Health Law Advisor

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

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.

OPM Issues Ebola Guidance to FEHBP Carriers

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As Ebola has become a worldwide threat, the U.S. Government has provided guidance to prepare numerous agencies and entities that may become involved or affected by Ebola.  On November 7, 2013, the Office of Personnel Management (OPM) issued guidance to Federal Employee Health Benefit Program (FEHBP) carriers on their responsibilities for handling members who have been exposed to or infected with the Ebola virus. FEHB Program Carrier Letter No. 2014-26 is available at http://www.opm.gov/healthcare-insurance/healthcare/carriers.

OPM instructs carriers that special consideration may need to be provided to ensure proper support to any exposed or infected members.  OPM identifies three specific areas for carriers to review and assess: use and requirements of various therapies, reimbursement for work-related exposures, and medical evacuation/patient transport.

First, carriers are reminded of prior OPM guidance regarding: determining coverage for experimental drugs when an emergency use is granted by the FDA; and not imposing additional conditions on the coverage of routine patient costs for items and services furnished due to participation in an approved clinical trial.  Additionally, on a case-by-case basis, carriers should be ready to reduce certain restrictions, such as referrals or pre-authorizations, in order to provide benefits for care at specialized centers, transportation reimbursements, or early refills of prescription medications for any displaced individuals.

Second, as federal employees are working in affected parts of the world, in the event that a work related exposure occurs, carriers are asked to provide immediate payment for exposed or infected members and to seek reimbursement from the Office of Workers’ Compensation Programs.

Finally, to accommodate the need for Ebola patients to be transported to specialized facilities throughout the country, OPM advises carriers to examine their air ambulance company contracts to determine whether resources are available to transport infectious patients.

In the event an FEHBP carrier has an exposed or infected member with Ebola and arranges care, carriers must notify their OPM contract specialists.  OPM will develop and post Frequently Asked Questions to the carrier website related to these Ebola issues as circumstances arise.

Epstein Becker & Green, P.C. will be hosting a complimentary webinar addressing the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases on November 17, 2014.  Additional information about the webinar is available here.

 

The Cost of Ebola Treatment

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Everyone is talking about Ebola, including the risk of contracting it, treatment for those who do contract it, and protection for those who treat patients who have it.  There has been very little discussion, though, about how to pay for the costs of treating Ebola patients, including whether health insurance will cover the treatment and pay the providers.

Most health insurance coverage that complies with the ACA minimum essential coverage standards will cover the costs of medically necessary hospitalization and physician services.  However, many of those policies have significant out of pocket expenses that must be paid by the patient, including deductibles and coinsurance amounts.  There is likely to be an annual cap on the out of pocket expenses (at least in ACA compliant plans), so that may limit the overall amount the patient has to pay.  Also, many policies do not cover, or provide very limited coverage, for care provided outside the country, or for evacuation expenses if you become ill while in another country- so if you are traveling you should check with your insurer and purchase travel health insurance if those expenses would not be covered.

Additionally, given that there is no actual treatment for Ebola itself, other than addressing the symptoms by providing intravenous fluids, balancing electrolytes, and maintaining oxygen and blood pressure, insurers could take the position that the inpatient level of service is not medically necessary (although none have stated this position.)

Furthermore, most insurers  use networks of providers, and either do not cover care out of the network or cover it at a lower rate of reimbursement- and the out of pocket annual limitations are not required to apply to out of network services.  In the event the patient is sent to a non-network facility for treatment, the insurer could classify the services as out of network, and either not cover them at all, or provide coverage that is subject to significantly higher coinsurance, deductibles and potentially limits based on “usual customary and reasonable costs,”  leaving the patient with a very large bill.

Finally, for providers that participate in an insurer’s network, there is generally a contracted rate for services provided.  If a facility has set up a specialized area for treatment of Ebola patients, and needs to provide more than the usual level of staffing for safety reasons, and purchases and uses expensive safety related gear and equipment, it is not clear whether those expenses would be reimbursed by the insurer.  Similarly, the cost of safety equipment for family members would also likely not be covered.

A number of insurers have posted information on their websites about the disease itself and when to get treated.  See, for example, Aetna. Similarly, Kaiser Permanente has lots of information about Ebola and treatment, but the materials mostly address obtaining care and being treated at Kaiser facilities.

Some insurers recommend that covered persons review their policies for coverage information.  See, e.g. Cigna. This may be useful with respect to coverage overseas and for evacuation services, but the policy is not likely to address the other questions discussed above.

The Blue Cross Blue Shield Plans affiliated with Health Care Service Corporation, including Texas, Illinois, Montana, New Mexico and Oklahoma, have information on their websites about Ebola, and indicates that treatment will be covered, including the hospital stay and other treatment, although some of the other issues are not addressed.

Given the fear and concern about this very deadly disease, it would be helpful if more insurers would clearly state their position regarding coverage.

 

ACA Tax Credits Under Review: Supreme Court Grants Certiorari in King v. Burwell

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Stuart M. GersonIn something of a surprise, the Supreme Court today granted certiorari 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. In doing so, the Supreme Court rebuffed the Solicitor General’s request that the Court decline cert. as various cases worked their way through the Courts of Appeals.

It was only a few days ago that the government had filed a brief in anticipation of the December 17 en banc oral argument in Halbig v. Burwell.  As you will recall, a DC Circuit panel held that the Affordable Care Act makes federal premium tax credits available to taxpayers only in states where the state has established an exchange – which is what the ACA literally provides.  On the same day, the Fourth Circuit issued a contrary decision in King v. Burwell, accepting the government’s argument that where HHS sets up an exchange in a state, that is a state exchange. The same argument is being made by the appellant (the government lost in District Court) in Oklahoma ex rel. Scott Pruitt v. Burwell, which is pending before the 10th Circuit.  Immediately following the contradictory decisions of DC Circuit and Fourth Circuit panels, the DC Circuit vacated the panel decision and set the case down for rehearing en banc.

It would now seem likely that all pending cases on the subject of the ACA tax credits will be stayed pending the decision of the Supreme Court, before which the King case will not be argued until early next year.

At issue is whether the program of tax credits applies only in exchanges set up by 16 states, and not at federally-run sites in 34 states. The Obama administration’s economic model for the ACA depends upon the tax subsidies being generally available and therein lies the significance of the case which puts a keystone element of the Affordable Care Act at risk.

OMHA’s Second Appellant Forum Prompts Opportunity for Stakeholder Comments on Reducing Appeals Backlog

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Amy F. LermanOn October 29, 2014, the Office of Medicare Hearings and Appeals (“OMHA”) hosted its second Medicare Appellant Forum (“Forum”) to address the status of the Medicare appeals backlog and related processing delays of Administrative Law Judge (“ALJ”) appeals, which are the third level of the Medicare appeals process that is available to suppliers, providers, and Medicare beneficiaries to challenge denied claims. Last week’s Forum was a follow-up to OMHA’s February 2014 Appellant Forum, which offered few assurances to stakeholders at the time that any effective remedies to the delays in the appeals process would have a meaningful impact in the near term. Much like OMHA’s February Forum, last week’s Forum provided an opportunity for OMHA to share with stakeholders an update regarding the actions that OMHA is taking to reduce the Medicare appeals backlog and the actions that OMHA plans to take going forward.

OMHA’s Chief ALJ, Nancy Griswold, and her colleagues described several meaningful steps forward that have occurred since February’s Forum. These developments include the February 2014 opening of OMHA’s fifth field office (adding additional ALJ capacity to handle pending cases), several key information technology and infrastructure initiatives that have been focused on improving and upgrading OMHA’s case intake and adjudication capabilities, and updates regarding the July 2014 launch of two pilot projects—the first involves statistical sampling, which OMHA says will provide appellants with an option for addressing large volumes of claims disputes at the ALJ level, and the second involves settlement conference facilitation, to try and bring appellants and Centers for Medicare & Medicaid representatives together in an alternative dispute resolution format to discuss the possibility of a mutually agreeable resolution to the appellant’s claims appealed to the ALJ hearing level.

Stakeholders across the board – providers, suppliers, and Medicare beneficiaries – take note!  Earlier this week, OMHA released a Request for Information (OMHA-1401-NC) “soliciting suggestions for addressing the substantial growth in the number of requests for hearing filed with [OMHA], and backlog of pending cases.” This notice was subsequently published in the Federal Register on November 5, 2014. Comments are due to OMHA no later than 5 PM (EST) on December 5, 2014. Based on the specific questions posed in the notice, OMHA may be acknowledging the possibility that thinking outside the box is needed in order to deal effectively with the current Medicare appeals backlog and to find the best possible path forward.

Until there is a comprehensive statutory or regulatory solution to the Medicare appeals backlog, interested parties should keep abreast of OMHA’s activities and how they may affect your organization’s legal strategies and business decisions involving Medicare participation, coverage, and reimbursement. You can read more about last week’s Forum here. Also, consider submitting comments to show OMHA that solutions may exist that the agency has not otherwise thought of. Epstein Becker Green is available to assist with the drafting and submission of comments to OMHA as well as developing a strategy for undertaking a Medicare appeal.

Complimentary Webinar – Eye on Ebola: Issues Impacting Health Care Providers

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WHEN: November 17, 2014

TIME:    2:00pm – 3:30pm EST

To register for this webinar, please click here.

Please join us for a complimentary webinar addressing the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases. This webinar will offer a clinical overview as well as a review of the guidelines which offer protocols for addressing concerns over Ebola and similar diseases, the health regulatory and risk management issues providers might consider in developing a response strategy, and the resulting labor and employment considerations facing health care employers. A question and answer period will follow the program.

Topics will include:

  • Clinical Overview and Emergency Management Issues
  • Health Regulatory Considerations for Providers
  • Risk Management Concerns
  • Employment Issues Confronting the Health Care Industry

Speakers:

  • Bruno Petinaux, M.D. – Associate Professor, Co-Chief of the Emergency Management Section, Department of Emergency Medicine, George Washington University Medical Faculty Associates
  • George B. Breen – Member, Epstein Becker Green, Chair, Health Care and Life Sciences Practice Steering Committee
  • Frank C. Morris, Jr. – Member, Epstein Becker Green, Employment, Labor and Workforce Management Practice
  • Amy F. Lerman – Associate, Epstein Becker Green, Health Care and Life Sciences Practice

To register for this webinar, please click here.

If you have questions regarding this event, please contact Whitney Krebs at (202) 861-0900, or wkrebs@ebglaw.com.

Halbig v. Burwell – En banc oral argument scheduled for December 17

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As you may recall, a DC Circuit panel held that the Affordable Care Act makes federal premium tax credits available to taxpayers only in States where the State has established an exchange – which is what the ACA literally provides. On the same day, the Fourth Circuit issued a contrary decision in King v. Burwell, accepting the government’s argument that where HHS sets up an exchange in a State, that is a State exchange. The same argument is being made by the appellant (the government lost in District Court) in Oklahoma ex rel. Scott Pruitt v. Burwell, which is pending before the 10th Circuit. Immediately following the contradictory decisions of DC Circuit and Fourth Circuit panels, the DC Circuit, en banc, vacated the panel decision and set the case down for rehearing en banc. The 4th Circuit King plaintiffs have filed a petition for cert. which has not been acted upon and likely won’t be favorably acted on unless a split were to arise in the Circuits. Given recent appointments to the DC Circuit and the fact that only active judges sit on the en banc court, it is likely that the full court will reach the same result as the Fourth did. The Tenth is another story altogether, so continue to watch this space for developments.

Protecting Your Workforce: What You Need to Know About Ebola

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The Ebola virus disease (“Ebola”) has become a worldwide threat, which, among many other effects, has forced employers to think about how to protect their employees. Employers also must consider how Ebola might impact employment policies and procedures, including, but not limited to, those addressing attendance, leaves of absence, discipline, and medical testing.

Employers are generally tasked with maintaining safe and productive workplaces for their employees, and the Ebola scare has brought many challenges in this regard. In particular, employers’ desire to maintain safe workplaces for their employees potentially may be at odds with the legal rights of those same employees to be free from employment discrimination. Employers that wish to maintain a safe workplace at all costs should be aware of the precise legal risks that they may face and the ramifications of their actions.

For the full Act Now Advisory, please click here.

Epstein Becker Green Enhances Its OSHA Capabilities with the Addition of Valerie Butera

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Epstein Becker Green is pleased to announce that Valerie Butera, an accomplished Occupational Safety & Health (OSHA) lawyer, has joined as a Member of the Firm based in the firm’s Washington, D.C., office.  Valerie is OSHA 30 certified and has substantial training and experience in process safety management (PSM). Valerie represents clients from numerous industries, including health care and life sciences and focuses on OSHA and other workplace safety and health issues.   For more information, click here.

 

Ebola Preparedness Portal Launched by The Joint Commission

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In response to the ongoing threat of the Ebola Virus Disease (“EVD” or “Ebola”) and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines and requirements, and reviewing emergency operations plans.  While stressing that The Centers for Disease Control and Prevention remains the primary source of information regarding Ebola, The Joint Commission has provided these resources in response to providers’ expectations of guidance, and also has seized the opportunity to stress to its accredited providers the importance of having adequate infection control procedures in place, a condition required of all Joint Commission accredited facilities.

Amid the uncertainty and threat of Ebola there has emerged a renewed focus by hospitals, as well as other types of health care providers, on thinking about the best ways to handle infectious disease cases safely.  Using the momentum created by the current Ebola crisis, providers should also look to the variety of Joint Commission Standards for Managing Ebola Patients to help safely and effectively manage infectious Ebola patients if any cases present themselves.