Sunday, August 15, 2021 is the last day Americans can apply for special enrollment in health coverage in the federal health insurance exchange in 2021.

Employers with more than 49 employees sponsoring health coverage should audit their 2020 health plan administration to confirm compliance with 40 federal requirements that if violated trigger an employer duty to pay excise taxes under Internal Revenue Code (“IRC”) Section 6939D if not caught and corrected before the original due date of the employer’s tax return along with other liabilities arising from those violations under the Employee Retirement Income Security Act (“ERISA”).

IRC Section 6039D requires an employer with 50 employees that sponsors a health plan to self report, self assess and pay excise tax penalties for those violations not caught and corrected before the original due date of businesses’ 2020 business tax return in addition to any benefit, fiduciary and other liabilities triggered for the plan and its fiduciaries under ERISA. The excise tax triggering violations include most Patient Protection and Affordable Care (“Obama Care”) adverse benefit determination and coverage requirements, the eligibility and nondiscrimination requirements of the Health Insurance Portability & Accountability Act (“HIPAA”), mental health parity, Consolidated Omnibus Reconciliation Act (“COBRA”) medical coverage continuation and others.

Employers should take well documented actions to audit compliance rather than presume the proper administration of their programs now to allow sufficient time to take corrective action before their original 2020 business tax filing deadline. While employers often are temped to presume or rely upon unaudited assurance from their insurer or third party administrator, sanctions imposed against major insurers by various regulatory agencies, complaints filed with the Department of Labor and state insurance departments and other audits reveal errors in administration frequently happen. Special COVID-19 rules and relief issued in response to the COVID-19 health care emergency enhance the likelihood of administrative errors during 2020. Given sensitive time deadlines and the information, employers ideally will want to complete this audit within the scope of attorney-client privilege sufficiently in advance of the earlier of the original due date of their business tax return or for self-insured health plans, the end of the stop loss run out period to allow sufficient time for necessary correction or other response. Paragraph

For more information about these or other employee benefit, heath and managed care, insurance or workforce issues, register and participate in the January Solutions Law Press, Inc. briefing on the 40 federal health plan rules covered by IRC Section 6039D  e-mail the author of this update, attorney Cynthia Marcotte Stamer.

More Information

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

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

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is nationally recognized for her work and thought leadership on health and other health and employee benefit issues. 

An attorney board certified in labor and employment law by the Texas Board of Legal Specialization and Fellow in the American College of Employee Benefit Counsel, Ms. Stamer has worked as an on demand, special project, consulting, general counsel or other basis with health and other employee benefit plans, their sponsors, insurers, administrators, providers and others and others has published and spoken extensively on these concerns. 

A former lead advisor to the Government of Bolivia on its pension  project, Ms. Stamer also has worked internationally and domestically as an advisor and advocate for employer and other plan sponsors, fiduciaries, administrators, insurers, technology and other service providers, managed care organizations, direct primary care and other health care providers and others  on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member,  past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com or contact Ms. Stamer via e-mail here.

About Solutions Law Press, Inc.™

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

• Guard Against COVID-19 Fraud Scams
• Proposed Privacy Rules Grant Health Plans New Flexibility, Add New Obligations
• Kickin’ COVID-19: Reopening Texas Summit October 8 On Facebook Live
• Employer Option To Defer Paying Some Employee Payroll Taxes Until 2021
• Free CDC COVID-19 Communication Resources
• DOL Invests $80.6 million in Apprenticeship Expansion Grants
• Businesses Should Confirm Using Benefits, Meeting Mandates Of Special COVID-19 Tax Rules
• Ezekiel Elliott COVID-19 Diagnosis Disclosure Outrage Highlights Need To Handle COVID-19 & Other Medical Information With Care
• Proposed Regulations Would Treat Direct Primary Care and Health Care Sharing Ministries Membership Dues As Qualifying Medical Expenses For Medical Deduction & HSA Reimbursement Purposes
• Wish Tax Guidance Were Clearer? Tell IRS/Treasury Your Suggested Topics For 2020-2021 Treasury Priority Guidance Plan
• New IRS Increased Health FSA Carryover, Gives COVID Health FSA Election Relief
• IRS Shares Initial CARES Act Plan Loan & Distribution Relief Guidance
• Employer Sponsors & Health Plans Face Rising Risk From Mental Health & Substance Abuse Coverage Violations
• Use Prudent Process To Manage Workforce & Other Business Changes To Help Minimize Business & Management Liabilities & Protect Future Recovery

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.  ©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™

Federal contractors or subcontractors (“government contractors”) that consider themselves religious organizations may wish to reevaluate their status as religious organizations and other implications of the new U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) Final Rule  “Implementing Legal Requirements Regarding the Equal Opportunity Clause’s Religious Exemption” (“Final Rule”) that took effect January 8, 2020 while keeping a close eye out for further modifications or refinement to the rules by the incoming Biden Administration and the courts. 

Executive Order 11246, Section 503 of the Rehabilitation Act of 1973 and the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, as amended, generally prohibit federal contractors to discriminate in employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. In addition, contractors and subcontractors are prohibited from discriminating against applicants or employees because they have inquired about, discussed, or disclosed their compensation or the compensation of others subject to certain limitations, and may not retaliate against applicants or employees for engaging in protected activities. These laws also require that federal contractors provide equal employment opportunity through affirmative action and report data about their employment practices.

While generally prohibiting religious discrimination in employment, Executive Order 11246, also acknowledges Constitutional religious freedom protections by providing religious organizations may prefer in employment “individuals of a particular religion,” to maintain their religious identity and integrity. The Final Rule announced by the Trump Administration on December 7, 2020 does not change the vast majority of federal contractors’ responsibilities to comply with their equal employment opportunity and affirmative action obligations under Executive Order 11246. However, it does seek to clarify and maximize the legal protection of religious exercise permitted by the Constitution and law taking into account the Religious Freedom Restoration Act by adding a rule of construction, definitions of key terms and several examples within the definition of “religious corporation, association, educational institution, or society” to better illustrate which organizations may qualify for the religious exemption.

Federal contractors that believe they qualify for coverage by the new Final Rule should document their qualification, keeping in mind that its applicability turns on a highly fact specific, evidence based test.  Those relying on the rules should work with experienced legal counsel to evaluate and preserve evidence demonstrating the basis of qualification and other risk management strategies, while simultaneously watching for potential refinements to the rules by the incoming Biden Administration, the courts or both.

For more information about the Final Rule or other federal employment discrimination and affirmative action rules, e-mail the author of this update, Texas Board of Legal Specialization Board Certified Labor and Employment Lawyer, Cynthia Marcotte Stamer.

More Information

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

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

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns. 

Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.

Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and federal and state discrimination, affirmative action and accommodation and other related human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress;  and many other risk management and compliance concerns.

A former lead advisor to the Government of Bolivia on its pension  project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member,  past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com or contact Ms. Stamer via e-mail here.

About Solutions Law Press, Inc.™

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

• Guard Against COVID-19 Fraud Scams
• Proposed Privacy Rules Grant Health Plans New Flexibility, Add New Obligations
• Kickin’ COVID-19: Reopening Texas Summit October 8 On Facebook Live
• Employer Option To Defer Paying Some Employee Payroll Taxes Until 2021
• Free CDC COVID-19 Communication Resources
• DOL Invests $80.6 million in Apprenticeship Expansion Grants
• Businesses Should Confirm Using Benefits, Meeting Mandates Of Special COVID-19 Tax Rules
• Ezekiel Elliott COVID-19 Diagnosis Disclosure Outrage Highlights Need To Handle COVID-19 & Other Medical Information With Care
• Proposed Regulations Would Treat Direct Primary Care and Health Care Sharing Ministries Membership Dues As Qualifying Medical Expenses For Medical Deduction & HSA Reimbursement Purposes
• Wish Tax Guidance Were Clearer? Tell IRS/Treasury Your Suggested Topics For 2020-2021 Treasury Priority Guidance Plan
• New IRS Increased Health FSA Carryover, Gives COVID Health FSA Election Relief
• IRS Shares Initial CARES Act Plan Loan & Distribution Relief Guidance
• Employer Sponsors & Health Plans Face Rising Risk From Mental Health & Substance Abuse Coverage Violations
• Use Prudent Process To Manage Workforce & Other Business Changes To Help Minimize Business & Management Liabilities & Protect Future Recovery

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.  ©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™

Businesses should raise their guard and warn employees and other business connections about avoiding potentially fraudulent COVID-19 related scams.

The U.S. Department of Health and Human Services Office of Inspector General is alerting the public about fraud schemes related to the novel coronavirus (COVID-19). Scammers are using telemarketing calls, text messages, social media platforms, and door-to-door visits to perpetrate COVID-19-related scams. 

Fraudsters are offering COVID-19 tests, HHS grants, and Medicare prescription cards in exchange for personal details, including Medicare information. However, these services are unapproved and illegitimate.

These scammers use the coronavirus pandemic to benefit themselves, and beneficiaries face potential harm. The personal information collected can be used to fraudulently bill federal health care programs and commit medical identity theft. 

Examples of some of these scams include:

• Scammers are using social media to perpetrate COVID-19-related scams. In one major scheme, fraudsters hack social media accounts and send direct messages to beneficiaries while posing as a friend or government employee. The impersonator claims the person is eligible for government grants (citing various reasons like COVID-19, disability, etc.) and urges them to call a phone number to collect the funds. Upon calling, the beneficiary is asked to pay a “processing fee” (using bank account information, gift cards, bitcoin) to receive the grant money. In return, targets of this scam never receive any money, but often large sums of their money are stolen from them. These alleged grants are entirely illegitimate. 
• Fraudsters are also continuing to offer COVID-19 tests to Medicare beneficiaries in exchange for personal details, including Medicare information. However, the services are unapproved and illegitimate. 
• In another fraud scheme, some medical labs are targeting retirement communities claiming to offer COVID-19 tests, but they are actually drawing blood and billing federal health care programs for medically unnecessary services. 
• Also, fraudsters are offering people a $200 Medicare prescription card when no such cards currently exist.

Peter Khaim, 40, and Arkadiy Khaimov, 37, both of Forest Hills, New York, each were charged with one count of conspiracy to commit health care fraud and wire fraud, and one count of conspiracy to commit money laundering.  Khaim was separately charged with two counts of concealment money laundering and one count of aggravated identity theft.  Khaimov was separately charged with two counts of concealment money laundering.

“These defendants allegedly lined their own pockets by exploiting Medicare flexibilities that were designed to ensure that patients obtained access to needed medications during the COVID-19 crisis,” said Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division.  “Together with our law enforcement partners, the Criminal Division is working to aggressively identify, investigate, and prosecute scammers who seek to take advantage of the COVID-19 crisis to defraud our public health care programs.”

“As alleged in the indictment, the defendants manipulated information in over a dozen pharmacies to defraud the Medicare program, including by taking advantage of systems that were intended to assist patients during the COVID-19 pandemic, and then went to great lengths to hide their ill-gotten gains through a network of sham companies,” said Acting U.S. Attorney Set D. DuCharme of the Eastern District of New York.  “This office and our law enforcement partners are committed to holding accountable those who seek to enrich themselves at the expense of vital taxpayer-funded health care programs upon which so many rely.”

“We allege Mr. Khaim and Khaimov used the COVID-19 pandemic as cover to exploit changes in the Medicare system,” said Acting Director in Charge William F. Sweeney Jr of the FBI’s New York Field Office.  “The changes to this program, funded by taxpayers, were put in place to help fellow citizens obtain needed medications during the pandemic, not line the pockets of fraudsters.  Those who attempt to illegally profit from our public funded healthcare programs should remember taxpayers also fund courts and jails, and behavior like the type announced today will be met with swift action from the FBI and our law enforcement partners.  If you are aware of frauds like the one announced today, please contact us at 1-800-CALL-FBI.”

“Fraudsters who target the Federal health care system attempt to undermine the integrity of programs that serve millions of individuals.  When they leverage a public health emergency to perpetrate schemes, their wanton disregard for the programs and beneficiaries is glaringly clear,” said Special Agent in Charge Scott J. Lampert of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG).  “We are responding aggressively with our law enforcement partners to pursue bad actors and to warn the public about these ongoing scams.”

“The defendants allegedly carried out a $30 million health care fraud and money laundering scheme, siphoning funds meant for patients during the COVID-19 pandemic,” said Special Agent in Charge Jonathan D. Larsen of IRS-Criminal Investigation (IRS-CI). “While Americans across the country are in dire need of medical and financial assistance, the defendants allegedly used the stolen proceeds to purchase real estate and luxury items. IRS-CI and our law enforcement partners will continue to work tirelessly to expose COVID-19 schemes and bring those responsible to justice.”

“This indictment describes allegations of crimes that are especially egregious and caused significant harm to the programs designed to protect the most medically vulnerable, jeopardizing the health of our Medicare system and then using our nation’s financial system to launder proceeds of the fraud,” said Special Agent in Charge Patricia Tarasca of the Federal Deposit Insurance Corporation, Office of Inspector General (FDIC-OIG).  “We appreciate the cooperation of our fellow law enforcement partners as we work to identify and investigate fraud of this type.”

According to the indictment, the defendants used COVID-19 emergency override billing codes in order to submit fraudulent claims to Medicare, for which they were allegedly paid over $30 million for expensive cancer medication Targretin Gel 1% that, in fact, never was purchased by the pharmacies, prescribed by physicians, or dispensed to patients, often during periods when pharmacies were non-operational, and using doctors’ names on prescriptions without their permission. 

The indictment alleges that the defendants acquired control over dozens of New York pharmacies by paying others to pose as the owners of the pharmacies and hiring pharmacists to pretend to be supervising pharmacists at the pharmacies, for the purpose of obtaining pharmacy licenses and insurance plan credentialing.  As the effects of the COVID-19 pandemic began to be felt in the United States, the defendants used the COVID-19 pandemic as an opportunity to capitalize on a national emergency for their own financial gain by using the COVID-19 “emergency override” billing codes to submit fraudulent claims for Targretin Gel 1%, which has an average wholesale price of approximately $34,000 for each 60 gram tube. 

The indictment also alleges that, with the proceeds of the fraud, the defendants engaged in a complex money laundering conspiracy where they created sham pharmacy wholesale companies, which they named after pre-existing pharmacy wholesalers, and fabricated invoices to make it appear that funds transferred from the pharmacies to the sham pharmacy wholesale companies  were for legitimate pharmaceutical drug purchases. 

In the first phase of the money laundering conspiracy, the defendants conspired with an international money launderer who arranged for funds to be wired from the sham pharmacy wholesale companies to companies in China for distribution to individuals in Uzbekistan.  In exchange, the defendants received cash provided by members of the Uzbekistani immigrant community to an unlicensed money transfer business for remittance to their relatives in Uzbekistan, minus a commission that was deducted by the money launderer. 

In the second phase of the money laundering conspiracy, when the amount of fraudulent proceeds exceeded the amount of cash available in the Uzbekistani immigrant community, the defendants directed the international money launderer to transfer funds back from the sham wholesale companies to the defendants, their relatives, or their designess, in the form of certified cashier’s checks and bags of cash that were dropped at their house in the middle of the night.  The defendants used the proceeds of the scheme to purchase real estate and other luxury items.

Protect Yourself

Businesses should protect themselves and warn their employees to guard against these and other scams. Recommended steps include:

• Be vigilant and protect yourself from potential fraud concerning COVID-19 vaccines. You will not be asked for money to enhance your ranking for vaccine eligibility. Government and State officials will not call you to obtain personal information in order to receive the vaccine, and you will not be solicited door to door to receive the vaccine.
• Beneficiaries should be cautious of unsolicited requests for their personal, medical, and financial information. Medicare will not call beneficiaries to offer COVID-19 related products, services, or benefit review.
• Be suspicious of any unexpected calls or visitors offering COVID-19 tests or supplies. If you receive a suspicious call, hang up immediately. 
• Do not respond to, or open hyperlinks in, text messages about COVID-19 from unknown individuals.
• Ignore offers or advertisements for COVID-19 testing or treatments on social media sites. If you make an appointment for a COVID-19 test online, make sure the location is an official testing site.
• Do not give your personal or financial information to anyone claiming to offer HHS grants related to COVID-19.
• Be aware of scammers pretending to be COVID-19 contact tracers. Legitimate contact tracers will never ask for your Medicare number, financial information, or attempt to set up a COVID-19 test for you and collect payment information for the test.

Health plans, health care providers, health insurers, health care clearinghouses (“Covered Entities”) and their business associates should budget and begin compliance plans, even as they comment on proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule announced by the Department of Health & Human Services Office of Civil Rights (“OCR”) in its December 10, 2020 Notice of Proposed Rulemaking (“Proposed Rule).  While the official Federal Register publication date has yet to be announced, OCR already is accepting comments pending the official publication. To assure consideration, comments must be received by OCR no later than 60 days from that official Federal Register publication date. 

More than 300 pages in length, the proposed HIPAA Privacy Rule changes include grant new flexibility to health plans and health care providers to share protected health information (“PHI”) for care integration and with family and other caregivers, while also imposing tighter requirements on Covered Entities for providing individuals access to PHI and other individual rights.  Through the proposed changes, OCR says it hopes to strengthen individuals’ rights to access their own electronic and other health information; improve information sharing for care coordination and case management for individuals; facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhance flexibilities for disclosures in the Opioid and COVID-19 public health emergencies or other emergency or threatening circumstances; and reduce administrative burdens on HIPAA covered health care providers and health plans. Highlights of some of the more significant proposed changes that the Proposed Rule will make if adopted as proposed include:

New Flexibility To Share PHI For Care Coordination and Case Management Activities

The Proposed Rule also would make a number of changes that OCR believes will remove the barriers created in the current Privacy Rule to Covered Entities, whether a health care provider or health plan, engaging in individual-level care coordination and case management activities.  Some of the key elements of these changes include the following:

• Clarification of Rules For Individual-Level Care Coordination. The Proposed Rule would revise existing rules regarding sharing of information for individual-level care coordination to apply to Covered Entities involved in such coordination activities, whether or not the participating Covered Entity is participating in the actual care or treatment of the individual by:
  • Revising the definition of “health care operations” in the current version of the Privacy Rule to clarify that the Privacy Rule allows sharing of PHI for individual-level care coordination among Covered Entities whether or not the participating Covered Entity is one involved in treatment or non-treatment involved Covered Entities such as health plans;
  • Revises the current minimum necessary restriction on the disclosure of PHI for purposes of individual-level care coordination to treat all Covered Entities engaging in individual-based care coordination and case management activities the same, regardless of whether performing the activities under the “treatment” or “health care operations” functions as defined by HIPAA.  Currently non-treatment involved Covered Entities participating in care coordination and case management can only receive and share the minimum necessary PHI as their lack of involvement in treatment disqualifies them for reliance upon the treatment exception to the Privacy Rule’s general requirement to limit disclosures to the minimum necessary.
  • The Proposed Rule also would allow Covered Entities to disclose PHI to community-based organizations, home and community-based services (HCBS) providers, social services agencies, and other similar third parties providing health-related services for individual-level care coordination and case management without obtaining a valid authorization from the individual.

Individual Access Rights Expanded

The Proposed Rule includes a number of changes that if adopted as proposed, will increase significantly the burdens upon Covered Entities of complying with the individual access requirements of the Privacy Rule.  Among other things, these include the following:

• Responding To Access Requests.  The Proposed Rule calls for:
• Reducing the maximum period that Covered Entities have to respond to requests to “as soon as practicable,” but in no case later than 15 calendar days after receipt of the request” instead of current 30 calendar days; 
• Clarifying the current requirement for Covered Entities to provide PHI in the form and format requested by the individual if “readily producible” in that form and format by providing that “readily producible” includes secure, standards-based APIs using applications chosen by the individuals, such as a “personal health application” and protect individual’s rights to take notes, videos, and photographs, or use other personal resources to view or capture PHI in person;
• Requiring Covered Entities to allow individuals access to inspect or obtain copies of their own PHI Free of charge when inspecting in person or accessing PHI on the internet, but continue to permit certain fees for labor, supplies, and postage for certain other means of access in accordance with Privacy Rules parameters.  In acquiescence to the District Court’s January, 2020 holding that the prohibition against Covered Entities charging for third party copies in the current regulations exceeded its statutory authority in Ciox Health, LLC v. Azar, however the Proposed Rule would allow Covered Entities to charge limited fees to an individual directing transmission of an electronic copy of PHI to a third party under specified circumstances.  The Proposed Rule also would require Covered Entities to provide advance notice of estimated fee schedules on their websites (if they have one) for common types of requests for copies of PHI and, upon request, provide individualized estimates of fees for copies and an itemized list of actual costs for requests for copies. 
• Right to Direct Copies to Third Parties.  The Proposed Rule will require  Covered Entities to transmit electronic PHI in an electronic health record to another Covered Entity as part of the individual’s access right.  In addition, also in response to the Coix Health, LLC ruling, the Proposed Rule will limit the current right of an individual to direct a copy of PHI to a third party to an electronic copy and will specify that third party direction request need not be in writing as long as it is “clear, conspicuous, and specific.”
• Verification. The Proposed Rule also would prohibit a Covered Entity from imposing “unreasonable” identity verification measures on an individual, including notarization of requests, requiring the individual to provide proof of identity in person when remove verification would be practicable, or requiring the individual to complete a full HIPAA authorization form for an access request.

Disclosures to Family Members and Other Caretakers in Certain Situations

Continuing a trend that OCR has followed over the past several years in its other guidance, the Proposed Rule also would modify the Privacy Rule under specified conditions to facilitate if not encourage health care providers more broadly to disclose PHI to family members or other caretakers of individuals with substance use disorders (SUD) or serious mental illness (SMI) and in emergency situations with less concern about exposing themselves to liability under HIPAA.  The key elements of these changes are accomplished as follows:

• The Proposed Rule would replace the current language that allows Covered Entities to make certain uses and disclosures of PHI based on their “exercise of professional judgment” with  language allowing disclosure based on a Covered Entity’s “good faith belief” that the use or disclosure is in the best interests of the individual and add a presumption of good faith by the health care provider for this purpose.
  • The Proposed Rule would enable Covered Entities to disclose PHI to avert a threat to the health or safety of a person or the public when a harm is “serious and reasonably foreseeable,” instead of the current stricter requirement that the Covered Entity see a “serious and imminent” threat to health or safety.

Clarification Regarding Disclosures to TRS Providers

The Proposed Rule also would amend the current Privacy Rules to remove  telephone relay service providers (“TRS providers”) from the definition of “business associates” and expressly to allow disclosures to TRS communications assistants for persons who are deaf, hard of hearing, deaf-blind, or who have a speech disability.

Required Updates To Notices of Privacy Practices

The Proposed Rule also would change the Privacy Rule Notice of Privacy Practices (“NPP”) requirements in a manner that would require most Covered Entities to update their NPPs and associated privacy policies. In the Proposed Rule, OCR proposes:

• Replacing the requirement that certain Covered Entities that have a direct treatment relationship with an individual obtain, and retain copies of, written acknowledgements from that individual confirming their receipt of the NPP with a right for the individual to discuss the NPP with a designee of the Covered Entity.
  • Modification of the required NPP content to include an additional description and instruction as to how individuals can exercise their access rights and a new, more detailed and instructive, required header meeting new specifications about the information the NPP provides to individuals with respect to their rights, how to exercise them, and the availability of the Covered Entity’s designated contact person.

Act Now

HIPAA Covered Entities, business associates and other concerned or impacted persons immediately should begin evaluating the Proposed Rule as soon as possible.  As the current comment will end 60 days after the impending publication of the Proposed Rule in the Federal Register, concerned persons desiring a change to any provision of the Proposed Rule should prepare and submit appropriate comments to OCR in a timely fashion within the comment period.  In addition, all Covered Entities and their business associates should review the rule  in preparation for its provisions taking effect with a particular eye toward understanding the actions necessary to comply with the modified rules and to budget the financial and operational resources likely to be required to accomplish that compliance.

More Information

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

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

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years legal and operational management work, coaching, public policy and regulatory affairs leadership and advocacy, training and public speaking and publications. As a significant part of her work, Ms. Stamer has worked extensively domestically and internationally on an demand, special project and ongoing basis with health industry, health plan and insurance and other business, government and community organizations and their leaders, spoken and published extensively on HIPAA and other privacy and data security concerns, as well as other health care and health benefits;  human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress;  and many other management concerns.

Board Certified in Labor and Employment Law By the Texas Board of Legal Specialization, Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, and the ABA RPTE Employee Benefits & Other Compensation Group and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer has extensive experience advising, representing, defending and training health care providers, health plans and insurers, employers, community organizations and others about HIPAA and other privacy concerns and has published and spoken extensively on these concerns.

Her involvement with HIPAA and other privacy and data concerns has taken place as part of her more than 30 years involvement working with public and private health industry, health insurance and other employers and organizations of all sizes, employee benefit plans, insurance and financial services, health industry and a broad range of public and private domestic and international business, community and government organizations and leaders on pandemic and other health and safety, workforce and performance preparedness, risks and change management, disaster preparedness and response and other operational and tactical concerns throughout her adult life. A former lead advisor to the Government of Bolivia on its pension  project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on crisis preparedness and response, privacy and data security, workforce, health care and other policy and enforcement, as well as regularly advises and defends organizations about the design, administration and defense of their organizations workforce, employee benefit and compensation, safety, discipline and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and shares insights and thought leadership through her extensive publications and public speaking. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

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

• Employers Prepare For Employment Tax Withholding Changes; Review & Comment On Proposed Rule Changes
• New PBGC Pension Rules Effective 3/5 May Require Action On Retirement Plans
• Revise Health Plan HIPAA Records Access Rules & Procedures To Use Newly Flexibility On Charging, Responding To Third Party PHI Requests
• 2/28 New Comment Deadline For NLRB Proposal To Exclude College Work Study Student Workers From NLRA Coverage
• Don’t Get Stuck Paying Another Employer’s Overtime Or Other Backpay
• 2019 OCR Enforcement Shows Getting Defensibly HIPAA Compliant Necessary In 2020!
• DOJ Omnicare/CVS Suit Highlights Potential Pharmacy Benefit Claims Abuse Exposure For Health Plans, Member Safety Risk
• OSHA Seeks Small Business Volunteers For Tree Care Safety Panel
• NLRB Restores Pre-Obama Era Union Dues Checkoff Rule
• $1.6M HIPAA Penalty Largely Caused By Inadequate Security Assessments & Oversight
• 10 Former NFL Payers Charged With Defrauding NFL Retiree Health Fund
• NLRB Order Directs Settlement Of McDonald’s Unfair Labor Practice Complaints Including Joint Employer Liability Charges Against McDonald’s USA
• 2018 US National Health Expenditures Grew Again
• ONC Patient Matching for Prescription Drug Monitoring Program Slides Available
• SBA Hosts Employee Benefits Roundtable 11/21
• College Pays $54,000 To Settle DOJ ADA Lawsuit For Paramedic Program’s Termination of TA With MS
• Business Leaders Serve Jail Time For Employment Tax Crimes
• New $2.15M OCR Penalty Shows Health Plans Risks Of HIPAA Violations
• Proposed NLRB Employee Definition To Exclude College Study Workers
• DOL Proposing To Allow Default Website ERISA Retirement Plan Disclosures
• Salary Threshold Increases Require Employer Review Of Salaried Worker FLSA Exemption Qualification

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.  ©2020 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.

The Centers for Disease Control is sharing the following recommendations to help Americans stay safe during the current pandemic outbreak:

More Information

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

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

About Solutions Law Press, Inc.™

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

• Proposed HHS Rule Making PBM Expenses Part of MLS Administrative Expense, Other Changes To ACA Helath Plan Rules Comment Deadline 5 P.M. Today
• Employers Prepare For Employment Tax Withholding Changes; Review & Comment On Proposed Rule Changes
• Employers Prepare For Employment Tax Withholding Changes; Review & Comment On Proposed Rule Changes
• New PBGC Pension Rules Effective 3/5 May Require Action On Retirement Plans
• Revise Health Plan HIPAA Records Access Rules & Procedures To Use Newly Flexibility On Charging, Responding To Third Party PHI Requests
• 2/28 New Comment Deadline For NLRB Proposal To Exclude College Work Study Student Workers From NLRA Coverage
• Don’t Get Stuck Paying Another Employer’s Overtime Or Other Backpay
• 2019 OCR Enforcement Shows Getting Defensibly HIPAA Compliant Necessary In 2020!
• DOJ Omnicare/CVS Suit Highlights Potential Pharmacy Benefit Claims Abuse Exposure For Health Plans, Member Safety Risk
• OSHA Seeks Small Business Volunteers For Tree Care Safety Panel
• NLRB Restores Pre-Obama Era Union Dues Checkoff Rule
• $1.6M HIPAA Penalty Largely Caused By Inadequate Security Assessments & Oversight  
• 10 Former NFL Payers Charged With Defrauding NFL Retiree Health Fund  
• NLRB Order Directs Settlement Of McDonald’s Unfair Labor Practice Complaints Including Joint Employer Liability Charges Against McDonald’s USA  
• 2018 US National Health Expenditures Grew Again  
• ONC Patient Matching for Prescription Drug Monitoring Program Slides Available  
• SBA Hosts Employee Benefits Roundtable 11/21  
• College Pays $54,000 To Settle DOJ ADA Lawsuit For Paramedic Program’s Termination of TA With MS  
• Business Leaders Serve Jail Time For Employment Tax Crimes  
• New $2.15M OCR Penalty Shows Health Plans Risks Of HIPAA Violations  
• Proposed NLRB Employee Definition To Exclude College Study Workers  
• DOL Proposing To Allow Default Website ERISA Retirement Plan Disclosures  
• Salary Threshold Increases Require Employer Review Of Salaried Worker FLSA Exemption Qualification  

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