OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released its 2017 Work Plan.  Published annually and updated throughout the year, the Work Plan identifies the OIG’s key areas of focus as it carries out its mission of protecting the integrity of programs within DHHS.  The OIG is charged with ensuring the integrity of more than 100 programs administered by DHHS, including those within the Centers for Medicare and Medicaid Services, Center for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Health. The OIG Work Plan summarizes the OIG’s current activities – comprised of both new and revised activities — along with information regarding previously identified activities that have been completed, postponed, or cancelled.

The Work Plan highlights new and continuing priorities applicable to various provider types, including hospitals, nursing homes, hospices, home health, clinical laboratories, physicians and other health professionals, medical equipment suppliers and manufacturers, pharmaceutical manufacturers and other providers and suppliers.

The 2017 Work Plan is available here.

The following is a sampling of some of the new and ongoing efforts highlighted in the Work Plan:

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Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

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OCR Issues Guidance on Ransomware Attacks and Determining Whether a Reportable HIPAA Breach Exists

The Office of Civil Rights (“OCR”) has issued new guidance in connection with an increase of malicious cyberattacks, namely ransomware attacks on healthcare organization’s computer systems. Ransomware is a defined by HHS as a type of malicious software whose defining characteristic is that it attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker until the requested ransom is paid.Read More

Chara O'Neale

Chara O'Neale

Chara O’Neale focuses her practice primarily on the representation of hospitals, physician groups and other health care providers in the resolution of legal, regulatory and business issues for entities involved in the health care industry.

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CMS Finalizes Rule on Reporting and Returning Medicare Overpayments

The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification.  Although this requirement has been in effect since 2010, the Centers for Medicare and Medicaid Services (“CMS”) has proposed but failed to promulgate rules serving to further clarify this requirement. On February 12, 2016, CMS published a final rule, which went into effect March 14, 2016.  The final rule applies to Part A and Part B of Medicare.

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Varsha Gadani & Matt Wolfe

Varsha Gadani focuses her practice on the health care industry. Her clients include hospitals, physicians, behavioral health care providers, long-term care facilities, and other providers. Prior to joining Parker Poe, Ms. Gadani served as Assistant Counsel at the North Carolina Medical Society (NCMS). In this role, she performed a variety of legal functions for the NCMS. She monitored and analyzed emerging state and federal health law issues and advised physicians on health policy matters. Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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Challenging Medicaid Prepayment Review

When the North Carolina Division of Medical Assistance (“DMA”) decides to place a Medicaid provider on prepayment review, it can be the equivalent of a death sentence for a small business.  The primary problem is that there are few avenues to appeal the decision to be placed on prepayment review, even when there is little or even no justification for DMA’s decision.  Prepayment review then becomes a waiting game reducing cash flow and overwhelming providers with a paper chase gotcha game. Although the initial decision to place a provider on prepayment review cannot be challenged, this does not mean that a Medicaid provider has no options to challenge the prepayment review process.

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Varsha Gadani

Varsha Gadani

Varsha Gadani focuses her practice on the health care industry. Her clients include hospitals, physicians, behavioral health care providers, long-term care facilities, and other providers. Prior to joining Parker Poe, Ms. Gadani served as Assistant Counsel at the North Carolina Medical Society (NCMS). In this role, she performed a variety of legal functions for the NCMS. She monitored and analyzed emerging state and federal health law issues and advised physicians on health policy matters.

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How Medicaid Providers Can Challenge Rate Cuts in the Wake of Armstrong v. Exceptional Children’s Center

The Federal Lawyer, a national magazine by the Federal Bar Association, just published an article by one of Parker Poe’s health care attorneys.   The article looks at the implications of a recent Supreme Court decision and explores how Medicaid providers can still challenge rate cuts.

The article is available here.

Matt Wolfe

Matt Wolfe

Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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Parker Poe Hosts Health Care Symposium on Supreme Court Decisions


Raleigh, NC –  On July 16, 2015, Parker Poe hosted a Health Care Symposium co-sponsored by the North Carolina Society of Health Care Attorneys, the Federal Bar Association’s Health Law Section, and the Federal Bar Association’s Eastern North Carolina Chapter.

The Symposium was a review of the United States Supreme Court’s decisions impacting health care in the 2015 term. Panelists reviewed the Court’s opinions and their legal and practical implications. The Symposium was designed for health care providers, lawyers, policy makers, and others interested in health law and policy.

Matt Wolfe, an attorney  in Parker Poe’s Raleigh office, moderated the Symposium’s panels.  Matt was joined by Kimberly Cogdell Boies of NCCU Law; Catherine Dunham, Elon Law; Mark Hall, Wake Forest Law; Joan Krause, UNC Law; Jane Perkins, National Health Law Project; Barak Richman, Duke Law; Richard Saver, UNC Law; and Don Taylor, Duke Public Policy. Click here for a link to the video of the session.

If you would like further information about topics discussed, please contact Matt Wolfe at 919-835-4647 or mattwolfe@parkerpoe.com.

Matt Wolfe

Matt Wolfe

Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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Cloud Computing Contracts Top Issues for Healthcare Providers

An increasing number of health care providers are outsourcing the hosting and maintenance of software applications, the storage of data, and related support services.  Outsourcing can provide cost savings, rapid deployment, system scalability, other efficiencies, and appropriate data security.  It also introduces additional issues into the provider’s risk management analysis, largely based on the fact that a third party rather than the provider has possession and control of vital and sensitive assets and information.  Before you enter into a contract that includes a cloud computing component, you should consider some of the following:

  • No business decision or activity is risk free.  Risk management is a balancing process based on the particular facts and circumstances.  For example, a provider may be less concerned about its inability to access its web-based job application submission portal than its electronic health record application.  Not all risks are the same, and a provider should devote more attention and resources to managing its greatest risks.
  • Risk management is a team sport.  Effective risk management requires the participation and interaction of representatives of the intended user group, financial analysts, compliance officers, information technology and data security experts, and legal counsel experienced in advising on and negotiating the particular type of contract.

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Steve Hunting

Steve Hunting

Steve has successfully guided health care providers, electric utilities and other clients through complex information technology, transmission, generation and other commercial projects and contract negotiations for more than 25 years. His experience as in-house counsel helps him provide seasoned, practical advice and have a better understanding of the daily challenges his clients face. His objective is to help his clients achieve their business goals effectively and efficiently.

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Supreme Court Holds that Medicaid Providers Do Not Have Right to Challenge Medicaid Reimbursement Rates under Supremacy Clause

Yesterday, the United States Supreme Court issued an opinion that denies providers the right to challenge low Medicaid reimbursement rates by suing state agencies in federal court.

In Armstrong v. Exceptional Child Center (No. 14-15), several residential care providers in Idaho sued on the grounds that its Medicaid program failed to pay providers increased Medicaid rates that had been approved by the federal government.  The providers were initially successful in convincing the district court and Court of Appeals for the Ninth Circuit that the State should be forced to pay the higher rates because federal Medicaid law requires states to pay rates that are sufficient to ensure access to care.  The providers contended that they had the right to sue Idaho in federal court under the United States Constitution’s Supremacy Clause—which provides that federal law trumps State law.

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Matt Wolfe

Matt Wolfe

Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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Office of Civil Rights Delays Phase 2 Audits

The Office of Civil RIghts (“OCR”) recently announced that Phase 2 of the HIPAA audits would be further delayed because the audit portals and project management tools that are needed to initiate the audit process are not ready and available for usage. Phase 2 of the HIPAA audits was initially slated to begin in the fall of 2014 and was subsequently moved to late 2014 or early 2015. Currently, no timeline has been provided as to when the next round of audits will officially begin.

A delay in Phase 2 of the OCR HIPAA Audits does not mean that covered entities and business associates should not continue to make sure they are in compliance with all HIPAA regulations. The potential consequences for failure to comply with HIPAA regulations are significant. While the audit portals are still under development, it is a good time for covered entities to (i) make sure their HIPAA policies and procedures are up to date and meet the latest privacy and security requirements, (ii) create a list of all business associates that provide services to the covered entity, and (iii) conduct an internal risk assessment to identify potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity.

Among other things, Parker Poe’s healthcare attorneys advise our healthcare clients about (i) compliance with HIPAA’s privacy requirements as they affect healthcare information, including preparing employee and patient notices, plan policies and procedures, plan amendments and authorization and other forms, and (ii) HIPAA compliance requirements for business associates.

Chara O'Neale

Chara O'Neale

Chara O’Neale focuses her practice primarily on the representation of hospitals, physician groups and other health care providers in the resolution of legal, regulatory and business issues for entities involved in the health care industry.

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A Christmas Present for Home Care Providers

The home care industry received a welcome holiday gift from the United States District Court in Washington, D.C. shortly before Christmas when Judge Richard J. Leon vacated a portion of a new regulation that would have required employers to pay minimum wage and overtime to workers providing companionship services.   (The regulation also impacts live-in providers of domestic services, but my focus here is on companionship services.)  The new regulation, first proposed in 2011, was set to go into effect on January 1, 2015, and had home care providers scrambling to figure out how they would pay significantly increased labor costs.

The Court’s December 22, 2014 ruling provided some welcome relief, but the final outcome remains uncertain. A new more restrictive definition of companionship services was set to go into effect on January 1, 2015.  Under the current rule, a worker providing companionship services can devote up to twenty percent of his/her time to general household work and engage in unlimited care tasks such as meal preparation, bed making, and clothes washing.   The new definition would limit all household and incidental care services to twenty percent of the worker’s time with the remaining hours dedicated to engaging the recipient in social, physical, and mental activities, such as conversation, reading, and games.

On December 31, 2014, however, Judge Leon issued a Temporary Restraining Order (TRO),  blocking DOL from enforcing the proposed definition of “companionship Services.”  In its motion for a temporary stay, the plaintiffs contended that home care recipients, providers, employees, and payers of services (like Medicaid) would suffer irreparable harm if the DOL rule went into effect.  The plaintiffs’ motion was supported by detailed affidavits of two disability rights advocacy groups, The Centers for Independent Living and ADAPT.  A hearing on plaintiffs’ preliminary injunction motion is scheduled for January 9, 2015.  Judge Leon has indicated that he will rule on the motion as early as at the hearing and no later than January 13, 2015.  If the requested injunction is granted, the exemption from overtime will continue until the trial court’s final ruling or an appellate court reverses the injunction.

To back up a bit, this case is about the Fair Labor Standards Act (“FLSA”), which requires employers to pay their employees at least minimum wage (and time and a half for any time worked over 40 hours in a single week), unless their employees are exempted from those requirements.   Employees who provide companionship services to individuals unable to care for themselves due to age or infirmity always have been exempted from the minimum wage and overtime rules.   The DOL wanted more workers to receive minimum wage and overtime, so it sought to narrow the exemption in two ways.

First, the DOL narrowed the definition of “companionship services.”     More on that aspect of the regulations, which was not vacated by Judge Leon, below.   Second, the DOL declared that third-party employers (like home care providers) would not be eligible to take advantage of the exemption at all.    As a practical matter, this meant that 90% of workers providing companionship services – the approximate percentage employed by home care entities – would have been entitled to receive minimum wage and overtime, regardless of how those services were defined.   The 10% of companionship services workers employed solely by individuals or families would have continued to be exempt from those requirements assuming that their schedules complied with the new, stricter definition of allowable services.

The National Association of Home Care, the Home Care Association of America, and the Independent Franchisers Association filed a lawsuit on behalf of their members to block the new regulations, arguing in part that the DOL did not have the authority to dictate which employers could take advantage of the exemption and which could not.   Judge Leon agreed, stating in his opinion that Congress intended the exemption to apply to all employees who provide companionship services and that the DOL is not entitled to draw policy lines “based on who cuts a check rather than what work is performed.”   Judge Leon went on to note that the purpose of the companionship exemption was to make it more financially feasible for families to care for infirm relatives at home and that whether home care entities were providing the workers is not of particular concern.    If the decision stands, it will mean that all workers providing companionship services will be subject to the same rules regardless of who employs them.

While the TRO is in effect, home care providers can continue to pay home care aides and personal care attendants without added overtime compensation—except if state law requires otherwise.  Providers should consult legal counsel to determine if they qualify for the exemption.  For additional information on how these new developments impact your business and assistance with next steps, contact one of the following members of our Parker Poe Team:  Sarah Ford (sarahford@parkerpoe.com, 919.835.4507) or Patti Bartis (pattibartis@parkerpoe.com, 919.890.4161).

Sarah Ford

Sarah Ford

Sarah Ford assists employers in the areas of compliance counseling, internal investigations and litigation. Ms. Ford has experience defending employers against the claims of current and former employees as well as charges brought by government agencies. These include the Equal Employment Opportunity Commission (EEOC), Citizenship and Immigration Services (USCIS), the Civil Rights Division of the U.S. Department of Education and the Federal and North Carolina Departments of Labor. Ms. Ford has experience handling sensitive employment issues such as claims of sexual harassment, racial bias and disability discrimination. Her clients include health care entities, schools and universities, financial institutions and retailers.

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