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

May 12, 2017

Health care providers, health plans, health insurers, healthcare clearinghouses, their business associates and others involved in health information technology or related activities should raise their cyber security defenses and use cyber security best practices to defend their information  systems and data against ongoing cyber security attacks targeting health industry information systems in the United States and abroad in a cyber security alert issued by Department of Health and Human Service (HHS) Laura Wolf Critical Infrastructure Protection Lead.

The cyber security alert states that there is evidence that cyber attacks affecting hospitals and healthcare information systems in the UK and other international locations” now are “occurring inside the United States.”

HHS states it is “working with our partners across government and in the private sector to develop a better understanding of the threat and to provide additional information on measures to protect your systems.

Meanwhile,HHS advises U.S. health industry organizations and information systems to exercise cyber security best practices – particularly with respect to email including HHS Ransomware Guidance available here and other information on ransomware in the following HHS Cyber Newsletters:

https://www.hhs.gov/sites/default/files/hippa-cyber-awareness-monthly-issue1.pdf

https://www.hhs.gov/sites/default/files/hipaa-cyber-awareness-monthly-issue3.pdf

https://www.hhs.gov/sites/default/files/february-2017-ocr-cyber-awareness-newsletter.pdf

 

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition 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 “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has 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 a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services 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 manage and defend compliance, public policy, regulatory, staffing and other operations and risk management concerns.

A core focus of this work includes work 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; dealings with JCHO and other accreditation and quality organizations; investigation and defense of private litigation and other federal and state health care industry investigations and enforcement; insurance or other liability management and allocation; process and product development; managed care, physician and other staffing, business associate and other contracting; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; 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.
Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other data security, privacy and breach laws.

 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 trade secret, HIPAA and other medical, consumer, insurance, tax, and other privacy and data security, 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.

In connection with 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 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.

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.
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.

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, 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 has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other 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 plans, 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.

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; an 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.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional 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 (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.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.

 


6/26 Deadline To Comment On Proposed Medicare SNF (Nursing Home) Rule Changes

May 10, 2017

June 26, 2017 is the deadline to submit comments to the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) on changes to Medicare’s Skilled Nursing Facility (nursing home) reimbursement, quality reporting and various other proposed by CMS in the Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Proposal To Correct the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020 (Proposed Rule) published May 4th.  With the U.S. aging population making SNF expenditures both a significant Medicare cost driver and a major care concern for American families and communities, SNF and other health care providers, payers, community leaders, caregivers and other concerned stakeholders should act promptly to review the proposed changes and timely submit feedback in response to the Proposed Rule.

Among other things, the Proposed Rule as currently proposed would revise Medicare reimbursement and terms of participation rules for SNFs to:

  • Update the Skilled Nursing Facility (SNF) prospective payment rates and other background information for Fiscal Year (FY) 2018 in response to §§ 1888(e)(4)(E) and (H) of the Social Security Act (the Act);
  • Update the requirements for the Skilled Nursing Facility Quality Reporting Program (SNF QRP) and additional proposals for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP);
  • Clarify requirements related to survey team composition and investigation of complaints under 42 C.F.R §§ 488.30, 488.301, 488.314, and 488.308;
  • Add a proposal related to the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP); and
  • Solicits comments about potential changes to the recently finalized Requirements for Long-Term Care Facilities that CMS intends to reduce regulatory burdens as well as potential CMMI models and other demonstration projects that would reduce cost and increase quality of care for SNF, or more generally Post-Acute Care patients.

The Proposed Rule regulatory burden reduction proposals primarily focus on three areas also invites input about other areas of burden reduction and cost changes that could be accomplished by revising current SNF requirements for Medicare participation:

  • The Grievance and Abuse/Neglect Reporting Processes
  • Quality Assurance and Performance Improvement (QAPI)
  • Discharge Notices

SNF and other healthcare providers, payers, accreditation and oversight, payers, caregivers and others concerned about SNF care and reimbursement for patients in SNFs should carefully evaluate these proposals and share their input on the proposals and other opportunities to improve the Medicare SNF quality and reimbursement rules as soon as possible.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition 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 “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has 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.

Throughout her career, she has helped health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training ;board, medical staff and other governance; compliance and internal controls; strategic planning, process and quality improvement; change management; assess, deter, investigate and address staffing, quality, compliance and other performance; meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other laws.

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, 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 has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

As a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services 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.

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 health care, disability, aging, workforce, retirement 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.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional 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 (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.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.


New HHS Webpage Highlights HHS Administrative Actions To Ease ACA Enforcement & Burdens

April 13, 2017

The Department of Health and Human Services recently launched a new web page on HHS.gov highlighting the regulatory and administrative actions the Department is taking to relieve the burden of the current healthcare law and support a patient-centered healthcare system in response to President Trump’s January 20, 2017 Executive Order Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal (the “Executive Order”).

In the Executive Order, President Trump among other things:

  • Confirmed the Trump Administration’s policy to seek the prompt repeal of the Patient Protection and Affordable Care Act (Public Law 111-148), as amended (the “ACA”); and
  • Announced the Trump Administration’s directivepending the planned ACA repeal to ensure that the law is being efficiently implemented, take all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the ACA, and prepare to afford the States more flexibility and control to create a more free and open healthcare market.

In furtherance of these policies, the Executive Order also directed the Secretary of HHS and and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the ACA to the maximum extent permitted by law:

  • To exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the ACA that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications;
  • To exercise all authority and discretion available to them to provide greater flexibility to States and cooperate with them in implementing healthcare programs;
  • To encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.

HHS intends to use the new web page to announce new measures as adopted by HHS in furtherance of the Executive Order with a planned emphasis in particular upon actions to

  • Lower costs and increase choices by providing relief from the burdensome regulations and fostering competition in insurance markets;
  • Work to ensure a stable transition period;
  • Offer states greater flexibility of their Medicaid programs to meet the needs of their most vulnerable populations; and
  • Increase the opportunities for patients to get the care they need when they need it.

According to statements on the new web page, HHS intends to purse these objectives by “going through every page of regulations and guidance related to the Affordable Care Act to determine whether or not they work for patients and whether or not they are making our health care system better.”

Check out and follow these developments here.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition  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 “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits”  and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has 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. Her experience encompasses  helping health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training ;board, medical staff and other governance;   compliance and internal controls; strategic planning, process and quality improvement; change management;  assess, deter, investigate and address staffing, quality, compliance  and other performance;  meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations 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, 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 has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

As a core component of her work,  Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services 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.

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 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 and governmental and regulatory affairs experience, Ms. Stamer also is widely recognized for regulatory and policy work, advocacy and outreach on healthcare, education, aging, disability, savings and retirement, workforce, ethics, and other policies.  Throughout her adult life and career, Ms. Stamer has provided thought leadership; policy and program design, statutory and regulatory development design and analysis; drafted legislation, proposed regulations and other guidance, position statements and briefs, comments and other critical policy documents; advised, assisted and represented health care providers, health plans and insurers, employers, professional. and trade associations, community and government leaders and others on health care, health, pension and retirement, workers’ compensation, Social Security and other benefit, insurance and financial services, tax, workforce, aging and disability, immigration, privacy and data security and a host of other international and domestic federal, state and local public policy and regulatory reforms through her involvement and participation in numerous client engagements, founder and Executive Director of the Coalition for Responsible Health Policy and its PROJECT COPE: the Coalition on Patient Empowerment, adviser to the National Physicians Congress for Healthcare Policy, leadership involvement with the US-Mexico Chamber of Commerce, the Texas Association of Business, the ABA JCEB, Health Law, RPTE, Tax, Labor, TIPS, International Life Sciences, and other Sections and Committees, SHRM Governmental Affairs Committee and a host of other  involvements and activities.

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. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

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.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional 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 (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 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.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™  All other rights reserved.   For information about republication or other use, please contact Ms. Stamer here.


$5.5M Memorial HIPAA Resolution Agreement Shows Need To Audit

February 16, 2017

Memorial Healthcare Systems (MHS) has paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. The nonprofit corporation which operates six hospitals, an urgent care center, a nursing home, and a variety of ancillary health care facilities throughout the South Florida area with affiliated physician offices through an Organized Health Care Arrangement (OHCA) also agreed to implement a robust corrective action plan as part of the Resolution Agreement.

The MHS Resolution sends a strong message to all health care providers, health plans health care clearinghouses (Covered Entities) and their business associates that simply adopting HIPAA policies alone is insufficient to avoid getting nailed by OCR under HIPAA;  Covered Entities and their business associates also must implement, audit and enforce those policies.

The MHS Resolution Agreement resulted from an investigation initiated by the HHS Office for Civil Rights (OCR) after  MHS reported to OCR that protected health information (PHI) of 115,143 individuals had been impermissibly accessed by its employees and impermissibly disclosed to affiliated physician office staff. This information consisted of the affected individuals’ names, dates of birth, and social security numbers. The login credentials of a former employee of an affiliated physician’s office had been used to access the ePHI maintained by MHS on a daily basis without detection from April 2011 to April 2012, affecting 80,000 individuals. 

The investigation revealed that although MHS had workforce access policies and procedures in place, MHS failed to implement procedures with respect to reviewing, modifying and/or terminating users’ right of access, as required by the HIPAA Rules. Further, MHS failed to regularly review records of information system activity on applications that maintain electronic protected health information by workforce users and users at affiliated physician practices, despite having identified this risk on several risk analyses conducted by MHS from 2007 to 2012.

MHS’ failure to follow through to implement the controls required by its policies and audit and enforce compliance with HIPAA and its HIPAA policies was a costly mistake.  Other Covered Entities should heed MHS’ painful lesson and take documented steps to ensure its HIPAA policies not only are adopted, but also implemented and monitored and audited for compliance.


$2.4M+ St. Joseph Health HIPAA Settlement Teaching Lesson For Other HIPAA-Covered Entities & Business Associates

October 25, 2016

St. Joseph Health (SJH)  has agreed to pay  a $2.4 million plus settlement payment, conduct an enterprise-wide risk analysis and implement and administer a comprehensive correction plan under a Resolution Agreement and Corrective Action Plan (SJH Settlement) reached with the  Department of Health & Human Services (HHS) Office of Civil Rights (OCR)  to settle OCR charges that SJH violated the Privacy & Security Rules of the Health Insurance Portability & Accountability Act (HIPAA) by allowing files containing electronic protected health information (ePHI) of 31,800 individuals that SJH created for its participation in the Medicare meaningful use program to be publicly accessible on the internet from February 1, 2011, until February 13, 2012.  The SJH Settlement announced here by OCR on October 18, 2016 demonstrates the mounting HIPAA enforcement exposures that HIPAA-covered health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) risk when a breach of ePHI or other prohibited use, access, destruction or disclosure of ePHI or other personal health information (PHI) results from the failure of the Covered Entity or its business associates to properly protect or secure it in accordance with HIPAA.  A review of the SJH Settlement drives home the point that Covered Entities should not assume that meaningful use or other electronic recordkeeping systems containing ePHI are properly secured in accordance with HIPAA.

SJH Investigation & Charges Resulting In $2.4 Million+ Settlement

A nonprofit integrated Catholic health care delivery system sponsored by the St. Joseph Health Ministry, who through its 24,000 employees and 6,000 physicians provides a range of health care services to more than 137,000 inpatients and 3.6 million outpatients each year at SHS’ 4 acute care hospitals, home health agencies, hospice care, outpatient services, skilled nursing facilities, community clinics and physician organizations located throughout California and in parts of Texas and New Mexico.

OCR’s charges against SJH arose out of OCR’s investigation into a 2012 breach notification report SJS filed with OCR.  On February 14, 2012, SJH reported to OCR that files containing electronic protected health information (ePHI) of 31,800 individuals from five of the SJH hospitals-St. Jude Medical Center, Mission Hospital, Queen of the Valley Medical Center, Santa Rosa Memorial Hospital, and Petaluma Valley Hospital that SJH created for its participation in the meaningful use program were publicly accessible on the internet from February 1, 2011, until February 13, 2012, via Google and possibly other internet search engines.

SJH’s report to OCR indicated that this public access resulted from a configuration within its network server in which PDF files containing following patient information were uploaded: patient names; BMI; blood pressure; lab results; smoking status; diagnoses lists; medication allergies; advance directive status and demographic information (language, ethnicity, race, sex, and birth date). The server SJH purchased to store the files included a file sharing application whose default settings allowed anyone with an internet connection to access them. Upon implementation of this server and the file sharing application, SJH did not examine or modify it. As a result, the public had unrestricted access to PDF files containing the ePHI of 31,800 individuals, including patient names, health statuses, diagnoses, and demographic information  from February 14, 2012 until SJH blocked external access to the ePHI when it shut down the application February 13, 2012.

OCR’s investigation indicated the following potential violations of the HIPAA Rules:

  • From February 1, 2011 to February 13, 2012, SJH potentially disclosed the PHI of 31,800 individuals;
  • Evidence indicated that SJH failed to conduct an evaluation in response to the environmental and operational changes presented by implementation of a new server for its meaningful use project, thereby compromising the security of ePHI;
  • Although SJH hired a number of contractors to assess the risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by SJH, evidence indicated that this was conducted in a patchwork fashion and did not result in an enterprise-wide risk analysis, as required by the HIPAA Security Rule.

SJH Settlement Agreement Highlights

Under the settlement agreement with SJH that OCR announced on October 18, 2016, SJH must pay a $2,140,500 settlement payment and adopt a comprehensive corrective action plan which among other things, requires SJH to conduct an enterprise-wide risk analysis, develop and implement a risk management plan, revise its policies and procedures, and train its staff on these policies and procedures.  SJH’s Chief Executive Officer, Annette M. Walker, is named in the Corrective Action Plan as the SJH authorized representative and contact person responsible for overseeing the CAP implementation.

Among other things, the Corrective Action Plan specifically requires that SJH:

  • Within 240 days, conduct an enterprise-wide analysis and provide a report to OCR which includes a complete inventory of all electronic equipment, data systems, and applications that contain or store ePHI, and prepare and deliver to OCR for review an enterprise-wide risk analysis that identifies all security risks and vulnerabilities that incorporates all electronic equipment, data systems, and applications controlled, administered, or owned by SJH, its workforce members, and affiliated staff that contains, stores, transmits, or receives electronic protected health information (ePHJ);
  • Revise this risk analysis plan as directed by OCR based on its review of the presented risk analysis;
  • Develop and implement to the satisfaction of OCR an organization-wide risk management plan to address and mitigate any security risks and vulnerabilities identified in the risk analysis;
  • Distribute the risk management plan as finally approved by OCR to to workforce members involved with implementation of the plan within 30 days of OCR approval;
  • Revise to OCR’s satisfaction, adopt and implement within 30 days of OCR’s approval compliant HIPAA policies and procedures;
  • Prepare for review of OCR training materials and once approved by OCR, provide initial training to required workforce members, and obtain certification of completion of that training from each required workforce member within 60 days of OCR’s approval of the training and thereafter at least annually as long as the Corrective Action Plan remains in force;
  • Promptly conduct a documented investigation of any information indicating a potential workforce member violation of the new HIPAA policies in the manner required by OCR and if the investigation confirms a violation (Reportable Event), notify OCR of the relevant facts, findings, corrective actions and sanctions imposed against the violating workforce member in the manner required by the Corrective Action Plan;
  • Submit annual report to OCR signed and attested to by an SJH officer, which contains the information and attestations of compliance with the requirements of the Corrective Action Plan in accordance with the Corrective Action Plan;
  • Retain for inspection and copying and provide to OCR upon request all documents and records relating to compliance with this Corrective Action Plan for six (6) years from the Effective Date of the SJH Settlement Agreement.

Take Away For Other Covered Entities & Business Associates

To help safeguard their own organizations against potential sanctions from OCR and other HIPAA enforcement risks, Covered Entities and their business associates should ensure that their organization possesses a well-documented current enterprise-wide risk assessment, as well as has in place and is administering as necessary to maintain the currency and adequacy of its risk assessment strong practices for conducting documented evaluations of their own HIPAA security, policies, practices, audits and investigations and other procedures necessary to comply with HIPAA, taking into account recent OCR guidance,  its initiation of its Phase II audit program, the insights offered by the SJH and other OCR’s ever growing list of enforcement actions and compliance tools, as well as changes in systems, documentation, software, equipment or other occurrences within the operations of the Covered Entity or business associate’s operations that could impact the currency and adequacy of its risk assessment or otherwise raise compliance risks..

 In this respect, Covered Entities and business associates are encouraged to take special note of the advisability of specifically reviewing and updating their HIPAA policies, practices, business associate agreements, training, oversight and documentation to in response to OCR’s;

As breaches of PHI and other violations of HIPAA also frequently give rise to responsibilities or risks under a broad range of other federal and state laws medical and financial privacy and data security, Medicare and other terms of federal program participation, medical credentialing, licensure and ethics, insurance and Employee Retirement Income Security Act fiduciary responsibilities in the case of health plans, contractual,  tort and other exposures, Covered Entities and their business associates also generally are best served to take into account these other responsibilities and exposures in conjunction with the design and administration of their HIPAA compliance and risk management policies and practices.

Covered Entities and their business associates also should seek advice from legal counsel regarding the adequacy of their compliance, investigatory, training, management oversight, training, reporting, documentation, document retention and other processes and procedures that could reduce risks of HIPAA violations and position the organization to effectively and more efficiently respond to a potential breach, audit, investigation or enforcement action and mitigate the costs and potential liability exposures that increasingly attends these events.  In addition, given the typically high financial, operational and legal costs typically incurred to conduct investigations, report and redress breaches, and respond to OCR audits or investigations, much less make any payments and implement any corrective actions required to settle OCR changes, most Covered Entities and their business associations will want to consider the advisability and adequacy of insurance and other sources of funding or indemnification for the often substantial costs that often attend a HIPAA breach, audit or enforcement event. Since HIPAA violations under certain circumstances also can give rise to felony criminal liability, boards of directors and other leaders of Covered Entities and business associates also will want to ensure that their HIPAA compliance policies and practices also are incorporated and monitored by management as part of their organization’s overall Federal Sentencing Guideline Compliance programs and practices.

About The Author

Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care and health plan concerns.

Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.

As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, Ms. Stamer has worked extensively throughout her career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with 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 concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; 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.

Beyond her extensive involvement advising and representing clients on privacy and data security concerns and other health industry matters, Ms. Stamer also has served for several years as a scrivener for the ABA JCEB’s meeting with OCR, the Chair of the Southern California ISSA Health Care Privacy & Security Summit, and an editorial advisory board member, author, program chair or steering committee member, and faculties for a multitude of other programs and publications regarding privacy, data security, technology and other compliance, risk management and operational concerns in the health care, health and other insurance, employee benefits and human resources, retail, financial services and other arenas.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE: Coalition on Patient Empowerment, 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; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Council, 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.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com  or contact Ms. Stamer via email here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

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

©2016 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™  All other rights reserved.  


North Memorial Hit With $3.9M HIPAA Fine For HIPAA Violations

March 25, 2016

Just one day after the announcement of a $1,555,000 settlement with North Memorial Health Care of Minnesota under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules, the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) announced March 17, 2016 that Feinstein Institute for Medical Research has agreed to pay  $3.9 million and will undertake a substantial corrective action plan to settle charges of HIPAA violations and  bring its operations into compliance.  The two settlements drive home again the substantial liability that health care providers, health plans, health care clearinghouses and their business associates risk for violating HIPAA. Register for March 30, 2016 Solutions Law Press, Inc. briefing to learn the latest about this and other new regulatory and enforcement guidance impacting the HIPAA compliance obligations and risks of health care providers, health plans, health care clearinghouses and their business associates.  3/30 Webex Shares Latest On Security, Patient Access & Other HIPAA Developments.

Feinstein Settlement

Feinstein is a biomedical research institute that is organized as a New York not-for-profit corporation and is sponsored by Northwell Health, Inc., formerly known as North Shore Long Island Jewish Health System, a large health system headquartered in Manhasset, New York that is comprised of twenty one hospitals and over 450 patient facilities and physician practices.

OCR’s investigation began after Feinstein filed a breach report indicating that on September 2, 2012, a laptop computer containing the electronic protected health information (ePHI) of approximately 13,000 patients and research participants was stolen from an employee’s car.  The ePHI stored in the laptop included the names of research participants, dates of birth, addresses, social security numbers, diagnoses, laboratory results, medications, and medical information relating to potential participation in a research study.

OCR’s investigation discovered that Feinstein’s security management process was limited in scope, incomplete, and insufficient to address potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the entity.  Further, Feinstein lacked policies and procedures for authorizing access to ePHI by its workforce members, failed to implement safeguards to restrict access to unauthorized users, and lacked policies and procedures to govern the receipt and removal of laptops that contained ePHI into and out of its facilities.  For electronic equipment procured outside of Feinstein’s standard acquisition process, Feinstein failed to implement proper mechanisms for safeguarding ePHI as required by the Security Rule.

“Research institutions subject to HIPAA must be held to the same compliance standards as all other HIPAA-covered entities,” said OCR Director Jocelyn Samuels.  “For individuals to trust in the research process and for patients to trust in those institutions, they must have some assurance that their information is kept private and secure.”

The resolution agreement and corrective action plan may be found here.

The Feinstein settlement announcement follows yesterday’s announcement of a $1.5 million plus settlement with North Memorial to resolve HIPAA charges that it failed to implement a business associate agreement with a major contractor and failed to institute an organization-wide risk analysis to address the risks and vulnerabilities to its patient information. North Memorial is a comprehensive, not-for-profit health care system in Minnesota that serves the Twin Cities and surrounding communities.  The settlement highlights the importance for healthcare providers, health plans, healthcare clearinghouses and their business associates to comply with HIPAA’s business associate agreement and other HIPAA organizational, risk assessment, privacy and security, and other requirements.

OCR’s announcement emphasizes the importance of meeting these requirements.  “Two major cornerstones of the HIPAA Rules were overlooked by this entity,” said Jocelyn Samuels, Director of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). “Organizations must have in place compliant business associate agreements as well as an accurate and thorough risk analysis that addresses their enterprise-wide IT infrastructure.”

The settlement comes from charges filed after OCR initiated its investigation of North Memorial following receipt of a breach report on September 27, 2011, which indicated that an unencrypted, password-protected laptop was stolen from a business associate’s workforce member’s locked vehicle, impacting the electronic protected health information (ePHI) of 9,497 individuals.

OCR’s investigation indicated that North Memorial failed to have in place a business associate agreement, as required under the HIPAA Privacy and Security Rules, so that its business associate could perform certain payment and health care operations activities on its behalf. North Memorial gave its business associate, Accretive, access to North Memorial’s hospital database, which stored the ePHI of 289,904 patients. Accretive also received access to non-electronic protected health information as it performed services on-site at North Memorial.

The investigation further determined that North Memorial failed to complete a risk analysis to address all of the potential risks and vulnerabilities to the ePHI that it maintained, accessed, or transmitted across its entire IT infrastructure — including but not limited to all applications, software, databases, servers, workstations, mobile devices and electronic media, network administration and security devices, and associated business processes.

In addition to the $1,550,000 payment, North Memorial is required to develop an organization-wide risk analysis and risk management plan, as required under the Security Rule. North Memorial will also train appropriate workforce members on all policies and procedures newly developed or revised pursuant to this corrective action plan.

The Resolution Agreement and Corrective Action Plan can be found here.

Settlement Latest Reminder To Manage HIPAA Risks

Following up on OCR’s imposition of its second-ever HIPAA Civil Monetary Penalty (CMP) and the latest in an ever-growing list of settlements by Covered Entities under HIPAA, the North Memorial settlement is another example of the substantial liability that Covered Entities face for violating HIPAA.  To avoid these liabilities, Covered Entities must constantly be diligent to comply with the latest guidance of OCR concerning their obligations under HIPAA.  As OCR continues to issue additional guidance as well as supplement this guidance through information shared in settlement agreements like the North Memorial settlement, even if Covered Entities reviewed their practices in the last 12-months, most will want to update this review in response to new OCR guidance and enforcement actions, including new guidance on obligations to provide plan members or other subjects of protected health information with access to or copies of their records and other guidance, as well as the ever expanding list of enforcement actions by OCR.

Since the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) amended HIPAA, Covered Entities face growing responsibilities and liability for maintaining the security of ePHI. In response to HITECH, OCR continues to use a carrot and stick approach to encouraging and enforcing compliance. As demonstrated by OCR’s imposition of the second-ever HIPAA Civil Monetary Penalty (CMP) of $239,000 against Lincare and the ever-growing list of Resolution Agreements OCR announces with other Covered Entities, OCR continues to step up enforcement against Covered Entities that breach the Privacy and Security Rules. See OCR’s 2nd-Ever HIPAA CMP Nails Lincare For $239,000.

On the other hand, OCR also continues to encourage voluntary compliance by Covered Entities by sharing guidance and tools to aid Covered Entities to understand fulfill their HIPAA responsibilities such as the HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework (Crosswalk) unveiled by OCR on February 24, 2016.The crosswalk that maps the HIPAA Security Rule to the standards of the National Institute of Standards and Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity (the Cybersecurity Framework) as well as mappings to certain other commonly used security frameworks.

While stating that the HIPAA Security Rule does not require use of the NIST Cybersecurity Framework, OCR says it hopes the Crosswalk will provide “a helpful roadmap” for HIPAA Covered Entities and their business associates to understand the overlap between the NIST Cybersecurity Framework, the HIPAA Security Rule, and other security frameworks that can help Covered Entities safeguard health data in a time of increasing risks and help them to identify potential gaps in their programs. At the same time, OCR’s announcement of its release of the Crosswalk also cautions users that “use of the Framework does not guarantee HIPAA compliance.” Rather, OCR says “the crosswalk provides an informative tool for entities to use to help them more comprehensively manage security risks in their environments.

With a USA Today report attributing more than 40 percent of data breaches to the healthcare industry over the last three years 91 percent of all health organizations having reporting breaches over the last two years, OCR has made clear that it intends to zealously investigate and enforce the Security Rules against Covered Entities that violate the Security Rules against Covered Entities that fail to take suitable steps to safeguard the security of PHI as required by the HIPAA Security Rule. To meet these requirements, the HIPAA Security Rule requires that Covered Entities conduct and be prepared to product documentation of their audit and other efforts to comply with the Security Rule Most Covered Entities will want to consider including an assessment of the adequacy of their existing practices under the Crosswalk and other requirements disclosed by OCR in these assessments to help position the Covered Entity to defend or mitigate HIPAA CMP and other liabilities in the event of a HIPAA breach or audit.

Latest Guidance Clarifies Patient Rights To Access PHI & Allowable Charges

In addition to maintaining adequate security, HIPAA also requires Covered Entities to provide individuals with the right to access and receive a copy of their health information from their providers, hospitals, and health insurance plans in accordance with the HIPAA Privacy Rule. In response to recurrent difficulties experienced by individuals in exercising these rights, OCR recently published supplemental guidance to clarify and promote better understanding and compliance with these rules by Covered Entities.

OCR started this process in January, 2015 by releasing a comprehensive fact sheet (Access fact sheet) and the first in a series of topical frequently asked questions (FAQs) addressing patients’ right to access their medical records, which set forth requirements providers must follow in sharing medical records with patients, including that they must do so in a timely manner and in a format that works for the patient.

Earlier this month, OCR followed up by publishing on March 1, 2016 a second set of FAQs addresses additional issues, including the fees individuals may be charged for copies of their health information and the right of individuals to have their health information sent directly to a third party if they so choose.

Covered entities and their business associates should move quickly to review and update their business associate agreements and other  practices to comply with this new guidance as well as watch for further guidance and enforcement about these practices from OCR.

Other Key HIPAA Regulatory & Enforcement Changes Raise Responsibilities & Risks

OCR’s new guidance on access to PHI follows a host of other regulatory and enforcement activities. While the particulars of each of these new actions and guidance vary, all send a very clear message: OCR expects Covered Entities and their business associates to comply with HIPAA and is offering tools and other guidance to aid them in that process.. In the event of a breach or audit, Covered Entities and their business associates need to be prepared to demonstrate their efforts to comply. Those that cannot show adequate compliance efforts should be prepared for potentially substantial CMP or Resolution Agreement payments and other sanctions.

Register For 3/30 Webex Briefing

Solutions Law Press, Inc.™ invites to catch up on the latest guidance on the Covered Entities’ responsibility under HIPAA to provide access to patients to PHI by registering here to participate in the “HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments” Webex briefing by attorney Cynthia Marcotte Stamer that Solutions Law Press, Inc.™ will host beginning at Noon Central Time on Wednesday, March 30, 2016. Get additional information or register here.

About The Author

Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care and health plan concerns.

Recognized as “LEGAL LEADER™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble and as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine; Ms. Stamer has more than 28 years of extensive proven, pragmatic knowledge and experience representing and advising health industry clients and others on operational, regulatory and other compliance, risk management, product and process development, public policy and other key concerns.

As a core component of her work as the Managing Shareholder of Cynthia Marcotte Stamer, PC, the Co-Managing Member of Stamer Chadwick Soefje PLLC, Ms. Stamer has worked extensively throughout her nearly 30 year career with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, their technology and other vendors and service providers, and others on legal and operational risk management and compliance with 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 concerns; prevention, investigation, response, mitigation and resolution of known or suspected data or privacy breaches or other incidents; defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies; reporting and redressing known or suspected breaches or other violations; business associate and other contracting; 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.

Beyond her extensive involvement advising and defending clients on these matters, Ms. Stamer also has served for several years as the scrivener for the ABA JCEB’s meeting with OCR for many years. She returns as Chair of the Southern California ISSA Health Care Privacy & Security Summit for the third year in 2016, as well as speaks and serves on the steering committee of a multitude of other programs.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares shared her thought leadership, experience and advocacy on HIPAA and other concerns by her service in the leadership of a broad range of other professional and civic organization including her involvement as the Vice Chair of the North Texas Healthcare Compliance Association, Executive Director of the Coalition on Responsible Health Policy and its PROJECT COPE; Coalition on Patient Empowerment, 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; former Board Compliance Chair and Board member of the National Kidney Foundation of North Texas, current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, immediate past RPTE Representative to ABA Joint Committee on Employee Benefits Council Representative and current RPTE Representative to the ABA Health Law Coordinating Counsel, 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.

Ms. Stamer also is a highly popular lecturer, symposia chair and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, InsuranceThoughtLeadership.com and many other prominent publications and speaks and conducts training for a broad range of professional organizations and for clientson the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see CynthiaStamer.com or the Stamer│Chadwick │Soefje PLLC or contact Ms. Stamer via email to here or via telephone to (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at http://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.  ©2016 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved.


55 Hospitals To Pay $35M+ To Settle FCA Claims Charges On Kyphoplasty Procedures

July 6, 2013

Whistleblowers Played A Big Role, Collectively Will Receive $5.5 Million From Settlement Proceeds

Fifty-five hospitals in 21 states will pay a total of more than $34 million to settle Justice Department allegations that the health care facilities submitted false claims to Medicare for a minimally-invasive procedure used to treat certain spinal fractures that often are due to osteoporosis known as “kyphoplasty.”

The settlement stems from charges by the Justice Department and Department of Health & Human Services (HHS) Office of Inspector General (OIG) that the settling hospitals frequently billed Medicare for performing kyphoplasty procedures on the more costly inpatient basis, rather than an outpatient basis, in order to increase their Medicare billings  when the kyphoplasty could have been performed safely and effectively as an outpatient procedure without any need for a more costly hospital admission.

With the settlements announced July 1,  the Justice Department says it has now reached settlements with more than 100 hospitals totaling approximately $75 million to resolve allegations that they mischarged Medicare for kyphoplasty procedures.   Justice Department officials credited whistleblowers with helping it to identify the charged misconduct in virtually all of the cases.  They collectively will receive an estimated $5.5 million of the total of $34 million to be paid under the settlements.

 55 Settlements Impact Systems & Providers Across The Nation

According to the Justice Department’s July 1 announcement of the settlements, the settling facilities, and the amounts they have agreed to pay, include 23 hospitals affiliated with HCA Inc., Nashville, TN, who have agreed to pay a total of $7,145,842.72.  These include:

  •  Aventura Hospital & Medical Center, Aventura, FL
  • Capital Regional Medical Center, Tallahassee, FL
  • Coliseum Medical Center,  Macon, GA
  • Coliseum Northside Hospital, Macon, GA
  • Conroe Regional Medical Center, Conroe, TX
  • Denton Regional Medical Center, Denton, TX
  • Doctors Hospital of Sarasota,  Sarasota, FL
  • Edmond Regional Medical Center, Edmond, OK
  • Fawcett Memorial Hospital, Port Charlotte, FL
  • Fort Walton Beach Medical Center, Fort Walton Beach, FL
  • Garden Park Medical Center, Gulf Port, MS
  • JFK Medical Center, Atlantis, FL
  • Los Robles Regional Medical Center, Thousand Oaks, CA
  • North Florida Regional Medical Center,  Gainesville, FL
  • Northlake Medical Center,  Tucker, GA
  • Oklahoma University Medical Center,  Oklahoma City, OK
  • Palmyra Medical Center,  Albany, GA
  • Redmond Regional Medical Center,  Rome, GA
  • Southwest Florida Regional Medical Center,  Fort Myers, FL
  • St. Lucie Medical Center,  Port Saint Lucie, FL
  • Summit Medical Center,  Hermitage, TN
  • Sunrise Hospital & Medical Center,  Las Vegas, NV
  • Wesley Medical Center, Wichita, KS

Also 6 hospitals affiliated with Lifepoint Hospitals, Inc., Brentwood, TN, have agreed to pay a total of $2,522,502.69.  These include:

  • Andalusia Regional Hospital, Andalusia, AL
  • Jackson Purchase Medical Center, Mayfield, KY
  • Lake Cumberland Regional Hospital,  Somerset, KY
  • Minden Medical Center,  Minden, LA
  • Russellville Hospital, Russellville, AL
  • Western Plains Medical Complex,  Dodge City, KS

Also, 5  hospitals affiliated with Trinity Health, Livonia, MI, have agreed to pay a total of $3,910,017.53.  These include:

  • Mercy Medical Center, – Dubuque,  Dubuque, IA
  • Mercy Medical Center – Sioux City,  Sioux City, IA
  • St. Joseph Mercy Hospital,  Pontiac, MI
  • Mercy Health Partners,  Muskegon, MI
  • Mount Carmel New Albany Surgical Hospital,  New Albany, OH

Justice Department officials also report that 4hospitals affiliated with Morton Plant Mease BayCare Health System, Clearwater, FL, have agreed to pay a total of $2,378,325.45.  These include:

  • Morton Plant Hospital,  Clearwater, FL
  • Morton Plant North Bay Hospital,  New Port Richey, FL
  • Mease Dunedin Hospital, Dunedin, FL
  • Mease Countryside Hospital, Safety Harbor, FL

Justice Department officials also say 3  hospitals affiliated with Baptist Memorial Health Care Corporation, Memphis, TN, have agreed to pay a total of $691,168.  These are:

  • Baptist Memorial Hospital-Golden Triangle, North Columbus, MS
  • Baptist Memorial Hospital-Collierville,  Collierville, TN
  • Baptist Memorial Hospital-Memphis,  Memphis, TN

In addition, Justice Department officials say 2 hospitals affiliated with Covenant Health, Knoxville, TN, have agreed to pay a total of $1,845,641.74.  These are  Parkwest Medical Center in  Knoxville, TN  and Methodist Medical Center of Oak Ridge in Oak Ridge, TN.

Meanwhile, 2 hospitals affiliated with Bayhealth Medical Center, Newark, DE, also reportedly have agreed to pay a total of $1,115,306.37.  These are Bayhealth Kent General Hospital,  Dover, DE  and Bayhealth Milford Memorial Hospital,  Milford, DE.

In addition to these hospitals, the following facilities have agreed to pay the following settlements:

  • Atrium Medical Center, Middletown, OH, has agreed to pay $4,232,992.50
  • Altru Health System, Grand Forks, ND, has agreed to pay $1,492,690
  • Cedars Sinai Medical Center, Los Angeles, CA, has agreed to pay $1,485,846
  • Des Peres Hospital, St. Louis, MO, has agreed to pay $900,000
  • Mount Sinai Medical Center, Miami, FL, has agreed to pay $1,846,194.00
  • New England Baptist Hospital, Boston, MA, has agreed to pay $374,814.48
  • St. Anne’s Hospital, Fall River, MA, has agreed to pay $552,745
  • The Queen’s Medical Center, Honolulu, HI, has agreed to pay $1,055,249.57
  • Trover Health System, Madisonville, KY, has agreed to pay $1,162,837
  • Wayne Memorial Hospital, Goldsboro, NC, has agreed to pay $1,250,000.

In addition to today’s settlement, the government previously settled with Medtronic Spine LLC, the corporate successor to Kyphon Inc., for $75 million to settle allegations that the company defrauded Medicare by counseling hospital providers to perform kyphoplasty procedures as inpatient rather than outpatient procedures.

According to Tom O’Donnell, Special Agent in Charge of the Office of Investigations of the HHS-OIG New York Regional Office,  “The settlements related to kyphoplasty billing that have been reached with over 100 hospitals represent one of the largest and most successful multi-party health care investigations in the nation.”

While these settlements relate specifically to kyphoplasty procedures, they send a message impacting all procedures and practice areas that they risk OIG and/or Justice Department prosecution if procedures are performed in a most costly manner to increase reimbursement which is not medically necessary.  Justice Department officials warned health care providers  that Justice and OIG will act “Whenever hospitals knowingly overcharge Medicare, critically needed resources are wasted and health costs are driven up.”

Whistleblower Involvement Played Big Role

As in other recently announced settlement agreements, see e.g., Whistleblower Collects $2.7 M of $14.5M Sound Inpatient Physicians Overbilling Settlement, whistleblower involvement played a key role in helping OIG and Justice to identify and prosecute the alleged misconduct.

According to the Justice Department, all but four of the settling facilities announced today were named as defendants in a qui tam, or whistleblower, lawsuit brought under the False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States and receive a portion of the proceeds of any settlement or judgment awarded against a defendant.  The lawsuit was filed in federal district court in Buffalo, N.Y., by Craig Patrick and Charles Bates.  Mr. Patrick is a former reimbursement manager for Kyphon, and Mr. Bates was formerly a regional sales manager for Kyphon in Birmingham, Ala.  The whistleblowers will receive a total of approximately $5.5 million from the settlements.

 Mitigate Risks With Effective Oversight of Both Documentation & Operations

As Acting Assistant Attorney General for the Civil Division Stuart F. Delery noted in the settlement announcement. “Physicians who participate in Medicare and other federal health care programs must document and bill for their services accurately and honestly.” With qui tam and other whistleblower participation, the Justice Department, HHS and other federal and state fraud investigators go beyond merely challenging whether the medical record documentation supports the charges billed to question whether the medical record itself accurately reflects the care in fact delivered by relying upon testimony of employees or other “insiders” often with an axe to grind against the provider.

To mitigate these exposures, health care providers clearly should work diligently both to ensure that their billing and other compliance programs accurately, honestly and completely document the care provided and code and bill for those services in accordance with the currently applicable federal program rules.  While these compliance and risk management programs are indispensable components of any effective health care fraud compliance program, health care providers also should recognize that the effectiveness of their health care fraud and other compliance program also may depend on the effectiveness of their operational and workforce oversight and management.  Along with effective billing and other fraud detection and compliance programs, providers also need effective medical quality and records documentation, provider and workforce performance and management, investigations and other management programs.

As a key element of these activities, providers should constantly be on watch for evidence of gaps between the medical and billing documentation and the factual realities looking at broad range of sources. Providers should target these activities to cover both specific medical documentation, coding and care, and other operational indicators that could show a problem.  With qui tam and other whistleblower claims rising, however, providers should keep in mind that mere auditing of records and billing patterns alone often fails to uncover key evidence of potential concerns.

To help identify potential areas of scrutiny, providers should carefully monitor and examine the adequacy of their compliance and risk management agreements against corporate integrity agreements with other providers who have reached settlements with the Department of Justice, HHS Office of Inspector General or other agencies like the TranS1 Inc. Corporate Integrity Agreement .

Health care providers also should take into account a plethora of other potential indicators including but not limited to peer review and quality assurance data, deficient as well as inexplicably exceptional medical record or other record keeping documentation, hotline, exist interview and other workforce feedback, disagreements among providers in patterns of care, political and interpersonal differences, and a host of other indicators that could show a valid compliance concern or a developing hostility that could become the incentive for a whistleblower or other complaint. Providers should document these and other efforts to investigate, monitor and redress potential concerns  In addition, providers also should guard against qui tam, retaliation and other claims by ensuring that their human resources, peer review, credentialing, background and other investigations, privacy and other operational activities are designed, documented to be both legally compliant and defensible.

For More Information Or Assistance

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. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters.

Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

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

About Solutions Law Press

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

 

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

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press, Inc..  All other rights reserved.


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