security Act of 1974 (“ERISA”) or health insurers or health care providers under applicable state medical privacy and records laws state insurance laws, and health care providers under applicable state medical practice laws The Privacy Rule also contains specific rules for determining the allowable fees, which typically are more restrictive than often concurrently applicable state laws applicable to health care providers or insurers.

Covered entities also should recognize that covered entities violating the right of access rule face a high likelihood of enforcement by OCR. Patients and other individuals and their personal representatives typically are well informed about their access rights due to HIPAA’s notice of privacy practices and posting requirements. Since right of access violations are one of the most common complaints and OCR frequently finds violations when investigating these complaints,

The $200,000 civil monetary penalty against OHSU along with the undisclosed legal fees and other expenses it incurred in responding to the investigation and enforcement action show the HIPAA liability covered entities can incur for violating the right of assess rule. In September 2024, OCR issued a Notice of Proposed Determination seeking to impose a $200,000 civil monetary penalty. OHSU waived its right to a hearing and did not contest OCR’s imposition of a civil monetary penalty. Accordingly, in December 2024, OCR imposed the $200,000 civil monetary penalty against OHSU in a December 2024 Notice of Final Determination. The OHSU civil monetary penalty arose from OCR’s investigation of a second complaint filed by an individual’s personal representative in January 2021 from the individual’s personal representative. The complaint was one of two OCR received on this matter. In September 2020, OCR resolved the first complaint received in May 2020 after OCR notified OHSU of its potential noncompliance with the Privacy Rule Right of Access provisions. Although OHSU provided part of the requested records in April 2019, OHSU did not provide all of the requested records in August 2021. This was 16 months after the first request for records in April 2019 and nearly a year after OCR previously warned OHSU about its HIPAA obligations in response to the initial complaint. Based on these findings, OCR determined OHSU violated the right of access rule by failing to take timely action in response to the right of access requests.

Along with showing the importance of overall timely compliance with the right of access rule, the OHSU civil monetary penalty also shows covered entities the importance of promptly and completely correcting any violation and their causes that results in a failure by the covered entity (including an employee or business associate responsible for responding to requests) has violated the right of access rule. OCR’s right of access rule investigation and enforcement history against covered entities, including the original complaint against OHSU, demonstrates that OCR seeks settlement with substantially smaller or even no financial payment required if the covered entity promptly and completely fixes the violation in response to OCR’s notice and technical assistance.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, nationally known and celebrated for her experience providing advice and representation on HIPAA and other risk management and compliance to employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, health and other insurers, third party administrators, health care and other managed care providers and organizations, human resources and health plan technology, and other businesses about health plan design, administration, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.

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Posted by Cynthia Marcotte Stamer

$200,000 OCR Penalty Warns Health Plans and Other HIPAA Entities To Timely Provide Records

March 7, 2025

The $200,000 civil monetary penalty [paid by Oregon Health & Science University (“OHSU”) for failing to provide requested medical records shows health plans, health care providers, and health care clearinghouses (“covered entities”) the perils of violating an individual’s Health Insurance Portability & Accountability Act of 1996 (“HIPAA”) right to timely access. As the 53^rd Department of Health and Human Services Office of Civil Rights (“OCR”) announced HIPAA right of action enforcement action, the penalty reaffirms OCR’s continued strong commitment to the enforcement of HIPAA rights of access against covered entities and demonstrates the potential high cost covered entities can face for noncompliance with these requirements. Like the 52 prior enforcement actions, the OHSU penalty warns health plans and other covered entities to confirm their compliance to avoid incurring similar liabilities.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, nationally known and celebrated for her experience providing advice and representation on HIPAA and other risk management and compliance to employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, health and other insurers, third party administrators, health care and other managed care providers and organizations, human resources and health plan technology, and other businesses about health plan design, administration, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.

For More Information

About the Author

About Solutions Law Press™

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Posted by Cynthia Marcotte Stamer

IRS Allows All Health Plans To Use Website To Fulfill ACA Annual Minimum Essential Coverage Statement Requirement

March 3, 2025

New Guidance Broadens Availability Of Website Alternative To All Health Plans

All health insurers and health plan administrators can now fulfill their obligation under the Patient Protection and Affordable Care Act (“ACA”) to send annual minimum essential coverage statements (“MEC Statements”) by timely posting a notice of the availability of the statements in lieu of providing the MEC statements by sending Internal Revenue Service (“IRS”) Forms 1095-B and 1095-C” to covered persons under guidance issued in IRS Notice 2025-15 on February 21, 2025.As part of the ACA minimum essential coverage mandates, Internal Revenue Code (“Code”) Section 6055 generally requires each health plan providing minimum essential coverage to any individual during a calendar year to notify the covered person named on an application who enrolls one or more individuals in the minimum essential coverage a statement that identifies each covered individual and the individual’s months of coverage. See Treas. Reg. § 1.6055–1(b)(11). While Section 6055 sets the statutory deadline to provide the MEC Notice as the January 31 immediately following the close of the plan year when the plan provides the coverage, Treasury Regulation § 1.6055-1(g)(4) provides an automatic 30-day extension of time in which to furnish these statements. As a result, covered health plans and health insurers must fulfill the annual MEC Statement requirement within 61 days of the close of the calendar year to which the MEC statement applies.

Internal Revenue Service (“IRS”) regulations generally require health plans to use Forms 1095-B and 1095-C to provide the MEC Statement to responsible individuals unless the health plan qualifies under Treasury Regulation § 1.6055-1(g)(4)(ii)(B) to provide the statement in the “alternative manner” of a qualifying website posting described in that Regulation.

Before February 21, 2025, Treasury Regulation § 1.6055-1(g)(4)(ii)(B) only allowed health plans to use the website posting alternative to fulfill their MEC Statement obligations if the individual shared responsibility payment amount under Code section 5000A(c) for the calendar year in which minimum essential coverage is provided is zero. Under IRS Notice 2025-15, however, all health plans and health insurers are permitted to use the alternative manner of a website posting to fulfill the MEC Statement mandate for all post-2023 plan years including the 2024 calendar notices without regard to the amount of the individual shared responsibility payment.

Health plans and health insurers wishing to use the to use the “alternative manner” of a website posting in lieu of Forms 1095-B and 1095-C to fulfill the MEC Statement requirement for 2024 or a subsequent calendar year must post in a location reasonably accessible to all responsible individuals a clear and conspicuous notice stating that responsible individuals may receive a copy of their statement upon request. Additionally, if an individual requests a statement, the health plan must deliver the requested statement within 30 days of the date the health plan receives the request.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, with decades of experience advising employers and other health plan sponsors, health plans, health plan fiduciaries and administrators, health and other insurers, third party administrators, managed care organizations, health plan technology, and other businesses about health plan design, administration, and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.

For More Information

About the Author

About Solutions Law Press™

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Posted by Cynthia Marcotte Stamer

Stamer To Discuss Emerging Health and Disability Litigation Trends To Watch In January 17 Virtual Welfare Benefit Plan Update

January 14, 2025

Solutions Law Press publisher and attorney Cynthia Marcotte Stamer will discuss tobacco cessation class actions, health plan PBM, excessive fee, antitrust and other selected emerging health and disability plan litigation trends to watch in 2025 as part of the Welfare Plan Update at the American Bar Association Real Property, Probate and Trust Section Employee Plans and Executive Compensation Group will host during its free committee call on January 17, 2025, at 11:30 AM Central Time.

Along with Ms. Stamer’s comments, the Update also will include updates on the mental health partiy final rules and implications of the January 1, 2025 expiration of high deductible health plan telemedicine relief by her fellow Welfare Benefit Committee Co-Chair Jacquelyn M. Abbott and Committee Vice Chair Julia Mader.

Members interested in the meeting are invited to use the following Zoom credentials to connect to the meeting:

Join Zoom Meeting Link: https://americanbar.zoom.us/j/93409339280?pwd=aQcwUtePdkKni1943AJ4UjIaac6F5v.1

Meeting ID: 934 0933 9280, Passcode: 602434

One tap mobile

+13092053325,,93409339280# US

+13126266799,,93409339280# US (Chicago)

About Cynthia Marcotte Stamer

Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization and a Fellow in the American College of Employee Benefits Counsel, Stamer is recognized for her decades of work on leading edge employee benefits, employment, health care and insurance concerns with recognition as a Martindale Hubble “Top Rated Lawyer” and “Legal Leader” in Health Care and Labor and Employment Law; as among the D Magazine “Best Lawyers In Dallas” in Labor & Employment, Tax: ERISA & Employee Benefits, Health Care and Business and Commercial Law.

Stamer has more than 35 years of experience guiding employers, health and other employee benefit and insurance programs and their fiduciaries, managed care, TPAs, PBMs, health care clearinghouses and their service providers; and other managed care and other health and health plan industry clients on program, product, systems and process design, administration, and defense; government and regulatory investigations and affairs; HIPAA and other data and systems privacy, cybersecurity and other integrity; workforce and other service provider credentialing, contracting, and management; government and private investigations, disputes, audits and enforcement; and other compliance, risk management and operations concerns in a wide range of contexts. Her work, and the interests of her clients are enhanced by her continuous involvement in federal and state legislative advocacy, regulatory affairs and government relations on these and other related concerns throughout her career.

In the course of this work, Stamer frequently advises and represents and defends health and other employee benefit plans, their fiduciaries, third party administrators, brokers, insurers, trustees and other plan service providers, debtor plan sponsors and their leaders, auditors, creditors and creditor committees, bankruptcy trustees, on prevention and mitigation of claims, fiduciary, licensing, prompt pay and other contractual, regulatory and other risks and liabilities arising from underfunded or distressed companies and employee benefit plans. She also advises employers, their boards, investors and management, third party administrators, preferred provider organizations, insurers and other plan service providers and others in fiduciary, claims and other audits, investigations and enforcement actions by private litigants, the Department of Labor, Department of Health & Human Services, Internal Revenue Service, Department of Justice, Federal Trade Commission, state insurance, attorneys’ general or other regulator, contractual arising out of workforce and staffing, employee benefit and insurance practices and programs in ongoing operations, corporate or credit transactions, bankruptcy or other situations and serves as special or consulting counsel for bankruptcy and other human resources, benefits, insurance, health care and regulatory compliance and investigation concerns. Stamer also counsels, represents and defends third party administrators, preferred provider and other managed care organizations, brokers and other regulated parties in state insurance and other regulators notice and reporting, investigations, audits, discipline and other enforcement actions.

Past Chair of the ABA RPTE Employee Benefit and Other Compensation Group, the Health Law Section Managed Care and Insurance Interest Group, and the Tort Trial and Insurance Section Medicine and Law Committee, Stamer also contributes her experience and knowledge by serving as Scribe for the American Bar Association (“ABA) Joint Committee on Employee Benefits (“JCEB”) annual agency meeting with the Department of Health and Human Services as well as a leader of employee benefits, human resources, health as an industry thought leader, Stamer also publishes and speaks extensively on health and other employee benefits, compensation, workforce, health care and related regulatory compliance and risk management matters.Her insights on these and other matters appear in publications of the American Bar Association, Bloomberg/BNA, Modern Healthcare, Aging In Place, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications. For additional information about Stamer, her speaking, legal, consulting and other experience and services, or to access other publications by Stamer see CynthiaStamer.com or contact Stamer directly via e-mail or telephone (214) 452-8287.

For more details about the Real Property Probate and Trust Section Employee Benefits and Other Compensation Committee or other employee benefits related committees and activities of the American Bar Association, see the American Bar Association website here.

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 and connect with Stamer on Linkedin. For important information concerning this communication click here. If you do not wish to receive these updates in the future, unsubscribe by updating your profile here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides health care, insurance, human resources and employee benefit, data and technology, regulatory and operational performance, and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education. These include extensive resources 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.

NOTICE: These statements and materials are for general information and 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 considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or 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 constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, 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.

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.

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Posted by Cynthia Marcotte Stamer

HHS Grants Limited Southern California Fire Limited Disaster Relief

January 10, 2025

Health plans and insurers, health care providers and other Southern California organizations impacted by the California fires may qualify for temporary waivers or modification of certain Department of Health and Human Services (“HHS”) regulatory requirements under the Declarations of a Public Health Emergency (“PHE”) published by HHS today.

The relief provided by the PHE includes:

An extensive list of resources and guidance to help health plans, health care providers and others to understand and cope with HHS requirements in disaster or other emergency situations such as:

For information about how the HIPAA Privacy Rule applies in a public health emergency, visit the OCR’S HIPAA Emergency Preparedness, Planning, and Response page (www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html) or you may use the HIPAA Disclosures for Emergency Preparedness Decision Tool (www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/decision-tool-overview/index.html).
For information and resources for emergency responders/officials to help ensure individuals have equal access to emergency services, including language access and effective communication, please see this checklist for emergency responders: HHS OCR Emergency Preparedness Checklist for Ensuring Language Access and Effective Communication (www.hhs.gov/sites/default/files/lang-access-and-effective-comm-checklist-for-emergency-responders.pdf).
For information about emergency requirements for long-term care facilities, visit the CMS Emergency Preparedness Rule page (www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html)

Health plans and other regulated entities impacted by the fire or other disasters should carefully review this guidance to understand the scope and availability of the current relief. Additionally, health plans, health care providers, business associates and other HHS-regulated entities and providers not currently impacted by today’s or another public health emergency declaration should use this guidance to plan and adopt policies and arrangements in advance of a disaster to provide for their continued ability to fulfill HHS regulatory obligations in the event of an emergency.

Health plans and other HHS-regulated entities should keep in mind the limited duration and scope of the relief provided by this PHE or any other HHS public health emergency declaration. Entities planning to rely on the PHE relief must review the scope, conditions and duration requirements and ensure their ability to defend their continued compliance taking into account these limited waivers and modifications.

Also the PHE guidance documents are not a final agency action, do not legally bind persons or entities outside the Federal government, and may be rescinded or modified in the Department’s discretion. Noncompliance with any voluntary standards (e.g., recommended practices) contained in these documents will not, in itself, result in any enforcement action.

Furthermore, health plans and other HHS regulated entities typically face a myriad of responsibilities beyond those imposed by the HHS. Health plans and other regulated entities should check other agencies disaster declaration webpages to determine whether the agency has issued any specific relief impacting their emergency in response to the broader disaster declaration issued by the Administration. Except to the extent covered by other declared disaster relief, coverage by or compliance with the HHS PHE guidance and policies does not insulate the health plan from potential liability for violating the requirements of the Employee Retirement Income Security Act or other laws creating responsibilities to plan members, providers, the Employee Benefit Security Administration or other agencies or parties other than HHS with respect to the HHS regulatory obligations for which the specific relief is provided in the PHE declaration. Accordingly, health plans, their fiduciaries, plan sponsors and service providers are urged to take necessary steps before, during and after any disaster to position themselves to demonstrate fulfillment of duties of prudence and other applicable responsibilities.

The author of this update, Cynthia Marcotte Stamer is an American College of Employee Benefits Counsel Fellow and attorney board certified in Labor and Employment Law by the Texas Board of Legal Specialization, who has decades of experience advising health care providers, health plans and insurers, third party administrators, managed care and other health care payers and providers, technology, and other businesses about crisis preparedness and response and other compliance, risk management and operational matters. If you have questions or need advice or help evaluating or addressing these or other compliance, risk management, or other concerns, contact her.

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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 her more than 35 years of health, insurance, employment and employee benefits and other industry management work, public policy leadership and advocacy, coaching, teachings, and publications including leading-edge work on crisis preparedness, response and recovery.

Author of many highly regarded compliance and risk management tools, training and other resources on health and other employee benefits, health care, insurance, workforce and other risk management and compliance, Ms. Stamer is widely recognized for her thought leadership and advocacy on these matters.

In addition, Ms. Stamer serves as a Scribe for the American Bar Association (“ABA”) Joint Committee on Employee Benefits annual agency meetings with OCR and shares her thought leadership as International Section Life Sciences Committee Vice Chair, 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.™

NOTICE: These statements and materials are for general information and 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 considering the specific facts and circumstances presented in their unique circumstances at the particular time. No comment or statement in this publication is to be construed as legal advice or 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 constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law-specific nuance, 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.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department 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.

©2025 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

AHIP Survey Shows Workers Value Employer-Provided Health Coverage

November 26, 2024

Public support and appreciation for employer-sponsored healthcare continues to run high, according to the results of a national online survey of 1,000 people with employer-provided coverage conducted by the research firm LSG on AHIPA from July 10-19, 2024. The survey results reflect employer-provided health coverage remains an important tool for employee recruitment and retention and widespread opposition to public policy changes that would replace employer-provided coverage with government-provided benefits or tax employer-provided coverage or benefits.

AHIP commissioned the survey to understand the perceptions, priorities, and expectations of consumers with employer-provided coverage about their current coverage and benefits, employers, and public policy impacting their coverage and compare their attitudes against results of a survey conducted in April 2023. LSG reports the survey has a margin of error of +/- 3% and was balanced to national demographics for gender, age, and region. AHIP announced the results of the survey on November 13, 2024.

According to AHIP, 50% of Americans received their health coverage from employer-provided plans. The survey responses revealed:

A growing majority of consumers (75%,+12% since April 2023) are satisfied with their current employer-provided coverage.
66% (+12%) are satisfied with the current health insurance system overall
Comprehensive coverage, affordability, and choice of providers their plans provide are key factors in creating this satisfaction
71% (+12%) feel the quality of their current health plan is high
74% (+6%) prefer to get their coverage through their employer over a federal or state government program
Costs remain a top consumer concern and a leading source of plan dissatisfaction, 66% (+13%) of respondents reported that what they currently pay for their coverage overall is reasonable and helps to lower their health care costs
While unhappy with coverage costs, 63% of respondents identified the comprehensiveness of coverage as a greater priority than affordability (31%).
Benefits most valued by respondents were emergency care (65%), prescription drugs (63%), and preventive care (57%).
88% of respondents reported their health plan covers preventive
services (88%), provides access to top providers (78%), and gives them financial peace of mind if something bad were to happen (75%).
53% of respondents reported feeling employer-provided coverage is effectively meeting children’s mental health needs and 61% reported believing the need for mental health care for children will increase.
67% of respondents reported considering it important for health insurance plans to cover telehealth services
76% of respondents reported believing it’s important for the federal government to maintain the COVID-19 telehealth flexibilities for patients

The survey also reflects the continued value of employer-provided health coverage in attracting and retaining employees. Sixty-one percent of respondents said health coverage plays an impactful role in employee recruitment and 80% reported health coverage was a reason for staying in their current position. Once informed that the average company pays 70-80% of the cost of coverage, a majority of respondents (71%) reported having a more favorable impression of companies that provide their employees with health insurance benefits.

The satisfaction and support from the study reflect likely opposition by workers to changes proposed by some politicians to change the current tax treatment of employer-provided coverage to tax employee health benefits. The survey found a growing majority oppose taxing employee health benefits (58%, +6%), and an even greater majority would be less likely to vote for a lawmaker who supports taxing them (63%).

Review the complete report of survey results here.

If you have questions about health plan design, administration or defense, contact the author of this update, Cynthia Marcotte Stamer.

More Information

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

About the Author

Management attorney and operations consultant Cynthia Marcotte Stamer uses a client objective oriented approach to help businesses, governments, associations and their leaders manage people, performance, risk, legislative and regulatory affairs, data, and other essential elements of their operations.

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+ years of workforce and other management work, public policy leadership and advocacy, coaching, teachings, scholarship and thought leadership. As a part of this experience, Miss Stamer has experience assisting clients with auditing, compliance, investigation and defense SCA, Davis-Bacon, Fair Labor Standards Act and other pay, benefits, compensation and fringe benefit concerns.

A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health 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, Ms. Stamer’s work throughout her 35 year career has focused heavily on working with government contractors, 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 an ongoing component of this work, she regularly advises, represents and defends businesses on Guideline Program and other compliance, risk management and other internal and external controls in a wide range of areas and has published and spoken extensively on these concerns.

Ms. Stamer also is widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on workforce, compensation, and other operations, risk management, compliance and regulatory and public affairs concerns.

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.

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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 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 circumstance 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 makes 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 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 of this publication.

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Posted by Cynthia Marcotte Stamer

Teva Pharmaceuticals’ $450M Settlement Penalty Shows Risks Of Participating In Pharma Anti-Kickback and Price Fixing Schemes

October 11, 2024

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Posted by Cynthia Marcotte Stamer

PBM Lawsuit Against FTC Signals Growing Battle To Rein In PBMs

September 17, 2024

Employers, health plan sponsors and fiduciaries, health care providers and individuals concerned about prescription drug prices and access should carefully follow the rapidly accelerating battle between the Federal Trade Commission (“FTC”) and pharmacy benefit managers (“PBMs”), which threatens to reshape how pharmaceutical products are priced and sold to health plans and consumers.

At the center of the complex pharmaceutical distribution chain that delivers prescription medicines from manufacturers to patients, PBMs generally are vertically integrated organizations that simultaneously serve and regulate health plans and pharmacists and play other roles in the drug supply chain.

This vertical integration allows these six PBMs to wield enormous power and influence over health plans’ and patients’ access to drugs and the prices they pay, as well as pharmacies’ access to prescription drugs and the price and other terms under which pharmacies qualify for health plan coverage or payment for these medications.

PBMs also exert substantial influence over independent pharmacies by imposing contractual terms imposed by PBMs as a condition of accessing medications, covering the pharmacies under health plans contracted with the PBMs, or both.

Mergers and consolidations within the PBM, pharmacy and health benefit industries that brought ownership of the largest PBMs under common ownership with large insurers and retail pharmacies they purport to both manage and work has increased the already significant power of PBMs to use their integration to control these and other aspects of prescription drug availability, access, distribution, and pricing/ Consequently, the sixth largest PMBs -Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. – now collectively negotiate and enforce access, coverage, pricing and other key terms and conditions governing the availability, access to, and cost of prescription drugs for hundreds of millions of Americans.

With the consolidation of ownership of large PBMs, payers and pharmacies further tightening these PBMs’ control over prescription drug distribution, pricing, and coverage and prescription drug costs continuing to rise, PBMs and their practices increasingly face scrutiny, challenges and calls for reform by employers and other plan sponsors, health care providers, independent pharmacies, the FTC and other regulators, Congress, state legislatures and regulators, consumers, and others. See Report on Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.

FTC July 2024 Interim Report On 6th Largest PBMS

In response to these and other growing concerns about consolidation, lack of transparency and other potential abuses about the PBM industry and prescription drug costs, the FTC began investigating the PBM industry in 2022. In July 2024, the FTC released its Report on Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies (the “FTC Report”) that reports the FTC’s interim findings from its ongoing study of the six largest PBMs – Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. use their vertical integration and concentration to inflate drug costs, squeeze Main Street pharmacies and engage in other practices harmful to patients and independent pharmacies.

The FTC Report shares interim findings based on the FTC staff’s review of more than 1,200 public comments to identify predominant areas of concern, initial submissions of internal documents and data from PBM respondents and their affiliates, interviews of various industry experts and participants and review of other public data and information. The FTC Report also discloses that certain PBMS have yet to produce the data and documents required in response to FTC orders issued more than two years ago. While stating its study continues and promising that the FTC will continue efforts to force the PBMs to produce the evidence demanded in the orders, the FTC Report also promises to share regular updates about its progress and findings.

While the investigation continues, the FTC Report shares the FTC’s interim findings that:

The market for pharmacy benefit management services has become highly concentrated, and the largest PBMs are now also vertically integrated with the nation’s largest health insurers and specialty and retail pharmacies;
As a result of this high degree of consolidation and vertical integration, the leading PBMs can now exercise significant power over Americans’ access to drugs and the prices they pay;
Vertically integrated PBMs may have the ability and incentive to prefer their own affiliated businesses, which in turn can disadvantage unaffiliated pharmacies and increase prescription drug costs;
Evidence suggests that increased concentration may give the leading PBMs the leverage to enter into complex and opaque contractual relationships that may disadvantage smaller, unaffiliated pharmacies and the patients they serve;
PBMs and brand drug manufacturers sometimes negotiate prescription drug rebates that are expressly conditioned on limiting access to potentially lower cost generic alternatives in exchange for higher rebates from the manufactures in a manner that may cut off patient access to lower-cost medicines and warrant further scrutiny by the Commission, policymakers, and industry stakeholders.

The FTC Report also shares the FTC’s concern that the six largest PBMs improperly use their integration and market control over 95 percent of all prescriptions filled in the United States:

To profit at the expense of patients and independent pharmacists;
To hike the cost of and overcharge for drugs
To squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care;
To wield enormous power over patients’ ability to access and afford their prescription drugs, allowing PBMs to significantly influence what drugs are available and at what price; and
To impose unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business and serve their communities.

The FTC Report concludes that PBMs’ have an “outsized influence” that comes not only from the expansion of their traditional, middlemen administrative services in processing patients’ pharmacy prescription claims but also from decades of consolidation and vertical integration across the healthcare delivery system where “the largest PBMs have come under common ownership with the largest, most dominant health insurers … [that] operate some of the largest retail, mail order, and specialty pharmacies in the country, which compete with local independent pharmacies. Given these relationships, PBMs and their affiliated entities may have the incentive and ability to engage in steering a growing share of prescription revenues to their own pharmacies through specialty drug classification, self-preferential pricing, and pharmacy contracting procedures to target and control the business operations of pharmacies. While the FTC Report principally focuses on the impact of these changing market dynamics on the operation and vitality of the nation’s pharmacies, the FTC Report also states that initial evidence about PBM and brand pharmaceutical rebating practices “urgently warrant further scrutiny and potential regulation.”

The FTC Report concludes that these interim findings underscore the importance and urgency of scrutinizing the role and influence of PBMs in the nation’s healthcare system, particularly as federal and state governments are the largest purchasers of healthcare.

Express Scripts Sues FTC Demanding Retraction Of FTC Report

Not surprisingly, the PBMs subject to the FTC Report generally have protested the reported findings. On September 17, 2024, CIGNA-owned Express Scripts sued the FTC, demanding the FTC retraction of the FTC Report. In the Express Scripts, Inc. v. FTC complaint, Express Scripts characterizes the FTC Report as “unfair, biased, erroneous, and defamatory.” In the Complaint, Express Scripts alleges:

“According to the Commission’s press release announcing the Report, the Report stems from special orders issued under Section 6(b) of the FTC Act to six PBMs, including Express Scripts, demanding data and information about the PBM industry. But the Report is not an analysis of the data and information produced by the PBMs. Instead, it is seventy-four pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release. The Commission disregarded the millions of documents and terabytes of data produced and relied instead on unverified comments from the very companies that PBMs negotiate against in order to help lower drug costs. Not surprisingly, those entities are incentivized to point the finger at PBMs for allegedly driving drug costs up, when it is PBMs who are, in fact, bringing drug costs down.”

Charging that the FTC Report “followed prejudice and politics, not evidence or sound economics, and wrongly concluded that PBMs inflate drug costs and harm independent pharmacies” and harmed Express Scripts’ business and reputation by the FTC’s “unlawful, unconstitutional, and arbitrary and capricious conduct and defamatory statements,” the Complaint alleges that the FTC Report “gets nearly everything wrong” as a result of FTC Chair Khan’s and the FTC’s bias against PBMs and failure to consider the evidence before them. For example, the Complaint asserts:

“It falsely accuses Express Scripts and other PBMs of “controlling” access to drugs and drug pricing when it is manufacturers who set drug prices and plan sponsors who decide which drugs to cover for their members.

It attacks Express Scripts for disadvantaging independent pharmacies when the evidence produced shows that on average independent pharmacies not affiliated with PBMs receive higher reimbursements than unaffiliated chain pharmacies, independent pharmacies are profitable, and the number of prescriptions filled at independent pharmacies is increasing.

It falsely claims that Express Scripts is “profiting by inflating drug costs,” including by taking rebates from drug manufacturers in return for putting high cost drugs on formularies when, in truth, the bulk of rebates and fees received by PBMs get passed through to plan sponsors and lower the net cost of drugs to plan sponsors and members. Moreover, Express Scripts prefers drugs with the lowest net cost to its plan sponsors on its largest standard formularies.

It makes the broad-brush claim that the PBMs failed to comply with the Commission’s 2022 6(b) orders, which demanded extensive data and information for production—without identifying who the supposed offenders are—even while Express Scripts had long ago complied with the Commission’s requests, which

the Commission knew and verbally acknowledged before and after issuing its Report. It falsely states that PBMs, including Express Scripts, “profit at the expense of patients by inflating drug costs” when the evidence shows that PBMs compete for the business of plan sponsors by offering lower costs for covered drugs than their competitors. PBMs have low and declining operating margins and any PBM that sought to inflate the cost of covered drugs would quickly lose its clients.

Due to these alleged false conclusions, the Complaint charges that the FTC Report violates federal and state law several times over, including in at least the following ways:

By exhibiting bias against PBMs and prejudgment of the facts, the Report violates Express Scripts’ right to due process under the Fifth Amendment to the U.S. Constitution.
It contains (i) assertions that will predictably be and have been interpreted as conclusions adverse to all PBMs and (ii) false statements unsupported by the record that demonstrate the Commission’s failure to consider the available contrary evidence and render its decision arbitrary and capricious.
It is not in the public interest and therefore exceeds the Commission’s statutory authority under Section 6(f) of the FTC Act.
It is unlawful because Commissioners exercise executive authority while enjoying statutory removal protections in violation of Article II of the U.S. Constitution.
And the Commission’s claim both in the Report and the accompanying press release that PBMs, including Express Scripts, are “inflating drug costs” and “profit by inflating drug costs at the expense of patients,” is false and defamatory.

Claiming that Express Scripts has suffered and continues to financial, business and reputational harm by the FTC Report’s allegedly false statements about its business practices and the insinuation that Express Scripts’ successful efforts to fight for lower prices for plan including being sued in multiple lawsuits invoking the FTC Report as evidentiary support for plaintiffs’ claims and faces multiple demands for information from state regulators and federal legislative committees. Contending these harms “have only just begun and will only be compounded over time,” Express Scripts asks the District Court:

To vacate and require the FTC to set aside the FTC Report;
Make the FTC correct the false statements it has made about PBMs; and
Require the recusal of FTC Chair Khan from further FTC proceedings regarding Express Scripts in light of her evident bias against PBMs, including Express Scripts.

Regardless of how the Express Scripts lawsuit plays out, employers and other health plan sponsors, fiduciaries, third party administrators, insurers, pharmacies, health care providers and individual Americans can expect to see continued challenges and attempts to reform PBMs to address perceived abuses. The direction and specifics of those challenges and changes remain unclear. Since political pressure is likely to significantly influence the ultimate outcome of any reforms, concerned individuals and organizations should carefully monitor and provide input.

Meanwhile, employer and other health plan sponsors and fiduciaries should also anticipate that the FTC Report and similar Congressional and other studies and investigations may increasingly fuel and provide evidence to support participants’ and beneficiaries’ questions and challenges to PBM features and practices within their health plans.

More Information

We hope this update is helpful. For more information about the or other health or other employee benefits, human resources, or health care developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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 her more than 35 years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including leading edge work on PBM, pharmacy and pharmaceutical and other health care, managed care, insurance, and insured and self-insured contracting, design, administration and regulation.

Author of numerous highly regarded works on PBM and other health plan contracting and design, Immediate Past Chair of the ABA International Section Life Sciences Committee and the Tort Trial and Insurance Practice Section Medicine and Law Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and past Group Chair and current Welfare Benefit Committee Co-Chair of 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 career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services, data and technology and many other 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; third party administrators and other health benefit service providers; hospitals, health care systems and other health care providers, 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; EMR, 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.

She also has extensive experience 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, EMR, 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 publications on “Transparent PBM Contracting,” “ACOs, Direct Contracting: Legal & Practical Challenges For Employers, Providers & TPAs,” “The Medicare Advantage Contracting Manual,” “Third Party Administrator (TPA) Contracting Principles and Strategies and a multitude of other highly regarded publications and presentations, Stamer is widely recognized for her thought leadership on PBM and other managed care and health plan contracting and design, and a multitude of other health care, health plan and other health industry matters. In addition, Ms. Stamer contributes her time and leadership to numerous policy, professional, civil and other organizations including service as the, 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.™

NOTICE: These statements and materials are for general information and 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 considering the specific facts and circumstances presented in their unique circumstance at the particular time. No comment or statement in this publication is to be construed as legal advice or 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 constantly and often rapidly evolves, subsequent developments that could impact the currency and completeness of this discussion are likely. The author and Solutions Law Press, Inc. disclaim and have no responsibility to provide any update or otherwise notify anyone of any fact or law specific nuance, 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.

©2024 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.

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Posted by Cynthia Marcotte Stamer

US Labor Department Seeks $300K+ Whistleblower Recovery Against Employer For Firing Worker

October 29, 2013

Clearwater Paper Corp is facing a Department of Labor lawsuit after firing an employee who raised

A whistleblower lawsuit against Clearwater Paper Corp reminds employers dealing with workplace safety and health complaints need to use care to manage potential retaliation claims by complaining workers.

The U.S. Department of Labor whistleblower complaint in the U.S. District Court for the District of Idaho against Clearwater Paper Corp. in Lewiston, Idaho, alleges the company illegally retaliated against an employee who raised workplace safety and health concerns. The Labor Department’s complaint charges that a Clearwater Paper fired an employee in 2010 in retaliation for filing a safety complaint with the Occupational Safety and Health Administration (OSHA). The employee was first suspended and then fired soon after OSHA conducted an inspection to assess excessive exposure to red cedar dust at Clearwater Paper’s sawmill in Lewiston. This facility was later sold in 2011. The Department seeks reinstatement of the employee as well as payment of more than $300,000 in damages and fees, including back pay, compensatory damages, emotional distress damages and punitive damages.

The Occupational Health and Safety Act (OSH Act) and most state occupational health and safety laws include provisions that prohibit retaliation against workers for making safety complaints or exercising other rights. OSHA enforces the whistleblower provision of the OSH Act and 21 other statutes protecting employees who report violations of various securities, trucking, airline, nuclear, pipeline, environmental, public transportation, workplace safety and health, consumer product safety, health care reform and financial reform laws. Under these laws, employers are prohibited from retaliating against employees who raise various protected concerns or provide protected information to the employer or to the government.

The protections and remedies for retaliation against whistleblowers reporting health and safety concerns are just one type of employee action that can trigger whistleblower or other retaliation protections under federal or state law. Even when the complaint or report made by worker proves unfounded, good faith reports can trigger the whistleblower protections of most of these statutes. Since the protections tend to follow the worker throughout his or her career with an employer, employers need to carefully document these reports and use care to monitor for improper retaliation risks or exposures. If improperly managed, the whistleblower or other retaliation complaints can create significant risks for dealing with a employee who has reported health and safety concerns or engaged in other protected activities. Employers disciplining or terminating these workers need to be prepared to defend against a potential whistleblower claim by providing sufficient documentation and other evidence to prove a valid business reason, rather than retaliation, lead to the adverse job action. Typically this should begin by establishing and administered consistent, well-documented practices for documenting performance and discipline for all employees not those who have made safety reports or engaged in other action that could provide a basis for a whistleblower complaint. While reviewing job discipline and terminations for potential whistleblower or other illegal bias also is a good practice, employers should use caution when conducting performance reviews or other performance or discipline activities with respect to safety or other potential whistleblowers to avoid the appearance of singling out the whistleblower for special scrutiny or heightened standards as this conduct could itself be used as potential evidence of illegal retaliation.

For Help or More Information

If you need help understanding or dealing with reviewing or negotiating your vendor agreements, or with other 2014 health plan decision-making or preparation, or with reviewing and updating, administering or defending your group health or other employee benefit, human resources, insurance, health care matters or related documents or practices, please contact the author of this update, Cynthia Marcotte Stamer.

A Fellow in the American College of Employee Benefit Council, immediate past Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Group and current Co-Chair of its Welfare Benefit Committee, Vice-Chair of the ABA TIPS Employee Benefits Committee, a council member of the ABA Joint Committee on Employee Benefits, and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer is recognized, internationally, nationally and locally for her more than 25 years of work, advocacy, education and publications on cutting edge health and managed care, employee benefit, human resources and related workforce, insurance and financial services, and health care matters.

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experienced with these and other employment, employee benefit and compensation matters, Ms. Stamer continuously advises and assists employers, employee benefit plans, their sponsoring employers, fiduciaries, insurers, administrators, service providers, insurers and others to monitor and respond to evolving legal and operational requirements and to design, administer, document and defend medical and other welfare benefit, qualified and non-qualified deferred compensation and retirement, severance and other employee benefit, compensation, and human resources, management and other programs and practices tailored to the client’s human resources, employee benefits or other management goals. A primary drafter of the Bolivian Social Security pension privatization law, Ms. Stamer also works extensively with management, service provider and other clients to monitor legislative and regulatory developments and to deal with Congressional and state legislators, regulators, and enforcement officials about regulatory, investigatory or enforcement concerns.

Recognized in Who’s Who In American Professionals and both an American Bar Association (ABA) and a State Bar of Texas Fellow, Ms. Stamer serves on the Editorial Advisory Board of Employee Benefits News, HR.com, Insurance Thought Leadership, Solutions Law Press, Inc. and other publications, and active in a multitude of other employee benefits, human resources and other professional and civic organizations. She also is a widely published author and highly regarded speaker on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, Modern and many other national and local publications. Her widely respected publications and programs include more than 25 years of publications on health plan contracting, design, administration and risk management including a “Managed Care Contracting Guide” published by the American Health Lawyers Association and numerous other works on vendor contracting. You can learn more about Ms. Stamer and her experience, review some of her other training, speaking, publications and other resources, and register to receive future updates about developments on these and other concerns from Ms. Stamer here.

Other Helpful Resources & Other Information

We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here . You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others 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 here. You can reach other recent updates and other informative publications and resources.

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Posted by Cynthia Marcotte Stamer

OSHA Citation Of Michigan VA Reminder To Manage Workplace Safety

March 1, 2013

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) citation of the Battle Creek Veterans Administration Medical Center, following a safety inspection conducted in July as part of OSHA’s Federal Agency Targeting Inspection Program for seven notices of unsafe or unhealthful working conditions reminds employers that OSHA expects employers to maintain safe workplaces.

Under the Occupational Safety and Health Act, federal agencies must comply with the same safety standards as private-sector employers. According to OSHA, its inspection uncovered several repeat safety violations, as well as certain other serious safety violations.

OSHA reports that three repeat safety violations involved failing to evaluate the workplace to identify if permit-required confined spaces were present and label such spaces with danger signs; failing to adequately guard automated laundry equipment to prevent employees from entering the work area, and failing to fully guard the belt and pulley of an air compressor. To issue notices for repeat violations, OSHA must have issued at least one other notice for the same violation at one of the agency’s establishments within the same standard industrial classification code, commonly known as the SIC code. OSHA previously has cited U.S. Department of Veterans Affairs facilities in Danville and North Chicago, Illinois, and Minneapolis, Minnesota for the same safety and health violations.

The serious safety violations found included three serious safety violations for unguarded floor openings in the general repair shop; failing to inspect powered industrial trucks prior to placing them in service, and failing to remove trucks from service in need of repair. Additionally, OSHA found a circuit breaker panel was not mounted correctly. OSHA issues a serious notice when it finds a substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known.

Beyond the repeated and serious violations, OSHA reports it also found one other-than-serious violation for failing to close unused openings on electrical cabinets and junction boxes. An other-than-serious violation is one that has a direct relationship to job safety and health, but probably would not cause death or serious physical harm.

The medical center has 15 business days from receipt of the notices to comply, request an informal conference with OSHA’s area director or appeal the notices by submitting a summary of the agency’s position on the unresolved issues to OSHA’s regional administrator.

While the medical center and other federal agencies are required to comply with the same OSHA rules as private sector employers, the VA and other federal agencies don’t face the same liabilities when cited. OSHA cannot propose monetary penalties against another federal agency for failure to comply with OSHA standards.

The risks for private sector employers is illustrated by another recent OSHA. OSHA recently cited Riddell All-American Sports Co. with eight serious violations following an OSHA investigation, which found that the company exposed workers to multiple safety and health hazards at its San Antonio facility. The violations include failing to ensure electrical equipment was free from recognized hazards, provide adequate machine guarding while employees operate industrial sewing machines and provide a fall protection program to prevent falls from the basket of a powered industrial truck. The Elyria, Ohio-based company, which employs about 25 workers in San Antonio, paints helmets for various sports. Proposed penalties total $44,000. Read the News Release.

Since private sector employers that don’t enjoy the VA’s immunity liability run much greater risks for failing to maintain workplace safety, including significant civil and in the case of a workplace death, potentially even criminal penalties, private sector hospitals and other organizations should exercise special care to ensure appropriate safety in their workplaces. “The Battle Creek Veterans Administration Medical Center failed to properly ensure the facility was in compliance with established safety and health procedures,” said Robert Bonack, director of OSHA’s Lansing Area Office. “All employers, including federal employers, are responsible for knowing what hazards exist in their facilities and taking appropriate precautions by following OSHA standards so workers are not exposed to such hazards.”

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help in conducting a risk assessment of or responding to an IRS, DOL, Justice Department, or other federal or state agencies or other private plaintiff or other legal challenges to your organization’s existing workforce classification or other labor and employment, compliance, employee benefit or compensation practices, please contact the author of this update, attorney Cynthia Marcotte Stamer here or at (469) 767-8872 .

Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, management attorney and consultant Ms. Stamer is nationally and internationally recognized for more than 23 years of work helping employers; employee benefit plans and their sponsors, administrators, fiduciaries; employee leasing, recruiting, staffing and other professional employment organizations; and others design, administer and defend innovative workforce, compensation, employee benefit and management policies and practices. The Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Committee, a Council Representative on the ABA Joint Committee on Employee Benefits, Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer often has worked, extensively on these and other workforce and performance related matters. She also is recognized for her publications, industry leadership, workshops and presentations on these and other human resources concerns and regularly speaks and conducts training on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications. For more information about Ms. Stamer and her experience or to get access to other publications by Ms. Stamer see here or contact Ms. Stamer directly at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ 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 in exploring other Solutions Law Press, Inc. ™ tools, products, training and other resources here and reading some of our other Solutions Law Press, Inc.™ human resources news here including the following:

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Posted by Cynthia Marcotte Stamer

Making Wellness Work On A Shoestring Budget

May 28, 2012

With tight budgets preventing many businesses from investing in wellness consulting resources, a tight budget doesn’t mean your company, church, or other group can’t have a thriving wellness program. Wellness is a culture. While the resources and advice of consultants and bells and whistles can be helpful sometimes, the inability to afford them doesn’t mean that your organization or group can’t have a healthy and effective wellness program.

The key to promoting wellness in your workplace, organization or community is to promote a culture of healthy eating, movement and lifestyles. Establish the culture by leading the way. Make healthy food choices available at meetings. Require or urge your leadership to model good eating behavior. Have a healthy pot luck and challenge employees to bring and share their tastiest, healthy dish.

Encourage leaders and others to incorporate movement into the day. Walking meetings and other inexpensive activities can help promote health with very little cost. Encourage employees to walk in walk-a-thons, participate in running groups, walk or skip to lunch, take the stairs, participate in sports leagues or other similar activities.

Don’t overlook the wealth of available free resources. Project COPE”s Play For Life Program relies upon a host of free often government provided resources. Many great wellness tools are available from NIH and other government sources at little or no cost including the newly released NIH and the Weight of the Nation resources just made available by NIH here.

Project COPE: Coalition On Patient Empowerment & Coalition For Responsible Health Care Quality

Project COPE: Coalition on Patient Empowerment & the Coalition for Responsible Health Care Quality are coalitions of individuals and organizations that share the belief that every American and American organization has a stake, and something to contribute to our ability to find and implement the best options for ensuring that the U.S. health care system provides quality, affordable health care.

Health care impacts every individual and every organization in America. Consequently, every American citizen and organization including but not limited to health care providers, employers, insurer, and community organizations should take part. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up or speak up.

Project COPE urges and invites each individual and organization speak up to help communicate and act to make health care work for themselves, their families and others when you can and share your input to help preserve and continue to develop real meaningful improvements to our health care system by joining Project COPE: Coalition for Patient Empowerment here by sharing ideas, tools and other solutions and other resources.

Other Helpful Resources & Other Information

Wellness is a culture. While the resources and advice of consultants and bells and whistles can be helpful sometimes, the inability to afford them doesn’t mean that your organization or group can’t have a healthy and effective wellness program.

The key to promoting wellness in your workplace, organization or community is to promote a culture of healthy eating, movement and lifestyles. Establish the culture by leading the way. Make healthy food choices available at meetings. Require or encourage your leadership to model good eating behavior. Have a healthy pot luck and challenge employees to bring and share their tastiest, healthy dish.

Encourage leaders and employees and others to incorporate movement into the day. Walking meetings and other inexpensive activities can help promote health with very little expense. Encourage employees to walk in walk-a-thons, participate in running groups, participate in sports leagues or other similar activities.

The key to wellness is getting started and keeping going. Making healthy living part of your culture can pay big benefits in health and absentee savings, increased productivity and workforce retention. What are you waiting for? Get moving!

Other Helpful Resources & Other Information

For Help or More Information

If you need help reviewing and updating, administering or defending your group health or other employee benefit, human resources, insurance, health care matters or related documents or practices, please contact the author of this update, Cynthia Marcotte Stamer.

A Fellow in the American College of Employee Benefit Council, immediate past Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Group and current Co-Chair of its Welfare Benefit Committee, Vice-Chair of the ABA TIPS Employee Benefits Committee, a council member of the ABA Joint Committee on Employee Benefits, and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer is recognized, internationally, nationally and locally for her more than 24 years of work, advocacy, education and publications on cutting edge health and managed care, employee benefit, human resources and related workforce, insurance and financial services, and health care matters.

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experienced with these and other employment, employee benefit and compensation matters, Ms. Stamer continuously advises and assists employers, employee benefit plans, their sponsoring employers, fiduciaries, insurers, administrators, service providers, insurers and others to monitor and respond to evolving legal and operational requirements and to design, administer, document and defend medical and other welfare benefit, qualified and non-qualified deferred compensation and retirement, severance and other employee benefit, compensation, and human resources, management and other programs and practices tailored to the client’s human resources, employee benefits or other management goals. A primary drafter of the Bolivian Social Security pension privatization law, Ms. Stamer also works extensively with management, service provider and other clients to monitor legislative and regulatory developments and to deal with Congressional and state legislators, regulators, and enforcement officials concerning regulatory, investigatory or enforcement concerns.

Recognized in Who’s Who In American Professionals and both an American Bar Association (ABA) and a State Bar of Texas Fellow, Ms. Stamer serves on the Editorial Advisory Board of Employee Benefits News, the editor and publisher of Solutions Law Press HR & Benefits Update and other Solutions Law Press Publications, and active in a multitude of other employee benefits, human resources and other professional and civic organizations. She also is a widely published author and highly regarded speaker on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, Modern and many other national and local publications. You can learn more about Ms. Stamer and her experience, review some of her other training, speaking, publications and other resources, and register to receive future updates about developments on these and other concerns from Ms. Stamer here.

Other Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

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 available at ww.solutionslawpress.com.

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Posted by Cynthia Marcotte Stamer

Mitigating Workplace Fallout of Pandemic Response

May 5, 2009

As the U.S. rushes to try to contain the spread of the swine influenza A (H1N1) virus infection (swine flu), businesses increasingly are facing employee leave requests and other employment and operational disruptions plans caused by school, day care or other closures and other business disruptions resulting from efforts to contain the disease while also working to take appropriate steps to prevent the spread of the disease within their own organizations.

Regardless of how deadly it ultimately proves to be, the pandemic proportion of the swine flu outbreak now ensures that most U.S. businesses will experience some disruption in operations as a result of the epidemic and efforts to contain it.

According to officials from the Centers for Disease Control and Prevention (CDC), as of 11:00 a.m. Eastern Time, 36 states had reported a total of 236 confirmed cases of swine flu and more cases are expected. That number includes the first U.S. swine flu fatality: a 22-month-old child from Mexico who died of the illness at a Houston, Texas hospital while visiting the United States last week. States currently hardest hit include New York (73 cases), Texas (41 cases), California (30 cases), Delaware (20 cases) and Arizona (17 cases). In the near future, however, CDC officials anticipate confirmed cases in all 50 states.

CDC officials and other experts continue to emphasize that the success of efforts to prevent the unnecessary spread of the disease depends largely on good health habits, limiting exposure to the virus and prompt diagnosis and treatment of afflicted persons. Employers can help reduce the risk that members of their workforce and their families will catch the virus by promoting good health habits and encouraging workers and their families to stay home and seek prompt treatment in the event of an illness. Simultaneously planning for and dealing with absences and other staffing challenges result from school, day care and other closings prevents a greater challenge for many employers, however.

Easy Preventive Safeguards

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 employees and family members 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. To help promote health habits within their workforce, many businesses may want to download and circulate to employees and families the free resources published by the CDC at http://www.cdc.gov/flu/protect/habits.htm. These and other resources make clear that Employers should encourage employees and their families to practice good health habits by telling employees and their families to take the following steps:

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.

Many businesses are promoting these and other conducts that help prevent the spread of disease by sharing educational materials such as the growing range of free materials provided by the CDC and others available at the government sponsored website, http://www.pandemicflu.gov. For instance, business can access and download free copies of the following publications at http://www.cdc.gov/flu/protect/habits.htm:

Cover Your Cough
Be a Germ Stopper: Healthy Habits Keep You Well
Flu Prevention Toolkit: Real People. Real Solutions
Stopping the Spread of Germs at Home, Work & School

Dealing With Lost Time & Productivity Challenges

Businesses also should begin preparing backup staffing and production strategies to prepare for disruptions likely to result if a significant outbreak occurs. Whether or not the disease afflicts any of its workers, businesses can anticipate the swine flu outbreak will impact their operations -either as a result of occurrences affecting their own or other businesses or from workflow disruptions resulting from safeguards that the business or other businesses implement to minimize swine flu risks for its workforce or its customers.

For many employers, however, planning for and dealing with requests for time off or other workplace disruptions resulting from pandemic containment efforts presents special challenges. While most employers have well established policies and procedures for providing medical leave to employees during periods of their own or a family member’s illness under the Family & Medical Leave Act (FMLA) or otherwise, many employers are experiencing difficulty in responding to leave requests of healthy employees necessitated by school or day care closings, suspected exposures, or other pandemic response disruptions.

Certainly, whether or not legally mandated, the CDC and other official advisories make clear that sick employees should not be in the workplace. Employers of course must provide medical leave as required by the FMLA or other similar state laws as well as any contractually agreed to leave. To better insulate their workforce against potential exposure to the virus, however, many employers also may wish consider temporarily modifying existing leave or other work policies with an eye to better defending their workforce against a major outbreak. In this respect, employers need to consider both how to respond to the present wave of the virus and to plan for the possible need to respond to another potentially stronger outbreak of the swine flu virus that the CDC and other experts caution likely may arise in the Fall or Winter.

As part of their efforts to insulate their workplaces against exposure to the virus, employers generally should discourage workers from coming to work if they or a family member are experiencing symptoms or have been exposed to the virus. For this reason, businesses generally evaluate workplace policies or practices that may pressure or encourage employees with swine flu or any other contagious disease to report to work. Employers should consider whether the potential risks make advisable adjustments to their current attendance, telecommuting, leave and paid time off and other policies.

In light of the current situation, many businesses may want to consider temporarily adjust their leave, telecommuting and other policies in light of the impending health risk. For instance, recognizing that the decision to close a school or child care facility in response to a known or suspected infection seeks to minimize the spread of the disease through exposure to other then undiagnosed cases, businesses generally should think twice about allowing employees to bring these potentially exposed children into the workplace. Instead, employers may wish to consider being more flexible in allowing employees to work from home or take leave to care for children whose schools or child care facilities are closed due to concerns about possible exposure to reduce the risk of creating unnecessary exposure in their workplace.

To help minimize financial pressures on workers to report to work when they may be ill or exposed to the virus, many employers also may want to consider providing or offering short-term disability insurance, expanding the availability of paid or unpaid leave or both.

Regardless of the specific choices a particular business makes, businesses need to take appropriate steps to document, implement, and communicate their decisions. If considering allowing or requiring employees to work from home, employers need to implement appropriate safeguards to monitor and manage employee performance, and to protect the employer’s ability to comply with applicable wage and hour, worker’s compensation, safety, privacy and other legal and operational requirements. They also should review and update family and medical leave act and other sick leave policies, group health plan medical coverage continuation rules and notices and other associated policies and plans for compliance with existing regulatory requirements, which have been subject to a range of statutory and regulatory amendments in recent years.

If considering allowing or requiring employees to work from home, for instance, employers need to implement appropriate safeguards to monitor and manage employee performance, and to protect the employer’s ability to comply with applicable wage and hour, worker’s compensation, safety, privacy and other legal and operational requirements. They also should review and update family and medical leave act and other sick leave policies, group health plan medical coverage continuation rules and notices and other associated policies and plans for compliance with existing regulatory requirements, which have been subject to a range of statutory and regulatory amendments in recent years.

In light of the growing responsibilities and exposures of business to medical privacy and disability liabilities associated with knowledge, collection, protection and use of information about the health and medical conditions of workers and their families, businesses also should review and update their procedures regarding the use, collection, disclosure, and protection of this and other sensitive information. Businesses, 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 publication “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. Schools, health care organizations, restaurants and other businesses whose operations involve significant interaction with the public also may need to take special precautions. These and other businesses may want to consult the special resources posted at http://www.pandemicflu.gov/health/index.html.

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting employers with these and other labor and employment, employee benefit, compensation, and internal controls matters. Ms. Stamer in particular has worked extensively with health care providers, government officials, and businesses to plan for and deal with pandemic and other absence, disease management and disaster preparedness concerns. If your organization needs assistance with assessing, managing or defending its wage and hour or other labor and employment, compensation or benefit practices, please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402, or your favorite Curran Tomko Tarski, LLP attorney. For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi, LLP team, see the http://www.cttlegal.com.

Comments Off on Mitigating Workplace Fallout of Pandemic Response | Absenteeism, COBRA, Disease Management, EEOC, Employee Benefits, Employers, Employment Agreement, ERISA, Health Plans, Human Resources, Insurance, Internal Controls, Pandemic, Privacy, Swine Flu, Telecommuting, Wellness | Tagged: Absenteeism, ADA, COBRA, Disability, Disability Discrimination, Disease Management, Employee Benefits, Employer, Employment, Employment Agreements, Family Leave, Health, Health Plans, Human Resources, Labor, Leave, Medical Coverage, Minimum Wage, Overtime, Paid Time Off, Pandemic, Privacy, PTO, Risk Management, Swine Flu, Wellness | Permalink
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