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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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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First, Do No Harm: Analyzing the Certificate of Need Debate in North Carolina

From time to time the Parker Poe Health Care Blog will be asking experts in the health care field to serve as guest bloggers. Our first guest blogger is Daniel Carter from Ascendient. Ascendient is a Health Care Consulting firm located in Chapel Hill, North Carolina, that provides strategic health care planning and Certificate of Need advice and analysis. Ascendient has recently completed an in-depth analysis of the Certificate of Need (“CON”) law in North Carolina to determine how a potential repeal of the law would affect health care providers and consumers in the state. After reading it, we decided we should share this analysis with you. Here is a summary with a link to the full report.

Much of the debate over whether North Carolina’s Certificate of Need (“CON”) law should be repealed has focused on market theories without a great deal of focus on measurable realities. Ascendient decided to expand the perspective beyond the ideological arguments and review the data to see if it could draw some conclusions about how a potential repeal of the CON law in North Carolina would affect health care providers and consumers.

Based on an analysis of facts and objective data, we conclude that any move now to deregulate North Carolina’s healthcare system by reducing or eliminating the CON program would be premature and put already vulnerable hospitals at much greater risk as new entrants pick off their best patients without taking up the burden of indigent care.

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State Council Release Draft 2016 Certificate of Need Plan

There has been a lot of discussion about major changes to North Carolina’s Certificate of Need law.  As these legislative discussions continue, the State Health Coordinating Council continues its work on next year’s State Medical Facilities Plan (“SMFP”).  The draft plan is available on the N.C. Division of Health Service Regulation’s website.  Public hearings on this proposed SMFP were held in July.  Several petitions have been submitted seeking adjustments to the new determinations in the proposed 2016 SMFP.

A summary of the need determinations in the proposed 2016 SMFP is set forth below. Petitions submitted to adjust the need determinations also are listed.

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Renee Montgomery

Renee Montgomery

Renee Montgomery focuses her practice in the health law area and has extensive experience in regulatory and administrative law. For more than 25 years, Ms. Montgomery has represented health care providers and other organizations in administrative proceedings and litigation matters. Ms. Montgomery frequently lectures on health law and administrative law issues.

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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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Supreme Court Case Does Not Directly Challenge Obamacare, But Could Lead to Its Implosion.

The media coverage in the run-up to today’s Supreme Court oral arguments in King v. Burwell has described King as an attack on Obamacare. That isn’t quite right. Understandably, some of the imprecise language is due to the need to make the “news fit.” But some of the media descriptions create confusion about what the action is and what the implications to the federal health law would be were the Supreme Court to decide in the challengers’ favor.

The King plaintiffs are not challenging the constitutionality of the Affordable Care Act (“ACA”) or Obamacare. In the last Supreme Court case grappling with the ACA, National Federation of Independent Business v. Sebelius, 132 S. Ct. 2566 (2012) (“NFIB”), the challenger was directly challenging the ACA. In NFIB, the main issue was whether Congress had the authority to mandate that individuals purchase health insurance or pay a penalty.  Because the provision was enacted as part of the ACA, there was no dispute that Congress intended to impose the individual mandate when enacting the ACA. Ultimately, in an opinion authored by Chief Justice Roberts and joined by a majority of the justices, the Supreme Court determined that Congress had the authority to impose individual mandates under Congress’ taxing power.

In the King case, the challengers are not attacking the constitutionality of the ACA. The challengers are not attacking the ACA itself. Instead, the challengers are questioning the IRS’ implementation of the ACA in extending tax subsidies to individuals who have purchased health insurance plans in States that have not set up their own health insurance exchanges and instead rely upon the default federal exchange. The King plaintiffs point to the ACA’s language authorizing subsidies only to individuals who buy insurance on an “Exchange established by the State.”

If the Supreme Court agrees with the challengers’ argument that the ACA limits subsidies to State-run health insurance exchanges, the ACA will remain intact. Nothing about the law itself would directly be impacted. The implications for such a ruling, however, would be significant. If the Supreme Court were to side with the plaintiffs, the Obama administration would not have any ability to extend subsidies to the affected individuals. According to the federal government, more than 8.5 million of the 11.4 million people who have acquired health insurance through the exchanges would no longer be eligible for subsidies.

One solution would be for the affected States to set up their own exchanges.  In some States, however, this solution would be politically or logistically challenging.  Another potential solution would be for President Obama and Congress to “fix” the law to extend subsidies to individuals in States that use the federal exchange. This statutory change could be made by simply amending the language of the ACA.

Given that both the U.S. House of Representatives and the U.S. Senate are now controlled by Republican majorities, it is unlikely that Congress would change the law without demanding more significant and fundamental reforms to the ACA. This would set up a showdown between President Obama and Congressional Republicans to see who blinks first. If the Congress and the President could not reach a compromise, it could create what some of have called a “death spiral,” wreaking havoc on the insurance markets and potentially the ACA. Even though the Supreme Court would not have struck down the ACA, the federal health law could collapse under its own weight. Today’s oral arguments contained some drama, and all signs point to it being a close case.  If the Supreme Court sides with the plaintiffs, the high drama may be yet to come.

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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No Judicial Relief to the ALJ Waiting Game — Yet

In May 2014, the American Hospital Association filed suit against the United States Department of Health and Human Services seeking to compel Administrative Law Judges (ALJs) to comply with applicable statutory deadlines for deciding Medicare claim appeals.

By law, ALJs are required to render a decision within ninety days of a request for hearing to appeal the second-level reconsideration determination (in the case of claims appeals) and the first-level reconsideration determination (in the case of entitlement appeals).   ALJs are currently not in compliance with this requirement.  The backlog of appeals is significant.   The number of appeals made to the ALJ increased by over 500% from the 2011 fiscal year to the 2013 fiscal year, largely driven by the appeal of determinations by Recovery Audit Contractors.  The number of appeals outstanding in July 2014 was 800,000.  While both the Office of Medicare Hearings and Appeals and the Centers for Medicare and Medicaid Services have implemented a number of projects and pilot programs to try to reduce the number of appeals currently before the ALJ, many providers expect to wait years for an ALJ hearing.

In December 2014, the United States District Court for the District of Columbia determined that the delay did not warrant judicial intervention and granted a motion to dismiss the lawsuit.   In a letter published in response to the decision, the AHA announced its intent to appeal the decision.

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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