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

October 2, 2020

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

Presented Via Facebook Live

October 8, 2020

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

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

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

ABOUT THE SUMMIT

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

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

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

Confirmed panelists include:

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

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

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

Traci Mayer, Executive Director, Hotel Association of North Texas

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

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

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

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

TOUR PANDEMIC MANAGEMENT RESOURCES IN VIRTUAL EXHIBIT HALL

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

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

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

©2020 Solutions Law Press, Inc. All rights reserved.


HHS Picks Hargan As Acting HHS Secretary

October 11, 2017

President Trump has appointed Eric D. Hargan Acting Secretary of the U.S. Department of Health and Human Services (HHS).

Hargan, who was just sworn into office as Deputy Secretary of HHS on Oct. 6, 2017, takes over the duties of former Secretary Dr. Tom Price, who recently resigned in response to criticism about his expenditures for charter flights.

Before joining HHS, Mr. Hargan was an attorney, most recently a shareholder in Greenberg Traurig’s Chicago office in the Health and FDA Business department, where he focused his practice on transactions, healthcare regulations and government relations. He represented investors, companies, and individuals in healthcare investments and issues across the entire sector.

From 2003 to 2007, Mr. Hargan served at HHS in a variety of capacities, ultimately holding the position of Acting Deputy Secretary. During his tenure at HHS, Mr. Hargan also served as the Department’s Regulatory Policy Officer, overseeing the development and approval of all HHS, CMS, and FDA regulations and significant guidances.

Prior to this role, he served HHS as Deputy General Counsel. More recently, he was tapped by Governor Bruce Rauner to serve during transition as lead co-chair for Gov. Rauner’s Healthcare and Human Services committee.

During his time in Illinois, Mr. Hargan taught at Loyola Law School in Chicago, focusing on administrative law and healthcare regulations. He was a member of the U.S. government team at the inaugural U.S.-China Strategic Economic Dialogue in Beijing in 2006-2007, worked with the State Department’s Bureau of Arms Control to advance biosecurity in developing nations, and initiated and led the HHS team that developed the first responses to international food safety and importation issues in 2007.

He received his B.A. cum laude from Harvard University, and his J.D. from Columbia University Law School, where he was Senior Editor of the Columbia Law Review. Mr. Hargan also received a Certificate in International Law from the Parker School of Foreign and Comparative Law at Columbia University.

Before returning to Washington, D.C., Mr. Hargan lived in the suburbs of Chicago with his wife, Emily, and their two sons.

About The Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management, disaster and other crisis preparedness and response, and other performance and operations management and compliance. Her experienced includes career long involvement in advising and defending health industry and other organizations about disaster and other crisis preparation, response and mitigation arising from natural and man-made disasters, government enforcement, financial distress, workplace emergencies and accidents, data breach and other cybersecurity and other events.  For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

About Solutions Law Press, Inc.™

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

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

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

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


CMS Proposes Cutbacks To Medicare Bundled Payment Program

August 15, 2017

A Centers for Medicare and Medicaid Services (CMS) proposed rule scheduled for publication in the August 18, 2017 Federal Register will propose to reduce the number of mandatory geographic areas for the joint bundled payment program and cancel the cardiac bundled payment program model for determining reimbursement of providers for care under Medicare as well as make other refinements to the bundled payment program scheduled to take effect in January.

Widely criticized by many providers including department of Health and Human Services Secretary Dr. Tom Price, the mandatory bundled payment program presently is scheduled to take effect in January, 2018 after multiple delays.

According to the advanced copy of the proposed rule released by CMS on August 15, 2017, the proposed rule will propose among other things the following changes to the bundled payment program:

  • Cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and rescind the regulations governing these models;
  • Revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model;
  • Make technical refinements and clarifications for certain payment, reconciliation and quality provisions; and
  • Increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.

Healthcare providers and others interested in the proposed changes should carefully review the proposed changes and provide feedback as soon as possible  and no later than the October 17, 2017 deadline the proposed regulation sets for submitting comments.

About The Author

The author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

An American Bar Foundation, American College of Employee Benefits Counsel, and Texas Bar Foundation Fellow, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section,  the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past  Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management and a broad range of other legal and operational concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical  staff performance, quality, governance, reimbursement, 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.

You can get more information about her health industry experience 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 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 found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates, publications, training program, advocacy and other initiatives available here.

Go here to register to receive other Solutions Law Press, Inc. updates and announcements about other upcoming briefings, training or other programs, products, services, and activities or to learn more about Solutions Law Press, Inc., its publications, programs and training, PROJECT COPE: Coalition on Patient Empowerment community service and education projects, event management and other resources and services.

For important information concerning this communication see 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.

©2017 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.


CMS Releases 2017 Provider Payment Program Hardship Exception Application

August 4, 2017

The Quality Payment Program Hardship Exception Application for the 2017 transition year now is available on the Quality Payment Program website.

MIPS eligible clinicians and groups may qualify for a reweighting of their Advancing Care Information performance category score to 0% of the final score, and can submit a hardship exception application, for one of the following specified reasons:

  • Insufficient internet connectivity
  • Extreme and uncontrollable circumstances
  • Lack of control over the availability of Certified EHR Technology (CEHRT).

Some MIPS eligible clinicians who are considered Special Status, will be automatically reweighted (or, exempted in the case of MIPS eligible clinicians participating in a MIPS APM), do not need to submit a Quality Payment Program Hardship Exception Application.
In addition to submitting an application via the Quality Payment Program website, clinicians also may contact the Quality Payment Program Service Center and work with a representative to verbally submit an application.

To submit an application, a physician or other applying clinician will need:

  • The Taxpayer Identification Number (TIN) for group applications or National Provider Identifier (NPI) for individual applications;
  • Contact information for the person working on behalf of the individual clinician or group, including first and last name, e-mail address, and telephone number; and
  • Selection of hardship exception category (listed above) and supplemental information.

Applicants for a hardship exception based on the Extreme and Uncontrollable Circumstance category, also must select one of the following and provide a start and end date of when the circumstance occurred:

  • Disaster (e.g., a natural disaster in which the CEHRT was damaged or destroyed);
  • Practice or hospital closure;
  • Severe financial distress (bankruptcy or debt restructuring);
  • EHR certification/vendor issues (CEHRT issues)

Once an application is submitted, CMS will send the applicant a confirmation email acknowledging receipt of the application and when it is pending, approved, or dismissed. Applications will be processed on a rolling basis.

Physician and other clinicians or practices interested in pursuing an exemption should act promptly.

About The Author

Cynthia Marcotte Stamer is a Martindale-Hubble “AV-Preeminent (Top 1%) rated practicing attorney and management consultant, health industry public policy advocate, widely published author and lecturer, recognized for her nearly 30 years’ of work on health industry and other privacy and data security and other health care, health benefit, health policy and regulatory affairs and other health industry legal and operational as a LexisNexis® Martindale-Hubbell® “LEGAL LEADER™ and “Top Rated Lawyer,” in Health Care Law and Labor and Employment Law; a D Magazine “Best Lawyers In Dallas” in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law,” a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel.

Technical advisor to the National Physicians Council for Healthcare Policy, Vice President of the North Texas Healthcare Professionals Association, American Bar Association (ABA) International Life Sciences Committee Vice Chair, Policy; Scribe for ABA JCEB annual agency meeting with OCR, Ms. Stamer is well-known for her extensive work and leadership throughout her career on healthcare and health policy, regulatory, operations and other industry topics. Her clients include public and private healthcare systems, hospitals and other healthcare facilities, health care providers, health insurers, health plans, employers, health and other technology and other vendors, communities and others.

In addition to representing and advising these organizations, she also speaks extensively and conducts training on health care and other privacy and data security and many other matters.

Beyond these involvements, Ms. Stamer also is active in the leadership of a broad range of other health care and other professional and civic organizations. Through these and other involvements, she helps develop and build solutions, build consensus, garner funding and other resources, manage compliance and other operations, and take other actions to identify promote tangible improvements in health care and other policy and operational areas.

For additional information about Ms. Stamer, see here or contact Ms. Stamer directly by e-mail here or by telephone at (469) 767-8872. ©2017 Cynthia Marcotte Stamer.  Limited, non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


$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.


All Covered Entities Should Learn Lessons From Mississippi Medical Center’s $2.75 Million HIPAA Resolution Agreement

July 27, 2016

Health care providers, health plans, healthcare clearinghouses (covered entities) and their business associates should reevaluate the adequacy of their practices and procedures for the protection of electronic protected health information (ePHI) on or accessible through laptops or other mobile devices in light of the $2.75 million penalty and other schooling the Department of Health and Human Services Office for Civil Rights (OCR) just gave the University of Mississippi (UM) Medical Center (UMMC) documented in a July 7, 2016 Resolution Agreement and Corrective Action Plan (Resolution Agreement) resolving OCR charges of multiple violations of the privacy, security and breach notification requirements of the Health Insurance Portability and Accountability Act (HIPAA) OCR says it uncovered while investigating UMMC’s breach notification report to OCR of the loss a laptop containing 328 files containing the ePHI of an estimated 10,000 patients.

UMMC Report of Missing Laptop Leads To Multiple Charges & Resolution Agreement

Mississippi’s sole public academic health science center, UMMC provides patient care in four specialized hospitals on the Jackson campus and at clinics throughout Jackson and the State as well as conducts medical education and research functions.  Its designated health care component, UMMC, includes University Hospital, the site of the breach in this case, located on the main UMMC campus in Jackson.

The settlement agreed to by UMMC stems from charges resulting from an OCR investigation of UMMC triggered by a breach of unsecured electronic protected health information (“ePHI”) affecting approximately 10,000 individuals.

Like many prior resolution agreements previously announced by OCR, UMMC’s HIPAA woes came to light after a laptop went missing.  OCR learned of the breach and opened its investigation in response to a March 21, 2013 notification UMMC filed with OCR.  UMMC made the breach notification to comply with HIPAA’s Breach Notification Rule requirement that health care providers, health plans and healthcare clearinghouses (Covered Entities) timely notify affected individuals, OCR and others of breaches of unsecured ePHI.

UMMC’s breach notification disclosed that UMMC’s privacy officer had discovered a password-protected laptop containing ePHI of thousands of UMMC patients missing from UMMC’s Medical Intensive Care Unit (MICU). UMMC additionally reported that based on its investigation, UMMC believed that the missing laptop likely was stolen by a visitor to the MICU who had inquired about borrowing one of the laptops.

After discovering the loss, UMMC disclosed the breach to local media and on its website and notified OCR of the breach but apparently did not individually notify the subjects of the missing ePHI.

In keeping with its announced policy of investigating all breach reports impacting 500 or more individuals, OCR opened an investigation into UMMC’s breach report.  Based on this investigation, OCR concluded that while the laptop apparently was password protected, UMMC had breached the Security Rules because ePHI stored on a UMMC network drive was vulnerable to unauthorized access via UMMC’s wireless network because users could use a generic username and password to access an active directory containing 67,000 files including 328 files containing the ePHI of an estimated 10,000 patients.

While OCR’s investigation confirmed that UMMC had implemented policies and procedures pursuant to the HIPAA Rules, OCR’s additionally found that the theft of the laptop that prompted UMMC’s breach report resulted from broad deficiencies in UMMC’s implementation and administration of these policies and its practices.

Based on these findings, OCR charged UMMC with the following HIPAA violations:

  • From the compliance date of the Security Rule, April 20, 2005, through the settlement date, UMMC violated 45 C.F.R. §164.308(a)(1)(i) by failing to implement policies and procedures to prevent, detect, contain, and correct security violations, including conducting an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of the ePHI it holds, and implementing security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level;
  • From January 19, 2013, until March 1, 2014, UMMC violated 45 C.F.R. §164.310(c) by failing to implement physical safeguards for all workstations that access ePHI to restrict access to authorized users;
  • From the compliance date of the Security Rule, April 20, 2005, to March 14, 2013, UM violated 45 C.F.R. § 164.312 (a)(2)(i) by failing to assign a unique user name and/or number for identifying and tracking user identity in information systems containing ePHI including, for example, allowing workforce members to access ePHI on a shared department network drive through a generic account, preventing UMMC from tracking which specific users were accessing ePHI; and
  • While UMMC provided notification on UMMC’s website and in local media outlets following the discovery of the reported breach of unsecured ePHI,, UMMC violated the Breach Notification Rule by failing to notify each individual whose unsecured ePHI was reasonably believed to have been accessed, acquired, used, or disclosed as a result of the breach.

Finally, OCR determined that UMMC was aware of risks and vulnerabilities to its systems as far back as April 2005, yet took no significant risk management activity until after the breach, due largely to organizational deficiencies and insufficient institutional oversight.

To resolve these charges, UMMC agrees in the Resolution Agreement to pay OCR $2.75 million and implement a comprehensive compliance plan which among other things, requires UMMC to conduct a sweeping review and correct its HIPAA privacy, security and breach notification policies and their implementation and administration to comply with HIPAA as well as implement and administer detailed management and OCR oversight and reporting processes over the implementation and administration of these procedures.

Lessons For Other Covered Entities From UMMC Resolution Agreement

The UMMC charges and Resolution Agreement contains several key lessons for other covered entities and their business associates, which OCR’s July 21, 2016 announcement warns other covered entities and business associates to heed..

Certainly, the $2.75 million settlement amount reaffirms that covered entities and their business associates risk substantial liability for failing to properly assess and protect the security of ePHI in accordance with HIPAA’s Privacy and Security Rule.

Furthermore, the charges and Resolution Agreement also adds a new twist to OCR’s now well established to stiffly sanction covered entities and their business associates that fail appropriately assess and address risks to the security of their ePHI on or accessible from laptops or other mobile devices. Through previous resolution agreements and guidance, OCR has made clear that it interprets the HIPAA Security Rule as generally requiring that covered entities and business associates encrypt all laptops or other mobile devices containing ePHI.  The UMMC charges and Resolution Agreement makes clear that the responsibility to protect ePHI on or accessible through laptops or other mobile devices does not end with encryption.  Rather, the Resolution Agreement makes clear that covered entities and their business associates also must take appropriate, well-documented steps to monitor, assess, identify, and timely and effectively address other potential risks to the security of the ePHI.

The Resolution Agreement makes clear that these additional responsibilities include, but are not necessarily limited to ensuring that proper safeguards are implemented and enforced to secure access not only to the ePHI contained on the laptop as well as other data bases and systems containing ePHI accessible through the laptop.  In this respect, the Resolution Agreement particularly highlights the need for covered entities and their business associates to assess risks and take appropriate steps:

  • To safeguard the physical security of laptops and other mobile devices;
  • To prevent the use of generic or other unsecure passwords to access ePHI on or accessible through the laptop or other mobile device;
  • To establish and administer appropriate, well-documented processes for assessing and addressing the adequacy of safeguards for and potential threats to the security of ePHI both initially and on an ongoing basis in a manner that meaningfully assesses the actual risks and effectiveness of safeguards against these risks, including those resulting from nonadherence to required safeguards and practices such as the sharing of passwords, changing systems or circumstances, and other developments that potentially threaten the adequacy of ePHI security.

Furthermore, OCR’s July 21, 2016 press release concerning the Resolution Agreement also sends a clear message to all covered entities and business associates that OCR views HIPAA as requiring organizations not only to adopt written policies and procedures that comply on paper or in theory with HIPAA, but also to take steps to monitor and maintain the effectiveness of their safeguard by continuously assessing and monitoring their HIPAA risks and acting as necessary to ensure that required safeguards of protected health information and ePHI and other HIPAA requirements are effectively implemented and administered in operation as well as form.

In OCR’s Press Release announcing the Resolution Agreement, OCR Director Jocelyn Samuels. Stated, “We at OCR remain particularly concerned with unaddressed risks that may lead to impermissible access to ePHI.”  She also warned “In addition to identifying risks and vulnerabilities to their ePHI, entities must also implement reasonable and appropriate safeguards to address them within an appropriate time frame.”

Additionally, the Resolution Agreement also illustrates need for covered entities and business associates to timely provide all individual and other notifications and otherwise fully comply with all requirements of the Breach Notification Rules.

Since the risk of a breach is ever-present even for Covered Entities and business associates exercising the highest degree of care to safeguard PHI and maintain compliance with HIPAA, Covered Entities and business associates are wise to take steps to position themselves to be able to demonstrate the adequacy of both their written policies and procedures and the effectiveness of their implementation and enforcement including ongoing documented practices for assessing, monitoring and addressing security risks and other compliance concerns as well as prepare to comply with the breach notification requirements in the event they experience their own breach of unsecured ePHI.

About The Author

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section,  the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past  Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also is known for her experience in HIPAA and other privacy and data security and breach concerns.  The scribe for ABA JCEB annual agency meeting with OCR for many years, 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, 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 popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical  staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, 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 or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

 

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Providers, Health Plans Should Confirm Copy Charges Comply With New OCR HIPAA Guidance

May 26, 2016

Healthcare providers, health plans, healthcare clearinghouses (Covered Entities) and their business associates should verify that their copying charges and other policies and practices for responding to requests of individuals for copies and other access to protected health information (PHI) comply with the Privacy and Security Rules (Privacy Rule) of the Health Insurance Portability & Accountability Act of 1996 (HIPAA) as construed in a new Frequently Asked Question (FAQ published May 24, 2016 as follow up to two other sets of guidance about HIPAA assess rights published by the Department of Health & Human Services Office of Civil Rights (OCR) since January, 2016.

New OCR Guidance Sheds New Light On HIPAA Access Rule Requirements

The OCR FAQ titled New Clarification – Up to $6.50 Flat Rate Option published May 24, 2016 is the third in a series of guidance materials OCR discussing OCR’s interpretation of individuals’ core right under HIPAA to access and obtain a copy of their PHI from Covered Entities since January, 2016 (the “Access Rule”).   With  OCR Enforcement Data already showing Access Rule violations among the top 5 issues in cases investigated by OCR every year since HIPAA took effect in 2003, Covered Entities can expect OCR to include Access Rule violations among the Privacy Rule violations OCR likely will target as it continues to ramp up its HIPAA audit, investigation and enforcement efforts.

As part of its sweeping requirements concerning the use, access, protection and disclosure of PHI, the Access Rule provisions of the Privacy Rule generally require Covered Entities to provide individuals, upon request, with access to the protected health information (PHI) about them in one or more “designated record sets” maintained by or for the Covered Entity or its business associate.  This includes the right to inspect or obtain a copy, or both, of the PHI, as well as to direct the Covered Entity to transmit a copy to a designated person or entity of the individual’s choice as long as the Covered Entity or a business associate on its behalf maintains the PHI, regardless of the date the information was created; whether the information is maintained in paper or electronic systems onsite, remotely, or is archived; or where the PHI originated (e.g., whether the Covered Entity, another provider, the patient, etc.).

With its publication of the New Clarification FAQ on May 24, 2016, OCR now has published three pieces of guidance (the Access Guidance) about its interpretation of the Access Rule since January, 2016 that it hopes will promote greater understanding of and compliance with the Access Rule by Covered Entities:

  • In January, OCR published a comprehensive Fact Sheet (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;
  • On March 1, OCR published a second set of FAQs accessible here addressing when Covered Entities may charge individuals to provide requested copies of their PHI, how Covered Entities must calculate these fees, when Covered Entities must send an individual’s PHI to a third party designated by the individual in its request for copies, and other issues relating to access rights guaranteed by the Privacy Rule; and
  • On May 24, 2016 OCR clarified this prior Access Guidance by publishing another FAQ titled New Clarification – Up to $6.50 Flat Rate Option .

Collectively, the Access Guidance addresses a broad range of questions and issues about the responsibilities of Covered Entities under the Access Rule including what PHI Covered Entities must provide as well as detailed guidance about when and how much Covered Entities can charge individuals for requested copies of their PHI or summaries of their PHI.  Since the OCR Access Guidance may restrict the charge that health care providers or other Covered Entities can charge for copies or other access more than applicable state law rules,  Covered Entities need to verify their practices comply with OCR’s Access Guidance in addition to any applicable state law rules.  The Access Guidance makes clear that OCR expects Covered Entities and their business associates to ensure that their charges for copying or providing other access to PHI guaranteed by the Privacy Rule complies with this Access Guidance even if that practice does not violate applicable state law.

Are You Charging Too Much? Charges For Copies of PHI Must Meet OCR Privacy Rule Guidance 

Concerning charges for copies of PHI requested by an individual, Privacy Rule § 164.524(c)(4) permits a Covered Entity to impose a reasonable, cost-based fee if the individual requests a copy of the PHI (or agrees to receive a summary or explanation of the information) provided that the Covered Entity properly and timely notifies the individual of the cost and properly determines the cost in accordance with OCR guidance.

Many physicians or other health care providers that use electronic health records (EHRs) certified to allow individuals to access their PHI in the system may be unaware that OCR views the availability of electronic access from the EHR affects the health care provider’s ability to charge for copies of requested PHI.  OCR’s position is that the Privacy Rule prohibits a Covered Entity from charging an individual for requested copies of PHI when the request is fulfilled by the individual accessing the requested PHI using the View, Download, and Transmit functionality of the provider’s certified electronic health record.

Assuming the request for access or copies is not fulfilled through download from an HER, the Access Guidance indicates q Covered Entity must use one of three potentially applicable OCR-approved methods to calculate the fee the Covered Entity charges an individual for copies of PHI or an agreed upon summary provided that the method used takes into account only labor costs for copying or producing an agreed upon summary as defined by OCR.:

  • The “Actual Cost” Method;
  • The “Average Cost” Method; or
  • For electronic copies of PHI maintained electronically, the “Flat Fee” Method.

Charging a flat fee not to exceed $6.50 is an option available to those entities that do not want to go through the process of calculating actual or average costs for requests for electronic copies of PHI under either the Actual Cost or Average Cost Methods.  However, by its terms, the “Flat Fee” Method is only an allowable for Covered Entities to use to avoid calculating actual or average allowable costs when a Covered Entity is providing electronic copies of PHI maintained electronically (and presumably when the access request is not fulfilled through download from an EHR).  When applicable, the Flat Fee Method allows a Covered Entity to charge a flat fee for all requests for electronic copies of PHI maintained electronically, provided the fee does not exceed $6.50, inclusive of all labor, supplies, and any applicable postage.  The New Clarification – Up to $6.50 Flat Rate Option clarifies that use of the Flat Rate Method is permitted not required when a Covered Entity  provides copies of PHI maintained electronically other through download directly from a certified EHR. Covered Entities that wish to charge more than the $6.50 flat rate allowed under the Flat Rate Option retain the right, if the facts and evidence warrant, to use either the Actual Cost Method or Average Cost Method to calculate the fee for providing electronic records electronically within the boundaries of what is permissible under the Privacy Rule.

Where the Flat Fee Method is inapplicable or the Covered Entity elects not to use it, the Covered Entity must use either the Actual Cost Method or the Average Cost Method to calculate the fee in accordance with OCR’s rules.

Under the “Actual Cost Method,” a Covered Entity may calculate actual labor costs to fulfill the request, as long as the labor included is only for copying (and/or creating a summary or explanation if the individual chooses to receive a summary or explanation) and the labor rates used are reasonable for such activity. The Covered Entity may add to the actual labor costs any applicable supply (e.g., paper, or CD or USB drive) or postage costs. Covered Entities that charge individuals actual costs based on each individual access request still must be prepared to inform individuals in advance of the approximate fee that may be charged for providing the individual with a copy of her PHI. An example of an actual labor cost calculation would be to time how long it takes for the workforce member of the Covered Entity (or business associate) to make and send the copy in the form and format and manner requested or agreed to by the individual and multiply the time by the reasonable hourly rate of the person copying and sending the PHI. What is reasonable for purposes of an hourly rate will vary depending on the level of skill needed to create and transmit the copy in the manner requested or agreed to by the individual (e.g., administrative level labor to make and mail a paper copy versus more technical skill needed to convert and transmit the PHI in a particular electronic format);

Under the “Average Cost” Method, in lieu of calculating labor costs individually for each request, a Covered Entity can develop a schedule of costs for labor based on average labor costs to fulfill standard types of access requests, as long as the types of labor costs included are the ones which the Privacy Rule permits to be included in a fee (e.g., labor costs for copying but not for search and retrieval) and are reasonable. Covered Entities may add to that amount any applicable supply (e.g., paper, or CD or USB drive) or postage costs.    This standard rate can be calculated and charged as a per page fee only in cases where the PHI requested is maintained in paper form and the individual requests a paper copy of the PHI or asks that the paper PHI be scanned into an electronic format. However OCR’s guidance states that OCR does not consider per page fees for copies of PHI maintained electronically to be reasonable for purposes of 45 CFR 164.524(c)(4);

Whether using the Actual Cost Method or the Average Cost Method, a Covered Entity must only take into account only “reasonable labor costs associated only with the: (1) labor for copying the PHI requested by the individual, whether in paper or electronic form; and (2) labor to prepare an explanation or summary of the PHI, if the individual in advance both chooses to receive an explanation or summary and agrees to the fee that may be charged.

OCR’s guidance makes clear that the reasonability of the charges for labor must reflect the technology available for providing this access.  In this respect, OCR’s guidance states that a Covered Entity cannot charge a fee under HIPAA for individuals to access the PHI from a health care provider’s EHR technology that has been certified as being capable of making the PHI accessible.   OCR’s position is that where a Covered Entity fulfills an individual’s HIPAA access request by allowing the individual to access the requested PHI using the View, Download, and Transmit functionality of the provider’s certified electronic health record (CEHRT), an individual requests or agrees to access her PHI available through the View, Download, and Transmit functionality of the CEHRT, there are no labor costs and no costs for supplies to enable such access.

To the extent that access is not provided through an CEHRT, the fee a Covered Entity charges an individual to provide copies of requested PHI or an agreed upon summary may include only the cost of:

  • Copying the PHI; and
  • Preparation of an explanation or summary of the PHI, if agreed to by the individual.

As interpreted by OCR, labor for copying includes only labor for creating and delivering the electronic or paper copy in the form and format requested or agreed upon by the individual, once the PHI that is responsive to the request has been identified, retrieved or collected, compiled and/or collated, and is ready to be copied.  For example, labor for copying may include labor associated with the following, as necessary to copy and deliver the PHI in the form and format and manner requested or agreed to by the individual:

  • Labor for copying the PHI requested by the individual, whether in paper or electronic form;
  • Supplies for creating the paper copy or electronic media (e.g., CD or USB drive) if the individual requests that the electronic copy be provided on portable media;
  • Postage, when the individual requests that the copy, or the summary or explanation, be mailed; and
  • Creating and executing a mailing or e-mail with the responsive PHI.

See 45 CFR 164.524(c)(4).

The Access Guidance states the fee may not include costs associated with verification; documentation; searching for and retrieving the PHI; maintaining systems; recouping capital for data access, storage, or infrastructure; outsourcing the function of responding to individual requests for PHI copies or other costs not listed above even if such costs are authorized by State law.  See 45 CFR 164.524(c)(4).

Of course, in any case, OCR’s guidance makes clear that regardless of how a entity chooses to calculate its fee to copy PHI, the Privacy Rule requires that the Covered Entity inform the requesting individual in advance of the approximate fee that may be charged for providing the copy requested and otherwise comply with the Privacy Rule as interpreted by OCR’s latest guidance concerning providing individuals access to PHI and other requirements.

Documented, Timely Action Needed To Mitigate OCR Audit, Investigation & Enforcement Risks

Beyond operationally complying with the Access Guidance, Covered Entities and their business associates generally will want to update their policies, practices and training to position themselves to defend their calculation of any charges made for copies provided in response to a request for access protected by the Privacy Rule and other compliance with the requirements of that rule and the otherwise applicable provisions of HIPAA as well as include monitoring and enforcement of these requirements as part of their ongoing HIPAA compliance efforts.

These and other HIPAA compliance efforts are particularly critical in light of the expanding audit, investigation and enforcement activities of OCR under the Privacy Rule.  OCR’s publication of the Access Guidance coincides with a surge in OCR’s HIPAA audit, investigation and enforcement activities.

OCR’s publication of the new Access Guidance comes as OCR is ramping up its interpretation, oversight and enforcement of HIPAA generally.  See, Brace For OCR HIPAA Audits & Enforcement; Update Privacy Practices For New OCR HIPAA Enforcement, Security & Records Access Guidance.  While continuing to offer guidance like the Access Guidance and other tools to encourage and help Covered Entities and their business to understand and comply with the Privacy Rule, OCR also increasingly now uses the expanded penalties and authority created by the HITECH Act to punish Covered Entities for violating Privacy Rule requirements.  HITECH Act amendments, among other things, broadened the duties of OCR to audit, investigate and sanction HIPAA violations as well as tightened various requirements of the Privacy Rules.

The risks to Covered Entities from violating the Privacy Rules are significant and growing.  Since the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) amended HIPAA, Covered Entities and their business associates face heightened risks that violations of HIPAA will trigger liability to pay a Civil Monetary Penalty (CMP) to OCR or other sanctions.  The two, multimillion dollar CMPs now imposed by OCR against two different Covered Entities caught violating the Privacy Rules only reflect a small part of OCR’s CMP enforcement.  Equally or perhaps more significant are the growing stream of high dollar settlement payments that an ever-growing list of Covered Entities to resolve OCR Privacy Rule violation charges that otherwise also might result in OCR’s assessment of a CMP against them.  See, e.g. $2 Million+ HIPAA Settlement, FAQ Warn Providers Protect PHI From Media, Other Recording Or Use; Provider Pays $750K To Settle HIPAA Business Associate Rule Breach Charges; North Memorial Hit With $3.9M HIPAA Fine For HIPAA Violations;  OCR’s 2nd-Ever HIPAA CMP Nails Lincare For $239,000; Lehey Pays $850K After Unencrypted Laptop Stolen.

These already substantial enforcement risks are likely to rise as OCR begins auditing the compliance of selected Covered Entities as part of its recently announced 2016 audit program.  As a result of audit requirements enacted as part of the HITECH Act, Covered Entities now need to be prepared to demonstrate the adequacy of their HIPAA compliance in case their organization becomes targeted for audit under OCR’s 2016 audit program.  Even if not selected for audit, however, Covered Entities and their business associates still face the risk that a complaint filed with OCR will trigger an OCR investigation of their practices for providing copies or other access or other compliance with the Privacy Rules.  In light of the growing aggressiveness of OCR’s enforcement, 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.  Consequently, Covered Entities and their business associates should move quickly to review and update their practices, communications and training to comply with this new Access Guidance as well as other guidance, enforcement and other developments that might impact the adequacy of their existing practices under the Privacy Rule generally.  Because of the risk that any review or investigation of the adequacy of its practices or complaints under the Privacy Rule will involve sensitive information or analysis, Covered Entities and their business associates are cautioned to consider the advisability of arranging for this analysis and review to be conducted within the scope of attorney-client privilege under the guidance of legal counsel experienced with the Privacy Rules and other related legal concerns.

 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, 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 clients, on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications. For additional information about Ms. Stamer, see www.CynthiaStamer.com, email Ms. Stamer cstamer@solutionslawyer.net or telephone her at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources at www.SolutionsLawPress.com 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 Health Care Pays $1.5M Plus HIPAA Settlement For Business Associate Agreement Deficiencies

March 16, 2016

North Memorial Health Care of Minnesota has agreed to pay $1,550,000 to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules by failing to implement a business associate agreement with a major contractor and failing 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 on the HHS website at: http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/north-memorial-health-care/index.html.

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.


New CDC Guidance on Opioid Prescribing

March 16, 2016

Responding to growing concern about widespread over prescription opioids, the  Centers for Disease Control (CDC) has just released a new guidance and other tools the help guide physicians and other prescribers to determine when and how to prescribe opioids to patients.

The lengthy new guidance and support of tools for clinicians for use and prescribing of opioids for their patients available at http://www.cdc.gov/drugoverdose/prescribing/resources.html include:

  • Detailed new guidelines
  • “Clinical Tools,” which essentially consist of digested summaries of the detailed guidance and a quick reference checklists; and
  • “Factsheets” for patients.

As irregularities and other improprieties in the prescription and management of painkillers and other controlled substances are a leading basis of serious discipline of physicians and other clinicians, physicians and other clinicians, clinics and hospitals, pharmacies in pharmacists and other healthcare providers involved in prescribing or supervising patients using or contemplating the use of opioids will want to review and incorporate these guidelines into their practices as soon as possible.

Health plan and other pay yours and the pharmacy benefit manager’s responsible for overseeing and evaluating prescriptions also likely will benefit from reviewing these materials and incorporating them into their practices as soon as possible.  Beyond the clinical use of these materials both health plans and healthcare providers likely will want to incorporate or use the fact sheets as communication tools for patients and their families to help educate patients about the  proper use, misuse, risks and other relevant information about opioid prescriptions.

 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.

 


Update Privacy Practices For New OCR HIPAA Enforcement, Security & Records Access Guidance

March 9, 2016

Health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) should review and update practices on protecting the security of and providing protected health information (PHI) and record access to patients, plan members and other subjects of that information in response to new guidance and enforcement actions of the Department of Health & Human Services Office of Civil Rights (OCR).

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.

To catch up on this latest guidance, Solutions Law Press, Inc. ™ invites you to register to participate in a special webex briefing on “HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments” on Wednesday, March 30, 2016 beginning at Noon Central Time on Wednesday, March 30, 2016.

New Guidance On PHI Records Access Rules & Security Standards

OCR continues to issue new guidance and tools on HIPAA compliance.  Keeping on top of and ensuring privacy and security practices are update for this guidance is an important part of the responsibilities of health plans and other Covered Entities including:

  • New guidance on the protection and safeguarding of the electronic and other PHI in response to the OCR’s new guidance Addressing Gaps in Cybersecurity: OCR Releases Crosswalk Between HIPAA Security Rule and NIST Cybersecurity Framework, of the imposition of its second Civil Monetary Penalty and ever-lengthening list of other data breach and security enforcement actions;
  • New guidance on responsibilities of Covered Entities to provide patient access to protected health information under HIPAA;
  • Guidance contained in announcements and resolutions agreements published about OCR enforcement actions; and
  • Other recent regulatory and enforcement developments.

OCR Cybersecurity & Other Security Guidance & Enforcement

HIPAA’s Privacy, Security and Breach Notification rules require Covered Entities to implement strong data security safeguards to ensure the confidentiality, integrity, and availability of all of the electronic protected health information (ePHI) and other PHI tthey create, receive, maintain or transmit. To help minimize their potential exposure to Civil Monetary Penalties or other risks associated with breaches of these Rules, Covered Entities generally will want to review and update as necessary their current practices for safeguarding the security of PHI and ePHI in light of the HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework (Crosswalk) unveiled by OCR on February 24, 2016 as well as guidance about OCR’s expectations concerning HIPAA Security compliance disclosed in the two HIPAA Civil Monetary Penalties and ever growing list of HIPAA Resolution Agreements published 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.

released a 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 week, 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.

The complete set of materials – the Fact Sheet and both the first and second set of FAQs – published to date as part of this effort to improve access, may be found on OCR’s website here.

Covered entities and their business associates should move quickly to review and update their 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.


3/30 Webex Shares Latest On Security, Patient Access & Other HIPAA Developments

March 9, 2016

Solutions Law Press, Inc. ™ Invites You To A Special WebEx Briefing  

HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments

Wednesday, March 30, 2016

1:00 P.M.-2:00 P.M. Eastern | 12:00 P.M.-1:00 P.M. Central 11:00 A.M-12:00 P.M. Mountain | 10:00 A.M-11:00 A.M. Pacific

Health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) face new imperatives to review and tighten their practices to ensure their practices comply with recently released guidance from the U.S. Department of Health & Human Services Office of Civil Rights (OCR)) emphasizing and clarifying the responsibilities of health care providers, health plans and the healthcare clearinghouses under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) to provide access to individuals that are the subject of protected health information or “PHI” to access or copies of their PHI in accordance with HIPAA’s rules and other recent HIPAA guidance and enforcement. With OCR’s recent release of added guidance and OCR enforcement statistics continuing to show HIPAA access rule violations among the most common HIPAA violations and OCR stepping up HIPAA enforcement, health care providers, health plans, healthcare clearinghouses can expect heightened scrutiny and enforcement of these requirements. Additionally, Covered Entities also should evaluate the adequacy of their other practices in light of other recent OCR guidance and enforcement actions.

Solutions Law Press, Inc.™ invites to catch up on the latest guidance on HIPAA’s requirements to provide access to patients to PHI by registering here to participate in the Solutions Law Press, Inc.™ “HIPAA Update: The Latest On Security, Patient Access & Other HIPAA Developments” WebEx briefing from Cynthia Marcotte Stamer on Friday, March 18, 2016.   During the Briefing, Ms. Stamer will provide participants with:

√ An update on OCR enforcement actiions and guidance over past 12 months

√ A detailed discussion of OCR’s new guidance about when Covered Entities must provide PHI access or copies to patients

√ Discuss rules and best practices for verifying the identity and credentials of an individual requesting PHI as a patient or personal representative of a patient

√ Share tips for contracting and dealing with business associates to facilitate administration of patient PHI access and security compliance activities

√ Share other practical considerations & best practices for compliance and risk management

√ Respond to participant questions on a time permitting basis

√ More

ABOUT THE SPEAKER

Recognized as “Legal Leader™ Texas Top Rated Lawyer” in both Health Care Law and Labor and Employment Law, a “Texas Top Lawyer,” and an “AV-Preeminent” and “Top Rated Lawyer” by Martindale-Hubble, singled out as among the “Best Lawyers In Dallas” in employee benefits 2015 by D Magazine;, Cynthia Marcotte Stamer is a practicing attorney and management consultant, author, public policy advocate and lecturer widely recognized for her more than 28 years extensive work and pragmatic thought leadership, experience, publications and training on HIPAA and other privacy, medical records and data and other health care, health plan and employee benefits, workforce and related regulatory and other compliance, performance management, risk management, product and process development, public policy and other key operational 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 including extensive involvement 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. Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health, employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with the US Congress, Departments of Labor, Treasury, Health & Human Services, Federal Trade Commission, HUD and Justice, as well as a state legislatures attorneys general, insurance, labor, worker’s compensation, and other agencies and regulators as well supports clients in defending litigation as lead strategy counsel, special counsel and as an expert witness.

Beyond her extensive involvement advising and defending clients on these matters, Ms. Stamer also has served as the scrivener for the ABA JCEB’s meeting with OCR on HIPAA 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 clients, serves on the faculty and planning committee of many workshops, seminars, and symposia, and on 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.

 REGISTRATION & PROGRAM DETAILS

Registration Fee per course is $75.00 per person. Registration Fee Discounts available for groups of three or more participants from the same organization. Limited opportunities for participation. Registration accommodated on a first come basis. Completed registration and payment required via website registration 48 hours in advance of the program. No checks or cash accepted. Persons not registered with completed payment at least 48 hours in advance will only participate subject to availability and completed registration and payment. Payment only accepted via website PayPal. Register Here!

The Webex will be conducted over the internet. Participants will receive access code and instructions for sign on to participate in the Webex and/or dial in to participate in the program via telephone after processing of completed registration. Participants must have access to a computer with internet access and to telephone access to dial in via telephone to participate in the program. Solutions Law Press, Inc. is not responsible for any interruption or interference in participation resulting from limitations in the internet connectivity, computer, telephone or other equipment used by the participant to access and participate in the program.

ABOUT SOLUTIONS LAW PRESS, INC.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders better anticipate legal and operational issues impacting their organization’s performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives. Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs. For additional information about upcoming programs, to inquire about becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com.   These programs, publications and other resources are provided only for general informational and educational purposes, the applicability of which to any particular circumstances may be impacted by legal changes, the specific facts and circumstances or other factors. Consequently, neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are not intended to or shall not be construed as establishing an attorney-client relationship, to constitute legal advice or a substitute for legal advice, or otherwise provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties that any participant or any other party can rely upon the information or any statements presented herein. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com. If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net. CIRCULAR 230 NOTICE: 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. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.   ©2016 Solutions Law Press, Inc.

 

 

 


Health Care Org’s ERISA Health Plan Reimbursement Opportunities & Compliance Obligations Free 9/15 Study Group Topic

September 9, 2015

Solutions Law Press, Inc. is happy to share information about this upcoming free health industry study group meeting on 9/15/2015 in Irving, Texas.

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONALS ASSOCIATION

Invites Members and Guests to Our Next Group Luncheon

Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act

Featuring

Kristi Gotcher

U.S. Department of Labor Employee Benefit Security Administration Investigator

Tuesday, September 15, 2015

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

DFW Hospital Council Offices

250 Decker Drive

Irving, Texas

RSVP here  by Noon on September 14, 2015

Space Limited!  Register Early To Reserve Your Spot To Participate!

 

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

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals to join us on Tuesday, September 15, 2015 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring a program on “Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act” from U.S. Department of Labor Employee Benefit Security Administration (EBSA) Investigator Kristi Gotcher.

The health and other employee benefit plan rules of the Employee Retirement Income Security Act (ERISA) generally offer important protections and create significant compliance challenges for health care organizations and providers.  On one hand, health care providers generally rely heavily on their or their patient’s ability to obtain health benefits promised under employer or union-sponsored health plans covering their patients to help reimbursement provider charges.  Meanwhile, health care providers and their leaders also can incur significant liability for failing to comply with ERISA’s rules when establishing and maintaining health or other employee benefit programs for their own employees.  Drawing on her involvement as investigator with the Department of Labor agency primarily responsible for both interpreting and enforcing ERISA’s rules, EBSA Ms. Gotcher will share key updates and insights on both how ERISA and the EBSA can help patients and providers enforce benefit rights under ERISA-covered health plans and key health and highlight employee benefit compliance responsibilities that health care organizations and their leaders need to ensure that their own health and other employee benefit programs meet to avoid violating ERISA.

About the Speaker

Kristi A. Gotcher is an Investigator with the United States Department of Labor, Employee Benefits Security Administration (EBSA) in the Dallas Regional Office.   Kristi began working for EBSA in the Dallas Regional Office in November 2007 as a Benefits Advisor.  She earned her Bachelor of Arts in Social Political Relations from St. Edwards University and a J.D. from Texas Wesleyan University School of Law (now Texas A&M University School of Law).  Ms. Gotcher is licensed to practice law in the State of Texas.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on Tuesday, September 15, 2015 at the DFW Hospital Council Offices located at 250 Decker Drive, Irving Texas.  Participants who timely R.S.V.P. will enjoy a complimentary luncheon. Networking and lunch service will begin at 11:30. Our program will begin at Noon.

NTHCPA encourages members and other interested health care compliance professionals to register early to reserve their spot to participate and to share this invitation with others in the industry who might benefit from participation.

There is no charge to participate in the meeting.  However space is limited and available only on a first come, first serve basis.  To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on September 14, 2015.  Walk in guests will be accommodated on a space-available basis only.

Thanks To Meeting Underwriter Stamer ׀ Chadwick ׀ Soefje, PLLC

NTHCPA and its members extend our thanks to Cynthia Marcotte Stamer, P.C. and the other members of Stamer ׀ Chadwick ׀ Soefje PLLC for underwriting this month’s study group luncheon and other support of NTHCPA.

A boutique firm of exceptionally experienced and skilled “big-firm” lawyers committed to changing the way law firms serve their clients, Stamer │Chadwick │Soefje, PLLC delivers sophisticated legal advice and innovative solutions to the most challenging and complex problems. Simply put, Stamer │Chadwick │Soefje, PLLC attorneys are “Solutions Lawyers™.”

Stamer │Chadwick │Soefje, PLLC attorneys deliver sophisticated legal advice and innovative solutions to the most challenging and complex problems. Stamer │Chadwick │Soefje, PLLC attorneys possess the breadth of experience to respond to the unique legal and operational challenges health industry and other clients face and help guide them toward pragmatic resolutions that make sense for them. “Solutions Lawyers™ possess the breadth of experience to respond to the unique challenges our corporate and individual clients face and help guide them toward pragmatic resolutions that make sense for them.

Founded by nationally-known, healthcare and labor & employment attorney Cynthia Marcotte Stamer; labor & employment attorney Robert G. Chadwick; and professional liability and civil litigation attorney Timothy B. Soefje, Stamer │Chadwick │Soefje, PLLC focuses on advising and representing businesses and professionals nationally in the areas of healthcare, cyber liability, ERISA, employee benefits, labor & employment, corporate and commercial litigation, professional liability, construction litigation, and insurance defense.  All three attorneys are rated AV® Preeminent™ by Martindale-Hubbell® Peer Review Ratings™ Ms. Stamer and Mr. Chadwick are both Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, are Fellows in the American Bar Foundation, and recognized as “Top Lawyers” in Labor and Employment Law.  Ms. Stamer also has received recognition as a “Top” attorney in health care and employee benefits law and is a Fellow in the American College of Employee Benefit Council.

Ms. Stamer more than 28 years’ experience advising and representing health industry and employee benefit clients on a wide range of legal, public policy, management and operational concerns as well as extensive leadership and management experience serving in on the board of health industry nonprofit organizations. Nationally recognized for her legal work, advocacy, publications, writings and presentations on health industry concerns, Ms. Stamer provides legal and management advice, training and coaching, defense, public policy and regulatory advocacy to health industry and other clients on health and other regulatory and operational compliance, federal and state public policy and enforcement, managed care and other contracting, reimbursement, fraud, quality, employment, staffing and other workforce, benefits, licensing, credentialing and peer review, safety, disaster preparedness and response, HIPAA and other privacy and data security, corporate governance, investigations and internal controls, and a host of other health industry compliance and risk management and other legal and operational concerns. In addition to her legal experience, Ms. Stamer also contributes her experience and talents to serving in a number of health industry and other civil and professional groups.  Among other things, Ms. Stamer serves as Vice President of the NTHCPA, the RPTE representative to the American Bar Association (ABA) Joint Committee on Employee Benefits Council and scrivener for its annual agency meeting with the Office of Civil Rights, the ABA International Section Life Sciences and Health Law Committee Vice President of Policy, RPTE Liaison to the ABA Health Care Coordinating Counsel, TIPS Employee Benefit Committee Vice Chair, Founder and Executive Director of the Project COPE:  The Coalition on Patient Empowerment, and National Physicians Council for Healthcare Policy.  She also previously served as President and Founding Board Member of the Alliance for Health Care Excellence and its Health Care Heroes and Patient Empowerment Programs, as RPTE Employee Benefits & Other Compensation Group Chair and Welfare Benefit Committee Vice Chair, Exempt Organizations Coordinator of the Gulf States Area TEGE Council, Board President and Audit Committee Chair of the Richardson Development Center for Children ECI Agency, National Kidney Foundation of North Texas Board Audit Committee Chair, the United Way of North Texas Long Range Planning Committee.  She also has and continues to serve in the leadership of many other civic and professional boards, seminar faculties, editorial advisory boards and publishes and speaks extensively on health industry and employee benefit related concerns.

Mr. Chadwick has extensive experience advising and defending health industry and other clients on OSHA and other occupational health and safety, employee benefits, compensation and other labor and employment  concerns as well as defending boards and other management leaders against management liability claims.

Mr. Soefje has extensive experience advising and representing health industry clients and professionals on medical malpractice, officers and directors liability and other professional liability, errors and omissions, construction defect and other litigation and disputes.

For additional information, contact Ms. Stamer cstamer@solutionslawyer.net

About the NTHCPA

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

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.

Other Helpful Resources & Other Information

We hope that this information is useful to you.   If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available hereYou also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

Examples of some of these recent health care related publications include:


OCR’s Proposed Sex & Other Discrimination Rules Spell Headaches & New Risks For Health Care Providers, Insurers & Others

September 3, 2015

November 6, 2015 is the deadline for health care providers, health insurance exchanges, Medicare Advantage plans, Medicaid Advantage plans, health insurers providing coverage in the health insurance marketplaces, their contractors and other concerned parties to comment on a proposed rule on Nondiscrimination in Health Programs and Activities published today by the Department of Health and Human Services (HHS) to implement the federal prohibition against sex discrimination in health programs and activities enacted under Section 1557 of the Patient Protection and Affordable Care Act (ACA) and tightening other nondiscrimination requirements that generally apply to Health Insurance Marketplaces, any health program that HHS itself administers, and any health program or activity, any part of which receives funding from HHS, such as hospitals that accept Medicare patients or doctors who treat Medicaid patients, and health insurance issurers participating in the Health Insurance Marketplaces, Medicare or Medicaid Advantage Plans and other entities covered by the HHS Office of Civil Rights (OCR) civil rights rules (covered entities) and various other programs and activities administered by HHS’ Office of Civil Rights (OCR).

Since OCR already aggressively investigates and enforces federal prohibitions against discrimination based on race, color, national origin, disability, age and sex against covered entities as part of the Obama Administration’s broader civil rights agenda, covered entities can look forward to OCR’s adoption of the proposed rules to add even more teeth and fire to the already aggressive enforcement by OCR of health care providers, insurers and other parties subject to the civil rights laws enforced by OCR. See. e.g., Health Care Employer’s Discrimination Triggers Medicare, EEOC Prosecutions; Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled; OCR Settlements Show Health Care & Disabled Housing Providers Face Growing Disability Discrimination Risks Given the often multimillion dollar penalties and other heavy sanctions that OCR already has imposed against a long and ever-growing list of state and other health care, child care, elder care, insurance and other entities for violating the discrimination or other civil rights rules administered by OCR, health care and other providers, Medicare and Medicaid Advantage and other insurers, and other covered entities generally will want both to carefully review and comment as appropriate on the proposed rules, as well as review and tighten as advisable their existing practices to reduce the risk of being sanctioned, excluded or both for violation of these nondiscrimination and other civil rights requirements by OCR. In this respect, covered entities will want both to evaluate their risks and responsibilities under the specific rules about Section 1557’s sex discrimination prohibits, as well as changes that more broadly affect the interpretation and enforcement of the nondiscrimination rules enforced by OCR generally.

Sex and Gender Identity Discrimination

Concerning the new prohibition against sex discrimination added by Section 1557 of the ACA, the proposed rule expressly provides that covered entities must treat woman equally with men in the health care they receive generally as well as specifically comments on the obligations of covered insurers with respect to sex discrimination including gender identity. While other provisions of the ACA bar certain types of sex discrimination in insurance, for example by prohibiting women from being charged more than men for coverage, the proposed regulation makes clear that the protections of Section 1557 reach even more broadly to prohibit sex discrimination both in the health coverage patients obtain as well as in the health services they seek from providers.

Not unexpectedly in light of the Supreme Court’s ruling in Obergefell and the Obama Administration’s proactive agenda on the advance of rights for lesbian, bisexual, gay and transsexual (LBGT) individuals, the proposed rule makes clear that OCR construes prohibited sex discrimination under Section 1557 to include discrimination based on gender identity as well as to address various coverage and care practices that OCR views as prohibited sex discrimination of LBGT individuals. In this respect, the proposed rule makes clear HHS’s commitment, as a matter of policy, to preventing discrimination based on sexual orientation by providing, among other things that Individuals may not be subject to discrimination based on gender identity by any covered entities including insurance policies and their issuers. OCR also highlights various policy provisions and other practices by insurers that it views as prohibited sex discrimination against transsexual individuals such as categorical exclusions on coverage of all care related to gender transition.  Similarly, the proposed rule also states that health care providers, insurers and other covered person must treat all individuals consistent with their gender identity, including in access to facilities. Beyond the already proposed safeguards against sex discrimination based on gender identity, OCR also requests comment on how a final rule can incorporate the most robust set of protections  against discrimination that are supported by the courts on an ongoing basis.

Other Nondiscrimination Rule Expansions

Beyond its requirements relating to sex discrimination, the proposed rule also addresses a host of other concerns relating to the civil rights rules more generally. As an initial matter, the proposed rule invites individuals in protected classes to file complaints and pursue other enforcement by confirming that OCR interprets Section 1557 as allowing individuals to seek legal remedies for discrimination under Section 1557. While OCR already has been allowing this in practice, this blessing of the right of individuals to seek legal remedies unquestionably will encourage the filing of more complaints and other private actions.

The proposed rule also would add more teeth to the already aggressive enforcement by OCR of its position that covered entities must accommodate community deficiencies of persons with cognitive, speech, hearing or other disabilities and English proficiency limitations on their ability to communicate on health care matters by establishing more detailed minimum standards for the provision of language services, such as oral interpreters and written translations to persons with limited English proficiency and to provide individuals with hearing or other disabilities affecting their ability to communicate to provide auxiliary aids and services, including alternative formats and sign language interpreters, and the accessibility of programs offered through electronic and information technology.  These proposed requirements are designed to provide more teeth and compliance with OCR’s expectation that covered entities will affirmatively act to offer accommodations needed to ensure the ability of individuals to communicate when the individual’s ability to understand or respond is impaired by disabilities or limited English proficiency.

Also, the proposed regulations specifically addresses various practices by Medicare and Medicaid Advantage plans and other insurers offering coverage in the marketplace that OCR views as discriminatory. For instance, the proposed rule states that insurers participating or offering coverage through any Health Insurance Marketplace cannot engage in any marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age, or disability.  This prohibition would extend to all the plans of insurers participating in the Marketplace are covered by the proposed rule.

Beyond the already proposed expansion in the current regulatory expectations, OCR also invites input about additional requirements to broaden the safeguards in the proposed regulations by requesting comment on whether Section 1557 should include an exemption for religious organizations and what the scope of any such exemption should be as well as comment on how a final rule can incorporate the most robust set of protections  against discrimination that are supported by the courts on an ongoing basis.

Unquestionably these and other changes proposed in the proposed regulation likely will impact the practices and risks of virtually all covered entities. The proposed rule is open for public comment through November 6, 2015. Covered entities and other interested persons will want to promptly review the specifics of the proposed regulation in light of OCR’s already existing investigation and enforcement activities and their current or contemplated practices. To the extent appropriate, covered entities will want to ensure that they carefully prepare and submit all revelevant comment or other feedback promptly submitted on or before the November 6, 2015 comment deadline. Whether or not a covered entity elects to comment of the proposed regulations, however, all covered entities also should begin tightening and adapting their existing policies and practices to respond to the positions revealed by the proposed regulations, as OCR’s enforcement activities reflect that OCR will act to enforce many of these expectations even as it pursues adoption of the proposed regulations in final form.

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, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 28 years experience advising health industry clients about these and other matters. Her experience includes more than 23 years experience advising and defending hospitals, nursing home, home health, rehabilitation and other health care, housing, insurance and other  clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to discrimination and other charges from OCR, HUD, EEOC, DOJ, private claimants and others.  She also advises and assists a broad range of health industry and other clients to respond to and defend Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR, CMS & other HHS agencies, Department of Labor, IRS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.  The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting for several years with OCR.  Ms. Stamer also works extensively with health care providers, health plans and insurers, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance, investigations, defense, and 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 discrimination and other civil rights, pandemic and other contagious disease, HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance, quality, reimbursement, and a broad range of other industry internal controls, compliance, risk management, employment, patient safety, staffing, credentialing, board governance, antitrust, contracting and other legal and operational concerns for a multitude of clients and associations ranging from the Association of State & Territorial Health Plans, Los Angeles County Health Department, ISSA, HIMMS, the ABA, the American Health Lawyers Association, the Medical Group Management Association, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, 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.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 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 from Ms. Stamer, see 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.

Other Helpful Resources & Other Information

We hope that this information is useful to you.   If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available hereYou also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.

Examples of some of these recent health care related publications include:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years

April 4, 2014

Yesterday’s announcement of the exclusion of the operator and manager of the national dental chain, Small Smiles Dental Centers, from exclusion in Medicaid, Medicare and other federal health programs highlights the risks health care providers run by failing to comply with a Corporate Integrity Agreement.

Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services, announced April 3, 2014 that the operator and manager of the Small Smiles Dental Centers, CSHM, LLC (formerly known as FORBA Holdings and Church Street Health Management (CSHM), has signed an Exclusion Agreement that bars CSHM from participating in Medicare, Medicaid, and all other Federal health care programs for 5 years. Small Smiles Dental Centers provides services primarily to children on Medicaid.

Mr. Levinson said that this exclusion “makes clear to the provider community that OIG closely monitors our CIAs, critically evaluates providers’ representations and certifications, and will pursue exclusion actions against providers that fail to abide by their integrity agreement obligations.”

According to the announcement, the exclusion is based on CSHM’s alleged material breaches of its Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG).

CSHM’s corporate predecessor entered into the CIA in 2010, as part of the resolution of a False Claims Act case involving allegations that the company had provided dental services to children on Medicaid that were medically unnecessary or failed to meet professionally recognized standards of care.

On March 7, 2014, OIG issued a Notice of Exclusion to CSHM based upon numerous material breaches of its obligations under the CIA. CSHM failed to report serious quality-of-care reportable events, take corrective action, or make appropriate notifications of those events to the State dental boards as required by the CIA, OIG found. CSHM also failed to implement and maintain key quality-related policies and procedures, comply with internal quality and compliance review requirements, properly maintain a log of compliance disclosures, and perform training as required by the CIA. Finally, CSHM submitted a false certification from its Compliance Officer regarding its compliance with CIA obligations.

This exclusion marks the culmination of a series of alleged failures by CSHM and its corporate predecessors to comply with its CIA. Under the CIA, an independent quality monitor conducted more than 90 site visits and reviews to monitor CSHM’s compliance. Since the 2010 settlement, OIG repeatedly cited CSHM and took actions to address those violations, promote improved compliance, and maintain access to care for an underserved population. These actions included imposing financial penalties and forcing the divestiture of one of the company’s clinics.

Despite these actions, CSHM remained in material breach of its CIA and OIG issued Notices of Intent to Exclude to the company in December 2013 and January 2014. In such cases, providers get the chance to show OIG that they have cured, or are in the process of curing, the material breaches. CSHM represented to OIG that it would cure the material breaches. However, through meetings with CSHM and its Board of Directors and review of its written submissions, OIG determined that CSHM had failed to cure the material breaches and proceeded with the exclusion.

CSHM disputed OIG’s determination that it was in material breach of the CIA. However, under the Exclusion Agreement, CSHM now has waived its objections to these findings.

To minimize immediate disruption of care to the hundreds of thousands of children treated at CSHM clinics and to enable an orderly, controlled shutdown of the company or divestiture of its assets, the exclusion takes effect September 30, 2014. CSHM waived its right to appeal this exclusion in any judicial forum.

Until the exclusion goes into effect on September 30, 2014, an independent monitor will continue to monitor the quality of care being provided to patients at CSHM clinics. CSHM is required to inform patients at least 30 days before closing a clinic. CSHM is also required to keep State Medicaid agencies abreast of developments and provide monthly status reports to OIG. Any divestiture of assets by CSHM must be through bona fide, arms-length transactions to an entity that is not related to or affiliated with CSHM.

Beyond the implications for Small Smiles Dental Centers, the announced exclusion carries important implications for other health care providers.  First, of course, the exclusion means that Small Smiles Dental Centers and CSHM as excluded providers are ineligible for hiring by other providers participating in Medicare or other Federal Health Programs.  Second, the exclusion also highlights the advisability for other providers covered by CIAs not only to see to comply with their CIA and in the event the OIG questions of the adequacy of that compliance to look for opportunities to work with OIG to rectify alleged concerns as cooperatively as possible unless a high degree of certainty that the provider can prove that OIG’s concerns are unfounded.

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.

Board Certified in Labor & Employment Law, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters.

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal 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.

Other Resources

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

About Solutions Law Press

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

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.

©2014 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.


 


NLRB Helps Union Force Another Health Care Employer To Recognize & Bargain With Union

March 13, 2014

Hospitals, skilled nursing and other health care organizations need to be concerned about union organizing of  their employees in light of the growing success of unions with the aid of the pro-union support and agenda of the National Labor Relations Board (NLRB)  under the Obama Administration’s leadership.  The Administration’s goal of telling health care providers what to do extends well beyond Medicare and Medicaid into their workforce and terms and conditions of employment.

 On February 21, 2014, for instance, the Obama Administration helped the Service Employees International Union (the Union) force Holy Cross Youth and Family Services, Inc., d/b/a Kairos Healthcare (the Employer), a provider of drug and alcohol rehabilitation services, to recognize and bargain with the  over terms and conditions of employees with the Union by securing a court order forcing the employer to recognize and bargain with the Union.

 Ruling in a lawsuit filed by the NLRB against the Employer on February 21,  a federal court judge for the Eastern District of Michigan ordered upheld the allegations made in August 23, 2013 by the National Labor Relations Board (NLRB) Detroit, Michigan Regional Office that the Employer violated the National Labor Relations Act when it withdrew recognition from Local 517M, made unilateral changes to employees’ terms and conditions of employment without affording the Union an opportunity to bargain over those changes, and failed to provide relevant information to the Union to help in its bargaining with the Employer on behalf of the employees.

The Regional Office sought, and the Board authorized, seeking interim injunctive relief to return the parties to the bargaining table pending final resolution of the matter, to require the Employer to provide the Union with the information it requested and, upon request, to rescind the unilateral changes made to employees’ terms and conditions of employment.

On February 21, 2014, the District upheld the Regional Office’s action.  It ruled that an interim injunction was appropriate to prevent loss of Union support, to keep the employees’ right to bargain with their Employer through their chosen bargaining representative, and to provide the Union with the information it needs to evaluate and make bargaining proposals while the administrative case is pending before the Board.

The case is one of a growing number of actions where the NLRB has used is powers to help Unions force health care and other employers to yield to union demands.  See e.g., Specialty Healthcare and Rehabilitation of Mobile, Board Case No. 15-CA-68248 (reported at 357 NLRB No. 174) (6th Cir. decided August 15, 2013 under the name Kindred Nursing Centers East, LLC f/k/a Specialty Healthcare and Rehabilitation of Mobile v. NLRB).

These decisions should remind health care and other employers of the highly union-friendly bent of the NLRB under the current administration, as well as the hazards of mishandling efforts to defend against union organizing and other protected activities under the NLRA.  Beyond the obligation to recognize and bargain with properly certified collective bargaining unions, the NLRB and other federal labor laws also grant employees a host of other protections.  Among these are recently affirmed rights-even for a worker not represented by a union – to insist another employee be present when participating in disciplinary and certain other meetings with management, rules limit the ability of employers to prohibit or restrict employees requiring employees to keep confidential and not discuss among each other  salary, wages or other terms of compensation or employment  terms and conditions, and others.  The Obama Administration has made known its desire to expand these rights further and has carried out an aggressive legislative, regulatory and enforcement campaign in pursuit of this goal since taking office.  For this reason, health care or other organizations should seek the advice and assistance of qualified legal counsel experienced with labor management relations matters to review policies for compliance, to prepare and administer anti-organizing activities, and to evaluate and respond to union organizing or bargaining activities.

For More Information Or Assistance

If you need assistance responding to health industry staffing and workforce, regulatory, enforcement or other developments, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, 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. Her experience includes extensive work advising, representing and training health industry and other clients on HIPAA and other privacy, data protection and breach and other related matters.  She also advises hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD, 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, Board Certified in Labor and Employment Law, Ms. Stamer’s experience includes continuous involvement in advising and representing health care organizations about employment, labor-management, peer review and staffing and other workforce management and compensation concerns.  Ms. Stamer also 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. Scribe for the ABA JCEB annual Technical Sessions meeting with OCR for the past three years, Ms. Stamer also is recognized for her extensive publications and programs including numerous highly regarding publications and programs on HIPAA and other privacy and data security concerns as well as a wide range of other workshops, programs and publications on other compliance, operational and risk management, and other health industry matters. 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 responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 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 from Ms. Stamer, see  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.  All other rights reserved.


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