Health Law Advisor

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

President Obama to Announce New Privacy Initiatives in SOTU

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By: Evan J. Nagler

The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.

SETTING A NATIONAL DATA BREACH REPORTING STANDARD

President Obama is planning on introducing a data breach bill that would standardize the reporting period nationwide at 30 days. The proposed Personal Data Notification and Protection Act would require direct customer notification. The law would also criminalize selling consumer identities overseas.

Presently, most states have their own consumer data protection laws requiring customer notification in the event of a breach. The new bill may preempt stricter state laws such as California’s 5-day window for reporting.

RESTRICTING THE USE OF STUDENT DATA

The White House will also propose the Student Digital Privacy Act, based on a California law passed last September. The main purpose of the bill is to restrict the sale of student data for use unrelated to education as well as restricting targeted advertising based on school-collected data. The bill seeks to restrict commercial uses while at the same time ensuring that outcome-based studies are allowed to continue.

ENACTING THE CONSUMER PRIVACY BILL OF RIGHTS

In 2012, the White House revealed plans for a Consumer Privacy Bill of Rights. This white paper laid out a set of seven guiding principles for consumer privacy (see Appendix A of the linked PDF). After receiving and incorporating suggestions during the last three years, the President will reportedly ask Congress to enact a revised Consumer Privacy Bill of Rights into law. The bill would ensure more control over personal data for individuals, more closely in line with the rules in place in the European Union.

STAY TUNED FOR UPDATES

As more information is released regarding the President’s privacy and security plans, we will cover it here, so check back in the coming days.

Comment Period on Proposed QHP Certification Guidance and Proposed Rule That May Impact Health Insurance Issuers’ Offering of Private Health Insurance Products

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By: Helaine I. Fingold

Stakeholders received insight on the Obama administration’s expected approach to the certification and oversight of qualified health plans (“QHPs”) late Friday, December 19, 2014, with the release by the Centers for Medicare & Medicaid Services (“CMS”) of its Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces (“Draft Letter”). This annual release comes more than a month earlier than the release of the 2015 version of this document.

While the Draft Letter largely mirrors the provisions of its 2015 predecessor, or restates earlier proposals, CMS does include several significant changes in approach for the 2016 application cycle. These changes include the use of an earlier timeline for application submission, review, and approval, as well as a more extensive review of benefit offerings for compliance with non-discrimination requirements.

That same day, the administration, through the Departments of Health and Human Services, Labor and Treasury (collectively, “Departments”) released a proposed amendment to expand federal regulations on excepted benefits to exempt wraparound coverage offered by group health plans from specific Affordable Care Act market-wide health insurance reform requirements (“Proposed Rule”).

The Draft Letter speaks specifically to issuers seeking to offer QHPs in the individual and small group markets through the Federally-facilitated Marketplaces.  However, issuers seeking to offer coverage in State-based Marketplaces and outside the Marketplace should also closely review this guidance for insights into CMS’s perspective on market-wide provisions discussed in the context of QHPs.  The Proposed Rule addresses small and large employer group health insurance offerings.

CMS is accepting comments on the Draft Letter through January 12, 2015. The Departments are accepting comments on the Proposed Rule through January 22, 2015.

 

Supreme Court Lowers the Bar for Class Action Removal

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Stuart M. GersonOn December 15, 2014, the Supreme Court of the United States decided Dart Cherokee Basin Operating Co. v. Owens, a class action removal case.

In short, the Dart case is welcome news to employers. Standards for removing a case from state to federal court have been an abiding point of concern for employers faced with “home town” class actions. In more recent times, this problem has become a point of interest to employers in health care and other industries that are beset by cybersecurity and data breach cases originating in state courts but calling for the application of federal privacy standards. Dart should help them substantially.

In the Dart decision, the Supreme Court held that a defendant seeking to remove a case from state to federal court – who must file in the federal forum a notice of removal “containing a short and plain statement of the grounds for removal”  pursuant to 28 U. S. C. §1446(a) – need include only a plausible allegation that the amount in controversy exceeds the jurisdictional threshold. The notice need not contain evidentiary submissions. Section 1446(a) thus tracks the general pleading requirement traditionally required by the Federal Rules of Civil Procedure.

The Dart decision also resolves a longstanding split among the Circuit Courts of Appeals, adopting the view of a majority of the lower courts while categorically rejecting the Tenth Circuit’s requirement that an evidentiary submission had to accompany the notice of removal under the Class Action Fairness Act.

Perhaps even more noteworthy than its rejection of any requirement to submit evidence in support of removal is the Supreme Court’s categorical refusal to imply any presumption against removal to federal court. Parties have been attempting to rely upon such a presumption, often with success, for years. The Supreme Court, however, has now made it clear that there is no basis in law for it and for that reason, coupled with the requirement that a party do no more than plausibly allege the jurisdictional amount in controversy, has substantially eased the burden on a defendant’s removal of a state court action to federal court.

For those who think that the judicial conservatives and liberals always vote in a bloc and that the conservatives are always pro-business, one notes that this arguably pro-business decision was authored by Justice Ginsburg, who was joined by the Chief Justice and by Justices Breyer, Alito, and Sotomayor.  Justices Scalia, Kennedy, Thomas, and Kagan were all in dissent. One also notes that the 5-4 split should not be taken as a sign of potential weakness in the majority opinion.  The four dissenters did not dwell on the merits; they simply believed that, for jurisdictional reasons, the issue decided was not properly before the Court.

Deadline Extended for Comments on Proposed Changes to Home Health Conditions of Participation

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In response to multiple requests, the Centers for Medicare and Medicaid Services (“CMS”) have extended the deadline for comments on the proposed changes to the home health conditions of participation (“CoPs”).  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by acknowledging the interdisciplinary view of patient care and allowing home health agencies greater flexibility in meeting quality care standards.  The proposed changes include:

  • Enhanced and expanded patient rights requirements;
  • Changes to plan of care requirements and the process for transfer and discharge of patients;
  • New requirements for the development of Quality Assessment and Performance Improvement (“QAPI”) programs; and
  • New requirements for infection prevention and control.

The 2013 Home Health Prospective Payment System final rule authorized CMS to impose intermediate sanctions on home health agencies that are found to be out of compliance with the CoPs.[2]  In addition to terminating a home health agency’s provider agreement, CMS may now impose alternative sanctions including, civil monetary penalties, suspension of payments for all new admissions, temporary management of the home health agency, directed plans of correction, and directed in-service training.[3]  In light of these potential sanctions, we urge home health agencies to closely review the proposed changes to the CoPs and consider how your organization will comply with the new requirements.  We also encourage home health agencies to respond to the various aspects of the proposed rule that CMS has specifically asked for comments on.

 


[1] 79 Fed. Reg. 61,164.

[2] 77 Fed. Reg. 67,068.

[3] 42 C.F.R. § 488.820.

Recent Legislative and Regulatory Efforts Continue to Change the Regulatory Landscape for Hospice and Home Health Providers

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Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

  • President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 (“the IMPACT Act”) into law;
  • The Centers for Medicare and Medicaid (“CMS”) published the Medicare Home Health Prospective Payment System final rule for calendar year 2015 (“Final Rule”); and
  • CMS published proposed changes to the home health conditions of participation and are accepting comments through December 8, 2014.

Each of these announcements has the potential to result in substantial changes to the hospice and home health industries.  For the full client alert, please click here.

 

EBG’s Stuart M. Gerson and Christopher Farella to Speak at Essex County Bar Super CLE Event

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On Wednesday, December 10, 2014 colleague Stuart M. Gerson of Epstein Becker Green’s Litigation and Health Care and Life Sciences practices in the firm’s Washington, DC and New York offices will join a panel discussion on “The Manay Faces of the Affordable Care Act.”  Christopher Farella of Epstein Becker Green’s Litigation and Labor and Employment practices in the firm’s Newark office will serve as moderator.

Issues to be addressed include:

  • State of play with respect to various aspects of the ACA, particularly the employer mandate, including a discussion of recent case law.
  • How recent election results could impact amendments to the ACA.
  • The interplay between the ERISA settler and fiduciary functions that the ACA requires.
  • The interplay between the ACA and other employment laws.
  • Managing employee populations and the treatment of full time, part time and variable hour employees for coverage offerings.
  • The impact of the ACA insurance market reforms on the individual and small employer insurance markets in NJ.
  • The unintended consequences of the ACA for employers.

For more information, click here.

Eye on Ebola: Latest Updates from the CDC

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The 2014 outbreak of the Ebola Virus Disease (“Ebola”) is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention (“CDC”) and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular interest to health care providers.

The first new CDC guidance is an official list of Ebola Treatment Centers. The current list includes 35 U.S. hospitals located in twelve states plus the District of Columbia. The CDC plans to update this list on a weekly basis as additional U.S. hospitals work with state and local health authorities and the CDC to assess their infrastructures and operational readiness to receive and provide comprehensive care to persons diagnosed with Ebola. As the CDC states in its Interim Guidance for Preparing Ebola Treatment Centers, the decision to designate a facility as an Ebola Treatment Center results from collaborative efforts between health authorities, the CDC, and hospital administration, as well as results from a CDC site visit conducted by an interdisciplinary team of experts.

The CDC also released new Interim Guidance for U.S. Hospital Preparedness for Patients with Possible or Confirmed Ebola Virus Disease: A Framework for a Tiered Approach. The CDC has developed this guidance to help state and local health departments, acute care hospitals, and other health care settings where emergency care is provided, develop appropriate preparedness plans for patients with possible or confirmed Ebola infection. The CDC developed this guidance as a means for tying together other, previously released guidance specific to Frontline Health Care Facilities (acute care facilities equipped for emergency care, not including primary care offices and other non-emergency ambulatory care facilities), Ebola Assessment Hospitals (facilities prepared to receive and isolate a patient with possible Ebola infection and to care for such patient until a diagnosis of Ebola can be confirmed or ruled out and until discharge or transfer is completed), and Ebola Treatment Centers (facilities that plan to care for and manage a patient with confirmed Ebola infection for the duration of the patient’s illness).

This latest CDC guidance is yet another reminder, even before the current Ebola epidemic is brought under control globally, that health systems worldwide must continue efforts to detect infectious disease outbreaks before they rise to crisis levels. As Dr. Thomas Frieden, Director of the CDC, recently told the Associated Press, “Ebola is a powerful reminder that a health threat anywhere can affect us.” Dr. Frieden stresses the ongoing importance, system wide, of addressing “weak links and blind spots around the world” that can lead with little warning to infectious disease outbreaks of Ebola-like proportions. Renewed global focus on these efforts has come in the form of a $600 million request from the Obama Administration for the CDC to implement its Global Health Security Agenda, through which CDC would work with an international coalition to improve disease detection in high-risk countries and guard against future infectious disease contagion.

HRSA Withdraws 340B “Mega-Reg;” Plans to Issue Guidance in 2015

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On November 13, 2014, the Health Resources and Services Administration (“HRSA”) announced its plans to abandon the much anticipated “mega-reg” amid questions concerning HRSA’s rule-making authority.  The “mega-reg” was expected to provide much needed clarity to the 340B drug discount program (the “340B Program”) by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.

HRSA submitted draft regulations to OMB in April 2014, and the proposed “mega-reg” was expected to be released in June 2014.  However, several legal challenges to other 340B Program regulations undermined HRSA’s legal posture to proceed.  A federal district court ruling in May 2014 determined that HRSA did not have the statutory authority to issue regulations concerning the Orphan Drug provision of the 340B Program.[1] This decision called into question HRSA’s authority for promulgating regulations for the 340B Program, except for limited rulemaking authority granted to it under the Affordable Care Act.[2]  In response to the May 2014 decision, on July 23, 2014, HRSA released a nonbinding Interpretive Rule that set forth the same Orphan Drug policies as the challenged regulation.[3]  EBG has previously posted more in-depth detail as to the court’s decision on the PhRMA lawsuit and the Interpretative Rule here.

After release of the Interpretative Rule, PhRMA filed a motion for miscellaneous relief arguing that the challenged regulation was outside of HRSA’s rulemaking authority and incapable of surviving as an Interpretive Rule.[4]  The court decided to limit its initial decision to whether HRSA had the authority to issue the Orphan Drug rule as a legislative rule, and PhRMA filed a second lawsuit on October 9, 2014, challenging HRSA’s Interpretive Rule as violative of the plain language of the statutory Orphan Drug exclusion.[5]  Despite questions concerning its rulemaking authority, HRSA has updated its frequently asked questions asserting that the failure to comply with statutory requirements as interpreted by HRSA could be considered a violation of the Orphan Drug statute and subjects the drug manufacturer to enforcement action.[6]

Despite the withdrawal of the “mega-reg,” HRSA has stated that it will pursue proposed rules where it has clear legislative rulemaking authority.  To this end, the HRSA Office of Pharmacy Affairs website includes a statement that HRSA will issue proposed rules pertaining to civil monetary penalties for manufacturers, calculation of the 340B ceiling price, and administrative dispute resolution in 2015.[7]  In addition, the website states that HRSA will issue proposed guidance to address “key policy issues,” which are surmised to include the areas that would have been addressed by the “mega-reg.”  Historically, HRSA has not issued regulations, but has issued program guidance through a series of Notices issued through the Federal Register, as well as other sub-regulatory guidance, including FAQs on its website.

HRSA’s ability to issue and enforce guidance will likely be impacted by ongoing litigation and challenges brought forth by the drug industry.  In addition, calls from the drug industry, and a new conservative majority in the Senate, may cause the Senate to reopen the original 340B statute to address the policy debates, lack of clarity regarding the permissible interpretation of 340B Program requirements and standards and HRSA’s rulemaking authority.  Thus, even in the absence of the “mega-reg,” significant changes to the 340B Program should be expected by stakeholders in 2015.

 


[1]Pharm. Research & Mfrs. of Am. v. United States HHS, No. 13-1501, 2014 U.S. Dist. LEXIS 70894 (D.D.C. May 23, 2014).

[2]As codified in the Public Health Service Act 42 U.S.C.§ 256b(d) (administrative dispute resolution), § 256b(d)(1)(B)(i)‒(ii) (calculation of 340B ceiling price), and § 256b(d)(1)(B)(vi)(I) (civil monetary penalties).

[3] HRSA, Notice Regarding Availability of Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program, 79 Fed. Reg. 42801 (July 23, 2014).  See also HRSA Freqeuntly Asked Questions, available at http://www.hrsa.gov/opa/faqs/index.html.

[4] PhRMA Supplemental Memorandum in Support of PhRMA’s Mot. for Misc. Relief, PhRMA v. HHS, No. 13-1501, ECF No. 52.

[5] PhRMA Complaint PhRMA v. HHS, Case No. 14-1685, ECF No. 1.

[6] HRSA, Office of Pharmacy Affairs website, Freqeuntly Asked Questions, available at http://www.hrsa.gov/opa/faqs/index.html (last visited Nov. 20, 2014) (follow link to“Orphan Drugs”).

[7]HRSA Office of Pharmacy Affairs website, available at http://www.hrsa.gov/opa/index.html (last visited Nov. 20, 2014).

 

American Hospital Association Features EBG’s “Eye on Ebola” Webinar

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Epstein Becker Green’s slides from the “Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers” webinar is featured on the American Hospital Association’s Ebola Preparedness Resourcesclick here.

 

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

  • Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section, Department of Emergency Medicine, George Washington University Medical Faculty Associates offered a clinical overview as well as a review of the guidelines which offer protocols for addressing concerns over Ebola and similar diseases.
  • Amy F. Lerman, Associate, Epstein Becker Green covered the health regulatory considerations.
  • George B. Breen, Member, Epstein Becker Green, Chair, Health Care and Life Sciences Practice Steering Committee elaborated on risk management issues providers might consider in developing a response strategy.
  • Frank C. Morris, Jr., Member, Epstein Becker Green, Employment, Labor and Workforce Management Practice discussed the resulting labor and employment considerations facing health care employers.

 

The webinar slides and recording can also be found here on Epstein Becker Green’s website.

 

DC Circuit Stays Halbig Action Pending SCOTUS Review of King, Upholds Accommodation for Contraceptive Coverage

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Stuart M. GersonOnly last week, we informed you of the Supreme Court’s somewhat surprising grant of cert. in the Fourth Circuit case of King v. Burwell, in which the court of appeals had upheld the government’s view that the Affordable Care Act makes federal premium tax credits available to taxpayers in all states, even where the federal government, not the state, has set up an exchange.

The Administration has taken something of a PR buffeting in the week following, after its principal ACA technical advisor’s comments on this issue were made public.

In any event, we suggested that the scheduled DC Circuit en banc argument in Halbig v. Burwell, which raises the same issue as the King case, would never take place. We were correct. The DC Circuit yesterday stayed action in its case pending Supreme Court resolution of King. We’ll continue to follow related developments.

Speaking of the DC Circuit, a panel of its most liberal judges today upheld religious organization accommodation for contraceptive coverage under the ACA, holding under Hobby Lobby that opt-out procedure does not substantially burden employer’s religious beliefs. Priests for Life v. U.S. Dep’t of Health & Human Services. There will be similar cases brought in other federal circuits, and we’ll report on those as well.