COVID-19 Telehealth Relief; CMS ESRD, General Practitioner Telehealth Toolkits Released

March 24, 2020

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

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

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

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

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

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

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

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

Today, the Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released two comprehensive toolkits on telehealth:

  • The Telehealth Toolkit for General Practitioners available here;
  • The End-Stage Renal Disease Providers Toolkit available here.

The Toolkits’ release follows up on last week’s Centers for Medicare & Medicare Services (“CMS”) loosening of requirements for Medicare coverage of telehealth services and privacy and data security requirements so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.

COVID-19 Emergency TeleHealth Waivers & Rules

Under this temporary new waiver, Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patient’s places of residence starting March 6, 2020.  The waiver applies to a range of providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to their patients.

  • New TeleHealth Toolkits

Each of the telehealth toolkits released today contains electronic links to reliable sources of information on telehealth and telemedicine, which will reduce the amount of time providers spend searching for answers and increase their time with patients. HHS intends these links to help providers choose learn about the general concept of telehealth, choose telemedicine vendors, initiate a telemedicine program, monitor patients remotely, and develop documentation tools. Additionally, the information contained within each toolkit also outlines temporary virtual services that could be used to treat patients during this specific period of time.

  • COVID-19 Temporary Limited Scope HIPAA Privacy Telehealth Relief

The HHS COVID-19 emergency teleheath waivers follow up on the HHS Office for Civil Rights (OCR) March 20, 2020 Notification of Enforcement Discretion on Telehealth Remote Communications (the “Notice”) announcing temporary, limited scope enforcement relief from some, but not all of the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Breach Notification Rules for health care providers using “non-public facing” communication technologies to provide telemedicine services during the COVID-19 health care emergency

Intended to allow health care providers greater latitude under HIPAA to  communicate with patients and provide telehealth services through remote communications technologies during the COVID-19 national emergency, the Notice allows covered health care providers wishing to use audio or video communication technology to provide telehealth to patients during the COVID-19 nationwide public health emergency the option to  any availabe “non-public facing” remote communication product to communicate with patients if the platform by verifying the platform is HIPAA compliant and securing the necessary business associate agreement (“BAA”) with the communication provider.

Specifically the Notice announces OCR is exercising its enforcement discretion  not to impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using non-public facing audio or video communication products during the COVID-19 nationwide public health emergency in accordance with the requirements set forth in the Notice.  The non-enforcement policy applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19.   During the COVID-19 emergency, this relief for non-public facing remote communications allows a health care providers  the flexibility when it determines appropriate in his or her professional judgement to request to examine a patient using a video chat application connecting the provider’s or patient’s phone or desktop computer in order to assess a greater number of patients while limiting the risk of infection of other persons who would be exposed from an in-person consultation.

The relief does not apply to “public facing” remote communications however,  Facebook Live, Twitch, TikTok, and similar video communication applications are considered “public facing.”  The OCR bulletin states health care providers should not use any of these or other public facing remote communications to provide telehealth services under the Bulletin.

The Notice also alerts health care providers providing telemedicine services under the Notice need to ensure they have in place appropriate business associate agreements {“BAAs”) with each technology vendors used to conduct these communications and that the vendor is otherwise HIPAA compliant.  The Notice lists the following as some vendors that have represented to OCR that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA include:

  • Skype for Business
  • Updox
  • VSee
  • Zoom for Healthcare
  • me
  • Google G Suite Hangouts Meet

Providers should note that the Notice also states that OCR does not endorse, recommend or certify any of these vendors or the adequacy of their BAAs.  Consequently, providers intending to use any of thes platforms should conduct their own documented due diligence to confirm that the necessary HIPAA requirements are met.    Providers also should keep in mind that the OCR Notice does not modify any otherwise applicable federal or state law, contractual or ethical requirements that may apply to their use of these telemedicine platforms.  As many provider’s HIPAA notices may have included statements inconsistent with the use of these technologies, the provider should consider providing notification of the change of its practices that includes disclosures about potentially lower privacy protections.  Because the relief is limited in scope and duration, providers relying on the relief also will need to closely monitor developments and adjust practices as necessary when the emergency waivers expire or are modified.

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

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

More Information & Resources

We hope this update is helpful. If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help.  To learn more about Ms. Stamer, her services, experience, publications or involvements; to review or request other developments, publications, resources and tools; or to register for future updates, see www.cynthiastamer.com, see www.cynthiastamer.com; connect on LinkedIn or Facebook; or contact us via e-mail or via telephone at (214) 452 -8297

About The Author

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

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, and a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel, Ms. Stamer is widely recognized for her pragmatic, leading edge work, scholarship and thought leadership on domestic and international, public and private sector health care and managed care, workforce and performance, safety, legal and operational compliance and risk management, crisis preparedness and response, and other essential legal and operational concerns.

Her experience includes extensive work domestically and internationally with hospitals, health care systems, clinics, skilled nursing and other long term care, rehabilitation and other health care facilities; physicians, medical staff and other health care providers and organizations; accreditation, peer review and quality committees and organizations;  health care management and technology and other health and managed care industry clients; self-insured and insured health and other employee benefit plans, their sponsors, fiduciaries, administrators, insurers and service providers and other payers; employers; billing, utilization management, quality, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

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

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

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 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.  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. ©2020 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™.


Court Ruling Gives Health Care & Other HIPAA Covered Entities Option To Reduce Costs of Responding To 3rd Party PHI Record Requests

January 29, 2020

Health care providers, health plans, health care clearinghouses and their records providers and other business associates should review and update their existing policies and practices on the charge and other procedures for responding to third party requests for records containing protected health information (“PHI”)  in response to newly allowed flexibility created by the January 23, 2020 federal district court order (the “Coix Order”) in Coix Health, LLC v. Azar, et al, No 18 –CV-0040 (D>D.C. January 23, 2020) that bars enforcement of certain requirements of the Department of Health & Human Service (“HHS”) Office of Civil Rights (“OCR”) rules implementing patient rights to access to PHI created by the Health Insurance Portability & Accountability Act (“HIPAA”) from health plans, health care providers, health care clearinghouses (“”Covered Entities”) and their business associates (“HIPAA entities”).  Utilizing the flexibility resulting from the Coix Order could help reduce health plan costs of compliance with the HIPAA right of access rule by allowing the health plan and its records providers more freedom to determine the charges and format for delivering PHI in response to records requests received from other insurers, lawyers and other third parties.  

Coix Order  Invalidates Pieces of OCR HIPAA Rules On PHI Record  Rules 

The new flexibility results from a January 23, 2020 Coix Order in response to a lawsuit brought by Coix Health, LLC (“”Coix”) challenging the “Patient Rate” and other provisions of OCR’s regulation implementing HIPAA’s right of access requirements under 45 C.F.R. §164.524 as adopted by OCR as part of its final rule entitled “Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules.”  (The “2013 Omnibus Rule”) on January 25, 2013.   In particular, the 2013 Omnibus Rule includes a “Patient Rate” rule that limits the charges that Covered Entities can make for delivering PHI requested by patients and third parties to prevent patient access to PHI from being thwarted by excessive fees.  As part of the Patient Rate rule, OCR restricted what Covered Entities and their records providers can charge to provide copies of protected health information.  The Patient Rate rule restricts charges that can be imposed to provide protected health information, restricts the methods for calculating these charges and limits the type and amount of labor costs that can be included when calculating the Patient Rate. The Patient Rate rule in the 201 Omnibus Rule also requires that Covered Entities and their records companies provide the requested PHI directly to the patient or to a third party designed by the patient and in the format requested by the patient regardless of the format in which the Covered Entity or its medical provider maintains the PHI within its record.  

When originally implemented, the medical records industry generally understood that the Patient Rate limitations applied only to requests for PHI made by the patient for use by the patient.  Before 2016, however, Covered Entities and their medical records providers generally understood that this Patient Rate rule did not apply to or limit fees that Covered Entities or their medical records providers could charge commercial entities or other third parties like insurance companies and law firms to fill requests for PHI.  That understanding changed, in 2016, however, when HHS issued guidance that stated that the Patient Rate applies even to requests to deliver PHI to third parties.  

A specialized medical-records provider that contracts with healthcare suppliers nationwide to maintain, retrieve, and produce individuals’ PHI, Cox handles tens of millions of requests for records containing PHI annually including demands by healthcare providers for treatment purposes, patients asking for their own PHI, and third parties, such as life insurance companies and law firms, seeking a patient’s PHI for commercial or legal reasons.  According to Cox, OCR’s interpretation of the Patient Rate rule as applicable to third party requests as well as direct patient requests cost it and other medical records companies millions of dollars in revenue. Accordingly, Coix filed the Coix Health, LLC v. Azar, et al lawsuit challenging OCR’s 2016 application of the Patient Rate to third party requests as violating the procedural and substantive protections of the Administrative Procedure Act (“APA”). In addition to this challenge to the scope of the Patient Rate, Coix also contested OCR pronouncements in the 2016 guidance document on (1) the types of labor costs that are recoverable under the Patient Rate; and (2) the three alternative methods identified for calculating the Patient Rate as violating the APA’s procedural and substantive provisions. Finally, Coix also challenged the requirement in the Patient Rate rule that records companies to send PHI to third parties regardless of the format in which the PHI is contained and in the format specified by the patient. According to Coix, Congress required only that certain types of electronic health records be delivered to third parties, not all records regardless of their format, as HHS’s regulations now command.  

In its January 23, 2020 ruling on HHS’s motion to dismiss and the parties’ cross-motions for summary judgment, the D.C. District Court agreed with OCR that OCR’s rule requiring the use of one of three methods for calculating the Patient Rate was unreviewable as a final agency action and dismissed Coix’ challenge to that requirement. Concerning Coax’s other challenges, the Court sided with Coix.  It ruled that:  

  • OCR’s 2013 rule compelling delivery of PHI to third parties regardless of the records’ format is arbitrary and capricious insofar as it goes beyond the statutory requirements set by Congress;  
  • OCR’s broadening of the Patient 3 Rate in 2016 is a legislative rule that the agency failed to subject to notice and comment in violation of the APA; and  
  • OCR’s 2016 explanation concerning what labor costs can be recovered under the Patient Rate is an interpretative rule that OCR was not required to subject to notice and comment.  

Accordingly, District Court in the Coix Order declares unlawful and vacates (1) the 2016 Patient Rate expansion and (2) the 2013 mandate broadening PHI delivery to third parties regardless of format within the individual right of access” set forth in the provisions of 45 C.F.R. §164.524 of the 2013 Omnibus Rule insofar as it expands the HITECH Act’s third-party directive beyond requests for a copy of an electronic health record with respect to protected health information of an individual in an electronic format.” Additionally, the federal court ordered that the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) only apply to an individual’s request for access to their own records, and does not apply to an individual’s request to transmit records to a third party.  

OCR Plans To Comply With Coix Order In Applying Patient Record Rule 

In an “Important Notice Regarding Individuals’ Right of Access to Health Records” released January 28, 2020, OCR announced that that it will comply with the Coix Order vacating the “third-party directive” within the individual right of access “insofar as it expands the HITECH Act’s third-party directive beyond requests for a copy of an electronic health record with respect to [protected health information] of an individual  . . . in an electronic format.” Additionally, OCR stated that the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) will apply only to an individual’s request for access to their own records, and not apply to an individual’s request to transmit records to a third party.   However, OCR also added that the right of individuals to access their own records and the fee limitations that apply when exercising this right are undisturbed and remain in effect.  OCR will continue to enforce the right of access provisions in 45 C.F.R. § 164.524 that are not restricted by the court order.  

Update Patient Rate & Access Provisions Of HIPAA Policies & Notices 

As a result of the Coix Order, Covered Entities and their medical records providers still must calculate the Patient Rate in accordance with one of the three allowed methodologies when providing a patient with records containing PHI in response to a patient request.  However, Covered Entities and their medical records provider now may exercise greater flexibility when determining the format and charges when responding to requests from third parties other than the patient for records containing PHI.  Before doing so, however, most Covered Entities and business associates will want to update their HIPAA policies and procedures to reflect the new practices consistent with the new HIPAA and other relevant requirements.  Updating the policies first is important because the 2013 Omnibus Rule states Covered Entities violate HIPAA by failing to follow their own HIPAA privacy and security policies when those practices are more restrictive than those mandated by OCR’s 2013 Omnibus Rule.  Consequently however, Covered Entities and their medical records companies desiring to exercise this newly available flexibility should revise their existing policies and procedures to authorize their exercise of this new flexibility consistent with the Coix Order and associated OCR guidance. 

More Information  

We hope this update is helpful. For more information about the Coix Order 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.  

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

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.  

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

This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, 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 leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here 

About Solutions Law Press, Inc.™  

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

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 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 considering 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 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.  

©2020 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. 


OCR Warns HIPAA Entities To “Get Serious” About HIPAA Compliance In Announcing Latest Settlement Against Ambulance Company

December 31, 2019

The $65,000 payment and corrective action plan commitments West Georgia Ambulance, Inc. (“West Georgia”) is making to settle Department of Health & Human Services Office for Civil Rights (“OCR”) charges it recurrently violated the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule sends a warning to all oher HIPAA-covered health care providers, health plans, health care clearighouses  and their business associates (“covered entities”)maintain and be prepared to defend their own HIPAA compliance under a Resolution Agreement and Corrective Action Plan (“Resolution Agreement”) OCR announced on December 30, 2019.

The Resolution Agreement resolves charges resulting from an OCR investigation initiated in response to a HIPAA breach report the Georgia based ambulance company filed in 2013 in which the company, which provides emergency and non-emergency ambulance services in Carroll County, Georgia,  disclosed the loss of an unencrypted laptop containing the protected health information (PHI) of 500 individuals. The breach occurred when an unencrypted laptop fell off the back bumper of an ambulance. The laptop was not recovered.  West Georgia reported that exactly 500 individuals were affected by the breach.

In the course of its investigation of the breach report, OCR’s investigation uncovered long-standing noncompliance with the HIPAA Rules, including failures to conduct a risk analysis, provide a security awareness and training program, and implement HIPAA Security Rule policies and procedures. Specifically, the Resolution Agreement states that West Georgia:

  • Did not conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. See 45 C.F.R. § 164.308(a)(1)(ii)(A);
  • Failed to have a HIPAA security training program, and failed to provide security training to its employees. See 45 C.F.R. § 164.308(a)(5);
  • Failed to implement Security Rule policies or procedures. See 45 C.F.R. § 164.316; and
  • Despite OCR’s investigation and technical assistance, “did not take meaningful steps to address their systemic failures.”

To resolve its exposure to the substantially higher civil monetary penalties that OCR could impose for violations of this nature, West Georgia agreed to pay a $65,000 resolution payment to OCR and implement and comply with a corrective action plan that in addition to requiring West Georgia to correct the compliance deficiencies, also subjects West Georgia to two years of OCR monitoring and oversight.

The Resolution Agreement and corrective action plan carry a number of important messages for other health care providers and other Covered Entities.  First, the OCR enforcement action against West Georgia coming at the end of yet another heavy HIPAA enforcement year by OCR reminds Covered Entities that OCR is serious about HIPAA enforcement on the heels of its 2018 HIPAA record setting collection of $28.7 million in civil monetary penalties and resolution payments including the single largest individual HIPAA settlement in history of $16 million with Anthem, Inc. See OCR Concludes 2018 with All-Time Record Year for HIPAA Enforcement.  While not topping this record, OCR during 2019 now has collected civil monetary penalties and resolution payments totaling more than $15 million from HIPAA Covered Entities and their business associates including:

Second, the Resolution Agreement and various other smaller settlements during the year show HIPAA compliance and enforcement is a concern for smaller provideres and other covered entities, not juswt the huge ones.  While the $65,000 settlement payment required by the Resolution Agreement is substantially smaller than the amounts of the civil monetary penalties and many of resolution payments OCR collected in its other 2019 enforcement actions, the West Georgia and other 2019 enforcement actions demonstrate the teeth behind the warning in the OCR Press Release announcing the West Georgia Resolution Agreement from OCR Director Roger Severino that“All providers, large and small, need to take their HIPAA obligations seriously.”  With OCR promises to keep up its vigorous investigation and enforcement of the HIPAA requirements, every Covered Entity and business associate should take the necessary steps to verify and maintain their HIPAA compliance and to be prepared to defend their compliance under the Privacy, Security, Breach Notification and HIPAA access and other individual rights mandates of HIPAA.

Third, OCR’s statement in the Resolution Agreement about the failure by West Georgia to meaningfully act to correct compliance deficiencies and cooperate in other corrective action during the period following the breach report highlights the importance for covered entities involved in a breach or other dealings with OCR on a potential compliance concern to behave appropriately to  express and exhibit the necessary concern OCR expects regarding the compliance issue to position themselves to request and receive the clemency OCR is empowered under HIPAA to extend when deciding the sanctions for any noncompliance.

Of course meeting the requirements of HIPAA is not the only concern that covered entities should consider as they review and tightened their HIPAA and other privacy and data security procedures.  Health care providers and other covered entities also should keep in mind their other obligations to protect patient and other confidential information under other federal laws, the requirements of which also are ever-evolving.  For instance, on January 1, 2020 Texas providers like other Texas businesses will become subject to a shortened deadline for providing notice of data breaches under a new law enacted by the Texas Legislature in its last session.  Arrangements should be designed to fulfill all of these requirements as well as any ethical or contractual.

Covered entities also should keep in mind that violations of HIPAA can have implications well beyond HIPAA.ramifications beyond HIPAA itself.  For instance, heath care providers can face disqualification from federal program participation, licensing and ethics discipline and other professional consequences.  Health plans and their fiduciaries also may face Department of Labor and other fiduciary claims, while insurers can face licensing and other regulatory consequences.

For More Information

We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with the Department of Health & Human Services Office of Civil Rights, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer has extensive legal, operational, and public policy experience advising and representing health care, health care and other entities about HIPAA and other privacy, data security, confidentiality and other matters.

Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services, public and private primary, secondary, and other educational institutions, and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has recurrently worked extensively with public school districts and public and private primary and secondary schools, colleges and universities, academic medical, and other educational institutions, insured and self-insured health plans; domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; 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, employers; and federal and state legislative, regulatory, investigatory and enforcement bodies and agencies on health care, education, and other data privacy, security, use, protection and disclosure; disability and other educational rights; workforce, and a host of other risk management and compliance concerns.

Ms. Stamer is most widely recognized for her decades-long 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.  This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, 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 leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

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 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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.

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.

©2019 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.


$1.6M HIPAA Penalty Mostly Due To Inadequate Security Assessment & Oversight

December 16, 2019

The $1.6 million civil monetary penalty (“CMP”) assessed against the Texas Health and Human Services Commission (“TX HHSC”) for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules between 2013 and 2017 committed by a predecessor agency, the Department of Aging and Disability Services (“DADS”) illustrates the critical need for all HIPAA covered entities and business associates to confirm the adequacy of their enterprise wide security assessment, oversight, and other HIPAA Privacy and Security compliance and risk management including documentation of the reassessment and updating of these materials and assessments in connection with any update or change in software, systems or other system and security relevant developments.

OCR imposed the CMPs against TX HHSC for violations of HIPAA OCR found DADS committed from 2015 to 2017, before it was reorganized into TX HHSC in September 2017.  Like most other large HIPAA CMPs and settlements paid to avoid CMPs, a review of the TX HSSC CMP events makes clear that the large penalty resulted mostly because of inadequate assessment and oversight of security, rather than the actual breach itself that prompted the investigation leading to the CMP assessment.

Before its merger into TX HHSC, DADS was the Texas agency primarily responsible for providing and administering the state’s long-term care services for aging and intellectually and physically disabled people.  TX HHSC now administers and provides the services previously provided by DADS as part of its broader operation of state supported living centers; provision of mental health and substance use services; regulation of child care and nursing facilities; and administration of hundreds of other programs for people needing supplemental nutrition benefits, Medicaid and certain other assistance including those previously provided by DADS.

DADS Breaches & Violations

The $1.6 million CMPs assessment against TX HHSC resulted after OCR investigated a 2015 breach report made by DADS.  On June 11, 2015, DADS submitted a Breach Notification Report (“Report”) notifying OCR that on April 21, 2015 names, addresses, social security numbers, treatment information and other electronic protected health information (“ePHI”) of 6,617 individuals was viewable over the internet when a software coding flaw allowed prohibited access to ePHI with access credentials when DADS moved an internal application from a private, secure server to a public server.  OCR’s investigation determined that, in addition to that impermissible disclosure, DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls on Community Living Assistance and Support Services and Deaf Blind with Multiple Disabilities (“CLASS/DBMD”) program information systems and applications intended to collect and report information about “Utilization Management and Review” activities to the Centers for Medicare & Medicaid Services (“CMS”) for the CLASS/DBMD waiver programs.. The CMS waiver programs required DADS to collect and report to CMS applicant and enrollee community and institutional service choice, Level of Care, Plan of Care, waiver provider choice  and other waiver program performance data for CLASS and DBMD as part of a required evidentiary report on all §1915(c) waiver programs.  The CLASS/DBMD application glitch compromised the ePHI by allowing an undetermined number of unauthorized users to view the ePHI without verifying user credentials. TX HHSC learned of the breach from an unauthorized user who accessed ePHI in the application without being required to input user credentials. Because of inadequate audit controls, DADS was unable to determine how many unauthorized persons accessed individuals’ ePHI.

OCR initiated a compliance review of DADS on June 23, 2015 in response to the breach notification. As HIPAA Security Rule at 45 C.F.R. ·§ 164.312(a)(l) requires a covered entity to implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs properly granted access rights under HIPAA Security Rule § 164.308(a)(4), OCR found that by placing the CLASS/DBMD application on their public server without requiring users to provide access credentials, TX HHSC violated HIPAA by failing to implement access controls on all of its systems and applications throughout its enterprise in violation of 45 C.F.R. § 164.312(a)(l).

The HIPAA Security Rule at 45 C.F.R. § 164.312(b) requires a covered entity to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI.  In the course of its investigation, OCR requested in its June 23, 2015 Data Request that DADS provide a copy of its current HIPAA administrative and technical policies and procedures.  As DADS provided no evidence that the application was capable of auditing user access after it was moved to the unsecure public server as required by 45 C.F.R. § 164.312(b) with its response, OCR also concluded from its investigation that TX HHSC failed to implement audit controls to all of its systems and applications, like the application involved in the breach, as required by 45 C.F.R. § 164.312(b).

Beyond these violations, OCR also found that DADS also violated the HIPAA Security Rule by failing to conduct the required accurate and thorough enterprise wised risk analysis required by the HIPAA Security Rule.  In this respect, the HIPAA Security Rule at 45 C.F.R. § 164.308(a)(1)(ii)(A) requires a covered entity to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI it holds.  In its August 31, 2015 response to OCR’s Data Request dated July 23, 2015, DADS acknowledged that, while it had performed ”risk assessment activities” on individual applications and servers, it never performed an “agency-wide” security risk analysis.   On July 28, 2017, OCR received the documentation that DADS represented to be the documentation of its risk analysis.  After reviewing this evidence, OCR additionally found DADS violated the HIPAA Security Rule by failing to conduct an enterprise-wide risk analysis and implement access and audit controls.

Calculation & Assessment CMPs Totaling $1.6 Million

On May 23, 2018, OCR issued a Letter of Opportunity and informed TX HHSC that OCR’s investigation indicated that TX HHSC failed to comply with the Privacy and Security Rules, which remained unresolved despite OCR’s attempts to do so. The letter stated that pursuant to 45 C.F.R. § 160.312(a)(3), OCR was informing TX HHSC of the preliminary indications of non-compliance and providing TX HHSC with an opportunity to submit written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 45 C.F.R. § 160.410 for OCR’s consideration in making a CMP determination under 45 C.F.R. § 160.404. The letter identified each area of noncompliance.  It also stated that TX HHSC also could submit written evidence to support a waiver of a CMP for the indicated areas of non-compliance.

Although the designated representative for TX HHSC as DADS successor received the Letter of Opportunity on May 24, 2018, . TX HHSC did not provide any written evidence of mitigating factors under 45 C.F.R. § 160.408 or affirmative defenses under 4S C.F.R. § 160.410 for OCR’s consideration in making the CMP determination or submit any written evidence to support a waiver of a CMP for the indicated areas of non-compliance.  Accordingly, after securing the requisite approval from the Justice Department, OCR issued a Notice of Proposed Determination of Civil Monetary Penalties (“Proposed CMP”) on July 29, 2019.

As explained by the Proposed CMP, as amended by the HITECH Act, Section 13410, 42 U.S.C. § 1320d-5(a)(3), HIPAA authorizes OCR as the designated representative of the Secretary of HHS to impose CMPs against a covered entity for post-February 18, 2009 HIPAA Privacy or Security Rule violations.  These current CMP provisions provide the following rules for the assessment of CMPs for such violations:

  • A minimum of$100 for each violation where the covered entity or business associate did not know and, by exercising reasonable diligence, would not have known that the covered entity or business associate violated such provision, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $25,000.
  • A minimum of$1,000 for each violation due to reasonable cause and not to willful neglect, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $100,000. Reasonable cause means an act or omission in which a covered. entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.
  • A minimum of $10,000 for each violation due to willful neglect and corrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $250,000.
  • A minimum of$50,000 for each violation due to willful neglect and uncorrected within 30 days, except that the total amount imposed on the covered entity or business associate for all violations of an identical requirement or prohibition during a calendar year may not exceed $1,500,000.

By law, OCR adjusts the CMP ranges and calendar year cap for each penalty tier for inflation.  The adjusted amounts are applicable only to CMPs whose violations occurred after November 2, 2015.

The Proposed CMP included notice of the CMPs OCR intended to impose CMPs totaling $1.6 million for the violations.  Characterizing each of the violations as due to reasonable cause and not willful neglect, the Proposed CMP Notice made note that OCR was authorized by statute to assess penalties of up to $50,000 per day for each day of the identified violations due for reasonable cause, rather than willful neglect, but authorized OCR to adjust the penalties in light of aggravating and mitigating factors.  The Proposed CMP stated that in arriving at the lesser daily penalty amount, OCR considered as mitigating factors that:

  • The violations did not result in any known physical, financial, or reputational harm to any individuals nor did it hinder any individual’s ability to obtain health care;  and
  • TX HHSC immediately removed the application once it received a report that unauthorized users could access the ePHI of individual beneficiaries.

However, OCR also took note that it viewed DADS failure to act promptly to remediate the breach and to keep a commitment made to OCR in August, 2015 timely to conduct and complete the agency wide risk analysis by August 31, 2016 as an aggravating factor.  Considering these factors, the Proposed CMP notified TX HHSC that OCR intended to assess a daily penalty amount of$1,000 per day ($1,141 after November 2, 2015) per violation capped at $100,000 per calendar year per violation. Applying these amounts, the CMP notified TX HHSC that OCR intended to impose CMPs totaling $1.6 million, as follows:

  • Impermissible disclosures in violation of 45 C.F.R. § 164.502(a), a $100,000 CMP
  • Inadequate access controls in violation of 45 C.F .R. § 164.312(a)(l), a $500,000 CMP
  • Inadequate audit controls in violation of 45 C.F.R. § 164.312(b), a $500,000 CMP
  • Failure to perform required enterprise wide risk analysis in violation of 45 C.F.R. § 164.308(a)(l)(ii)(a), a $500,000.

After TX HHSC , as successor to DADS, did not file a request for hearing before an administrative law judge within the 90 days, OCR imposed the $1.6 million CMP in dated  October 25, 2019 made public on November 7, 2019.

Lessons For Other Health Care Providers, Health Plans, Clearinghouses & Business Associates

The latest in a growing series of multimillion dollar CMPs and Resolution Payments assessed and collected by OCR, the TX HHSC CMP illustrates the critical necessity for all covered entities and business both to take appropriate, well-documented action to prevent, timely discover and redress, and report ePHI breaches and otherwise comply with the otherwise applicable requirements of the HIPAA Privacy, Security and Breach Notification Rules including the conduct and continuous maintenance of appropriate enterprise wide security assessments, audits, and oversight.  With OCR promising to continue its enforcement, all covered entities and business associates should verify the existence and adequacy of their existing enterprise wide risk assessments and safeguards and procedures for monitoring, investigating potential security risks and other breaches and other HIPAA compliance oversight.  Beyond these compliance efforts, the TX HHSC and other CMP actions also drive home the strong advisability for covered entities or business associates that experience a known or potential breach or other violation promptly to investigate and mitigate potential breaches and other violations.  As part of these efforts, covered entities and business associates should seek assistance in conducting their assessments as well as responding to any preexisting and emergent breach or other compliance concerns within the scope of attorney-client privilege from qualified legal counsel with the necessary knowledge and experience of HIPAA and other federal and state laws, regulations and administrative and judicial decisions that define and shape their exposure.  In the event of a breach or other compliance concern, timely guidance and representation by legal counsel with both experience of these requirements and with dealing with OCR and other agencies may help mitigate exposures by expediting timely and appropriate response.

For More Information

We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation GroupMs. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; 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.

Ms. Stamer is most widely recognized for her decades-long 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.  This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve  sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, antikickback, 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 leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

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 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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The 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.

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.

©2019 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.


IRS Proposes Easing Disclosure Requirements For Certain Tax-Exempt Entities

October 9, 2019

December 10, 2019 is the deadline for charitable and other tax-exempt organizations to comment on proposed regulations the Internal Revenue Service (“IRS”) intends to use to implement clarify the reporting requirements generally applicable to tax-exempt organizations as they apply to returns filed after September 6, 2019.

The proposed regulations officially published by the IRS in the September 10, 2019 Federal Register implement changes in response to various statutory amendments and certain grants of reporting relief announced by the Treasury Department and the IRS in prior guidance to help many tax-exempt organizations generally find the reporting requirements in one place.  Among other provisions, the proposed regulations incorporate the existing exception from having to file an annual return for certain organizations that normally have gross receipts of $50,000 or less, which is found in Revenue Procedure 2011-15.

In addition, the proposed regulations also reissue relief for certain tax-exempt entities from requirements to report contributor names and addresses on annual returns filed by certain tax-exempt organizations.  Originally announced last year in Revenue Procedure 2018-38, the relief was invalidated by a district court ruling that the Treasury Department and the IRS failed to follow required notice and comment procedures.  Under the proposed regulations, filing requirements for Section 501(c)(3) organizations and Section 527 political organizations remain unchanged, and all organizations are required to keep the contributor information and make it available to the IRS upon request.

Additionally, the IRS issued Notice 2019-47 (PDF) providing penalty relief for certain exempt organizations that, consistent with the 2018 guidance from the IRS, do not report the names and addresses of contributors on annual returns for tax years ending on or after December 31, 2018, but on or before July 30, 2019.

Need more information or help evaluating or responding to this or developments?  Contact the author licensed attorney experienced in FDA and other health care and other regulatory affairs matters.

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications including extensive experience advising and representing health care systems and providers about sexual abuse, assault, harassment, discrimination and other personal and professional misconduct policies, training and other prevention and investigation, peer review and other discipline, mitigation and charges defense, as well extensively published and conducted workshops on “Sex, Drugs & Rock ‘N Role:  Preventing and Addressing Personal Misconduct In Healthcare,” “What To Do When Your Employee’s Life Becomes Your Business,” and other educational training and publications for health industry clients and others on these concerns.

In these and other legal, management, governmental affairs work and speaking and publications, Ms. Stamer When working with these and other clients, Ms. Stamer merges a talent for creative problem solving with her detailed legal and operational knowledge and experience to help her clients develop and use legally defensible, pragmatic, client-centric law, performance and risk management tools and processes to manage people, performance, quality, compliance, risk and other operational needs on a real-time, “on demand” basis as well as outsourced general, operations, regulatory affairs or other special counsel capacity on an interim, special project, or ongoing basis.  Her clients have included domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients.

Her involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, discipline and defend 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, antikickback, 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 leading works on a multitude of health care, health plan and other health industry matters, 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 here or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2019 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.


Air Ambulance Bills Drawing Congressional “Surprise Billing” Scrutiny

July 31, 2019

Congress is looking into air ambulance rates. The top Republican on the House Ways and Means Committee Kevin Brady (R-TX) and Committee Chairman Richard E. Neal (D-MA) sent a letter to Department of Transportation (DOT) Secretary Elaine Chao, urging her to comply with congressional requirements and promptly convene the Air Ambulance and Patient Billing (AAPB) Advisory Committee.

Part of continuing Congressional concern about reports that patients and their families suffer financial hardship from “surprise bills” for emergency care, Congress directed DOT to establish this task force within 60 days of enactment of the FAA Reauthorization Act of 2018, but 10 months have passed since the President signed the bill into law and the advisory committee still has not met. The task force’s purpose is to inform Congress on air ambulance medical patient billing as Ways and Means Committee leaders work to address the issue of balance billing.

The Government Accountability Office (GAO) issued a report this year that found that nearly 70 percent of analyzed air ambulance transports conducted in 2017 for privately insured patients were out-of-network, a significantly higher rate than other emergency services. The cost of these out-of-network air ambulance services are leaving patients exposed to unexpectedly high out-of-pocket bills.

The AAPB Advisory Committee is required to provide Congress, DOT, and the Department of Health and Human Services with recommendations to protect consumers from balance billing for air ambulance transports, requirements for the disclosure of charges and fees for these services, and consumer protection and enforcement authorities of both the DOT and states. “This information is critical as Congress considers appropriate steps to find the best solution to protect consumers from surprise bills,” wrote Brady and Neal. “However, the committee has failed to convene, let alone produce a report. Additionally, Congress mandated the Secretary of DOT to submit a report to the appropriate committees of Congress on air ambulance oversight, which has also yet to be provided.”

Brady and Neal requested that, within 14 days, DOT provide updated deadlines for the appointment of individuals to the task force, along with a timeline for convening the advisory committee and providing recommendations and a final report.

Patients using air ambulance and other services used in emergency circumstances generally don’t have the option of choosing network participating providers and often their health plans may not cover or only provide limited coverage for that transportation. On the other hand, air ambulance operators point out that the services are costly to own and operate requiring substantial investment in equipment, staff, regulations and other operating costs on standby and ready to respond on demand. They also point out that limited coverage for their services already creates a high uncollectible debt load. Because of these and other challenges many cities, counties and other governmental entities assume or subsidize these operating costs to help preserve the availability of services. They caution that increased regulation likely would adversely impact the availability of these services in rural or other areas where prompt transportation can mean the difference between life and death for critical patients.

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; 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 investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Author of leading works on a multitude of health care, health plan and other health industry matters, 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 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 your profile here.

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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2019 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.


Listen In on Free 11/15 Telemedicine Twitter Chat

November 6, 2018

Health care providers, health plans, communities and others interested in telemedicine should consider listening in on Thursday, November 15 to the Health Resources and Services Administration (HRSA) Twitter chat focusing on telehealth and how technology can help the primary health workforce in rural areas improve quality and accessibility of care. Join subject matter experts, grantees, and key federal and non-federal partners to #Talktelehealth. Follow them on Twitter and join their Twitter chat on November 15 at 2 pm ET.

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage patients, providers and other workforce members, vendors and other people and organizations, their performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; telemedicine, billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients as well as a diverse array of other business and government entities. Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with operational compliance and risk management; strategic planning; product and services development and innovation; workforce and operations management: crisis preparedness and response; public and regulatory affairs and host of other concerns.

As part of this work, Ms. Stamer continuously advises clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters.   She helps clients to establish and administer compliance and risk management policies; 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 investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.  She also helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

As part of this work, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer also continuously works with a diverse array of clients to monitor, shape and respond to federal and state legislative, regulatory, enforcement and other public policy and regulatory affairs concerns.

Author of leading works on a multitude of these and other concerns, 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, and Board Certified by the Texas Board of Legal Specialization in Labor and Employment Law, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or experience publications, speaking, public advocacy or other involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 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 your profile here.

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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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.


Record $16M Anthem HIPAA Settlement Signals Need To Tighten HIPAA Compliance & Risk Management

October 16, 2018

Health care providers, managed care organizations, health plans and insurers, health care clearinghouses and their business associates should study and learn from the just announced, record-setting $16 million resolution agreement between health insurance giant, Anthem, Inc. and the Department of Health & Human Services Office of Civil Rights (OCR).  The resolution agreement resolves OCR charges that Anthem, Inc.’s violations of the Health Insurance Portability & Accountability Act (HIPAA) Privacy and Security Rules exposed the electronic protected health information (ePHI) of almost 79 million people.  In addition to reviewing the adequacy of their own HIPAA privacy and security practices, health care providers, health plans, their employer and union sponsors and fiduciaries also should consider assessing the advisability of tightening their business associate and other agreements with health insurers, third party administrative services providers and other vendors in light of the resolution agreement and practical experiences with the fallout of the Anthem breach to better position themselves to assess and enforce HIPAA compliance, receive notice and respond in the event of an insurer or other vendor breach and mitigate financial costs and liabilities resulting from breaches or other compliance deficiencies.

Anthem’s Record Setting Breach & Resolution Agreement

The settlement agreement announced October 15, 2018 by OCR requires Anthem, Inc. to pay a $16 million resolution payment to OCR and take a series of corrective actions to resolve HIPAA liabilities to OCR for allowing the largest known U.S. health data breach in history in 2015.

The record $16 million resolution payment eclipses the prior record resolution payment of $5.55 million Memorial Healthcare System (MHS) paid OCR to settle HIPAA charges in 2016.

An independent licensee of the Blue Cross and Blue Shield Association and one of the nation’s largest health benefits companies, Anthem provides medical care coverage to one in eight Americans through its affiliated health plans.  The breach that resulted in the settlement agreement affected ePHI Anthem maintained for its affiliated health plans including many employer or union sponsored self-insured and insured group health plans and other HIPAA-covered entity health plans.

On March 13, 2015, Anthem filed a breach report with the HHS Office for Civil Rights  that disclosed that Anthem discovered on January 29, 2015 that cyber-attackers had gained access to and engaged in continuous and targeted cyberattack on Anthem’s IT system for the apparent purpose of extracting data, otherwise known as an advanced persistent threat attack.  After filing its breach report, Anthem discovered cyber-attackers had infiltrated their system through spear phishing emails sent to an Anthem subsidiary after at least one employee responded to the malicious email and opened the door to further attacks. OCR’s investigation revealed that between December 2, 2014 and January 27, 2015, the cyber-attackers stole the ePHI of almost 79 million individuals, including names, social security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information.

In addition to the impermissible disclosure of ePHI, OCR’s investigation revealed that Anthem failed to conduct an enterprise-wide risk analysis, had insufficient procedures to regularly review information system activity, failed to identify and respond to suspected or known security incidents, and failed to implement adequate minimum access controls to prevent the cyber-attackers from accessing sensitive ePHI, beginning as early as February 18, 2014.

Beyond the consequences for the millions of individuals whose ePHI was disclosed through the breach, the breach also triggered responsibilities and concerns for heath care providers who contracted to provide care or services to Anthem plan members, fiduciaries and sponsors of the employer and union-sponsored group health plans administered or insured by Anthem.  Health care providers and their patients were forced to deal with the fall out of having patient data exposed in the breach.  In addition sponsors and fiduciaries of private sector employer or union sponsored plans struggled to obtain information and cooperation from Anthem necessary to evaluate and fulfill their health plans’ HIPAA obligations as well as the fiduciary responsibility requirements of the Employee Retirement Income Security Act (ERISA).

In addition to the $16 million settlement that Anthem is paying to resolve OCR’s HIPAA charges stemming from the breach, the OCR settlement agreement also requires Anthem to undertake a robust corrective action plan to comply with the HIPAA Rules.

In addition to the $16 million paid under the OCR resolution agreement, anthem already has paid more than $115 million to settle lawsuits arising out of the breach under other laws.

Anthem Follows On Other Recent Enforcement

The record setting Anthem resolution agreement is notable in part as one of the few high dollar settlement agreements involving a health plan.  To date, the overwhelming majority of HIPAA enforcement actions have involved health care providers.

Rgeardless of the category of the covered entity involved, however, the Anthem settlement again drives home the risks health care providers, health plans and other covered entities and their business associates run for lax HIPAA compliance and risk management.  The latest in the growing list of high dollar HIPAA settlements OCR has collected from health care provider and other covered entities including the $999,0000 in settlement payments OCR announced on September 20, 2018 that Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH) paid  for putting publicity before patient privacy by allowing ABC News documentary film crews to film patients and access other patient information for a news documentary without obtaining prior patient authorization under three settlement agreements.

Act To Manage Compliance & Risks

Unquestionably, health care providers, other health insurers, employer, union and association sponsored group health plans, and their vendors and business associates should evaluate the adequacy and defensibility of their own health plan privacy and security practices in light of the Anthem breach and resolution agreement.  In addition, employer, union or association health plan sponsors, administrative service providers and fiduciaries also should consider the advisability of strengthening their business associate agreements with insurers, third party administrators and other health plan service providers to incorporate safeguards, audit, oversight or other provisions and practices to help prudently monitor potential risks and improve their ability to receive timely notice, respond to, and preserve rights of recourse against insurers or other vendors in the event of a breach or other deficiency.

Since Covered Entities also are likely to be subject to other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by the Privacy Rule, most Covered Entities also will want to consider and take steps to identify and address other potential legal or ethical responsibilities such as medical confidentiality duties applicable to physicians and other health care providers under medical ethics, professional licensure or other similar rules, contractual responsibilities, as well as common law privacy or other related exposures when conducting this review.  Additionally, most Covered Entities also will want to take into account and manage their potential exposure to privacy, theft of likeness or other intellectual property, or other statutory or common law tort or contractual claims that might attached to the unauthorized filming, photographing, or surveillance of individuals under federal or state common or statutory laws.

Since this analysis and review in most cases will result in the uncovering or discussion of potentially legally or politically sensitive information, Covered Entities should consider consulting with or engaging experienced legal counsel for assistance in structuring and executing these activities to maximize their ability to claim attorney-client privilege or other evidentiary protections against discovery or disclosure of certain aspects of these activities.

Finally, Covered Entities should keep in mind that HIPAA compliance and risk management is an ongoing process requiring constant awareness and diligence.  Consequently, Covered Entities should both monitor OCR and other regulatory and enforcement developments as well as exercise ongoing vigilance to monitor and maintain compliance within their organizations.

About The Author

A practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C, Cynthia Marcotte Stamer’s more than 30 years’ of leading edge work as an practicing attorney, author, lecturer and industry and policy thought leader have resulted in her recognition as a “Top” attorney in employee benefits, labor and employment and health care law.

Board certified in labor and employment law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, Scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) Annual Agency Meeting with the Office of Civil Rights and a former JCEB Council Representative; former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; and past Chair, former Welfare Benefit Committee Co-Chair and current Fiduciary Responsibility Committee Co-Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, former Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, Ms. Stamer is recognized nationally and internationally for her practical and creative insights and leadership on HIPAA and other health care, managed care and insurance, and other employee benefit, human resources, and related antitrust, corporate, privacy and data security, tax and other internal controls, regulatory affairs and public policy concerns.

Ms. Stamer’s legal and management consulting work throughout her career has focused on helping organizations and their management use the law and process to manage people, process, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps public and private, domestic and international health, insurance and financial security, and other businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

In this respect, Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, regulatory compliance and operational and performance management. She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Well known for her extensive work with health care, insurance and other highly regulated entities on corporate compliance, internal controls and risk management, her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.

As a key part of this work, Ms. Stamer uses her deep and highly specialized health, insurance, labor and employment and other knowledge and experience to help health industry, insurance and financial services and other employers and other employee benefit plan sponsors; health, pension and other employee benefit plans, their fiduciaries, administrators and service providers, insurers, and others design legally compliant, effective compliance and internal controls, risk management, human resources and other workforce performance, discipline, compensation, employee benefits and related programs, products and arrangements.

In the course of this work, Ms. Stamer has accumulated an impressive resume of experience advising and representing clients on HIPAA and other privacy and data security concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights for several years, Ms. Stamer has worked extensively with health plans, health care providers, health care clearinghouses, their business associates, employer and other sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health plans, health insurers, health care providers, banking, technology and other vendors, and others. Beyond advising these and other clients on privacy and data security compliance, risk management, investigations and data breach response and remediation, Ms. Stamer also advises and represents clients on OCR and other HHS, Department of Labor, IRS, FTC, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also is the author of numerous highly acclaimed publications, workshops and tools for HIPAA or other compliance including training programs on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

Ms. Stamer also is deeply involved in helping to influence the health care, workforce, insurance and financial services, employee benefit, privacy and data security and other federal, state and local laws, regulations and enforcement actions. She both helps her clients respond to and resolve emerging regulations and laws, government investigations and enforcement actions and helps them shape the rules through dealings with Congress and other legislatures, regulators and government officials domestically and internationally. A former lead consultant to the Government of Bolivia on its Social Security reform law and most recognized for her leadership on U.S. health and pension, wage and hour, tax, education and immigration policy reform, Ms. Stamer works with U.S. and foreign businesses, governments, trade associations, and others on workforce, social security and severance, health care, immigration, privacy and data security, tax, ethics and other laws and regulations. Founder and Executive Director of the Coalition for Responsible Healthcare Policy and its PROJECT COPE: the Coalition on Patient Empowerment and a Fellow in the American Bar Foundation and State Bar of Texas. She also works as a policy advisor and advocate to health, insurance and financial services, employee benefits and other business, professional and civic organizations.

Author of the thousands of publications and workshops these and other employment, employee benefits, health care, insurance, workforce and other management matters, Ms. Stamer also is a highly sought out speaker and industry thought leader known for empowering audiences and readers. Ms. Stamer’s insights on employee benefits, insurance, health care and workforce matters in Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, Modern Healthcare, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications. Ms. Stamer also regularly serves on the faculty and planning committees for symposia of LexisNexis, the American Bar Association, ALIABA, the Society of Employee Benefits Administrators, the American Law Institute, ISSA, HIMMs, and many other prominent educational and training organizations and conducts training and speaks on these and other management, compliance and public policy concerns.

Ms. Stamer also has a lifelong history of involvement with and service with a diverse range of professional, community and charitable organizations and causes including as founder and Executive Director of the Coalition for Responsible Health Care Policy and its PROJECT COPE: Coalition for Patient Empowerment; technical advisor to the National Physicians’ Council for Health Care Policy; a founding Board Member and President of the Alliance for Healthcare Excellence and its Patient Empowerment and Health Care Heroes Projects; a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; a member of the Dallas United Way Long Range Planning Committee; as well as leadership involvement in the ABA Joint Committee on Employee Benefits Council, the North Texas Healthcare Compliance Professionals Association; the ABA RPTE Employee Benefits & Other Compensation Committee, the ABA Health Law Section, the ABA International Section Life Sciences Committee, and the ABA TIPS Employee Benefit Committee; TEGE Coordinator of the Gulf Coast TEGE Council TE Division; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association; Dallas, Regional and State BACPAC Chair of the Texas Association of Business; SHRM Regional Chair and National Advisory Board Chair; WEB Network of Benefits Professionals National and Dallas Boards; as a contributing author and the Advisory Board member of the BNA EBCD CD, InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications and as chair or planning faculty of a multitude of symposia.. For additional information about Ms. Stamer, see www.cynthiastamer.com, or contact Ms. Stamer via email here or via telephone to (214) 452.8297.

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 may be interested reviewing other Solutions Law Press, Inc.™ resources at www.solutionslawpress.com such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


Comments Due Tomorrow (10/17) On ONC Request for Information (RFI) for Input on EHR Reporting Program

October 16, 2018

Comments are due tomorrow on the Department of Health & Human Services Office of the National Coordinator’s (ONC’s) Electronic Health Record (EHR) Reporting Program Request for Information (RFI).

Section 4002(c) of the 21st Century Cures Act requires HHS to establish the program which provides publically available, comparative information on certified health IT. ONC recently issued an RFI for the public to share their views on the components of the EHR Reporting Program, and to provide feedback that will inform the development of EHR Reporting Program criteria and processes as required by the Cures Act.

ONC encourages stakeholders to provide their comments through the online submission process available on the Federal Register. Comments are due at 5:00pm ET tomorrow, October 17, 2018.  Interested persons may submit their comments here

About The Author

A practicing attorney and health industry consultant and policy advocate, Cynthia Marcotte Stamer’s more than 30 years’ of leading edge work as an practicing attorney, author, lecturer and industry and policy thought leader have resulted in her recognition as a “Top” attorney in employee benefits, labor and employment and health care law.

Board certified in labor and employment law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, Scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) Annual Agency Meeting with the Office of Civil Rights and a former JCEB Council Representative; former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; and past Chair, former Welfare Benefit Committee Co-Chair and current Fiduciary Responsibility Committee Co-Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, former Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, Ms. Stamer is recognized nationally and internationally for her practical and creative insights and leadership on HIPAA and other health care, managed care and insurance, and other employee benefit, human resources, and related antitrust, corporate, privacy and data security, tax and other internal controls, regulatory affairs and public policy concerns.

Ms. Stamer’s legal and management consulting work throughout her career has focused on helping organizations and their management use the law and process to manage people, process, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps public and private, domestic and international health, insurance and financial security, and other businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

In this respect, Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, regulatory compliance and operational and performance management. She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Well known for her extensive work with health care, insurance and other highly regulated entities on corporate compliance, internal controls and risk management, her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.

As a key part of this work, Ms. Stamer uses her deep and highly specialized health, insurance, labor and employment and other knowledge and experience to help health industry, insurance and financial services and other employers and other employee benefit plan sponsors; health, pension and other employee benefit plans, their fiduciaries, administrators and service providers, insurers, and others design legally compliant, effective compliance and internal controls, risk management, human resources and other workforce performance, discipline, compensation, employee benefits and related programs, products and arrangements.

In the course of this work, Ms. Stamer has accumulated an impressive resume of experience advising and representing clients on HIPAA and other privacy and data security concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights for several years, Ms. Stamer has worked extensively with health plans, health care providers, health care clearinghouses, their business associates, employer and other sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health plans, health insurers, health care providers, banking, technology and other vendors, and others. Beyond advising these and other clients on privacy and data security compliance, risk management, investigations and data breach response and remediation, Ms. Stamer also advises and represents clients on OCR and other HHS, Department of Labor, IRS, FTC, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also is the author of numerous highly acclaimed publications, workshops and tools for HIPAA or other compliance including training programs on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

Ms. Stamer also is deeply involved in helping to influence the health care, workforce, insurance and financial services, employee benefit, privacy and data security and other federal, state and local laws, regulations and enforcement actions. She both helps her clients respond to and resolve emerging regulations and laws, government investigations and enforcement actions and helps them shape the rules through dealings with Congress and other legislatures, regulators and government officials domestically and internationally. A former lead consultant to the Government of Bolivia on its Social Security reform law and most recognized for her leadership on U.S. health and pension, wage and hour, tax, education and immigration policy reform, Ms. Stamer works with U.S. and foreign businesses, governments, trade associations, and others on workforce, social security and severance, health care, immigration, privacy and data security, tax, ethics and other laws and regulations. Founder and Executive Director of the Coalition for Responsible Healthcare Policy and its PROJECT COPE: the Coalition on Patient Empowerment and a Fellow in the American Bar Foundation and State Bar of Texas. She also works as a policy advisor and advocate to health, insurance and financial services, employee benefits and other business, professional and civic organizations.

Author of the thousands of publications and workshops these and other employment, employee benefits, health care, insurance, workforce and other management matters, Ms. Stamer also is a highly sought out speaker and industry thought leader known for empowering audiences and readers. Ms. Stamer’s insights on employee benefits, insurance, health care and workforce matters in Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, Modern Healthcare, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications. Ms. Stamer also regularly serves on the faculty and planning committees for symposia of LexisNexis, the American Bar Association, ALIABA, the Society of Employee Benefits Administrators, the American Law Institute, ISSA, HIMMs, and many other prominent educational and training organizations and conducts training and speaks on these and other management, compliance and public policy concerns.

Ms. Stamer also has a lifelong history of involvement with and service with a diverse range of professional, community and charitable organizations and causes including as founder and Executive Director of the Coalition for Responsible Health Care Policy and its PROJECT COPE: Coalition for Patient Empowerment; technical advisor to the National Physicians’ Council for Health Care Policy; a founding Board Member and President of the Alliance for Healthcare Excellence and its Patient Empowerment and Health Care Heroes Projects; a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; a member of the Dallas United Way Long Range Planning Committee; as well as leadership involvement in the ABA Joint Committee on Employee Benefits Council, the North Texas Healthcare Compliance Professionals Association; the ABA RPTE Employee Benefits & Other Compensation Committee, the ABA Health Law Section, the ABA International Section Life Sciences Committee, and the ABA TIPS Employee Benefit Committee; TEGE Coordinator of the Gulf Coast TEGE Council TE Division; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association; Dallas, Regional and State BACPAC Chair of the Texas Association of Business; SHRM Regional Chair and National Advisory Board Chair; WEB Network of Benefits Professionals National and Dallas Boards; as a contributing author and the Advisory Board member of the BNA EBCD CD, InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications and as chair or planning faculty of a multitude of symposia.. For additional information about Ms. Stamer, see www.cynthiastamer.com, or contact Ms. Stamer via email here or via telephone to (214) 452.8297.

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 may be interested reviewing other Solutions Law Press, Inc.™ resources at www.solutionslawpress.com such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 


$999K Price Hospitals Pay To Settle HIPAA Privacy Charges From Allowing ABC To Film Patients Without Authorization

September 21, 2018

With New Settlements, OCR Collections From HIPAA Covered Entities For Improperly Allowing Filming Or Other PHI Disclosures To Media Now Exceed $3 Million

$999,0000 is the collective price tag paid by Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH)(collectively, the “Hospitals”) for putting publicity before patient privacy by allowing ABC News documentary film crews to film patients and access other patient information for a news documentary without obtaining prior patient authorization under three settlement agreements with the Hospitals just announced by the Department of Health and Human Services (HHS) Office of Civil Rights (OCR).

On Thursday, September 20, 2018, OCR announced the three Hospitals collectively have paid a total of $999,000 to settle OCR charges that each Hospital separately violated each violated patients’ Health Insurance Portability & Accountability Act (HIPAA) privacy rights by allowing ABC television documentary film crews to observe and film patients and otherwise access to patient’s protected health information (“PHI”) without prior HIPAA-compliant patient authorization.  The payments were made under three separate settlement agreements between OCR and each respective Hospital made public by OCR in connection with the September 20, 2018 announcement stemming from the Hospital’s allowing ABC film crews to film in patient treatment and other areas for  the ABC medical documentary “Save My Life: Boston Trauma” series.

Considered in conjunction with OCR’s April 16, 2016 announcement of its $2.2 million HIPAA settlement (NY-Presby Settlement) with New York-Presbyterian Hospital for allowing film crews from the “NY Med” television series to film patients and OCR’s concurrently-published 2016 Frequently Asked Question (Media FAQ) addressing Covered Entities’ responsibilities when dealing with the media, the three newly-announced settlement agreements drive home the need for physicians, hospitals and other health care providers, health plans, health care clearinghouses and their business associates (“Covered Entities”) to protect patients and their PHI against unauthorized filming, photography, observation and other access by news or other media or even other staff, patients or visitors.  With OCR now having collected nearly $3 million in settlement proceeds from 4 separate providers for violating these rules, all Covered Entities should review and tighten their current policies, practices and staff training regarding media access and relations, filming and photographing of patients and patient information within their facilities and other HIPAA compliance to reduce the potential that their organizations will fall subject to similar enforcement by OCR.

Media FAQ Highlights Duty To Protect Patients Against Unauthorized Filming, Photography & Other PHI Disclosures By Media, Others

OCR specifically alerted Covered Entities about their responsibility to safeguard patients and their PHI in dealings with the media in the Media FAQ OCR published in connection with its 2016 announcement of its $2.2 million settlement with New York-Presbyterian Hospital.

Among other things, the Media FAQ states that HIPAA prohibits health care providers and other Covered Entities from inviting or allowing media personnel into treatment or other areas where patients or patient PHI will be accessible in written, electronic, oral, or other visual or audio form, or otherwise making PHI accessible to the media without prior written authorization from each patient or other subject of the PHI who is or will be in the area or whose PHI otherwise will be accessible to the media except in a very limited set of circumstances set forth in the Media FAQ.

The Media FAQ also states, “It is not sufficient for a health care provider to request or require media personnel to mask the identities of patients (using techniques such as blurring, pixilation, or voice alteration software) for whom an authorization was not obtained, because the HIPAA Privacy Rule does not allow media access to the patients’ PHI, absent an authorization, in the first place.

In addition, the Media FAQ states that a health care provider also must ensure that reasonable safeguards are in place to protect against impermissible disclosures or to limit incidental disclosures of other PHI that may be in the area but for which an authorization has not been obtained.

Concerning the limited circumstances when a health care provider or other Covered Entity or business associate may disclose to the media or allow unconsented filming, photographing or use of PHI to the media or other film crews, the Media FAQ also clarifies that the HIPAA Privacy Rule does not require health care providers to prevent members of the media from entering areas of their facilities that are otherwise generally accessible to the public like public waiting areas or areas where the public enters or exits the facility.

In addition, the Media FAQ states a health care provider or other Covered Entity may:

  • Disclose limited PHI about the incapacitated patient to the media in accordance with the requirements of 45 C.F.R. 164.510(b)(1)(ii) when, in the hospital’s professional judgment, doing so is in the patient’s best interest; or
  • Disclose a patient’s location in the facility and condition in general terms that do not communicate specific medical information about the individual to any person, including the media, without obtaining a HIPAA authorization where the individual has not objected to his information being included in the facility directory, and the media representative or other person asks for the individual by name as specified in 45 C.F.R. 164.510(a).

The Media FAQ also discusses circumstances where a healthcare provider or other Covered Entity may use the services of a contract film crew to produce training videos or public relations materials on the provider’s behalf if the provider ensures that the film crew acting as a business associate enters into a HIPAA compliant business associate agreement with the Covered Entity which among other things ensures that the film crew will safeguard the PHI it obtains, only use or disclose the PHI for the purposes provided in the agreement, and return or destroy any PHI after the work for the health care provider has been completed as required by 45 C.F.R. 164.504(e)(2). The Media FAQ also states that as a business associate, the film crew must comply with the HIPAA Security Rule and a number of provisions in the Privacy Rule, including the Rule’s restrictions on the use and disclosure of PHI.  In addition, the Media FAQ reminds Covered Entities and business associates of the need to obtain prior authorizations from patients whose PHI is included in any materials before any of those materials are posted online, printed in brochures for the public, or otherwise publicly disseminated.

Finally, the Media FAQ states Covered Entities can continue to inform the media of their treatment services and programs so that the media can better inform the public, provided that, in doing so, the covered entity does not share PHI with the media.

4 High Dollar HIPAA Settlements HIPAA Sanctions Covered Entities Risk By Allowing Improper Media & Other Recording, Use Or Access To PHI

The nearly $3 million in total settlement payments collected under the original 2016 NY-Presby Settlement and three additional settlement agreements announced by OCR on September 20, 2018 collectively make clear that health care providers or other Covered Entities risk substantial sanctions from OCR for allowing television or other media to film or access patients or their PHI without first obtaining a HIPAA-compliant authorization from the patient.

  • $2.2 Million NY-Presby Settlement

OCR originally made clear that its intention that other Covered Entities learn from the NY- Presbyterian experience in its April 21, 2016 announcement of the Resolution Agreement.  The announcement quoted OCR Director Jocelyn Samuels as stating, “This case sends an important message that OCR will not permit covered entities to compromise their patients’ privacy by allowing news or television crews to film the patients without their authorization.”

Of course, even without then OCR Director Samuel’s warning, the $2.2 million settlement amount OCR required NY-Presbyterian Hospital to pay under the NY-Presby Resolution Agreement alone strongly signaled OCR’s willingness to harshly sanction health care providers and other Covered Entities for putting media coverage before patients.

According to the NY-Presby Resolution Agreement, OCR’s investigation revealed that NY-Presbyterian “blatantly” violated HIPAA when it allowed ABC film crews and staff virtually unfettered access to its health care facility.  OCR says the access NY-Presbyterian allowed ABC effectively created an environment where patients PHI could not be protected from impermissible disclosure to the ABC film crew and staff filming the episode.  While the Resolution Agreement reflects allowing the filming and other access to ABC without prior HIPAA-compliant authorization from patients in the facility itself violated HIPAA, OCR also particularly found “egregious” the facility allowing ABC film crews and staff to film a dying patient and another patient in significant distress without first obtaining a HIPAA-compliant authorization from each of those patients and even more so that NY-Presbyterian failed stop the filming even after a medical professional urged the crew to stop.

Based on its investigation, OCR charged NY-Presbyterian with violating 45 C.F.R. §§ 164.502(a) and 164.530(c) by:

  • Impermissibly disclosing the PHI of two identified patients to the film crew and other staff of “NY Med”; and
  • Failing appropriately and reasonably to safeguard its patients’ PHI from disclosure during the filming of “NY Med” on its premises; and
  • Failing to implement policies, procedures and practices to protect the privacy of its filming of aforementioned television show.
  • BMC Settlement Agreement

The circumstances that resulted in the three resolution agreements announced on September 20, 2018 are strikingly similar to those underlying the NY-Presby Resolution Agreement. Notably, the investigations that resulted in the three settlement agreements all arose out of the respective Hospital’s permitting an ABC documentary film crew filming a medical documentary to access patient areas of their hospitals.  OCR’s investigation of MGH arose in response to an announcement about the impending filming on its website while OCR’s investigations of BMC and BWH started in response to a January 12, 2015 Boston Globe article that reported the Hospitals each separately had allowed ABC film crews filming a documentary to access PHI and film patients without obtaining patient authorization.  See Boston Medical Center Resolution Agreement (BMC Settlement Agreement);  Brigham and Women’s Hospital Resolution Agreement (BWH Settlement Agreement); and Massachusetts General Hospital Resolution Agreement (MGH Resolution Agreement)

The MGH Resolution Agreement reflects that OCR’s investigations began with an investigation of MGH on December 17, 2014 based on a news story posted to MGH’s website on October 3, 2014, indicating that ABC News would be filming a medical documentary program at MGH. The MGH Resolution Reports that the investigation revealed that before allowing the filming between October 2014 to January 2015, MGH reviewed and assessed patient privacy issues related to the filming and implemented various protections regarding patient privacy, including providing the ABC film crew with the same HIPAA privacy training received by MGH’s workforce.

Information contained in the respective settlement agreements reflect that OCR’s investigations of BMC and BWH began about a month later on January 25 and 26, 2015 respectively in response to the Boston Globe article. The BWH Settlement Agreement states that the BWH investigation revealed that like MGH, BWH reviewed and assessed patient privacy issues related to the filming and implemented various protections regarding patient privacy, including providing the ABC film crew with the same HIPAA privacy training received by BWH’s workforce before allowing the filming by the ABC film crew that occurred between October 2014 to January 2015.  The BMC Settlement Agreement does not state that OCR found BMC engaged in similar deliberations or undertook the same or other efforts to safeguard patients and their PHI.

The BMC Settlement Agreement reports that the OCR concluded based on the BMC investigation showed that BMC impermissibly disclosed PHI of patients to ABC employees during the production and filming of a television program at BMC in violation of HIPAA.  Meanwhile, while acknowledging the privacy deliberations and efforts undertaken at MGH and BWH, OCR also concluded that each of those organizations also violated HIPAA because in allowing the film crew access and to film patients and patient areas:

  • The timing at which they obtained patient authorizations showed MGH and BWH impermissibly disclosed the PHI of patients to ABC employees during the production and filming of a television program at BWH; and
  • Despite the various patient privacy protections that were put in place, MGH and BWH failed to appropriately and reasonably safeguard its patients’ PHI from disclosure during a filming project conducted by ABC on its premises in 2014 and January 2015.

To resolve potential HIPAA violations, BMC has paid OCR $100,000, BWH has paid OCR $384,000, and MGH has paid OCR $515,000. In addition, each Hospital agreed to provide workforce training as part of a corrective action plan that will include OCR’s guidance on disclosures to film and media in the 2016 Media FAQ.

OCR To Covered Entities:  Prevent Unauthorized Filming, Photography & PHI Access & Disclosures To Media, Other Third Parties

Given the clear warnings communicated by OCR in its Media FAQ and September 20, 2018 and NY-Presby Settlements, all Covered Entities should take steps to verify that their current policies, practices and training are appropriately designed and administered to ensure their ability to demonstrate compliance with OCR’s interpretation of the Privacy Rule as prohibiting health care providers or other Covered Entities from allowing film or media to film, photograph or even access areas where patients or their PHI are accessible or otherwise disclosing PHI to members of the media without first obtaining a HIPAA-compliant authorization from each patient whose presence or PHI could be observed, recorded or otherwise accessed.

When considering the adequacy of their current policies, practices and training concerning filming, photography and other access and disclosure to patients, patient treatment areas and other PHI, Covered Entities should resist the temptation to read the Media FAQ and media settlement agreements as relevant only to their policies concerning filming, photography and PHI access by members of the media.  In this respect, it bears noting that the NY-Presby Settlement expressly required NY-Presbyterian as part of its required corrective action to adopt and enforce policies requiring that “all photography, video recording and audio recording conducted on NY-Presbyterian premises” be reviewed, preapproved and actively monitored by appropriate NY-Presbyterian representatives for compliance with the Privacy Rule and NY-Presbyterian’s policies.  This requirement to adopt and administer appropriate safeguards to control filming or photography and other access to patients and their PHI generally, rather than just by the media, reflects a recognition by OCR that HIIPAA’s requirement that Covered Entities secure prior HIPAA-compliant authorization before allowing others to access or disclosing PHI to others applies to access or disclosure to “any third party not involved in patient care,” not merely those to media or film crews. Consequently, Covered Entities also should consider the implications of the guidance shared in the Media FAQ and media settlement agreements on the adequacy and defensibility of their current policies, practices and training about filming, photographing, or other access or disclosure to patients, patient treatment areas and PHI by any party within their facilities and organizations.

When evaluating these responsibilities and risks, Covered Entities are encouraged not only to take into account potential risks from filming, photographs or other access to patients or patient treatment or recordkeeping areas by third-parties unaffiliated with their organizations as well as filming, photographs and other access by staff, employees or business associates within their facilities.  Covered Entities should take steps to monitor and properly restrict and protect any filming, photography or other observations, records or other access to patients or their information by individuals within their workforce, as well as to regulate the access and activities of unrelated third parties.  In this respect, Covered Entities are cautioned about the need to prohibit and enforce restrictions against members of their workforce using their own personal devices or other equipment to film, photograph, and copy or disseminate photographs, film, recordings or other records or data that qualifies as or contains PHI without authorization in accordance with established protocols.  Covered Entities should ensure that their policies and training make clear that these prohibitions apply whether or not the workforce member believes that identity of the patient or patient information is concealed or otherwise not discoverable.  Moreover, even with respect to photographs, films or other recordings or records legitimately created for treatment, payment or operations purposes, Covered Entities generally need to take steps to restrict use, access and disclosure of the photographs or other recordings to individuals legitimately involved in patient treatment, operations, payment or other activities allowed by the Privacy Rule and to safeguard those materials against use, access or disclosure to others within or outside their workforce except as allowed by HIPAA and other applicable law. .

As part of these activities, Covered Entities should consider conducting a well-documented assessment of their current policies, practices and workforce training on allowing media or other parties to enter, film, photograph or record within their facilities or otherwise disclosing or allowing media access to their facilities as well as their policies about when parties not involved in care of a particular patient can film, photograph, or otherwise record, observe or access areas where patients or patient PHI is or might be present without prior written consent of the patient.

Since Covered Entities also are likely to be subject to other statutory, ethical, contractual or other privacy or confidentiality requirements beyond those imposed by the Privacy Rule, most Covered Entities also will want to consider and take steps to identify and address other potential legal or ethical responsibilities such as medical confidentiality duties applicable to physicians and other health care providers under medical ethics, professional licensure or other similar rules, contractual responsibilities, as well as common law privacy or other related exposures when conducting this review.  Additionally, most Covered Entities also will want to take into account and manage their potential exposure to privacy, theft of likeness or other intellectual property, or other statutory or common law tort or contractual claims that might attached to the unauthorized filming, photographing, or surveillance of individuals under federal or state common or statutory laws.

Since this analysis and review in most cases will result in the uncovering or discussion of potentially legally or politically sensitive information, Covered Entities should consider consulting with or engaging experienced legal counsel for assistance in structuring and executing these activities to maximize their ability to claim attorney-client privilege or other evidentiary protections against discovery or disclosure of certain aspects of these activities.

Finally, Covered Entities should keep in mind that HIPAA compliance and risk management is an ongoing process requiring constant awareness and diligence.  Consequently, Covered Entities should both monitor OCR and other regulatory and enforcement developments as well as exercise ongoing vigilance to monitor and maintain compliance within their organizations.

About The Author

A practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C, Cynthia Marcotte Stamer’s more than 30 years’ of leading edge work as an practicing attorney, author, lecturer and industry and policy thought leader have resulted in her recognition as a “Top” attorney in employee benefits, labor and employment and health care law.

Board certified in labor and employment law by the Texas Board of Legal Specialization, a Fellow in the American College of Employee Benefit Counsel, Scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) Annual Agency Meeting with the Office of Civil Rights and a former JCEB Council Representative; former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group; and past Chair, former Welfare Benefit Committee Co-Chair and current Fiduciary Responsibility Committee Co-Chair of the American Bar Association (ABA) RPTE Section Employee Benefits Group, former Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, Ms. Stamer is recognized nationally and internationally for her practical and creative insights and leadership on HIPAA and other health care, managed care and insurance, and other employee benefit, human resources, and related antitrust, corporate, privacy and data security, tax and other internal controls, regulatory affairs and public policy concerns.

Ms. Stamer’s legal and management consulting work throughout her career has focused on helping organizations and their management use the law and process to manage people, process, compliance, operations and risk. Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer helps public and private, domestic and international health, insurance and financial security, and other businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

In this respect, Ms. Stamer works with businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, regulatory compliance and operational and performance management. She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Well known for her extensive work with health care, insurance and other highly regulated entities on corporate compliance, internal controls and risk management, her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.

As a key part of this work, Ms. Stamer uses her deep and highly specialized health, insurance, labor and employment and other knowledge and experience to help health industry, insurance and financial services and other employers and other employee benefit plan sponsors; health, pension and other employee benefit plans, their fiduciaries, administrators and service providers, insurers, and others design legally compliant, effective compliance and internal controls, risk management, human resources and other workforce performance, discipline, compensation, employee benefits and related programs, products and arrangements.

In the course of this work, Ms. Stamer has accumulated an impressive resume of experience advising and representing clients on HIPAA and other privacy and data security concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights for several years, Ms. Stamer has worked extensively with health plans, health care providers, health care clearinghouses, their business associates, employer and other sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health plans, health insurers, health care providers, banking, technology and other vendors, and others. Beyond advising these and other clients on privacy and data security compliance, risk management, investigations and data breach response and remediation, Ms. Stamer also advises and represents clients on OCR and other HHS, Department of Labor, IRS, FTC, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She also is the author of numerous highly acclaimed publications, workshops and tools for HIPAA or other compliance including training programs on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

Ms. Stamer also is deeply involved in helping to influence the health care, workforce, insurance and financial services, employee benefit, privacy and data security and other federal, state and local laws, regulations and enforcement actions. She both helps her clients respond to and resolve emerging regulations and laws, government investigations and enforcement actions and helps them shape the rules through dealings with Congress and other legislatures, regulators and government officials domestically and internationally. A former lead consultant to the Government of Bolivia on its Social Security reform law and most recognized for her leadership on U.S. health and pension, wage and hour, tax, education and immigration policy reform, Ms. Stamer works with U.S. and foreign businesses, governments, trade associations, and others on workforce, social security and severance, health care, immigration, privacy and data security, tax, ethics and other laws and regulations. Founder and Executive Director of the Coalition for Responsible Healthcare Policy and its PROJECT COPE: the Coalition on Patient Empowerment and a Fellow in the American Bar Foundation and State Bar of Texas. She also works as a policy advisor and advocate to health, insurance and financial services, employee benefits and other business, professional and civic organizations.

Author of the thousands of publications and workshops these and other employment, employee benefits, health care, insurance, workforce and other management matters, Ms. Stamer also is a highly sought out speaker and industry thought leader known for empowering audiences and readers. Ms. Stamer’s insights on employee benefits, insurance, health care and workforce matters in Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, Modern Healthcare, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications. Ms. Stamer also regularly serves on the faculty and planning committees for symposia of LexisNexis, the American Bar Association, ALIABA, the Society of Employee Benefits Administrators, the American Law Institute, ISSA, HIMMs, and many other prominent educational and training organizations and conducts training and speaks on these and other management, compliance and public policy concerns.

Ms. Stamer also has a lifelong history of involvement with and service with a diverse range of professional, community and charitable organizations and causes including as founder and Executive Director of the Coalition for Responsible Health Care Policy and its PROJECT COPE: Coalition for Patient Empowerment; technical advisor to the National Physicians’ Council for Health Care Policy; a founding Board Member and President of the Alliance for Healthcare Excellence and its Patient Empowerment and Health Care Heroes Projects; a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; a member of the Dallas United Way Long Range Planning Committee; as well as leadership involvement in the ABA Joint Committee on Employee Benefits Council, the North Texas Healthcare Compliance Professionals Association; the ABA RPTE Employee Benefits & Other Compensation Committee, the ABA Health Law Section, the ABA International Section Life Sciences Committee, and the ABA TIPS Employee Benefit Committee; TEGE Coordinator of the Gulf Coast TEGE Council TE Division; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association; Dallas, Regional and State BACPAC Chair of the Texas Association of Business; SHRM Regional Chair and National Advisory Board Chair; WEB Network of Benefits Professionals National and Dallas Boards; as a contributing author and the Advisory Board member of the BNA EBCD CD, InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications and as chair or planning faculty of a multitude of symposia.. For additional information about Ms. Stamer, see www.cynthiastamer.com, or contact Ms. Stamer via email here or via telephone to (214) 452.8297.

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 may be interested reviewing other Solutions Law Press, Inc.™ resources at www.solutionslawpress.com such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 


Key House Committee Votes To Advance HSA & Other Health Choice Reforms; Plans 7/17 Health Care Fraud Hearings

July 13, 2018

A flurry of activity in the House Ways & Means Committee and other Congressional committees over the past few weeks signals the advisability of keeping a close eye on health care and health benefit reform proposals this Summer in anticipation of both the Fall health benefit enrollment and renewal season and the mid-term November Congressional elections.

Certainly continued Congressional commitment to pursue reform is evident from the House Ways & Means Committee’s health care heavy agenda of hearings and votes that this week alone resulted in its voting in favor of 11 health care reform bills promising new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors. While it remains to be seen if the House and Senate can agree on any or all of these proposal, the bi-partisan sponsorship of many of these proposals and the intensity of the focus of the Committee and others in Congress reflects a strong interest in health care reform by both parties leading up to November that could impact health benefit and other health care choices for providers, employers and American families in the Fall annual enrollment season.

The legislation passed by the Ways & Means Committee this weeks include bills that would:

  • Provide relief for employers relief from the Obamacare’s employer mandate and delay for an additional year the effective date of the widely disliked “Cadillac Tax;”
  • Overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for healthcare flexible spending arrangement plans (HFSAs) that currently forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year;
  • Offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage using their subsidies; and
  • Expand expand the availability and usability of HSAs in a multitude of ways.

While the recurrent stalling of past reform efforts over the past few years calls into question whether any or all of these proposals can make it through the highly politicized and divided Congress, bi-partisian sponsorship of most of the bills reported out this week at least raises the possibility that some of these proposals enjoy sufficient bi-partisan support to potentially pass before the elections. With both parties viewing health care reform as a key issue in the upcoming elections, voter feedback on these proposals could play a big role in determining the prospects for passage this Summer.

Passage of any or all of these proposed reforms between now and year end likely will fuel the need for last minute reconsideration and potential adjustments in plan design choices of employers and other health plan sponsors and administrators, reconsideration of health benefit enrollment choices of individual Americans and their families and a reconsideration of practice billing and health plan participation decisions of physicians and other health care providers. Accordingly, health care providers, employers and other health plan sponsors, American taxpayers and their families and others impacted by health care and health benefit policies will want to carefully monitor these reforms as the Summer progresses:

  • To provide timely input to Congress on proposed reforms of particular benefit or concern;
  • To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
  • To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

To learn more details about this proposed legislation, its potential implications or other related concerns, see here or contact the author.

About the Author

After holding hearings on health savings account reforms and passing a flurry of health care reform bills intended to give employers relief from two key Obamacare mandates, to allow Obamacare subsidy-eligible Americans the choice to use the subsidies to purchase health care coverage not offered by the Obamacare exchanges,  and a host of bills that would expand availability and usability of health savings account (HSA) and health care flexible spending account (HFSA) programs this week, the House Ways and Means Committee will turn its attention to health care fraud oversight and reform next week by holding hearings Tuesday on those health concerns.  Health care providers, employer and other health plan sponsors, individual Americans and their families, and others interested in health benefit and health care reform will want to keep a close eye on these and other developments as Congress continues to debate health care reform in the runup to the upcoming 2018 health benefit plan renewal and annual enrollment season and November’s mid-term elections.

Committee Approved 11 Health Care Reform Bills This Week

As a part of its health reform efforts this week, the Committee voted to advance 11 health care reform bills offering new flexibility for employers about how to design their health plans and American families more health care choices and choice about how to pay for it and what coverage to buy popular with many providers, patients and employer and other health plan sponsors.

Among the approved legislation is a bill that would provide key relief for employers from certain key Obamacare mandates that have been widely unpopular with employers.  H.R. 4616, the “Employer Relief Act of 2018,” sponsored by Rep. Devin Nunes (R-CA) and Rep. Mike Kelly (R-PA), which would give employers sponsoring health plans for their employees retroactive relief from Obamacare’s onerous employer mandate and delay for an additional year the effective date of another Obamacare requirement that when effective, will forces employers to pay the 40 percent tax on amounts paid for employer sponsored health care coverage  that exceeds cost limits specified in the Obamacare legislation commonly known as the “Cadillac Tax.”  Relief from the Cadillac Tax is widely perceived as benefiting bother employers and their employees, as its provisions penalize employers for spending more for employee health coverage than limits specified in the Obamacare law.  These provisions also are particularly viewed by many as unfair because rising health plan costs since Obamacare’s passage make it likely that many employers will incur the tax penalty simply by sponsoring relatively basic health plans meeting the Obamacare mandates.

In addition to H.R. 4616,  the Committee also voted to approve H.R. 6313, the “Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018,” sponsored by Rep. Steve Stivers (R-OH), which would overrule the “Use it Or Lose It” requirement in current Internal Revenue Regulations for HFSAs.  Currently, this rule forces employers sponsoring HFSAs to draft their plans to require employees to forfeit unused salary reduction contributions in their HFSA accounts at the end of the year.  The bill would allow employers to eliminate this forfeiture requirement so that employees could carry over any remaining unused balances in their HFSAs at the end of the year to use in a later  year.

The Committee also voted to advance legislation to offer individuals and families eligible for Obamacare created health premium subsidies more choice about where to obtain that coverage.  H.R. 6311, the “Increasing Access to Lower Premium Plans Act of 2018,” sponsored by Chairman Peter Roskam (R-IL) and Rep. Michael C. Burgess, M.D. (R-TX), would provide individuals receiving subsidies to help purchase health care coverage through the Obamacare-created health insurance exchange the option to use their premium tax credit to purchase health care coverage from qualified plans offered outside of the exchanges.  Currently, subsidies may only be used to purchase coverage from health plans offered through the exchange, which often are much more costly and offer substantially fewer coverage options and less provider choice.  In addition, the bill would expand access to the lowest-premium plans available for all individuals purchasing coverage in the individual market and allows the premium tax credit to be used to offset the cost of such plans.

Along with these reforms, the Committee also voted to pass a host of bills that would expand the availability and usability of HSAs including:

  • H.R. 6301, the “Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act of 2018,” co-sponsored by Health Subcommittee Chairman Peter Roskam (R-IL) and Rep. Mike Thompson (D-CA), which seeks to expand access and enhance  the utility of Health Savings Accounts (HSAs) by offering patients greater flexibility in designing their plan design while still being able to maintain their eligibility for HSA contributions.
  • H.R. 6305, the “Bipartisan HSA Improvement Act of 2018,” sponsored by Rep. Mike Kelly (R-PA) and Rep. Earl Blumenauer (D-OR), which also would expand HSA access and  utility by allowing spouses to also make contributions to HSAs is their spouse has an FSA and lets employers offer certain services to employees through on-site or retail clinics.
  • H.R. 6317, the “Primary Care Enhancement Act of 2018,” co-sponsored by Rep. Erik Paulsen (R-MN) and Rep. Earl Blumenauer (D-OR), which seeks to protect HSA-eligible individuals who participate in a direct primary care (DPC) arrangement from losing their HSA-eligibility merely because of their participation in a DPC. In addition, it allows DPC provider fees to be covered with HSAs.
  • H.R. 6312, the “Personal Health Investment Today (PHIT) Act,” sponsored by Rep. Jason Smith (R-MO) and Rep. Ron Kind (D-WI), which seeks to fight obesity and promote wellness by allowing taxpayers to use tax-preferred accounts to pay costs of gym membership or exercise classes, children’s school sports programs and certain other wellness programs and activities.
  • H.R. 6309, the “Allowing Working Seniors to Keep Their Health Savings Accounts Act of 2018,” sponsored by Rep. Erik Paulsen (R-MN), which would expand HSA eligibility to include Medicare eligible seniors who are still in the workforce.
  • H.R.6199, the “Restoring Access to Medication Act of 2018,” sponsored by Rep. Lynn Jenkins (R-KS) and Rep. Grace Meng (D-NY), which would reverse Obamacare’s prohibition on using tax-favored health accounts to purchase over-the-counter medical products and would add feminine products to the list of qualified medical expenses for the purposes of these tax-favored health accounts.
  • H.R. 6306, the “Improve the Rules with Respect to Health Savings Accounts,” sponsored by Rep. Erik Paulsen (R-MN), which would increase the contribution limits for HSAs and further enhances flexibility in plans by allowing both spouses to contribute to make catch-up contributions to the same account and creating a new grace period for medical expenses incurred before the HSA was established.
  • H.R. 6314, the “Health Savings Act of 2018,” sponsored by Rep. Burgess (R-TX) and Rep. Roskam (R-IL), would expand eligibility and access to HSAs by allowing plans categorized as “catastrophic” and “bronze” in the exchanges to qualify for HSA contributions.

Committee Considers Health Care Fraud Next Week 

The Committee next week will turn its attention to health care fraud by holding two hearings on Tuesday.

Both hearings are scheduled to take place in Room 1100 Longworth and their proceedings will be live streamed on YouTube.

The Committee’s health care reform focus this week and next are reflective of the continued emphasis of members of Congress in both parties on health care reform legislation as they prepare for the impending mid-term elections in November.  As a part of these efforts,  the House and Senate already over the past several months have held a wide range of hearings in various committees and key votes on a multitude of reform proposals.  Numerous other hearings and votes are planned over the next several months as Congressional leaders from both parties work to advance their health care agendas in anticipation of the upcoming elections.

Key health care and health benefit reform  proposals that the Republican Majority has designated for priority consideration include:

  • Prescription drug costs by checking perceived negative effects of health industry and health plan consolidations involving large health insurers, pharmacy benefit  management companies (PBMs), pharmacy companies and other health industry and health insurance organizations on health care costs and patient, plan sponsor and plan sponsor choice and health care quality;
  • Oversight and reform of existing STARK, anti-kickback and other federal health care rules and exemptions relied upon by PBMs and other health industry organizations;
  • Efforts to understand and address health care treatment, health care and coverage costs and related social concerns associated with mental health and opioid and other substance abuse conditions and their treatment;
  • Efforts promote health  benefit and health care choice, affordability and coverage;  improve patient and employer choice; promote broader health care access and quality; reduce counterproductive regulation; and other health insurance and care improvements through expanded availability of health savings accounts, direct primary care and other consumer directed health care options, association health plan and other program options, streamlining quality reporting and regulation, billing and coding, physician and other health care provider electronic billing and recordkeeping,  and other provider,  payer, employer, individual and other health insurance mandates and other federal health care and health plan rules; and
  • More.

Health care providers, employers and other health plan sponsors, American taxpayers and their families and others will want to carefully monitor these reforms as the Summer progresses:

  • To provide timely input to Congress on proposed reforms of particular benefit or concern;
  • To help plan for and deal with rules changes that could impact their options and choices during the upcoming health plan renewal and enrollment season this Fall and going forward; and
  • To be prepared to make informed choices when voting in the upcoming mid-term Congressional elections in November.

About the Author

Recognized repeatedly 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 30+ years of health industry, health and other benefit, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer’s clients include employer, associations, government and other health benefit sponsors and administrators, public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry, insurance, technology, government and other management clients.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in pensions, healthcare, workforce, immigration, tax, education and other areas, Ms. Stamer has been extensively involved in U.S. federal, state and local health care and other legislative and regulatory reform impacting these concerns throughout her career.

Beyond her public policy and regulatory affairs involvement, Ms. Stamer also has extensive experience helping these and other clients to design and reform programs and practices; establish and administer compliance and risk management policies; comply with requirements, investigate and respond to government; accreditation and quality organizations; private litigation and other federal and state health care industry investigations and enforcement actions; evaluate and influence legislative and regulatory reforms and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns. supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and employer and association group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns.

Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients design, document and enforce plans, practices, policies, systems and solutions; manage regulatory, contractual and other legal and operational compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Author of leading works on a multitude of health care, health plan and other health industry matters, 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 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 your profile here.

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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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


Check Out CMS 2018 Qualified Clinical Data Registry

February 23, 2018

Physicians and other practitioners should check out the measure specifications for the approved 2018 Qualified Clinical Data Registry (QCDR) measures posted by the Centers for Medicare & Medicaid Services (CMS) yesterday (February 22, 2018).

Rather than being grouped by QCDR, this file allows users to group measures by specialty and topic to see what QCDR measures are most applicable to their practice and/or specialty.

CMS also says, the posting of this specification file will act as a reference tool for existing and potential new QCDR vendors who may be interested in developing their own QCDR measures, and should help them to avoid developing and submitting measures that are duplicative of existing QCDR measures.

About The Author

Repeatedly 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, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with health care providers, health plans, insurers and financial services, and other clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career.  Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.

Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers.    Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

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 here including:

Fresenius Medical Care Pays $3.5 Million HIPAA Settlement

CDC Director Fitzgerald Resigns

Development of Potentially Preventable Hospitalization Measures for Home Health Agencies Panelist Nominations Due 9/22

MAC Operations Continue During Shutdown

HHS Proposes “Conscience Rule” Expanding Abortion And Other Religious Choice

New Medicaid Guidance Gives States More Flexibility On Abortion

New Trump Executive Order Directs More Veterans Health Care Choice, Mental Health Care

Bankrupt Oncology Provider’s $2.3M Settlement Payment & Other HIPAA Breach Consequences Shows Why To Prioritize HIPAA Compliance In 2018

Bill Allowing FDA Emergency Use Authorizations To Protect Military From Biological Warfare Threats Sent to President

OIG Tells Texas Stop Paying Medicaid MCOs For Dead Patients

Michigan Doctor Pleads Guilty To Billing Medicare For Illegally Prescribed Drugs

Anesthesiology Practice Nailed For Improperly Billing For Moderate Sedation

Florida Doctor Sentenced For Multi-Million Dollar Drug & Alcohol Addiction Treatment Health Care Fraud, Money Laundering & Forced Prostitution Scheme

CMS Announces New Medicare Provider Ombudsman

Comment By 1/8 on Guidance for Industry on Expedited Programs for Serious Conditions– Drugs and Biologics

Time To Tighten Business Travel Policies

DOL Spending Reports Required As Taxpayer Tool Need Improvement

Check & Protect Health & Other Electronic Systems & Data Against New Security Threat

Success 2018

April 1 New Deadline To Update Benefit Plan Disability Determination Claims & Appeals Procedures; Hear More on 1/26

Arizona Proposal To Ban Sexual Harassment Confidentiality Agreements Sign Of Growing Employer Risks

$23M Penalty Small Part of 21st Century’s Data Breach Fallout; Offers Data Breach Lessons For Other Businesses

Take Care of Your Good People

Read Tax Cuts and Jobs Act Conference Report For Tax Reform From Source

Check How IRS 2018 Retirement & Saving Plan Limits and Amounts Cost Of Living Adjustments Impact Your HR & Retirement Plan Administration & Planning

Confirm Your Benefit Plans Ready For New Disability Determination Rules on 1/1/18

Individual Accountability For Performance Matters

Give NLRB Your Input On Union Representation Election Regulations

IRS Prepares To Nail Employers Under Obamacare Mandate While Giving Some Individual Mandate Relief 

HHS Picks Hargan As Acting HHS Secretary

OCR Gives Health Care Providers, Other Covered Entities Post-Las Vegas Shooting HIPAA Medical Privacy Guidance On Disclosures To Family, Media & Others For Notification & Other Purposes

RAISE Act Immigration Visa, Visa Holder Public Benefit Limits Create Potential Health Industry Concerns 

SCOTUS Bars State Law Restrictions On Health, Other Arbitration Agreement Enforceability 

Health Care, Health Plan & Other Health IT Systems Warned of E-Mail Cyber Attack 

$2.4M HIPAA Settlement Warns Providers About Media Disclosures Of PHI

CardioNet $2.5M HIPAA Resolution Agreement Schools HIPAA Entities To Clean Up Their Acts 

Medical Clinic HIPAA Resolution Agreement Shows Need For Current Business Associate Agreements

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 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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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.


Fresenius Medical Care Pays $3.5 Million HIPAA Settlement

February 2, 2018

Fresenius Medical Care North America (FMCNA) is paying $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopting a comprehensive corrective action plan, under a voluntary resolution agreement that settles FMCNA exposures to OCR for violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules OCR asserts it found from an investigation it conducted into five separate HIPAA breach reports FMCNA filed in January 21, 2017.

Widespread publicity and fallout from data breaches involving Equifax, Blue Cross, the Internal Revenue Service and many other giant organizations have ramped up public awareness and government concern about health care and other data security.  The resulting pressure is adding additional fuel to the already substantial concern of OCR and other agencies about compliance with HIPAA and other data security and breach laws.  Like the $2.3 million HIPAA resolution agreement OCR announced with now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO) earlier this year,  see, e.g., $23M Penalty Small Part of 21st Century’s Data Breach Fallout; Offers Data Breach Lessons For Other Businesses, the growing list of OCR resolution agreements and other enforcement actions against FMCNA, 21CO and other covered entities and other legal and market fallout that covered entities and other organizations experience following the announcement of breaches or other security deficiencies make the case for why HIPAA-covered health care providers, health plans, health care clearinghouses and their business associates (covered entities) must prioritize HIPAA compliance and other medical and other data security protection, privacy and risk management a top priority in 2018.

HIPAA Privacy, Security & Breach Notification Rule Responsibilities & Risks

The Privacy Rule requires that health plans, health care providers, health care clearinghouses (covered entities) and their vendors that qualify as “business associates” under HIPAA comply with detailed requirements concerning the protection, use, access, destruction and disclosure of protected health information.  As part of these requirements, covered entities and their business associates must adopt, administer and enforce detailed policies and practices, assess, monitor and maintain the security of electronic protected health information (ePHI) and other protected health information, provide notices of privacy practices and breaches of “unsecured” ePHI, afford individuals that are the subject of protected health information certain rights and comply with other requirements as specified by the Privacy, Security and Breach Notification Rules.  In addition, covered entities and business associates also must enter into a written and signed business associate agreement that contains the elements specified in Privacy Rule § 164.504(e) before the business associate creates, uses, accesses or discloses PHI of the covered entity. Furthermore, the Privacy Rule includes extensive documentation and keeping requirements require that covered entities and BAs maintain copies of these BAAs for a minimum of six years and to provide that documentation to OCR upon demand.

Violations of the Privacy Rule can carry stiff civil or even criminal penalties.  Pursuant to amendments to HIPAA enacted as part of the HITECH Act, civil penalties typically do not apply to violations punished under the criminal penalty rules of HIPAA set forth in Social Security Act , 42 U.S.C § 1320d-6 (Section 1177).

Resolution Agreements like the $3.2 million FMCNA resolution agreement allow covered entities and business associates to resolve potentially substantially larger civil monetary penalty liabilities that OCR can impose under the civil enforcement provisions of HIPAA.  As amended by the HITECH Act, the civil enforcement provisions of HIPAA empower OCR to impose Civil Monetary Penalties on both covered entities and BAs for violations of any of the requirements of the Privacy or Security Rules.  The penalty ranges for civil violations depends upon the circumstances associated with the violations and are subject to upward adjustment for inflation.  As most recently adjusted here effective September 6, 2016,  the following currently are the progressively increasing Civil Monetary Penalty tiers:

  • A minimum penalty of $100 and a maximum penalty of $50,000 per violation, for violations which the CE or BA “did not know, and by exercising reasonable diligence would not have known” about using “the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances;”
  • A minimum penalty of $1,000 and a maximum penalty of $50,000 per violation, for violations for “reasonable cause” which do not rise to the level of “willful neglect” where “reasonable cause” means the “circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the violated Privacy Rule requirement;”
  • A minimum penalty of $10,000 and a maximum penalty of $50,000 per violation, for violations attributed to “willful neglect,” defined as “the conscious, intentional failure or reckless indifference to the obligation to comply” with the requirement or prohibition; and
  • A minimum penalty of $50,000 and a maximum penalty of $1.5 million per violation, for violations attributed to “willful neglect” not remedied within 30 days of the date that the covered entity or BA knew or should have known of the violation.

For continuing violations such as failing to implement a required BAA, OCR can treat each day  of noncompliance as a separate violation.  However, sanctions under each of these tiers generally are subject to a maximum penalty of $1,500,000 for violations of identical requirements or prohibitions during a calendar year.  For violations such as the failure to implement and maintain a required BAA where more than one covered entity bears responsibility for the violation, OCR an impose Civil Monetary Penalties against each culpable party. OCR considers a variety of mitigating and aggravating facts and circumstances when arriving at the amount of the penalty within each of these applicable tiers to impose.

In addition to these potential civil liability exposures, however, covered entities, their business associates and other individuals or organizations that wrongfully use, access or disclose electronic or other protected health information also can face civil liability under various circumstances.  The criminal enforcement provisions of HIPAA authorize the Justice Department to prosecute a person who knowingly in violation of the Privacy Rule (1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person, punishable by the following criminal sanctions and penalties:

  • A fine of up to $50,000, imprisoned not more than 1 year, or both;
  • If the offense is committed under false pretenses, a fine of up to $100,000, imprisonment of not more than 5 years, or both; and
  • If the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, a fine of up to $250,000, imprisoned not more than 10 years, or both.

Because HIPAA Privacy Rule criminal violations are Class A Misdemeanors or felonies, Covered Entities and business associates should include HIPAA compliance in their Federal Sentencing Guideline Compliance Programs and practices and need to be concerned both about criminal exposure for their own direct violations, as well as imputed organizational liability for violations committed by their employees or agents under the Federal Sentencing Guidelines, particularly where their failure to implement or administer these required compliance policies and practices or failure to properly investigate or redress potential violations enables, perpetuates or covers up the criminal breach.

Fresenius Breach, Charges & Settlement Agreement Illustrate Civil Exposures

The FMCNA resolution agreement is another example of a growing list of resolution agreements various HIPAA covered entities have entered into to resolve their exposure to potentially greater liability should OCR assess civil monetary penalties under HIPAA’s civil sanction scheme.

The breach reports filed on January 21, 2017 reported five separate breach incidents occurring between February 23, 2012 and July 18, 2012 implicating the electronic protected health information (ePHI) of five separate FMCNA owned covered entities (FMCNA covered entities):  Bio-Medical Applications of Florida, Inc. d/b/a Fresenius Medical Care Duval Facility in Jacksonville, Florida (FMC Duval Facility); Bio-Medical Applications of Alabama, Inc. d/b/a Fresenius Medical Care Magnolia Grove in Semmes, Alabama (FMC Magnolia Grove Facility); Renal Dimensions, LLC d/b/a Fresenius Medical Care Ak-Chin in Maricopa, Arizona (FMC Ak-Chin Facility); Fresenius Vascular Care Augusta, LLC (FVC Augusta); and WSKC Dialysis Services, Inc. d/b/a Fresenius Medical Care Blue Island Dialysis (FMC Blue Island Facility).

OCR concluded its investigation showed the breaches resulted because FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI.  OCR also concluded:

  • The FMCNA covered entities impermissibly disclosed the ePHI of patients by providing unauthorized access for a purpose not permitted by the Privacy Rule.
  • FMC Ak-Chin failed to implement policies and procedures to address security incidents.
  • FMC Magnolia Grove failed to implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain ePHI into and out of a facility; and the movement of these items within the facility.
  • FMC Duval and FMC Blue Island failed to implement policies and procedures to safeguard their facilities and equipment therein from unauthorized access, tampering, and theft, when it was reasonable and appropriate to do so under the circumstances.
  • FMC Magnolia Grove and FVC Augusta failed to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances.

In addition to a $3.5 million monetary settlement, a corrective action plan requires the FMCNA covered entities to complete a risk analysis and risk management plan, revise policies and procedures on device and media controls as well as facility access controls, develop an encryption report, and educate its workforce on policies and procedures.

 

HIPAA Enforcement A Growing Risk

Covered entities, their business associates and members of their workforce need to recognize that the FMCNA and other resolution agreements are part of a growing trend, rather than isolated incidents of enforcement.

While civil monetary penalty enforcement remains much more common than criminal prosecution, covered entities, their business associates and members of their workforce must understand that HIPAA enforcement and resulting liability is growing.

While Department of Justice federal criminal prosecutions and convictions under HIPAA remain relatively rare, they occur and are growing.  See e.g.,  Former Hospital Employee Sentenced for HIPAA Violations (Texas man sentenced to 18 months in federal prison for obtaining protected health information with the intent to use it for personal gain); Three Life Sentences Imposed On Man Following Convictions For Drug Trafficking, Kidnapping, Using Firearms and HIPAA Violations (drug king pin gets multiple 10 year consecutive prison terms for unauthorized access to private health information in violation of HIPAA; his health care worker friend sentenced for accessing electronic medical files and reporting information to him); Former Therapist Charged In HIPAA Case; Hefty Prison Sentence in ID Theft Case (former assisted living facility worker gets 37 months in prison after pleading guilty to wrongful disclosure of HIPAA protected information and other charges); Hefty Prison Sentence in ID Theft Case (former medical supply company owner sentenced to 12 years for HIPAA violations and fraud).  While the harshest sentences tend to be associated with health care fraud or other criminal conduct, lighter criminal sentences are imposed against defendants in other cases as well. See e.g., Sentencing In S.C. Medicaid Breach Case (former South Carolina state employee sentenced to three years’ probation, plus community service, for sending personal information about more than 228,000 Medicaid recipients to his personal e-mail account.); HIPAA Violation Leads To Prison Term (former UCLA Healthcare System surgeon gets four months in prison after admitting he illegally read private electronic medical records of celebrities and others.)

While criminal enforcement of HIPAA remains relatively rare and OCR to date only actually has assessed HIPAA civil monetary penalties against certain Covered Entities for violating HIPAA in a couple isolated instances, the growing list of multi-million dollar resolution payments that FMCNA and other covered entities caught violating HIPAA make clear that HIPAA enforcement is both meaningful and growing.   See e.g., Learn From Children’s New $3.2M+ HIPAA CMP For “Knowing” Violation of HIPAA Security Rules ($3.2 million Children’s Medical Center HIPAA Civil Monetary Penalty); 1st HIPAA Privacy Civil Penalty of $4.3 Million Signals CMS Serious About HIPAA Enforcement;  $400K HIPAA Settlement Shows Need To Conduct Timely & Appropriate Risk Assessments$5.5M Memorial HIPAA Resolution Agreement Shows Need To Audit.  For more examples, also see here.

Coming on the heels of  an already lengthy and growing list of OCR high dollar HIPAA enforcement actions, the FMCNA and other resolution agreements and civil monetary penalties these and other announced enforcement actions clearly reflect that OCR takes HIPAA compliance seriously and stands ready to impose substantial penalties when it finds violations in connection with breach notice investigations.  Viewed in the context of these and other enforcement actions, the FMCNA Resolution Agreement and others clearly reflect the time for complacency in HIPAA compliance and leniency in HIPAA HIPAA enforcement are passed.  Rather, these and other enforcement actions make clear why health care providers, health plans, healthcare clearinghouses and their business associates must make HIPAA compliance a priority now.

Covered entities and business associates also should recognize their potential responsibilities and risks for breaches or other improper conduct concerning patient or other sensitive personal financial information, trade secrets or other data under a wide range of laws beyond HIPAA and its state law equivalents.  As documented by the media coverage of the legal and business woes of Alteryx, eBay, Paypal owner TIO Networks, Uber, Equifax and a long list of other previously trusted prominent businesses have and continue to incur from data breaches within their organizations, health care or other covered entities experiencing breaches often also face FTC or other government investigations and enforcement under the Fair and Accurate Credit Transactions Act (FACTA) and other federal or state identity theft, data privacy and security, electronic crimes and other rules as well as business losses and disruptions; civil litigation from breach victims, shareholders and investors, and business partners as well as OCR, FTC, and state data security regulation enforcement.  Amid this growing concern, OCR has indicated that it intends to continue to diligently both seek to support and encourage voluntary compliance by covered entities and their business associates and  investigate and enforce HIPAA against HIPAA covered entities and their business associates that fail to adequately safeguard PHI and ePHI in accordance with HIPAA. In the face of these growing risks and liabilities, covered entities and their business leaders face a strong imperative to clean up and maintain their HIPAA compliance and other data security to minimize their exposure to similar consequences.

In light of these rises, leaders, investors, insurers, lenders and others involved with covered entities and their business associates should take steps to verify that the covered entities and their business associates not only maintain compliance with HIPAA, but also comply with data security, privacy and other information protection requirements arising under other laws, regulations, and contracts, as well as the practical business risks that typically follow the announcement of a breach.  Considering these risks, covered entities and their business associates must recognize and take meaningful, documented action to verify their existing compliance and ongoing oversight to ensure their organizations can demonstrate appropriate action to maintain appropriate practices, insurance and other safeguards to prevent, respond to and mitigate exposures in the event of a breach of protected health information or other sensitive data.

In response to these growing risks and concerns, covered entities and their business associates should ensure that they have conducted, and maintain and are ready to produce appropriate policies and procedures backed up by a well documented, up-to-date industry wide risk assessment of their organization’s susceptibility to breaches or other misuse of electronic or other protected health information.  The starting point of these efforts should be to adopt and enforce updated written policies, procedures, technical and physical safeguards, processes and training to prevent the improper use, access, destruction or disclosure of patient PHI.  Processes also should create, retain and be designed to cost effectively track, capture, and retain both all protected health information, its use, access, protection, destruction and disclosure, and the requisite supportive documentation supporting the appropriateness of those action to position the organization  cost-effectively and quickly to fulfill required accounting, reporting and other needs in the event of a data breach, audit, participant inquiry or other event.

As part of this process, covered entities and business associates should start by reviewing and updating their policies, HIPAA audits and assessments and other documentation and processes.  In doing so, they must use care to look outside the four corners of their Privacy Policies and core operating systems to ensure that their policies, practices, oversight and training address all protected health information within their operations on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.

In connection with these efforts, the enforcement actions make clear that Covered Entities and business associates should adopt, implement and monitor PHI privacy, and security on an entity wide basis.  These efforts should include both general policies, practices and procedures as well as specifically tailored policies, processes and training to protect PHI and preserve HIPAA compliance throughout their organization  as well as the business associate agreements and other processes to provide for HIPAA compliance with respect to protected health information created, used, accessed or disclosed to business associates or others not part of their direct workforce or operating outside the core boundaries of their facilities.

Covered entities and their business associates also must recognize and design their compliance efforts and documentation recognizing that HIPAA compliance is a living process, which require both constant diligence about changes in systems or other events that may require reevaluation or adjustments, whether from changes in software, systems or processes or external threats.

Because the cost of responding to and investigating breaches or other compliance concern can be quite burdensome, covered entities and their business associates also generally will want to pursue options to plan for and minimize potential expenses in the design and administration of their programs as well as to minimize and cover the potentially extraordinary costs of breach or other compliance investigation and results that commonly arise following a breach or other compliance event.  As a part of this planning, covered entities and their business associates also generally will want to add consideration of changes to federal tax rules on the deductibility of compliance penalty and other related compliance expenditures.

While the Internal Revenue Code traditionally has prohibited businesses and individuals from deducting penalties, fines and other expenditures arising from violations of federal or state laws under Section 162(f) of the Internal Revenue Code, Section 13306 of the Tax Cuts and Jobs Creation Act creates a new exception for amounts  (other than amounts paid or incurred any amount paid or incurred as reimbursement to the government or entity for the costs of any investigation or litigation) that a taxpayer establishes meet the following requirements:

  • Constitute restitution (including remediation of property) for damage or harm which was or may be caused by the violation of any law or the potential violation of any law, or
  • Are paid to come into compliance with any law which was violated or otherwise involved in the investigation or inquiry into a violation or potential violation of any law;
  • Are identified as restitution or as an amount paid to come into compliance with such law, as the case may be, in the court order or settlement agreement, and
  • In the case of any amount of restitution for failure to pay any tax imposed under this title in the same manner as if such amount were such tax, would have been allowed as a deduction under this chapter if it had been timely paid.

Because the true effect of these modifications will be impacted by implementing regulations and a number of other special conditions and rules may impact the deductibility of these payments and the reporting obligations attached to their payment, covered entities will want to consult with legal counsel about these rules and monitor their implementation to understand their potential implications on compliance expenditures and penalties.

About The Author

Repeatedly 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, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career.  Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.

Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers.    Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

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 here including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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.


HHS Proposes “Conscience Rule” Expanding Abortion And Other Religious Choice

January 19, 2018

The Department of Health and Human Services (HHS) today (January 19, 2018) announced two additional actions to protect life and the conscience rights of Americans.

First, HHS’ Centers for Medicare & Medicaid Services (CMS) issued new guidance to state Medicaid directors restoring state flexibility to decide program standards. The letter to State Medicaid Directors issued today rescinds 2016 guidance that specifically restricted states’ ability to take certain actions against family-planning providers that offer abortion services.

Additionally, HHS’ Office for Civil Rights (OCR) also announced it is issuing a new proposeds rule (“Conscience Rule”) to enforce 25 existing statutory conscience protections for Americans involved in HHS-funded programs, which protect people from being coerced into participating in activities that violate their consciences, such as abortion, sterilization, or assisted suicide.

Modeled on existing regulations for other civil rights laws, the proposed rule provides protections for Americans’ conscience rights. Interested persons will have 60 days to comment on the proposed rule. However since President Trump took office OCR already has stepped up enforcement of these conscience statutes, many of which saw little to no enforcement activity under the previous administration.

The proposed rule when finalized will apply to entities that receive funds through programs funded or administered in whole or in part through HHS. It requires, for instance, that entities applying for federal grants certify that they are complying with the above-mentioned conscience-protection statutes.

The release of the proposed rule was accompanied by the rescission by the Centers for Medicare and Medicaid Services of a letter to State Medicaid Directors rescinding restrictions on state flexibility to decide when and how their state Medicaid programs cover abortion and certain other reproductive care. It also follows the Trump Administration’s announcement of plans to found a new division within the Office of Civil Rights that will focus on enforcement of conscience and religious rights.

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 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, 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, antikickback, 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; 1557 and other Civil Rights; 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.

Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; 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 investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Author of leading works on a multitude of health care, health plan and other health industry matters, 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, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, 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, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 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 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 your profile here.

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 advise 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 is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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.


New Trump Executive Order Directs More Veterans Health Care Choice, Mental Health Care

January 10, 2018

Veterans transitioning back to civilian life can look forward to expanded mental health services, more choices for accessing care under some circumstances and other expanded assistance and support transitioning to civilian life under the Presidential Executive Order on Supporting Our Veterans During Their Transition From Uniformed Service to Civilian Life President Donald J. Trump signed this morning (January 9, 2018) to ensure veterans have the resources they need as they transition back to civilian life..

The Executive Order declares, “t is the policy of the United States to support the health and well-being of uniformed service members and veterans.  After serving our Nation, veterans deserve long, fulfilling civilian lives.  Accordingly, our Government must improve mental healthcare and access to suicide prevention resources available to veterans, particularly during the critical 1-year period following the transition from uniformed service to civilian life,

The Executive Order acknowledges the current system fails adequately to care for veterans transitioning to civilian life. It states, “Unfortunately, in some cases within the first year following transition, some veterans can have difficulties reintegrating into civilian life after their military experiences and some tragically take their own lives.  Veterans, in their first year of separation from uniformed service, experience suicide rates approximately two times higher than the overall veteran suicide rate.” To help prevent these tragedies, the Executive Order states all veterans should have seamless access to high-quality mental healthcare and suicide prevention resources as they transition, with an emphasis on the 1-year period following separation.”

In announcing the Executive Order, President Trump said caring for veterans is a “top priority.”

“We want them to get the highest care and the care that they so richly deserve,” he said.

To implement the necessary improvements to improve veterans care, the Executive Order direct the Secretary of Defense, the Secretary of Veterans Affairs, and the Secretary of Homeland Security to collaborate to address the complex challenges faced by our transitioning uniformed service members and veterans to accomplish the following:

  • Within 60 days, the Secretary of Defense, the Secretary of Veterans Affairs, and the Secretary of Homeland Security must submit to the President, through the Assistant to the President for Domestic Policy, a Joint Action Plan that describes concrete actions to provide, to the extent consistent with law, seamless access to mental health treatment and suicide prevention resources for transitioning uniformed service members in the year following discharge, separation, or retirement.
  • Within 180 days, the Secretary of Defense, the Secretary of Veterans Affairs, and the Secretary of Homeland Security shall submit to the President, through the Assistant to the President for Domestic Policy, a status report on the implementation of the Joint Action Plan and how the proposed reforms have been effective in improving mental health treatment for all transitioning uniformed service members and veterans that addresses progress on certain specific reforms and any additional reforms that could help further address the problems that obstruct veterans’ access to resources and continuous mental healthcare treatment, including any suggestions for legislative and regulatory reforms; and
  • A timeline describing next steps and the results anticipated from continued and additional reforms.

The actual Executive Order tells little about how the Trump Administration intends to implement these directives. The White House press release about the Executive Order states President Trump believes that our veterans deserve the best healthcare in the world, and is working with the Department of Veterans Affairs (VA) to expand and modernize their care including through four already announced initiatives to expand healthcare access for our veterans through technological innovation:

  • An expansion of the VA’s “Anywhere to Anywhere” healthcare, which allows VA providers to use tele-health technology to remotely treat veterans regardless of geographic location.
  • A greater adoption of VA Video Connect, an application for mobile phones and computers, which directly connects veterans and healthcare providers from anywhere in the country.
  • At over 100 VA sites across the nation, a rollout of the new Online Scheduling Tool, which enables veterans to schedule appointments from their mobile devices or computers.
  • A launch of the VA’s “Access and Quality Tool,” which allows veterans to view online both wait times at VA locations and important quality-of-care data.

The press release also states President Trump has ensured continued access to care in the Veterans Choice Program by signing the VA Choice and Quality Employment Act, authorizing $2.1 billion in additional funds for the Veterans Choice Program (VCP).

The VCP gives eligible veterans their choice of private care if they live more than 40 miles from the closest eligible VA facility, experience wait times over 30 days from the clinically indicated date, or face an excessive burden in accessing VA care.

On addition, the press release states the Department of Veterans Affairs will adopt the same Electronic Health Record (EHR) as the Department of Defense (DOD) so all patient data will reside in one common system, enabling the immediate availability of service member’s medical records and seamless care between the departments.

Concerning veterans mental health, President Trump notes that Secretary Shulkin already expanded access to urgent mental healthcare to former service members with other-than-honorable (OTH) discharges.

As in the past, the effect of these promises remains to be seen. The announced changes only provide a portion of the reforms needed and past reform programs have promised much but have failed to resolve access issues and failed to address notorious neglect and abuse recurrently uncovered in many veterans hospitals and other care facilities across the nation. Veterans, their families and treating physicians and others concerned with veterans health issues should monitor proposed changes and provide input as needed to ensure these reforms are properly designed and implemented as well as recommend other improvements.

About The Author

Repeatedly 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, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

She is nationally recognized for her more than 30 years on involvement through her profession practice and pro bono work with PROJECT COPE and others she is recognized for her work, experience, leadership and publications on veterans and other health and workforce policy and law and regulation for more than 30 years.

Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers.    Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

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 here including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

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 reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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.

©2018 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


%d bloggers like this: