Category: Health Care Law

EEOC Alleges Hospital’s Mandatory Flu Vaccine Policy Violates Title VII

Mandatory Flu VaccineAs summer temperatures soar, one might think the last thing to worry about is the upcoming flu season. And while that may be true in most respects, the flu is on the minds of the Equal Employment Opportunity Commission (EEOC). A lawsuit filed by the EEOC sheds light on the issue for healthcare employers who impose mandatory flu vaccine requirements on employees as a condition of continued employment.

The EEOC alleges in EEOC v. Mission Hospital, Inc. – a lawsuit that includes class allegations – that Mission Hospital violated Title VII by failing to accommodate employees’ religious beliefs and by terminating employees in connection with the hospital’s mandatory flu vaccination program. In particular, the EEOC took issue with the hospital’s alleged strict enforcement of its deadlines, which required employees to request an exemption by Sept. 1 and, if the exemption request was denied, to obtain the vaccination by Dec. 1.

According to Lynette Barnes, regional attorney for the EEOC’s Charlotte District Office, “An arbitrary deadline does not protect an employer from its obligation to provide a religious accommodation. An employer must consider, at the time it receives a request for a religious accommodation, whether the request can be granted without undue burden.”

The key takeaway here is that, similar to what is required under the Americans with Disabilities Act (when, for example, an employer is analyzing the application of a policy to a particular employee with a disability), employers should consider analyzing their duty to accommodate under Title VII based on the facts and circumstances of the particular case, as opposed to applying an (allegedly) inflexible rule without regard to the circumstances of the particular case. The other take-away here is that employers should consider basing this kind of employment decision on more than one reason – for example, a missed deadline plus a determination that granting the exemption would (or would not) be an undue burden (and why).

A copy of the EEOC’s lawsuit is found here and a copy of Mission Hospital’s answer is found here.

ARTICLE BY Norma W. Zeitler of Barnes & Thornburg LLP
© 2016 BARNES & THORNBURG LLP

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

affordable drugsFollowing months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and approval; and (2) agree on a shared safety protocol for so-called “REMS products.” The CREATES Act is the latest in a string of legislative efforts around the country focusing on drug affordability and price transparency.

A. Regulatory Background

When and how a generic or biosimilar product (or brand drug or biologic) enters the pharmaceutical supply chain varies depending on whether the product is subject to Risk Evaluation and Mitigation Strategies (“REMS”) requirements. REMS originated with the FDA Amendments Act of 2007, which authorizes distribution restrictions and other REMS for medicines with higher toxicity and risk potential.  A REMS may include Elements to Assure Safe Use (“ETASU”), such as restricted distribution, physician and patient education, and/or evidence of safeuse conditions.

By law (21 U.S.C. § 355-1(f)(8)), REMS requirements cannot be used to “block or delay” generic approval. Nevertheless, FDA has publicly stated“we have found cases in which sponsors have tried to use the REMS to block generics.” Such efforts have been challenged in private antitrust litigation and generated more than 100 inquiries to FDA. The Federal Trade Commission has told Congress it “continue[s] to be concerned about potential [REMS] abuses . . . to impede generic competition,” which “may violate the antitrust laws.” Enter the CREATES Act.

B. The CREATES Act

Section 3 of the CREATES Act would establish causes of action for “delays of generic drugs and biosimilar biological products.” An “eligible product developer,” i.e., an ANDA applicant or 351(k) applicant, could bring a federal civil action against the license holder for a “covered product”—defined as an approved drug or biological other than one for which there is a short-term shortage—alleging the license holder

(1) “has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms”; or

for products subject to a REMS with ETASU

(2) (i) “failed to reach agreement with respect to a single, shared system of elements to assure safe use with respect to the covered product[] or . . . at least 120 days have elapsed since the developer first initiated an attempt to reach an agreement”; or

(ii) “refused to allow the eligible product developer to join a previously approved system of elements to assure safe use with respect to that product.”

The Act would authorize judges to award injunctive relief and damages “sufficient to deter” similar delaying conduct. Damages could not exceed the revenue earned from sale of the drug during the refusal period, however.

The CREATES Act would exempt innovators from liability from “the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities.” Additionally, innovators would not be liable if, in fact, they “had [no] access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms” or if “the covered product could be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder.”

C. Reactions and Implications

The CREATES Act enjoys broad support from the generic industry, physicians, pharmacists, hospitals, consumer advocacy groups, antitrust experts, and insurers. During a recent Congressional hearing, the CREATES Act waspraised for confronting anticompetitive regulatory manipulation by promoting competition and, in turn, improving consumer choice and welfare. The hearing’s lone dissenter, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), claimed the bill “uses a blunt instrument to address a narrow issue.”  Among other things, PhRMA objected to litigation as the mechanism for resolving product safety concerns and breakdowns in complex, multiparty REMS negotiations.

These criticisms raise legitimate issues. Reliance on litigation to remedy delays in generic entry risks a slow, expensive, and unpredictable enforcement process. Determining if a “term” is “commercially reasonable,” for example, presents fact-bound, context-specific questions typically reserved for a finder of fact. What legal consequence, if any, flows from a generic’s failure to engage in good faith negotiations to join the brand’s shared REMS?

The law also could leave innovators facing conflicting statutory obligations. It would allow “[a]n eligible product developer [to] submit . . . a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU,” in which case “provision of the covered product by the license holder under the terms of [an] authorization will not be a violation of the REMS for the covered product.” Yet, it (currently) does not amend the statutory provisions governing the enforcement of REMS programs (21 U.S.C. § 355(p)(1)(B); 21 U.S.C. § 333(f)(4)(A)). Without a legislative fix, sharing samples of a drug with REMS with ETASU could expose a brand company to civil and criminal penalties.

Some or all of these matters may be mooted by amendments to the CREATES Act as it makes it way through the legislative process.  Time will tell.

D. Striking A Balance

The CREATES Act seeks to tweak the elusive balance between encouraging development and continued research for new drugs and biologics while ensuring timely availability of lower-cost generic and biosimilar drugs.  While the fate of the CREATES Act remains uncertain, its impact on the American healthcare system would be significant for stakeholders on all sides of the public debate over drug affordability.

ARTICLE BY James W. Matthews, David L. Rosen, Katy E. Koski & Jason L. Drori of

Foley & Lardner LLP
© 2016 Foley & Lardner LLP

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

medical devices health dataOn June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized data from medical devices from device manufacturers to patients.

In the draft guidance, FDA clarifies that medical device manufacturers may share “patient-specific information” from legally marketed medical devices with patients at the patients’ request without additional premarket review by the agency, provided such dissemination falls within the lawful scope for which the manufacturer may market the device. For purposes of the draft guidance, “patient-specific information” is any information that is unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of the device, may be recorded, stored, processed, retrieved and/or derived from that device. Examples of patient-specific information include recorded patient data, device usage/output statistics, provider inputs, alarms and/or records of device malfunctions. Patient-specific information does not, however, include any interpretation of such data aside from interpretations normally reported by the device to the patient or the patient’s healthcare provider.

When sharing patient-specific information with patients, FDA recommends that manufacturers consider the following factors to ensure that such information is usable by patients and to avoid the disclosure of confusing or unclear information:

  • Content of information provided.  The information provided to patients should be comprehensive and up-to-date, and manufacturers should take measures to ensure that such information is easily understood and useful to the patient. Depending on the type and scope of information being shared, the manufacturer should provide supplementary instructions, materials or references to help patients understand the data. In deciding what measures may be necessary, the manufacturer should be sure to consider whether any characteristics of the intended recipient audience (e.g., mental capacity) may affect the interpretability of the information.

  • Context in which information should be understood.  Manufacturers should provide the information in context to avoid situations where the information may be misinterpreted, leading to invalid or inappropriate conclusions.

  • Necessity of access to follow-up information.  Manufacturers should consider what, if any, information they should include about whom to contact for follow-up information.  At minimum, manufacturers should advise patients to contact their health care providers with any questions about their data. Manufacturers should also consider providing their own contact information to facilitate response to patient questions about the device.

The draft guidance is the latest in a line of documents in which FDA has attempted to clarify its expectations for—and in many cases, allay the concerns of—developers of mobile health products. Though short on specifics, developers should find the guidance helpful insofar as they have questions regarding the extent to which they can disseminate medical device data to patients. Notably, however, the FDA does not address how manufacturers should proceed with respect to the dissemination of many patient-specific analyses, likely because the agency intends to address such issues in its long-awaited guidance on clinical decision support software.

ARTICLE BY Michael W. Ryan of McDermott Will & Emery
© 2016 McDermott Will & Emery

Informed Consent and Health Information Security Essential: New American Medical Association Guidelines for Telemedicine

american medical associationOn June 13, 2016, the American Medical Association (AMA) approved new ethical guidelines pertaining to the appropriate use of audio-video technologies to connect with and treat patients remotely. Through these guidelines, the AMA advocates for greater use of telemedicine by physicians while concomitantly encouraging such providers to inform patients regarding the limitations of any technology, including explaining the capabilities and limitations of such services and documenting the same. Further, the new AMA guidance emphasizes the need for appropriate protocols to prevent unauthorized access and to protect the security and integrity of patient information obtained through telemedicine or disseminated to subsequent health care providers following a telemedicine encounter.

The new ethical guidelines will be codified in Opinion E-5.025, “Physician Advisory or Referral Services by Telecommunication,” and Opinion E-5.027, “Use of Health-Related Online Sites.” Through these guidelines, physicians who provide telemedicine services to patients remotely should:

(a) Inform prospective patients about the limitations of the telemedicine relationship and services.

(b) Advise prospective patients regarding the potential need for follow-up care as indicated.

(c) Encourage patients who have existing primary care providers to inform such physicians about the patient’s receipt of telemedicine consultations and services, even if subsequent in-person care is not immediately needed.

(d) Be proficient in the use of relevant technologies.

(e) Recognize the limitations of such technologies and take appropriately steps to overcome or address any such limitations.

(f) Prudently perform appropriate diagnostic evaluations or prescribe medications by:

  • Establishing the patient’s identity;
  • Confirming that the telemedicine services are appropriate for that patient’s individual situation and medical needs;
  • Evaluating the indication, appropriateness and safety of any prescriptive medication in accordance with best practices and state prescriptive formularies; and
  • Sufficiently documenting the clinical evaluation and prescription and a medical record.

(g) Obtain an appropriately documented informed consent regarding the distinctive features of telemedicine in addition to information regarding the specific medical issues and treatment options.

(h) Take appropriate steps to preserve continuity of care, including giving consideration to the preservation of information and accessibility of such information for subsequent providers.

In addition to disseminating the above guidelines – violation of which could expose a physician to professional licensure sanction by state licensing boards – the AMA is encouraging physicians to collectively advocate for the access of telehealth and telemedicine services for all patients who could benefit from receiving care electronically. The AMA is similarly advocating for professional organizations and institutions to monitor telehealth and telemedicine developments to identify and proactively address both positive and negative outcomes to bring about further improvement in such technologies.

In light of the AMA’s advocacy of telehealth and telemedicine, such support could lead to relaxed restrictions on physician’s use of such technology to treat patients remotely and encourage greater levels of reimbursement by Medicare, Medicaid and private insurers for such treatment. Nonetheless, physicians should recognize that their fundamental duties to ensure patient safety and quality of care are not lessened when providing services via telehealth and telemedicine. Moreover, physicians should also be cognizant that the AMA guidelines do not supersede or displace state laws pertaining to telehealth and telemedicine; rather, the guidelines complement such regulations.

ARTICLE BY Daniel S. Zinsmaster of Dinsmore & Shohl LLP
© 2016 Dinsmore & Shohl LLP. All rights reserved.

False Claims Act: DOJ Appealing AseraCare Loss

False Claims ActOn May 27, 2016, the US Department of Justice said it will appeal to the Eleventh Circuit its loss in the False Claims Act (FCA) case against hospice chain AseraCare Inc. The government’s decision to appeal comes as no surprise, and it means that the substantial attention this case has received will continue.

As a reminder, this case, U.S. ex rel. Paradies v. AseraCare, Inc., focused on whether AseraCare fraudulently billed Medicare for hospice services for patients who were not terminally ill. AseraCare argued (and the district court ultimately agreed) that physicians could disagree about a patient’s eligibility for end-of-life care and such differences in clinical judgment are not enough to establish FCA falsity.

The government appealed three orders issued by the US District Court for the Northern District of Alabama. We previously posted about each of these three orders.

The first order on appeal is the district court’s May 20, 2015 decision bifurcating the trial, with the element of falsity to be tried first and the element of scienter (and the other FCA elements) to be tried second. The government had unsuccessfully sought reconsideration of this decision.  This is the first instance in which a court ordered an FCA suit to be tried in two parts.

The second order on appeal is the district court’s October 26, 2015 decision ordering a new trial, explaining that the jury instructions contained the wrong legal standard on falsity. This order came after two months of trial on the element of falsity and after a jury verdict largely in favor of the government.

The third order on appeal is the district court’s March 31, 2016 decision, after sua sponte reopening summary judgment, granting summary judgment in favor of AseraCare. In dismissing the case, the court explained that mere differences in clinical judgment are not enough to establish FCA falsity, and the government had not produced evidence other than conflicting medical expert opinions.

The government must file its opening brief 40 days after the record is filed with the Eleventh Circuit. We will be watching this case throughout the appellate process.

ARTICLE BY Allison E. Fleischer of McDermott Will & Emery

© 2016 McDermott Will & Emery

OCR Continues to Verify Entity Contact Info for Phase 2 HIPAA Audits

Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive verification emails in May.  We understand that Covered Entities continue to receive emails requesting contact information verification this week.Inbox, Email, HIPAA Audit Notices

Emails are sent from OSOCRAudit@hhs.gov and request a response from the entity verifying its information within five days.  A sample copy of the email is available from OCR’s website.  The receipt of an email requesting contact verification does not necessarily mean that an entity will ultimately be selected for an audit.  Covered Entities can begin to prepare for the next step in the audit process by reviewing OCR’s audit pre-screening questionnaire.

For the time being, Business Associates are not being contacted.  OCR will request a list of Business Associates from Covered Entities and plans to begin contacting Business Associates selected for audit this summer.  Business Associates should use this extra time to ensure that they are ready for an audit should they be selected.   OCR has provided a sample template for Covered Entities to use to list their Business Associates.

In order to assist covered entities and business associates with their HIPAA compliance efforts, we have repackaged the audit protocol into a more user-friendly format that can be downloaded here.

Article By Kate F. Stewart of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

©1994-2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

FDA Outlines Future Medical Device Coordinating Center

FDALogoThe federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by building a more coordinated and efficient system that would track medical devices and share evidence regarding safety and efficacy.

In the report, issued on April 5, 2016, NMDES is described as a voluntary, coordinated network of partnerships that include government agencies, device manufacturers, provider organizations, health plans, and patient communities that share the common goal of “generating higher quality data and evidence at lower costs to inform and improve patient care.” The Coordinating Center proposed by the Planning Board would be responsible for governing, coordinating, and standardizing efforts among these participants. The Coordinating Center would not have explicit regulatory authority, but FDA’s authorities could authorize and initiate activities through the Coordinating Center.

NMDES as a Coordinated Network of Partners

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This proposed network would build on the currently-existing limitations in obtaining evidence regarding medical devices, such as the absence of a broad adoption of unique device identifiers (UDIs) for tracking purposes, the expense of manual data entry and delays in data extraction, and limited participation in medical device tracking experts by health care providers and patients.

Although the Coordinating Center should be able to meet its objectives of optimizing data sharing, promoting best practices for device evaluation, and developing a process for disseminating safety and efficacy information, the proposed plan still has several hurdles to overcome. Under the timeline proposed in the report, it is “unlikely that a de novo entity can be organized.” Therefore, the Coordinating Center would have to be incubated at an “established hosting entity” with the plan to spin off the Coordinating Center and Governing Board into a “financially stable and independent entity.” Additionally, there is little concrete discussion of the source of early seed funding. Until such organizational and funding details are determined, NMDES and the Coordinating Center will remain aproposed system; however, as the report is the first in a series of papers to be released by the Planning Board, we expect more information to be forthcoming.

Article By M. Leeann Habte & Lindsey E. Gabrielsen of Foley & Lardner LLP

© 2016 Foley & Lardner LLP

Ohio Following National Trend in Clarifying Permissible Telemedicine Activities

On April 15, 2016, the State Medical Board of Ohio (Ohio Board) released proposed rules outlining the requirements for practitioners to prescribe or cause a prescription drug to be provided to a person who is at a location remote from the practitioner and for whom the practitioner has never conducted a physical examination. The proposed rules were a result of Ohio Revised Code Section 4731.74, enacted March 23, 2016, which tasked the Ohio Board with developing clear standards for practitioners who treat patients through telemedicine platforms. The proposed rules will replace Ohio Administrative Code Rule 4731-11-09.

Ohio defines “the practice of telemedicine” as “the practice of medicine in this state through the use of any communication, including oral, written, or electronic communication, by a physician located outside of this state.”i While this definition only references physicians, the Ohio Board has indicated that the proposed rule will also be applicable to podiatrists and physician assistants who have prescriptive authority. Any practitioner who treats a patient located in Ohio through telemedicine must be licensed by the Ohio Board or possessing a limited Ohio telemedicine certificate issued by the Ohio Board.

With regard to non-controlled substances, the proposed rules will authorize a practitioner to establish a practitioner-patient relationship by the use of appropriate technology in a manner consistent with the minimal standard of care for in-person treatment by a practitioner. This encompasses a medical evaluation and the collection of relevant clinical history as needed to establish a diagnosis, identify any underlying conditions, and identify any contraindications to the treatment recommended or provided. This information must be documented in the patient’s medical record along with confirmation of the patient’s identity, the patient’s physical location, and the patient’s informed consent for treatment through remote examination.

In accordance with the proposed rules, controlled substances may only be prescribed by a practitioner who has met the steps outlined above for authorizing non-controlled substances and one of the following situations exists:

  • The person is an “active patient” of a health care provider who is a colleague of the practitioner and the controlled substances are provided through an on call or cross coverage arrangement between the health care providers. Note that “active patient” means that within the previous 24 months, the practitioner conducted at least one in-person medical evaluation.

  • The person has been admitted as an inpatient or resident of an institutional facility such as a hospital, nursing home, or psychiatric facility.

  • The practitioner is appropriately engaged in the practice of telemedicine as defined in 21 C.F.R. 1300.04.

The Ohio Board’s proposed rules follow similar recent developments from other state licensing agencies, including Indiana, West Virginia and Washington State. The Ohio Board is accepting comments regarding the intended regulations through Thursday, May 12, 2016. For more information on the proposed rules and/or submitting comments about the rules, please contact a Dinsmore health care attorney.

Article By Daniel S. Zinsmaster & Jenna Moran ofDinsmore & Shohl LLP

© 2016 Dinsmore & Shohl LLP. All rights reserved.

1 Ohio Revised Code Section 4731.296.

Health Care Companies Agree to “Core Commitments” to Improve Access to EHR

Last month, the Department of Health and Human Services (HHS) announced that a number of large health care companies and providers had “agreed to implement three core commitments” to improve access to electronic health records (EHR).  HHS touted the commitments as a significant step toward increased EHR interoperability.

The three core commitments to which the health care entities agreed are as follows:

  1. Consumer Access: To help consumers easily and securely access their electronic health information, direct it to any desired location, learn how their information can be shared and used, and be assured that this information will be effectively and safely used to benefit their health and that of their community.

  2. No Blocking/Transparency: To help providers share individuals’ health information for care with other providers and their patients whenever permitted by law, and not block electronic health information (defined as knowingly and unreasonably interfering with information sharing).

  3. Standards: Implement federally recognized, national interoperability standards, policies, guidance, and practices for electronic health information, and adopt best practices including those related to privacy and security.

HHS highlighted the number and importance of the entities that have agreed to this “Interoperability Pledge.”  According to HHS, the nation’s five largest private health care systems signed the Interoperability Pledge, as well as “[v]endors who provide 90 percent of hospital electronic health records used nationwide.”

Notably, the three commitments in the Pledge are not enforceable.  At most, the Interoperability Pledge represents an agreement by its signatories that access and interoperability are key goals of EHR use.

 
Article By Philip Peisch of Covington & Burling LLP

© 2016 Covington & Burling LLP

Department of Justice Launches Targeted Elder Justice Task Forces

Woman Pushing Man in WheelshairOn March 30, the Department of Justice (“DOJ”) announced the formal launch of 10 regional Elder Justice Task Forces designed to identify nursing homes and other long-term care (“LTC”) facilities that provide “grossly substandard care” to residents.

Similar to DOJ’s previously launched Medicare Fraud Strike Force and Health Care Fraud Prevention & Enforcement Action Team (“HEAT”) initiative, the newly created Elder Justice Task Forces will focus on coordination and information sharing among federal, state and local enforcement agencies to combat suspected cases of physical abuse and financial fraud. Each task force will consist of representatives from the U.S. Attorneys’ Offices, state Medicaid Fraud Control Units, state and local prosecutors’ offices, the Department of Health and Human Services, state Adult Protective Services agencies, Long-Term Care Ombudsman programs and other law enforcement officials.

Part of the larger DOJ Elder Justice Initiative, the task forces will have a national footprint with locations in the following districts: Northern District of California, Northern District of Georgia, District of Kansas, Western District of Kentucky, Northern District of Iowa, District of Maryland, Southern District of Ohio, Eastern District of Pennsylvania, Middle District of Tennessee and the Western District of Washington.

The new Elder Justice Task Forces signal heightened interest and attention on the LTC industry, a move that comes on the heels of last summer’s Centers for Medicare and Medicaid Services’ proposed rule to overhaul requirements for participation by LTC facilities in federal health care programs.

Article By Jessica Talati of Barnes & Thornburg LLP

© 2016 BARNES & THORNBURG LLP