Health Law Advisor

Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Positive Change for the Home Health Community in New Jersey

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On March 3, 2015, the New Jersey State Board of Nursing (“Board”) issued a comprehensive set of proposed amendments, repeals and new rules pertaining to Delegation and Certification; Homemaker-Home Health Aides.  The changes broaden the authority of registered professional nurses (“RNs”) and permit RNs to train, and then delegate tasks to licensed practical nurses (“LPNs”), certified home health aides (“CHHAs”) and other assistive persons (collectively “assistants”).  This certainly seems like a positive step for the Home Health industry and its patients.  Nurses will be able to serve a broader patient base by maximizing the talents of more caregivers who are, perhaps, being under-utilized in the current model.

Currently New Jersey limits those tasks which an RN can delegate.  Those restrictions were understandable.  Delegation of nursing duties is a delicate and complex process.  An RN must fully assess and understand a patient’s needs and the potential for complication before feeling secure enough to assign another responsibility for that care.  The law change seems to embrace the fact that RNs have always had this key competency, the art of assessment and delegation, but were lacking the necessary assurances that their assistants were able to accept higher levels of responsibility, or that their license would be protected if something were to go wrong. Thus, the new law tightens the screening and training processes employed by HHAs to ensure that the assistants are “equal to the task” of accepting delegation.

It would certainly seem that New Jersey has made changes to benefit the Home Health Industry’s clients.  Among those benefits:

  • Safe and efficient care is delivered with highly skilled RNs able to devote significant time and attention to those patients in need of specialized care;
  • Duplication of services is minimized;
  • More care givers are empowered and more patients treated;
  • A “team” is established to effectuate goals and problem-solve;
  • Care is administered in a more efficient and cost-effective manner.

As with any changes, however, we have to be on the lookout for unintended consequences.  There are legal and ethical consequences to delegation.  Those nurses who master the art of delegation are still responsible for the care rendered and supervision is key.  The RNs must be certain they are delegating to people who are properly trained, understanding of their role, and capable of administering safe nursing care.  The delegates must be comfortable with this increased reliance on their skills.  Any hiccup in the link between the delegator and the delegate could create patient safety issues.  Thus, if any other states are inclined to follow New Jersey’s lead, attention not only to the benefits of delegation, but also to the attendant training and supervision requirements is essential for success.

Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency

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On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee[1] (the “Subcommittee”) held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration (“HRSA”), the Director of the Office of Pharmacy Affairs (“OPA”) of HRSA,[2] the Director of Health Care of the Government Accountability Office (“GAO”), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”).

The purpose of the hearing was to assess the functionality of the 340B Program, and, in particular, HRSA’s activities to address the findings in the GAO report, issued in September 2011, titled “Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement,”[3] and OIG report, issued in February, 2014, titled “Contract Pharmacy Arrangements in the 340B Program.”[4]

The GAO issued a follow-up report on March 24, 2015, titled “Drug Discount Program, Status of GAO Recommendations to Improve 340B Pricing Program Oversight.”  The follow-up report stated that HRSA had implemented two of the GAO’s four recommendations and that HRSA plans to address the remaining two recommendations to clarify the patient definition and hospital criteria for eligibility.  The OIG also recommended that HRSA clarify patient definition, particularly in to the context of contract pharmacies.  The OIG provided examples of how eligibility determinations in the contract pharmacy setting can result in diversion based on the lack of clarity in the patient definition.  Additionally, the OIG stated that HRSA could increase 340B Program transparency by sharing 340B ceiling prices with providers and Medicaid state agencies (though the OIG acknowledged that HRSA lacked the authority to share 340B prices with Medicaid state agencies).

Throughout the hearing, several members of the Subcommittee expressed their support for the Program and acknowledged that the 340B Program is necessary for hospitals, health centers, and other Covered Entities to serve underserved populations.  At the same time, Subcommittee members expressed concerns that the 340B Program needs greater clarity, oversight by HRSA, and transparency.  Subcommittee Chairman Joseph R. Pitts’ (R.-PA) opening statement sums up the message delivered by Congress:

“This program, designed to stretch scarce federal dollars, is critically important for indigent and low-income patients who may otherwise be unable to access needed drugs or afford treatment. . . . One thing I hope we can all agree on, is that to preserve the 340B program and ensure that it is serving those who most need help, greater oversight and transparency is needed to increase the program’s accountability. Today’s hearing marks the first step in that direction.”[5]

The following are several themes that were discussed during the hearing:

  • Chairman Pitts suggested that Medicaid expansion as a result of the Affordable Care Act may lead to more hospitals meeting the disproportionate share hospital (“DSH Hospitals”) percentage, and thus, becoming Covered Entities under the 340B Program. Chairman Pitts questioned whether the DSH percentage was an appropriate proxy for determining the extent to which a hospital serves low income populations and whether a different methodology would be more appropriate.
  • A few Subcommittee members expressed concern that DSH Hospitals have no obligation to report how 340B savings are used to benefit underserved patients. One member expressed the more specific concern that there was no transparency to determine the extent to which the 340B discount is passed on to uninsured individuals.   The Subcommittee members contrasted this with HRSA grantees, such as health centers, which are required to reinvest proceeds to advance grant purposes. HRSA’s Deputy Administrator noted that such reporting and use of 340B savings by DSH hospitals is not required by the statute and, in response, a member of the Subcommittee suggested that this was an issue being discussed among the members that could potentially require a legislative fix.
  • A few Subcommittee members broached the topic whether, in light of HRSA’s limited rulemaking authority, whether HRSA’s issuance of guidance was a “long term solution” and whether HRSA needed more expansive rulemaking authority. Although HRSA’s Deputy Administrator acknowledged that enforcement of rules would strengthen HRSA’s oversight, the Deputy Administrator did not explicitly request rulemaking authority or other legislative change and stated simply that HRSA would use all the tools at its disposal to enforce 340B Program compliance.
  • Certain Subcommittee members expressed concern over the lack of clarity surrounding the patient eligibility definition; noting that compliance cannot be enforced if the definition is unclear.
  • Several Subcommittee members expressed concern and asked questions regarding the transparency of 340B ceiling prices to Covered Entities and the length of time it has taken HRSA to implement the pricing database. HRSA noted that the secure website would be operational later this year. Other Subcommittee members posed questions regarding whether the ceiling prices needed to be shared with state Medicaid agencies, even though HRSA does not have such authority.

Based on the Subcommittee’s questions and the testimony, it appears that the Subcommittee is intent on “preserving” the 340B Program, and exploring whether legislative “fixes” are needed.  The Subcommittee discussed some areas that can only be addressed through the legislative process, such a change of methodology to 340B hospitals, and transparency requirements with respect to the utilization of 340B savings.

However, there currently does not appear to be any consensus on the scope of such legislation, or even whether legislation is needed.  Ultimately, legislation will likely depend on HRSA’s ability to ensure 340B Program compliance with its current tools, including Covered Entity and manufacturer audits, limited rulemaking authority, and the issuance of guidance.

[1] The full Energy and Commerce committee has primary jurisdiction over the 340B Program in the House of Representatives.

[2] The Office of Pharmacy Affairs is tasked with Administratoring the 340B Program.

[3] http://www.gao.gov/products/GAO-11-836

[4] http://oig.hhs.gov/oei/reports/oei-05-13-00431.pdf

[5] Opening Statement of Subcommittee Chairman Joseph R. Pitts, available at http://energycommerce.house.gov/hearing/examining-340b-drug-pricing-program.

EEOC Issues Proposed Wellness Program Amendments to ADA Regulations

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My colleagues Frank C. Morris, Jr., Adam C. Solander, and August Emil Huelle co-authored a Health Care and Life Sciences Client Alert concerning the EEOC’s proposed amendments to its ADA regulations and it is a topic of interest to many of our readers.

Following is an excerpt:

On April 16, 2015, the Equal Employment Opportunity Commission (“EEOC”) released its highly anticipated proposed regulations (to be published in the Federal Register on April 20, 2015, for notice and comment) setting forth the EEOC’s interpretation of the term “voluntary” as to the disability-related inquiries and medical examination provisions of the American with Disabilities Act (“ADA”). Under the ADA, employers are generally barred from making disability-related inquiries to employees or requiring employees to undergo medical examinations. There is an exception to this prohibition, however, for disability-related inquiries and medical examinations that are “voluntary.”

Click here to read the full Health Care and Life Sciences Client Alert.

EEOC Wellness Regulations – What Do They Mean for Employer-Sponsored Programs?

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The U.S. Equal Employment Opportunity Commission issued proposed regulations addressing how the Americans with Disabilities Act (“ADA”) applies to corporate wellness programs.  Namely, the proposed rule amends the ADA regulations to provide guidance on the extent to which employers may use incentives to encourage employees to participate in wellness programs that include disability-related inquiries and/or medical examinations.  The proposed rule will be published in the Federal Register on April 20, 2015.  Comments will be due 60 days from the date of publication.  The pre-publication version of the proposed rule can be viewed here. For additional information, visit Epstein Becker Green’s website to sign up for our upcoming webinar:  EEOC Wellness Regulations – What Do They Mean for Employer-Sponsored Programs?

 

SCOTUS Update – Armstrong v. Exceptional Child Center, Inc.

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On March 31, 2015, the Supreme Court of the United States decided Armstrong v. Exceptional Child Center, Inc. The Court handed down a hodgepodge of opinions but, in the end, five Justices concurred in the judgment that the Constitution’s Supremacy Clause does not confer a private right of action, and that Medicaid providers, therefore, cannot sue for an injunction requiring compliance with the reimbursement laws.  This ruling will adversely affect at least those health care companies that have contemplated suing on the basis that the reimbursement they are getting is less than what the law entitles them to. 

 

FTC Focus on Privacy

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At the International Association of Privacy Professionals (“IAPP”) Global Privacy Summit in Washington, D.C. on March 5th and March 6th, the Federal Trade Commission (“FTC”) was clear in its message that privacy was a top priority for the agency.  The FTC had a strong presence at the conference.  Three of the five Commissioners and the Director of the Bureau of Consumer Protection (Jessica Rich) all spoke at the conference and relayed a message of the importance of consumer privacy and security.  In that regard, the FTC speakers stressed the importance of:

  • informing consumers of the collection of consumer information;
  • informing consumers how such collected information will be used; and
  • providing strong safeguards for information collected.

The FTC speakers also announced that the FTC will be beginning a new security campaign to engage businesses of all sizes in understanding the importance of securing consumer information.  The FTC speakers also emphasized the FTC’s concern and focus on the collection of health information by organizations that are not covered under HIPAA (for example organizations developing wearable devices or other consumer driven apps).  Given the tenor of the discussions, there is no question that FTC will continue to make privacy enforcement a top priority.  As a result, device manufacturers, pharmaceutical manufacturers, and mobile health developers should remember to think beyond HIPAA when they think of U.S. privacy compliance.  For a listing of prior privacy enforcement actions by the FTC see, https://www.ftc.gov/news-events/media-resources/protecting-consumer-privacy/enforcing-privacy-promises.

Higher Bar for “Good Faith Compliance” in Second Year of Exchange Operations

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The Centers for Medicare & Medicaid Services (“CMS”) expects Qualified Health Plan (“QHP”) Issuers to be more familiar with Marketplace requirements and better reflect those standards in Issuers’ written policies and procedures, officials stated at the recent 2015 QHP Certification Conference held at CMS Headquarters in Baltimore, Maryland.

Twenty-three Issuers across fifteen Federally-facilitated Marketplace (“FFM”) States were audited for compliance with Federal QHP requirements during 2014.  The audits focused largely on QHP’s policies and procedures relating to FFM operations, including oversight of first tier, downstream and related entities (“FDRs).  While CMS held to its previously announced policy to not pursue sanctions against non-compliant Issuers which made a good faith effort to comply with requirements, officials noted that audit findings showed a lack of familiarity with Federal QHP requirements.  Many QHPs’ Marketplace-related policies and procedures were either non-existent, newly created near the time of the audit or generic, not addressing Marketplace-specific requirements.  Other common findings included QHP failure to:

  • Meet notice accessibility requirements;
  • Address requirements on maintaining current and accurate provider directories;
  • Ensure compliance with agent/broker training and registration requirements; and,
  • Ensure that agent/broker compensation is equal inside and outside the Exchange.

CMS is reviewing available data to select Issuers for audit during 2015.  Audit initiation will be staggered throughout the year and may be conducted on a standard or expedited timeframe.  The process may be managed as a desk review or may be onsite, but will include review of QHP systems and documents as well as interviews and will look at QHP oversight of FDRs.  Despite CMS’s decision to extend its good faith compliance policy through 2015, it may be difficult to find a QHP to have acted in good faith where policies and procedures fail to reflect FFM requirements, such requirements remain unimplemented or QHPs fail to monitor contractor compliance with FFM rules.

Complimentary Webinar – The Age of Data Breaches: How to Avoid Being the Next Headline

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Security Image

Tuesday, March 24, 2015 at 12:00 p.m. – 1:00 p.m. EDT

The past year has demonstrated that no organization is immune to security incidents that could affect its employees, customers, and reputation.  Understanding the complex legal framework governing data privacy and developing a plan to mitigate risk can be the difference between an incident and a disaster.

Join Epstein Becker Green’s Privacy & Security Practice for a comprehensive overview of data breach priorities impacting organizations that deal in electronic data.  Presenters will identify strategies to prepare for and prevent security incidents as well as summarize key takeaways from the biggest breaches of 2014.

Attendees will also learn about:

  • Complying with the evolving legal landscape
  • Minimizing data breach exposure
  • Developing an incident response plan and effectively responding to an incident
  • Setting organizational priorities, and getting buy-in

Speakers:

Adam C. Solander, Member of the Firm

Patricia M. Wagner, Member of the Firm

Who Should Attend:

Compliance Professionals, In-House Counsel, Board Members, and Information Security Professionals

To register for this webinar, please click here.

Key Issues Facing Places of Public Accommodation at the 25th Anniversary of the ADA

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Epstein Becker Green’s recent issue of its Take 5 newsletter focuses on the 25th Anniversary of the ADA and recent developments and future trends under Title III of the ADA.

  1. Website Accessibility
  2. Accessible Point-of-Sale Devices and Other Touchscreen Technology
  3. Movie Theater Captioning & Audio (Narrative) Description
  4. The Availability of Sign Language Interpreters at Health Care Facilities
  5. “Drive By” Design/Construction Lawsuits

Read the full newsletter here.

Extension of Timeline for Publication of the Final Rule – Medicare Programs; Reporting and Returning of Overpayments

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By George B. Breen and David E. Matyas.

CMS announced on February 13  (and to be published in a Federal Register notice this week) that despite the general guideline that final rules be issued within 3 years of a proposed or interim final rule, CMS will be taking an additional year to finalize the “Medicare Program; Reporting and Returning of Overpayments” final rule.   In February 2012 (see EBG’s February 22, 2012 Client Alert), CMS issued a proposed rule on the requirements under the ACA to report and return overpayments within 60 days to the Medicare program for providers and suppliers of services under Parts A and B.  CMS stated, “in this case, the complexity of the rule and scope of comments warrants the extension of the timeline for publication.”

While this does not otherwise impact the necessity, per the statute, that overpayments must be returned, as CMS reminds in its announcement – it is interesting that CMS has taken this long to finalize a rule implementing this requirement.  Significantly, this delay means we still await the fate of CMS’s proposal to implement a ten-year look-back period for paid claims – in contrast to the current 4 year period for claims re-openings, except in cases of fraud.