Supreme Court Holds Providers Cannot Sue States to Challenge Low Medicaid Rates

Foley and Lardner LLP The Supreme Court ruled, on March 31, in a 5-4 decision, that hospitals and all other providers cannot sue to force a state to pay higher Medicaid rates. The name of the case is Armstrong v. Exception Child Center. In Armstrong, the plaintiffs were a group of Idaho providers that furnish “habilitation services.” These are in-home care services, and the providers contended that but for the provision of such services, the Medicaid recipients would require care provided in a hospital or a nursing facility or intermediate care facility for the mentally retarded.

The providers asked the Federal district court to issue an injunction to require the Idaho Medicaid agency to increase the rates for habilitation services. The district court issued the injunction, and on appeal the Ninth Circuit Court of Appeals affirmed. The Supreme Court reversed, however. Although the Medicaid statute says  that each State’s Medicaid plan must set rates that are “sufficient to enlist enough providers so that care and services are available,” the Supreme Court held that providers cannot sue to enforce this provision, but rather only the Secretary of HHS can enforce this provision by withholding Federal funds from the State.

The Supreme Court majority (Scalia, Roberts, Breyer, Thomas, Alito) found that the Supremacy Clause in the Constitution while giving Federal courts the power to declare State action invalid in light of contrary Federal law, does not provide private citizens a right to bring suit to enforce Federal laws. Nor could the providers invoke the court’s power to do equity because in providing the Secretary with the authority to cut off federal funding to States that do not pay sufficient Medicaid rates, Congress impliedly foreclosed all other relief. Also, the fact that Congress used broad and subjective language in the Medicaid statute provision at issue (“consistent with efficiency, economy, and quality of care”) indicates that Congress meant to leave it to the Secretary to come up with standards and enforce them rather than give the courts the power to decide when Medicaid rates are too low.

The four dissenters (Kennedy, Kagan, Ginsburg, Sotomayor) agreed with part of the majority’s reasoning. However, the dissent believed that it should be presumed that Congress intended to give the federal courts the equitable power to set aside rate determinations by agencies, including State Medicaid agencies, unless Congress affirmatively manifests a contrary intent.

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Important Recommendations from the MedPAC March Report to Congress, Part Two

McBrayer, McGinnis, Leslie and Kirkland, PLLC

Earlier we have discussed the recommendations of the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) with regard to fee-for-service (“FFS”) payment systems. Today’s post will discuss the Commission’s recommendations with regard to making FFS payments site-neutral, as well as its status reports on Medicare Advantage (“MA”) and the Medicare prescription drug program (“Part D”).

Similar Services in Different Settings

Inpatient and outpatient hospital rates for 2016 would receive an update of 3.25% per the Commission, provided that changes would be made to equalize payments for similar services provided in different care settings, making them site-neutral. Certain conditions treated both in skilled nursing facilities and in inpatient rehabilitation facilities would receive site-neutral payments, for example. Payments under the long-term care hospital payment system would also be reduced for patients who are not characterized as chronically critically ill, so that the payment rate would then be similar to what acute care hospitals receive.

Medicare Advantage

The Commission made some of the same recommendations in 2015 about MA as it did in March 2014, namely that hospice care should be integrated into the MA benefit package and bidding rules should be improved. According to MedPAC, Hospice inclusion in MA would increase coordination of care as well as innovation in end-of-life care, in addition to promoting accountability. The Commission also believes that employer group MA plans should be more consistent with comparable nonemployer plans in terms of payment, and the application of the national average bid-to-benchmark ratio for nonemployer plans to employer plans could achieve this goal. The Commission also recommended a decrease in benchmarks to equalize the payment system between MA and the FFS program enough to where neither is favored.

As for access to MA, MedPAC found that 99 percent of all Medicare beneficiaries have access to an MA plan. The report also found that data from a quality bonus program shows that plans are responding favorably to the measure by paying closer attention to quality measures that form the basis of these payments.

Medicare Part D

MedPAC made no recommendations as to Part D. It found high participation in the plan, with premiums remaining stable over the past year. The Commission did note an increase in spending between 2007 and 2013, which it attributed to two trends: (1) an overall shift towards the use of generic drugs, which affects the benefit spending that plan sponsors base premiums on, and (2) reinsurance payments have grown every year at an average rate of 16 percent.

Full Speed Ahead for Meaningful Use re: Medicare and Medicaid Electronic Health Records

Sheppard, Mullin, Richter & Hampton LLP

On Friday, March 20, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule which would make significant changes to the federal Medicare and Medicaid Electronic Health Records (“EHR”)Incentive Programs (collectively the “Meaningful Use Program”).

The Meaningful Use Program operates in 3 stages, with providers required to demonstrate increasing use/metrics at each stage to continue to receive payments.  Under the Meaningful Use Program, eligible professionals, eligible hospitals and critical access hospitals can receive incentive payments for demonstrating Meaningful Use of certified EHR technology.  Furthermore, starting in 2015, health care providers who are eligible to participate in the program, but choose not to participate or are not able to demonstrate Meaningful Use, may see downward payment adjustments to the amounts reimbursed by Medicare.  Thus, the Meaningful Use Program has been a source of additional income to some providers, but for many others it has been a serious concern due to the significant capital outlays required to demonstrate Meaningful Use of certified EHR and potential penalties that may be forthcoming.  The proposed rule from last Friday has some providers even more concerned about the feasibility of meeting Meaningful Use standards and the push to achieve Meaningful Use when so many are struggling.

Under the proposed rule, CMS will make several changes to the Meaningful Use Program.  The following are descriptions of some of CMS’ important proposals:

  • Stage 3 Meaningful Use will have an optional year in 2017 and starting in 2018, all providers will report on the same definition of Meaningful Use at Stage 3, regardless of prior participation. CMS intends this requirement to respond to stakeholder input re the complexity of the program, success to date and to set a long-term sustainable foundation for the Meaningful Use Program.

  • In order to align the Meaningful Use Program with other CMS incentives, such as the Physician Quality Reporting System or PQRS, CMS will require all providers to report on a calendar year EHR reporting period beginning in 2017.

  • CMS desires to promote improved patient outcomes and health information exchange in Stage 3 and thus the rule focuses on patient engagement. For example, providers must meet two of the following three requirements for patient engagement: (i) patients view, download or transmit their health information; (ii) secure messaging between providers and patients; and (iii) patient generated health data from a non-clinical setting is incorporated into a certified EHR.

While CMS sets forth many goals in support of its proposed rulemaking (e.g., the triple aim), one message comes through clearly, CMS is pushing forward with EHR and is not slowing down due to sluggish adoption by health care practitioners.  Accordingly, providers and their industry groups have been lamenting the onerous burdens of the Meaningful Use Program and the fact that less than 35% of hospitals and only a small fraction of physicians have met Stage 2 requirements. Furthermore, providers who fail to meet the minimum use thresholds could be subject to hundreds of millions of dollars in penalties.

Contrary to providers, those in the health information technology or digital health industry should be quite pleased with the rule as it may provide them with additional customers and markets as providers try to interface with and collect data from patients’ health wearables (e.g., smart watches with heart rate sensors).

In sum, the proposed rule clearly signifies that CMS is planning to take a stringent approach to ensure that providers are meaningfully compliant by 2018.  Providers can take steps to mitigate their exposure to penalties by investing in certified EHR, perhaps in conjunction with applying for hardship exemptions from the Meaningful Use Program’s requirements, to delay the date where they must comply or be subject to penalties.  Health information technology vendors generally and EHR vendors specifically should plan to modify and ensure that their technology is compliant and sufficiently differentiated to provide value to health care providers that must comply with the Meaningful Use Program’s requirements.

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French Supreme Court Specifies Requirements for Health Care Companies Under the Sunshine Act

McDermott Will & Emery

Law no. 2011-2012 of 29 December 2011, also known as the French Sunshine Act, introduced into French law disclosure obligations imposed on health care companies (HCC).  The French Medical Board and a nonprofit organisation challenged the law’s implementing decree of 21 May 2013 and its explanatory circular of 29 May 2013.  On 24 February 2015, the Conseil d’Etat annulled some of the challenged provisions of the aforementioned decree and circular, and provided useful clarifications on the scope of the disclosure obligations.

Pursuant to the decree of 21 May 2013 and the explanatory circular of 29 May 2013, there were three exceptions to the obligation to disclose (i) benefits in kind or cash exceeding EUR10 and (ii) written agreements:

  • Payments made as reasonable compensation for services rendered and for salaries did not have to be disclosed.

  • Companies that manufacture or commercialise cosmetic and tattoo products did not have to disclose agreements other than those relating to the conduct of health and safety work assessments and biomedical or observation research on these products.

  • Companies that manufacture or commercialise health products did not have to disclose commercial sales agreements of goods and services.

Under the Conseil d’Etat decision of 24 February 2015, the two first exceptions no longer apply, and the scope of the third exception has been specified.  The three main changes entailed by this decision are described herein.

All payments made from 1 January 2012 by HCCs to HCPs that do not constitute salaries must be disclosed.

The Conseil d’Etat specified the limits of the concept of “benefit in cash or in kind” that must be disclosed.  The 2013 explanatory circular had given a narrow definition of this concept, stating that it excluded payment made as reasonable compensation for services rendered and for salaries.

According to the Conseil d’Etat, however, the provisions of Law no 2011-2012 exclude only salaries received by health care professionals (HCPs) working exclusively as employees of HCCs.  According to the words of the General Advocate (Rapporteur Public) before the Conseil d’Etat, the exclusion relates to an “HCP who works exclusively as an employee in a HCC.”

Consequently, the Conseil d’Etat annulled the provisions of the explanatory circular which disregarded both Law no. 2011-2012 and the decree of 21 May 2013 by excluding from the scope of the disclosure obligations payment made as reasonable compensation for services rendered.

Companies manufacturing or distributing non-corrective contact lenses, cosmetic or tattoo products must disclose all agreements concluded with French HCPs, regardless of the object of the agreement.

With regard to companies manufacturing or distributing non-corrective contact lenses, cosmetic or tattoo products, the decree limited the scope of the disclosure obligations to agreements concluded with HCPs relating to the conduct of health and safety work assessments and biomedical or observation research on the products.

The Conseil d’Etat stated that by limiting the scope of the disclosure obligations, the decree disregarded the provisions of Law no. 2011-2012, and therefore annulled the regulatory provisions at stake.

The only commercial sales agreements of goods and services that are excluded from the disclosure obligations are those in which the HCP is the buyer.

The Conseil d’Etat clarified the content of Article R. 1453-2 of the French Code of Public Health, which excluded from the disclosure obligations commercial sales agreements of goods and services.  Even though this article was explained in the circular, it remained unclear which agreements it really targeted.

According to the judges, this exemption concerns solely commercial sales agreements of goods and services in which the HCP is the buyer.  Furthermore, despite the rather unclear wording of Conseil’s decision, it must be noted that, in light of the words of the General Advocate, the decision clarified that this exemption does not apply to purchase of advertising space by HCCs in medical journals.

Conclusions

Since the Conseil d’Etat did not time-differentiate the effects of its decision, its 24 February 2015 interpretation of the Sunshine Act is deemed to apply to all conventions concluded and benefits paid from 1 January 2012.  Therefore, HCCs should now disclose the following:

  • All payments made from 1 January 2012 by HCCs to HCPs for services rendered that do not constitute salaries

  • All agreements concluded from 1 January 2012 between companies manufacturing or distributing non-corrective contact lenses, cosmetic or tattoo products and French HCPs

  • Commercial sales agreements of goods and services in which the HCP is not the buyer

In accordance with the principle of legal certainty, HCCs should be given reasonable and sufficient time to adapt to the regulation as interpreted by the Conseil d’Etat, during which period of time they should not be sanctioned.

The Unhappy Intersection of Hospital Mergers and Antitrust Laws

McBrayer, McGinnis, Leslie and Kirkland, PLLC

The rapidly-evolving field of health care has been moving lately towards a single-minded goal – coordination of patient care in the name of efficiency and efficacy. Hospital systems are more and more often merging with other medical practices to better achieve the standards and goals of the Patient Protection and Affordable Care Act (“ACA”). TheNinth Circuit Court of Appeals, however, recently provided a stark reminder that the ACA isn’t the only law hospitals need to consider compliance with in these mergers.

Saltzer Medical Group in Nampa, Idaho, had been seeking to make a change from fee-for-service to risk-based reimbursement and approached St. Luke’s Health System in Boise in 2012about a formal partnership. They entered into a five-year professional service agreement that contained language about wanting to move away from fee-for-service reimbursement but without any clear language on making that change. Saltzer received a $9 million payment on the deal. Other hospital systems in the area, the FTC, and the Idaho Attorney General all filed suit to enjoin the merger.

The Ninth Circuit affirmed the district court’s holding that St. Luke’s violated state and federal antitrust laws when acquiring Saltzer. St. Luke’s argued that acquisition of the other provider would improve patient outcomes and care in the community of Nampa, Idaho, where Saltzer operates, but both courts agreed that the anticompetitive concerns surrounding the merger outweighed the benefits to quality care.

This case and other similar cases brought by the FTC provide a bleak outlook for health care providers looking to merge with other entities to provide care and efficiency under the aims of the ACA. While the court ultimately found that St. Luke’s aims were beneficial and not anticompetitive in and of themselves, antitrust laws only truly take the effect on competition into account, and courts are not ready to place quality of care under the ACA on equal footing.

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Affordable Care Act Issues for U.S. Expatriates

By now most employers are beginning to come to terms with the Affordable Care Act coverage mandates and reporting requirements that apply to the group health coverage of their U.S. workforce. For global businesses, though, the problems do not stop at the U.S. border. These companies must also determine how ACA affects U.S. citizens and lawful permanent residents working abroad.

Most companies face four major questions concerning health coverage for U.S. expatriates:

  • Must they provide group health coverage to employees working abroad in order to satisfy the employer mandate?

  • Must their employees working abroad maintain a minimum level of health coverage in order to satisfy the individual mandate?

  • If an individual is covered by a foreign group health plan or insurance policy, does that coverage qualify as minimum essential coverage that satisfies the employer and individual mandates?

  • If an employer provides group health coverage to U.S. citizens or residents working abroad, is that coverage subject to the same requirements that apply to employer health coverage in the U.S.?

When Are Expatriates Subject to the Employer Mandate?

An employer with at least 50 full-time employees must offer minimum essential health coverage to substantially all of its full-time employees (and their dependents) in order to avoid an excise tax. For 2015, “substantially all” means 70% of the employer’s full-time workforce; starting in 2016, it means 95% of the employer’s full-time workforce. An employee who works on average at least 30 hours a week is considered to be a full-time employee. (For more information on the employer mandate, see IRS Proposes Shared Responsibility Tax Rules for Employers and Top Ten Things to Know about the Final Shared Responsibility Regulations.)

Service Outside the U.S. When an employer determines which employees are “full-time employees” covered by the employer mandate, the employer disregards hours of service performed outside the U. S. to the extent that the related compensation is foreign-source income. The “source” of compensation ordinarily is the location where the work is performed. Accordingly, for example, if a U. S. company has a substantial foreign branch, the U. S. company generally is not required to offer health coverage to employees working at the foreign branch in order to satisfy the employer mandate. This rule applies regardless of whether the employees working outside the U.S. are U.S. citizens or foreign nationals.

International Transfers. Complications can arise when an employer transfers employees between U.S. and foreign positions. Many employers rely on a lookback rule to determine an employee’s status as a full-time employee: if the employee works full-time in the U. S. during a measurement period, the employee is considered to be a full-time employee throughout a subsequent stability period lasting up to 12 months. As a result, an employee who works full-time in the U. S. during the measurement period might retain his or her status as a full-time employee for up to 12 months after the employee is transferred to a foreign affiliate.

The regulations include special rules to address the problem of international transfers. The employer may treat an employee transferred abroad as having terminated employment (so that the employee is no longer a “full-time employee” covered by the employer mandate) if the transfer meets two conditions: the employee is expected to remain in the foreign position indefinitely or for at least 12 months, and substantially all of the employee’s compensation will be foreign-source income. (In the reverse situation, when an employee based outside the U.S. on an assignment expected to last indefinitely or for at least 12 months transfers back to the U.S., the employer generally may treat the employee as a new hire.)

When Are Expatriates Subject to the Individual Mandate? 

U.S. citizens and U.S. residents generally must maintain minimum essential health coverage for themselves and their dependent children each month or pay an excise tax. U.S. citizens and residents working outside the U.S. are deemed to have the requisite health coverage for a given month, however, if the month falls in a period during which the individual meets one of three conditions:

  • The individual is a U.S. citizen whose tax home is a foreign country, and the individual has been a bona fide resident of a foreign country or countries for an uninterrupted period that includes an entire taxable year; or

  • The individual is a U.S. citizen or resident whose tax home is a foreign country, and the individual is present in a foreign country for at least 330 full days during a 12-month period; or

  • The individual is a bona fide resident of a U.S. possession (Guam, American Samoa, the Northern Mariana Islands, Puerto Rico, or the Virgin Islands).

The exemption from the employer mandate and the exemption from the individual mandate do not completely overlap. As a result, the employer mandate might require an employer to offer minimum essential coverage to an expatriate employee who is already deemed to have minimum essential coverage for purposes of the individual mandate. Conversely, the employer mandate might not apply to an expatriate employee who is nevertheless required to maintain minimum essential coverage in order to satisfy the individual mandate. Employers will have to think through these issues carefully and communicate them accurately to their expatriate employees.

When Is Foreign Coverage Minimum Essential Coverage? 

A U.S. citizen or resident working abroad often will be covered by a health insurance arrangement maintained by the foreign office where he or she works. To the extent that the employee is subject to the employer mandate or the individual mandate, the question will arise whether this coverage constitutes “minimum essential coverage” that satisfies the mandates.

Self-Insured Arrangements. A self-insured group health plan offered by an employer to an employee qualifies as minimum essential coverage regardless of where the plan is located. Accordingly, if an expatriate is covered by a self-insured group health arrangement maintained by a foreign employer, the arrangement will satisfy both the employer mandate and the individual mandate.

Insured Arrangements. An insured employer group health plan also qualifies as minimum essential coverage if the insurance is offered in the group insurance market within one of the 50 states or the District of Columbia, even if the policy covers U. S. expatriates. In contrast, however, an employer group health plan that is insured by a policy issued outside the U. S. market must meet a complicated set of requirements in order to qualify as minimum essential coverage.

HHS issued informal guidance in 2013 stating that foreign group health insurance would qualify as minimum essential coverage with respect to a covered individual for a given month as long as the insurer was regulated by a foreign government and the covered individual either (1) was physically absent from the U.S. for at least one day in the month, or (2) if physically present in the U. S. for the entire month, was covered while in expatriate status. In 2014 the agency proposed to modify this rule and apply it to foreign self-insured plans as well as foreign insured plans; but the proposal was not included in the final regulation.

The informal guidance states that the employer must notify all covered U.S. citizens and U.S. nationals that the plan constitutes minimum essential coverage, and must satisfy IRS reporting requirements under Internal Revenue Code section 6055 for those individuals, even if they are not subject to the individual mandate. (The term “U.S. nationals” includes, in addition to U.S. citizens, certain persons born in outlying possessions of the U.S. and their descendants.) The notice and reporting requirements are easily overlooked by a foreign employer that is not otherwise subject to the Affordable Care Act.

New Legislation. The Expatriate Health Coverage Clarification Act of 2014 (the “Act”), enacted in December 2014 as Division M of the Consolidated and Further Continuing Appropriations Act (H.R. 83), states that any plan that qualifies as an “expatriate health plan” is deemed to provide minimum essential coverage. Like HHS’s informal guidance, the Act requires the sponsor of an expatriate health plan to meet the IRS reporting requirements for minimum essential coverage under Internal Revenue Code section 6055, and it also requires a large employer to satisfy the reporting requirements under Internal Revenue Code section 6056. The Act permits expatriate health plan sponsors to furnish participants with electronic versions of the section 6055 and 6056 statements as long as a participant has not explicitly refused electronic delivery.

In most cases, an employer group health plan will qualify as an “expatriate health plan” for purposes of the Act only if substantially all of the covered employees are either (1) employees who work outside the U.S. for at least 180 days in a 12-month period that overlaps the plan year, or (2) employees who are temporarily assigned to the U.S. for job-related reasons and who receive other multinational benefits (such as tax equalization or moving allowances). Foreign nationals who reside in their home country are ignored for purposes of applying the “substantially all” test. Accordingly, for example, a foreign employer that maintains a group health plan in its home country cannot satisfy the test solely by reason of the fact that its entire local workforce meets the 180-day condition. Instead, substantially all of the expatriates covered by the plan must satisfy the test without taking local citizens into account. If the plan meets the “substantially all” test with respect to covered expatriates, however, it can qualify as an “expatriate health plan” even though it also covers a large proportion of local citizens.

In addition to covering eligible expatriates, a group health plan must meet a number of substantive requirements in order to qualify as an expatriate group health plan under the Act. For example, the plan must:

  • provide significant health coverage (hospitalization, outpatient facility, physician, and emergency services) that is not limited to excepted benefits such as dental and vision coverage;

  • satisfy the applicable pre-ACA requirements for health plans, such as HIPAA nondiscrimination, genetic nondiscrimination, minimum maternity stay, and mental health parity requirements;

  • cover at least 60% of the costs covered under a typical large group health plan;

  • cover dependent children until they turn age 26 if the plan provides dependent coverage; and

  • be insured, or if self-insured be administered, by an insurer or administrator that is licensed to sell insurance in more than two countries and has a global presence prescribed by the Act (such as maintaining network agreements with providers in eight or more countries).

Under the Act, the term “expatriate health plan” applies both to a group health plan and to health insurance coverage issued in connection with a group health plan. Accordingly, U. S.-insured, foreign-insured, and self-insured plans can qualify as expatriate health plans if they meet the Act’s requirements.

Effective Date. The Act applies only to expatriate health plans issued or renewed on or after July 1, 2015. When the Act becomes applicable, it is not clear how it will coordinate with existing guidance concerning expatriate health plans. It is likely that the regulatory agencies will address this point in the coming months.

At present, it appears that all U.S.-based self-insured employer group health plans and insured plans covered by insurance issued in the U.S. group market will continue to qualify as minimum essential coverage whether or not they meet the definition of “expatriate health plans” under the Act. As explained in the next section, the bigger question for these plans is whether they can avoid some of ACA’s substantive requirements and fees by qualifying as expatriate health plans.

Which ACA Provisions Apply to Expatriate Plans?

Employers often provide health coverage to U.S. expatriates under a foreign health plan maintained by the local business where they work, or under a special group health policy for expatriates and third-country nationals issued outside the U.S. insurance market by a U. S. or foreign issuer. In either case, the plan or policy must comply with local rules governing group health coverage. In some cases, these rules are incompatible with ACA’s mandates; and foreign insurers often are not equipped to comply with ACA’s intricate reporting and participant disclosure requirements.

A plan maintained outside the U.S. for employees substantially all of whom are nonresident aliens is exempt from ERISA’s substantive requirements, including the group health plan mandates added by the Affordable Care Act. Accordingly, an employer that includes a few U. S. expatriates in a foreign group health plan that predominantly covers local nationals generally does not have to worry about compliance with ERISA. Unfortunately, however, the parallel group health plan mandates in the Internal Revenue Code do not include a similar exemption for foreign plans. As a result, an employer that is subject to tax in the U. S. might incur substantial excise taxes if it fails to comply with applicable group health plan mandates.

The regulatory agencies issued temporary guidance in FAQs XIII and FAQs XVIII exempting some expatriate plans from most of ACA’s mandates through the end of 2016. The exemption applies only to insured plans with enrollment limited to primary insureds who live outside their home country or outside the United States for at least 6 months during a 12-month period and their dependents. The temporary guidance provides no relief for self-insured plans. In order to qualify for the exemption, an insured plan must comply with a number of pre-ACA mandates, such as the mental health parity provisions, the HIPAA nondiscrimination requirements, the ERISA claims procedures, and ERISA reporting and disclosure obligations.

The Act expanded the definition of “expatriate health plans” to include self-insured plans, and it made the temporary relief permanent. If an insured or self-insured plan qualifies for relief under the Act, it is broadly exempt from most ACA mandates and fees.

The Act also modified the requirements that an insured or self-insured group health plan must meet in order to qualify for the relief, as described in the preceding section. For example, unlike the temporary guidance, the Act requires a group health plan to comply with certain ACA requirements—such as the requirement to provide minimum-value coverage, the requirement to cover dependents until age 26, and the reporting and disclosure obligations in Internal Revenue Code sections 6055 and 6056—in order to qualify for the relief. In addition, the Act provides that expatriate plans will be subject to the so-called Cadillac tax on high-cost health coverage (effective in 2018) with respect to employees assigned to work in the U.S.

Multinational employers will wish to evaluate the requirements for relief under the Act between now and July 1 and to consider whether to revise and re-issue plans covering U.S. expatriates so that they will qualify for relief under the Act.

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Still Waiting for ADA and GINA Guidance on Wellness Incentives

Jackson Lewis P.C.

March is here. The EEOC’s perspective on wellness program incentives is not. Yet again.

In its Fall 2014 regulatory agenda, the EEOC stated it would be issuing in February 2015 amended regulations concerning the size of incentives an employer may offer, yet still have a “voluntary” wellness program under the ADA and GINA.  The EEOC listed these same amendments on its Spring 2014 regulatory agenda. The regulatory agenda is a preliminary statement of priorities under consideration and is not a binding commitment to issue the regulations on the stated date.

The EEOC noted on its agenda that these amendments were needed to address whether an employer’s compliance with HIPAA rules concerning wellness program incentives, as amended by the Affordable Care Act (ACA), also complies with the ADA. The EEOC added that an amendment would also address the size of inducements allowed under GINA “to employees’ spouses or other family members who respond to questions about their current or past medical conditions on health risk assessments.”

The allowed size of wellness incentives matters to the growing number of employers with wellness programs. The ACA has a clear compliance standard for such incentives.  Until 2014, the EEOC had stayed on the sidelines of the wellness incentive debate, not offering any guidance beyond its general view that if the incentive was too large, the program was not “voluntary.”

In 2014, the EEOC sued three employers, claiming the size of their wellness incentives (or penalties, depending on your perspective) transformed otherwise voluntary wellness programs into involuntary programs. In the third case, the EEOC sought to enjoin the company from continuing the incentives in its wellness plan. There was no claim that the incentives violated the ACA standard. Our report on that case is here.

At the oral argument on the injunction hearing, the court asked the EEOC numerous times to define the line between a lawful and unlawful incentive under the ADA and GINA. The EEOC declined to define a specific line. The court denied the EEOC’s injunction request.

More than a year ago, we posted that waiting for the EEOCs guidance on incentives under wellness programs is like waiting for Beckett’s Godot, where Estragon and Vladimir lament daily that Godot did not come today, he might come tomorrow. The waiting continues.

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Bring Your Own Device To Work Programs: Regulatory and Legal Risks and How To Minimize Them

Poyner Spruill LLP Attorneys at Law, a North Carolina Law Firm

If you’ve ever left your mobile phone on an airplane, in a restaurant, or somewhere other than in your possession, you know it’s frightening enough to think of losing the device itself, which costs a premium, as well as your personal photos or information stored on the device. Now imagine if you lost your mobile phone, but it also had protected health information (PHI) associated with your health care work stored on it.  The lost device suddenly presents the potential for reputational damage and legal or regulatory obligations, in addition to the inconvenience and cost of replacement.

Mobile phones are lightweight, palm sized, and cordless, which makes them convenient and easily portable. These same features make mobile phones highly susceptible to theft or loss. As such, there are serious compliance risks to consider and mitigate when allowing personal mobile device use for work purposes, or a bring your own device (BYOD) program, especially in a healthcare setting. Despite the known risks, current research shows that in some industries, up to 90% of employees are using their personal devices for work purposes whether “allowed” or not.  For example, an assisted living nurse using a personal device for work purposes might send a text message to a patient’s primary care physician (PCP) to obtain guidance or to provide an update.  That communication includes PHI, raising compliance obligations, such as state laws or HIPAA security requirements. In the long term care setting, it’s also a clear violation of applicable privacy laws and the Centers for Medicare and Medicaid Services will, and has been, citing such infractions on surveys.  We suspect the Division of Health Service Regulation would do likewise under state law if this occurred in an adult care home.

There is no quick and easy remedy to completely eliminate all risks associated with the use of mobile phones, particularly employee-owned devices. However, there are steps that can be taken to minimize those risks while allowing the use of mobile technology to provide enhanced and continuous care to patients. One such step is implementing a mobile device management (MDM) solution. An MDM solution allows a secure connection for employees to access work networks and information resources remotely, using an application installed on their personal device. That solution keeps “work applications” such as the employer’s email program technically separated from “personal applications” like social media apps. In addition, an MDM solution allows the employer to force technical controls on the device, such as password requirements, encryption or the ability to remotely wipe all data from the device.

Recognizing that employers must relinquish ownership and technical control to make a BYOD program work, employers also must implement robust policies and procedural controls. For example:

  • Permissible Uses. Document the permissible uses of personal devices for work purposes, including whether employees are ever permitted to transfer PHI or other types of sensitive personal information on a personal device and the employment terms associated with such uses.

  • Device Security Controls. Document the policies that govern device controls (such as requiring employees to use passwords, up-to-date malware protection, device time-out, authentication or encryption on the device).

  • Training and Sanctions. Enforce training requirements and frequency as part of the terms of use and implement clear sanctions policies for unauthorized access or use.  Employers may also consider whether the same training and policies/procedures will apply to vendors or contractors.

  • HR Policies.  Review other important employment law considerations such as employee privacy rights, social media policies, and policies for removing applicable data from the devices of terminated or exiting employees.

There are many compliance considerations to keep in mind when deciding whether to implement a BYOD program. A comprehensive security framework, including technical controls, policies, procedures, and training, can reduce the high risks associated with the use of personal mobile devices for work purposes.

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FDA Issues Final Guidance Documents on Medical Device Data Systems and Medical Mobile Apps

Barnes & Thornburg LLP Law Firm

The FDA recently issued two final guidance documents signaling its intention either not to regulate, or to give minimal oversight, to two categories of medical devices, medical device data systems and medical mobile apps. The guidance on medical device data systems bears the wordy title, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The app guidance is titled simply, “Medical Mobile Applications.”

The data systems guidance defines “medical device data systems” as “a hardware or software product that transfers, stores, converts formats, and displays medical device data” and cites 21 CFR 880.6310 for a somewhat more elaborate definition. In perhaps record brevity, the substance of the guidance is expressed as follows:

The FDA does not intend to enforce compliance with the regulatory controls that apply to the following devices:

  • MDDS subject to 21 CFR 880.6310,

  • Medical image storage devices subject to 21 CFR 892.2010, and

  • Medical image communications devices subject to 21 CFR 892.2020.

The guidance notes that a medical device data system (MDDS) “does not modify the data, and it does not control the functions or parameters of any connected medical device. An MDDS does not include devices intended for active patient monitoring.”

The medical mobile app guidance states that it was changed from a prior final version only to be made consistent with the MDDS guidance. Our prior alert summarizing the medical mobile app guidance can be found here.

Copies of the final guidance documents can be found here and here.

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Gear Up for Increased CMS Scrutiny of Hospice Services for Assisted Living Facility Residents

Poyner Spruill LLP Attorneys at Law, a North Carolina Law Firm

A recent study issued by the evaluation and policy division of the U.S. DHHS Office of Inspector General (OIG) indicates that hospices can expect increased scrutiny regarding the services they provide to assisted living facility residents. The study, dated January 13, 2015, was based upon an evaluation of all Medicare hospice claims from 2007 through 2012. Key observations made by OIG included the following:

  • Hospices provided care significantly longer for individuals in the assisted living facility setting as compared with other settings such as private homes and skilled nursing facilities.

  • For-profit hospices received much higher Medicare reimbursement per beneficiary than did nonprofit hospices.

  • Residents of assisted living facilities often had medical diagnoses that required less complex care.

  • Hospices often furnished fewer than five hours of visits for routine home care patients in assisted living facilities.

The OIG study does not speak to the important reality that residents of assisted living facilities typically are healthier than residents of skilled nursing facilities, which would tend to support a higher median number of hospice days in the assisted living setting.

OIG recommends to CMS that, as part of its ongoing hospice payment reform efforts, it should reduce incentives for hospices to target assisted living facility residents with certain diagnoses and those likely to have extended periods of care. Of course, this follows a similar recommendation by MedPac. OIG’s study recommends that CMS “target certain hospices for review.” These include hospices with a high percentage of CMS payments for patients in assisted living facilities, and hospices with a high percentage of  patients receiving care over 180 days or patients with certain diagnoses. In the wake of this critical study, hospices, especially for-profit hospices, can expect increased scrutiny of the services they provide to assisted living facility residents.

Hospice providers whose patients include a high number of assisted living facility residents should expect to be subject to increased Medicare review. Hospices should consider taking preemptive defensive steps now, such as:

  • Evaluating their data on assisted living facility residents in order to identify any outliers or potentially unsupported distinctions from services provided in other settings; and

  • Conducting internal compliance reviews regarding the services provided to assisted living facility residents.

This is especially true of for-profit hospices that fall in or near the category of high service to assisted living facility residents.

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