340B Mega Guidance Withdrawn

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance).   The guidance addressed a number of significant issues under the 340B Program, including the definition of eligible patient and contract pharmacy arrangements.   The Mega Guidance was issued by HRSA in August 2015 after a HRSA “Mega Rule” was withdrawn in response to concerns that the issuance of the issuance of the “Mega Rule” exceeded HRSA’s regulatory authority.

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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EEOC Settlement Reminds Healthcare Employers of Limits on Mandatory Vaccinations

The policy seemed straightforward. A hospital required all employees to receive seasonal flu vaccinations based on its assessment of the dangers of influenza to patients with compromised immune systems. The hospital went further, providing an exemption from the policy for employees with medical or religious reasons for avoiding the vaccinations. Nevertheless, the Equal Employment Opportunity Commission (EEOC) recently announced that it had reached a $300,000 settlement with the hospital based on its claims that the vaccination policy violated the religious rights of six terminated employees under Title VII.

The EEOC claimed that in practice, the Pennsylvania hospital rejected religious claims for exemption from the flu vaccine, while routinely granting medical exemptions. The settlement specifically prohibits the hospital from requiring that employees seeking a religious exemption from the vaccinations provide notes from clergy certifying the religious basis for the objection. In general, Title VII prohibits employers from inquiring into the basis for or sincerity of the employee’s religious practices or beliefs.

The settlement does allow the hospital to continue denying vaccination exemption requests if it can prove undue hardship. This is a difficult standard, requiring the employer to demonstrate something close to certainty of harm in the event that the exemption is granted. In the hospital’s case, undue hardship could arise for example, with employees whose jobs requires regular and close contact with patients known to have compromised immune systems.

The EEOC’s position obviously provides employees who simply prefer not to get vaccinated an avenue to claim a questionable religious exemption to the requirement. Absent clear evidence that the employee does not hold a sincere religious belief supporting the accommodation request, the employer has little recourse other than to determine whether the accommodation presents the undue hardship allowed by the EEOC.

Jonathan Crotty

Jonathan Crotty

Jonathan Crotty has been a successful counselor and problem solver for large and small employers in the Carolinas and beyond for over 20 years. He heads Parker Poe’s Employment and Benefits practice group and represents employers in all aspects of the employment relationship, from hiring to discharge. Mr. Crotty provides guidance to employers as they navigate the complex array of laws and regulations applicable to the employment relationship, including employment discrimination laws, OSHA compliance, FMLA, and wage and hour matters. If employers face legal or administrative claims resulting from their employees and employment practices, he defends and resolves those disputes in line with the client’s goals and expectations.

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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 Releases Hospital Quality Star Ratings

On July 27, 2016, the Overall Hospital Quality Star Ratings were released on Medicare’s Hospital Compare website.  The Star Ratings represent a summary compilation of individual hospital performance on 64 measures designated by CMS to represent the quality of care delivered at over 4,000 Medicare-certified hospitals. Star ratings are on a scale of one to five, with a five-star rating being the best.

Medicare’s instructions to patients regarding how to use the Hospital Compare website describe the ratings as one factor to be taken into account by patients when determining where to seek non-emergent care.

According to Medicare, the purpose of the star ratings is to not only provide a tool to consumers, but also to encourage hospitals to improve the quality of care that they provide.  Industry groups and others have criticized the rating system for a lack of transparency, as well as failure to take into account different hospital types for purposes of compiling the comparative information.  CMS delayed release of the information in Spring 2016 following letters signed by 60 Senators and 225 members of the House of Representatives urging reconsideration of the ratings system.  CMS was not convinced to extend the delay, however, despite a bill introduced on July 26, 2016 to prevent release of the Star Ratings for another year.

The CMS Compare sites are the official sites for information published by Medicare regarding the quality of health care providers. Quality of care ratings for nursing homes, home health, dialysis facilities, group practices, and other health professionals have previously been issued by CMS on the Compare websites and can be accessed here.

Parker Poe’s healthcare practice group works closing with the firm’s government relations team to represent our client’s interests on the federal and State levels.  Our government relations and lobbying practice encompasses activities such as formulating strategy, drafting legislation, appearing before legislative committees and study commissions, and intervening directly with legislative officials.

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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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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New Part B Drug Payment Model Proposed

On March 11, 2016, CMS proposed implementation of a new two-phase model for drugs reimbursed under Part B of the Medicare Program (“the Proposed Model”).  Drugs reimbursed under Part B include drugs administered in hospital outpatient departments or in physician offices.  The purpose of the Proposed Model is to test alternative drug payment designs with the goal of (i) reducing overall costs to the Medicare program, and (ii) enhancing quality of care.Read More

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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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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