Tag: healthcare

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.

ARTICLE BY

Molly Nicol Lewis
McBrayer, McGinnis, Leslie and Kirkland, PLLC

Nation’s Highest Court Schedules Oral Arguments in King v. Burwell re: Affordable Care Act

Sheppard Mullin Law Firm

A Supreme Court of the United States (SCOTUS) spokesperson announced on December 22, 2014, that the Court will hear oral arguments in King v. Burwell on March 4, 2015. This means that not only could the highest court soon resolve the circuit split on the case’s key issue, but that the future course of the landmark Affordable Care Act (ACA) could be decided as soon as June 2015.

At issue in King is whether a May 2012 IRS rule should be upheld or stricken.[1] The rule provides that health insurance premium tax credits are available to all U.S. taxpayers, irrespective of whether they obtain coverage through a state or federal exchange. Challengers to the IRS rule contend that the plain language of the ACA restricts the availability of the tax credits to health insurance policies purchased through state exchanges and not through the federal exchange. Reading the ACA statutory language strictly, challengers note that there is no alternative interpretation to the words noting that premium tax credits are available for plans obtained “through an Exchange established by the State under section 1311” of the Act.[2] (italics added).

The government has countered that other provisions of the ACA support the legislative intent of Congress—that the premium tax credits are meant to be made available for all taxpayers nationwide, including those who purchase plans on the federal exchange. It has noted that the IRS rule should not be invalidated because of a simple drafting error.

Earlier this year in July, the U.S. Court of Appeals for the Fourth Circuit had unanimously concluded in King that the ACA was ambiguous on the question of whether the tax credits applied to plans purchased through the federal exchange. Because of this, it allowed for the government to have a “reasonable interpretation” of the ACA via the IRS rule.[3]This decision directly conflicted with the July 2014 U.S. Court of Appeals (District of Columbia) decision in Halbig v. Burwellon the same issue.

The D.C. Court sided with the plain language interpretation and restricted the tax credits to plans purchased through the state exchanges. The Court subsequently vacated the decision and is not expected to render its opinion until Spring 2015.

If SCOTUS resolves the circuit split in favor of the challengers, there are several potential implications that could leave millions of Americans without health insurance:

  • Coverage would be less affordable for those on the federal exchange;

  • Without the tax credit, individuals would be exempt from the individual mandate;[4] and

  • The ACA employer “pay-or-play” provision would not apply to as many employers.

The latter implication is likely due to the fact that pay-or-play penalties are triggered only if a covered employer fails to offer health insurance coverage and an employee takes advantage of a tax subsidy by purchasing an exchange plan.  Without premium tax credits or subsidies available through the federal exchange, fewer employers would be penalized for failure to provide coverage in the first place.

The Supreme Court’s decision in the summer of 2015 may set the tone for the longevity of the ACA in light of the most recent mid-term elections.

ARTICLE BY

Florence T. Wang
OF
Sheppard, Mullin, Richter & Hampton LLP

[1] See 26 C.F.R. § 1.36B–1(k); Health Insurance Premium Tax 7 Credit, 77 Fed.Reg. 30,377, 30,378 (May 23, 2012) (collectively the “IRS Rule”).

[2] See ACA § 1401(a), codified at 26 U.S.C. § 26B(c)(2)(A)(i).

[3] The Fourth Circuit U.S. Court of Appeals opinion can be found here.

[4] As a matter of law, health insurance would be “unaffordable” and the individual mandate would be waived. See 26 U.S.C. § 5000A.

The Affordable Care Act—Countdown to Compliance for Employers, Week 1: Going Live with the Affordable Care Act’s Employer Shared Responsibility Rules on January 1, 2015

Mintz Levin Law Firm

Regulations implementing the Affordable Care Act’s (ACA) employer shared responsibility rules including the substantive “pay-or-play” rules and the accompanying reporting rules were adopted in February.  Regulations implementing the reporting rules in newly added Internal Revenue Code Sections 6055 and 6056 came along in March. And draft reporting forms (IRS Forms 1094-B, 1094-C, 1095-B and 1095-C) and accompanying instructions followed in August.

With these regulations and forms, and a handful of other, related guidance items (e.g., a final rule governing waiting periods), the government has assembled a basic—but by no means complete—compliance infrastructure for employer shared responsibility. But challenges nevertheless remain. Set out below is a partial list of items that are unresolved, would benefit from additional guidance, or simply invite trouble.

1.  Variable Hour Status

The ability to determine an employee’s status as full-time is a key regulatory innovation. It represents a frank recognition that the statute’s month-by-month determination of full-time employee status does not work well in instances where an employee’s work schedule is by its nature erratic or unpredictable. We examined issues relating to variable hour status in previous posts dated April 14, July 20, and August 10.

An employee is a “variable hour employee” if—

Based on the facts and circumstances at the employee’s start date, the employer cannot determine whether the employee is reasonably expected to be employed on average at least 30 hours of service per week during the initial measurement period because the employee’s hours are variable or otherwise uncertain.

The final regulations prescribe a series of factors to be applied in making this call. But employers are having a good deal of difficulty applying these factors, particularly to short-tenure, high turnover positions. While there are no safe, general rules that can be applied in these cases, it is pretty easy to identify what will not work: classification based on employee-type (as opposed to position) does not satisfy the rule. Thus, it is unlikely that a restaurant that classifies all of its hourly employees, or a staffing firm that classifies all of its contract and temporary workers, as variable hour without any further analysis would be deemed to comply. But if a business applies the factors to, and applies the factors by, positions,  it stands a far greater chance of getting it right.

2.  Common Law Employees

We addressed this issue in our post of September 3, and since then, the confusion seems to have gotten worse. Clients of staffing firms have generally sought to take advantage of a special rule governing offers of group health plan coverage by unrelated employers without first analyzing whether the rule is required.

While staffing firms and clients have generally been able to reach accommodation on contractual language, there have been a series of instances where clients have sought to hire only contract and temporary workers who decline coverage in an effort to contain costs. One suspects that, should this gel into a trend, it will take the plaintiff’s class action bar little time to respond, most likely attempting to base their claims in ERISA.

3.  Penalties for “legacy” HRA and health FSA violations

A handful of promoters have, since the ACA’s enactment, offered arrangements under which employers simply provided lump sum amounts to employees for the purpose of enabling the purchase of individual market coverage. These schemes ranged from the odd to the truly bizarre. (For example, one variant claimed that the employer could offer pre-tax amounts to employees to enroll in subsidized public exchange coverage.) In a 2013 notice, the IRS made clear that these arrangements, which it referred to as “employer payment plans,” ran afoul of certain ACA insurance market requirements. (The issues and penalties are explained in our June 2 post.) Despite what seemed to us as a clear, unambiguous message, many of these schemes continued into 2014.

Employers that offered non-compliant employer-payment arrangements in 2014 are subject to penalties, which must be self-reported. For an explanation of how penalties might be abated, see our post of April 21.

4.  Mergers & Acquisitions

While the final employer shared responsibility regulations are comprehensive, they fail to address mergers, acquisitions, and other corporate transactions. There are some questions, such as the determination of an employer’s status as an applicable large employer, that don’t require separate rules. Here, one simply looks at the previous calendar year. But there are other questions, the answers to which are more difficult to discern. For example, in an asset deal where both the buyer and seller elect the look-back measurement method, are employees hired by the buyer “new” employees or must their prior service be tacked? The IRS invited comments on the issue in its Notice 2014-49.

Taking a page from the COBRA rules, the IRS could require employers to treat sales of substantial assets in a manner similar to stock sales, in which case buyers would need to carry over or reconstruct prior service. While such a result might be defensible, it would also impose costly administrative burdens. Currently, this question is being handled deal-by-deal, with the “answers” varying in direct proportion to the buyer’s appetite for risk.

5.  Reporting

That the ACA employer reporting rules are in place, and that the final forms and instructions are imminent should give employers little comfort. These rules are ghastly in their complexity. They require the collection, processing and integration of data from multiple sources—payroll, benefits admiration, and H.R., among others. What is needed are expert systems to track compliance with the ACA employer shared responsibility rules, populate and deliver employee reports, and ensure proper and timely delivery of employee notices and compliance with the employer’s transmittal obligations. These systems are under development from three principal sources: commercial payroll providers, national and regional consulting firms, and venture-based and other start-ups that see a business opportunity. Despite the credentials of the product sponsors, however—many of which are truly impressive—it is not yet clear in the absence of actual experience that any of their products will work. It is not too early for employers to contact their vendors and seek assurances about product delivery, reliability, and performance.

Just in Time for the Holidays: Another HIPAA Settlement

Mcdermott Will Emery Law Firm

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution Agreement and Corrective Action Plan (CAP) to settle alleged violations of the HIPAA Security Rule, which governs the safeguarding of electronic protected health information (ePHI).  OCR initiated an investigation into ACMHS’s compliance with HIPAA after receiving a March 2, 2012 notification from the provider regarding a breach of unsecured ePHI affecting 2,743 individuals.  The breach resulted from malware that compromised ACMHS’s information technology resources.

OCR’s investigation found that ACMHS (1) had never performed an accurate and thorough risk assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS; (2) had never implemented Security Rule policies and procedures; and (3) since 2008, had failed to implement technical security measures to guard against unauthorized access to ePHI transmitted electronically, by failing to ensure that appropriate firewalls were in place and regularly updated with available patches.

ACMHS agreed to pay $150,000 and to comply with the requirements set forth in the CAP to settle the allegations.  The CAP has a two-year term and obligates ACMHS to take the following actions:

  • Revise, adopt and distribute to its workforce updated Security Rule policies and procedures that have been approved by OCR

  • Develop and provide updated security awareness training (based on training materials approved by OCR) to applicable workforce members, and update and repeat the training annually

  • Conduct annual risk assessments of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS, and document the security measures implemented to reduce the risks and vulnerabilities to a reasonable and appropriate level

  • Investigate and report to OCR any violations of its Security Rule policies and procedures by workforce members

  • Submit annual reports to OCR describing ACMHS’s compliance with the CAP

In announcing the settlement, OCR Director Jocelyn Samuels said, “[s]uccessful HIPAA compliance requires a common sense approach to assessing and addressing the risks to ePHI on a regular basis.  This includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”  A copy of the Resolution Agreement and CAP can be found here.

The settlement is another reminder that covered entities and business associates should ensure that they have taken steps necessary and appropriate to safeguard the ePHI in their possession.  Conducting regular ePHI risk assessments, addressing any identified security vulnerabilities, implementing and updating comprehensive HIPAA policies and procedures, and appropriately training workforce members who have access to ePHI are all steps that covered entities and business associates must take to comply with HIPAA and protect ePHI.

Health Resources and Services Administration (HRSA) Withdraws 340B Program Proposed Rule

Mcdermott Will Emery Law Firm

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the 340B Federal Drug Pricing Program.  The “mega rule,” which had been submitted to the White House Office of Management and Budget in April 2014, was expected to cover important 340B Program matters, such as patient eligibility, contract pharmacy arrangements, and eligibility for hospitals and off-site facilities.  Now, in lieu of the proposed rule, HRSA has announced its intention to release notice-and-comment guidance to “address key policy issues raised by various stakeholders committed to the integrity” of the 340B Program.  Additionally, HRSA plans to issue proposed rules related to civil monetary penalties for manufacturers, calculating the 340B ceiling price and administrative dispute resolution.

The decision to withdraw the proposed rule, coupled with HRSA’s intention to release regulatory guidance on similar issues, may be viewed as a response by HHS to a recent federal court decision limiting HHS’s ability to promulgate notice-and-comment rules.  In a May 23, 2014, decision, the U.S. District Court for the District of Columbia held that HHS did not have the requisite statutory authority to promulgate a notice-and-comment rule pertaining to the purchase of orphan drugs by certain Covered Entities.  Further, the withdrawal may indicate a decision by HRSA to scale back its issuance of notice-and-comment rules for the 340B Program, limiting formal rulemaking to areas where the statutory authority to do so is explicit.  The withdrawal of the proposed mega rule demonstrates HRSA’s position that it does not possess the broad authority necessary to issue a formal rule of this scope.

Without the proposed rule, important facets of the 340B Program remain uncertain.  Manufacturers and Covered Entities that sought guidance on key practical issues such as patient definition now must continue to wait for clarification.  As noted, going forward HRSA will seek to clarify “key policy issues” but has yet to announce whether the topics covered by the proposed rule will be addressed.  HRSA’s regulatory guidance on these issues may never come, however, if the U.S. District Court for the District of Columbia (which is hearing further briefing on the aforementioned case concerning HHS’s regulatory guidance on the orphan drug rule) further restricts HHS’s ability to issue guidance.

In the face of continuing uncertainty, 340B Program participants, including Covered Entities, should stay current and closely follow available guidance from HRSA and the 340B Prime Vendor (Apexus).  Until clear guidance has been issued pertaining to subjects such as patient definition and contract pharmacy compliance, 340B Program participants should continue to follow and document best practices to ensure compliance with all 340B Program requirements.

ARTICLE BY

David S. Ivill
Emily J. Cook
Joseph M. Parise
OF
McDermott Will & Emery

Special Edition Health Care Law Update – November 11, 2014

Mintz Levin Law Firm

Elections Wrap Up, Lame Duck Preview, and a Changing Congress

In this ML Strategies Special Edition Health Care Update, we bring you a detailed look at two of the most pressing health care policy topics facing policymakers:

  1. Sorting out Congressional leadership changes post-midterm elections and looking ahead to the  upcoming Lame Duck session of Congress; and
  2. Monitoring the rapidly escalating effort to combat the Ebola epidemic.

Impact of Midterm Elections

On November 4th, voters cast their ballots giving the Republican Party control of the upcoming 114th Congress. Looking ahead to the new Congress, there will be some significant changes to the leadership on Committees of jurisdiction. While leadership will not be officially decided until Congress convenes in January, some predictions are below.

  • Senate Finance Committee: Senator Orrin Hatch (R-UT) will chair the Committee. As Chairman, Hatch is expected to focus on tax reform and is likely to advance his bill S. 232, to repeal the Affordable Care Act’s (ACA) excise tax on medical devices as part of this process. Hatch can also be expected to push for additional transparency from the Department of Health and Human Services (HHS) and support policy changes to the ACA such as we have seen the House pass in the 113th Congress. Senator Ron Wyden (D-OR) will be the ranking member. Hatch and Wyden have a strong working relationship and share interest in tax reform. Wyden is also a strong supporter of the ACA and is unlikely to support repealing or replacing the health care law, be they partial or wholesale proposals. On the whole, Democrats will likely have to cede at least two seats to the Republicans, meaning they will have to drop at least one member from the committee.
  • Senate Health, Education, Labor and Pensions (HELP) Committee: Senator Lamar Alexander (R-TN) is expected to chair the HELP Committee. Alexander will likely turn first to Ebola, should there be lingering issues unresolved after the Lame Duck. Alexander and the Committee’s current chair, Senator Tom Harkin (D-IA), introduced a bill to accelerate the development of Ebola treatments and vaccines. Alexander will also try to chip away at the ACA. In the past, he has said the Committee will vote early in the next Congress to repeal the ACA, though he conceded that the law will stay in effect as long as President Obama is in office. Alexander is more optimistic about tweaks to the ACA. Among his top priorities are addressing wellness, passing a 40 hour work week bill, and tackling small business insurance.

The Democrats have yet to pick their ranking member. As Senator Barbara Mikulski (D-MD) will opt for the ranking membership of the Appropriations Committee, Senators Patty Murray (D-WA), Bernie Sanders (I-VT), and Bob Casey (D-PA) could all be the lead Democrat on the Committee. The subcommittee chairs will likely be Senator Mike Enzi (R-WY) for Children and Families, Senator Richard Burr (R-NC) for Primary Health and Aging, and Senator Johnny Isakson (R-GA) for Employment and Workplace Safety.

  • House Energy and Commerce Committee: Representative Fred Upton (R-MI) will continue to chair the Committee. His agenda will resemble that in the 113th Congress, promoting the 21st Century Cures Initiative, which, among other things, promotes accelerated discovery of cures, streamlined development of drugs and devices, and greater use of health care technology to offset rising health care costs. He will also likely continue to try and reign in various provisions of the ACA. Other than the law’s repeal, which the Committee will likely take up at the start of the next Congress, Upton may seek to scuttle the employer mandate and the medical device tax. In addition, he may seek to overhaul or even dismantle the Independent Payment Advisory Board (IPAB), which would administer provider cuts unilaterally if certain spending thresholds are surpassed. Upton recently released the Committee’s record of success webpage and outlined several priorities for the new Congress, including building on the work already done on the 21st Century Cures Initiative.

On the Democratic side, with Representatives Henry Waxman (D-CA) and John Dingell (D-MI) retiring, Representative Frank Pallone (D-NJ) is in line to be ranking member. However, Minority Leader Pelosi has been a strong advocate for Representative Eshoo to take the Ranking Membership. With top slots opening up on other committees because of midterm losses, some congressional analysts believe that Pallone could end up moving back to the Natural Resources committee in place of Rep. Peter DeFazio (D-OR), who is likely to become Ranking Member on the House Transportation and Infrastructure Committee, following the loss of current Ranking Member Nick Rahall (D-WV). Of the 10 or so House Democrat losses, including Representatives John Barrow (D-GA) and Brad Schneider (D-IL), that are official, the majority of them have indicated explicitly, or have been characterized by others, as Pallone supporters- so it will be interesting to see how that plays out if it comes down to the last few votes.

  • House Ways and Means Committee: Representatives Paul Ryan (R-WI) and Kevin Brady (R-TX) are jockeying for the chairmanship, but it is widely believed that Representative Ryan will most likely prevail. Like Senator Hatch, Ryan will focus on tax reform. He will inherit Chairman Camp’s template, which he’ll likely keep with some changes. This effort could very well effect the health care community should Ryan join Senator Hatch in an attempt to repeal the medical device tax. Ryan will also address health care, separate from taxes, including holding hearings to critique the law and to demand more transparency and build on efforts in the 113th Congress to pursue Medicare fraud, waste, and abuse legislation. Representative Sander Levin (D-MI) is expected to remain the Ranking Member. However, House Democrats are eyeing Representative Chris Van Hollen (D-MD) to rejoin the committee. A budget expert with a strong grasp on tax policy, Van Hollen could serve as a vocal counterweight to Ryan, reprising a role he played opposite Ryan on the Budget Committee.

Lame Duck Preview

President Obama, who began his presidency with a Democratic majority in the Congress, will now round out his last two years in office with a Republican majority. This leaves the upcoming Lame Duck session as the last opportunity for the president and his Democratic colleagues in the Senate to set the legislative agenda.

Among one of the items most likely to pass is the FY 2015 appropriations legislation. With no appropriations legislation finalized prior to recessing for elections, Congress approved a short-term Continuing Resolution (CR) funding the Federal government at Fiscal Year 2014 levels through December 11, 2014. Before the CR expires, the Lame Duck Congress will likely pass either: 1) another short-term CR running through February or March 2015; 2) a long-term CR for the remainder of the fiscal year ending on September 30, 2015; or 3) an Omnibus appropriations bill setting new spending levels for FY15. Additionally, in the days after the midterm election, President Obama submitted an emergency funding request of $6.18 billion for the fight against Ebola and will push Congress to pass the request during the Lame Duck.

The Lame Duck offers some hope of passing a permanent solution to the Medicare physician payment formula, also known as the “SGR” or the “Doc Fix.” Looking to vehicles such as tax extenders or an omnibus spending bill, Congress still must determine how to pay for reforming the SGR. Members of the House GOP Doctors Caucus wrote to House leadership requesting that Congress take up SGR reform before the end of the year. The letter notes that the Lame Duck is a unique opportunity to bring much-needed stability to the Medicare program that will benefit seniors and physicians alike and requested more discussions on offsetting an SGR repeal.

While stakeholders and experts remain skeptical that such an effort would be successful, lawmakers are pulling out all the stops to engage industry to support a potential SGR fix this year. However, the current temporary extension of the SGR patch continues through March 2015, meaning that action could slip to next year.

Should Congress attempt to push through a comprehensive SGR bill in the Lame Duck, this would provide a vehicle for other Medicare proposals that are kicking around the House Ways and Means Committee—including Representative Brady’s draft fraud, waste, and abuse package, Protecting Integrity in Medicare Act of 2014 (PIMA), and Medicare extenders. Representative Brady reportedly wanted to introduce PIMA in the Lame Duck and, if there is bipartisan interest, pass the legislation under suspension. However, there has been no groundwork laid for this package in the Senate, so passing the package without a larger vehicle (such as SGR) may be unlikely.

Ebola Epidemic and Lame Duck Response

On November 4th, President Obama convened his national security and public health teams to discuss Ebola preparedness at home and the whole-of-government approach to contain the epidemic at its source in West Africa. The President’s advisors noted HHS’ efforts to ensure U.S. hospitals and the broader health system are prepared to identify, isolate, and treat patients. The team also discussed the screening of individuals traveling from the affected West African countries and the monitoring requirements these individuals are subject-to upon arrival in the U.S. There was consensus that, despite initial signs of progress in Liberia, the international community must continue to attack the problem aggressively at the source of the epidemic in West Africa.

Following this meeting, the Obama Administration announced it is seeking $6.18 billion through an emergency funding request to Congress to enhance efforts to address the Ebola crisis. The White House has requested $2.43 billion for HHS, including $1.83 billion for the Centers for Disease Control (CDC) to prevent, detect, and respond to the Ebola epidemic, $333 million for the Public Health and Social Services Emergency Fund (PHSSEF) for health worker training, manufacturing of synthetic therapeutics and vaccines, and modeling and genetic sequencing of the Ebola virus, $238 million for the National Institutes of Health (NIH) to conduct clinical trials of investigational vaccines and therapies, and $25 million for the Food and Drug Administration (FDA) to regulate Ebola vaccines and therapeutics. The Administration is also requesting $1.98 billion for USAID to scale up foreign assistance in West Africa, $127 million for the Department of State to support UN Mission for Ebola Emergency Response (UNMEER)operations, and a $1.54 billion contingency fund.

The President communicated this request to Congress in a November 5th letter to congressional leadership requesting that Congress consider his Administration’s $6.18 billion emergency appropriations request to implement a comprehensive strategy to contain and end the Ebola outbreak at its source in Africa, enhance domestic preparedness, speed procurement and testing of vaccines and therapeutics, and accelerate global capability to prevent spread of future infectious diseases. President Obama urged expeditious consideration of the proposal.

As we enter the Lame Duck, Congress is expected to tackle Ebola as a priority when it reconvenes. On November 12th, the Senate Appropriations Committee will hold a hearing on the U.S. Government response to the Ebola outbreak. Witnesses will include HHS Secretary Sylvia Matthews Burwell, CDC Director Dr. Tom Frieden, National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci, DHS Secretary Jeh Johnson, Deputy Secretary of State for Management and Resources Heather Higginbottom, USAID Assistant Administrator for Democracy, Conflict, and Humanitarian Assistance Nancy Lindborg, Assistant Secretary of Defense for Special Operations and Low Intensity Conflict Michael Lumpkin, and Joint Chiefs of Staff Deputy Director for Political-Military Conflict James Lariviere.

On the heels of the Appropriations Committee hearing, the House Foreign Affairs Committee will hold a November 13th hearing to examine international and U.S. efforts to combat the Ebola epidemic in West Africa. The hearing, “Combating Ebola in West Africa: the International Response,” will feature witnesses including: USAID Administrator Rajiv Shah, State Department Deputy Assistant Secretary for the Bureau of African Affairs Bisa Williams, DOD Assistant Secretary of Defense for Special Operations and Low-Intensity Conflict Michael Lumpkin, DOD Deputy Director for Politico-Military Affairs (Africa) Major General James Lariviere, and DOD Joint Staff Surgeon Major General Nadja Y. West.

As Congress turns its attention to the Administration’s response, the FDA continues to work with industry to develop a vaccine to combat Ebola. Outlining a plan at an American Society of Tropical Medicine and Hygiene conference last week, Dr. Luciana Borio, head of the FDA’s Ebola response team, said the FDA is taking a “novel” approach and will test multiple drugs at once in an umbrella study with a single comparison group. This plan is intended to accelerate the testing process as patients will be paired with a drug and with someone from a comparison group to look for patterns.

* * *

Implementation of the Affordable Care Act

In-Patient Hospitalization Guidance: HHS and the Internal Revenue Services (IRS) released guidance stating that group health plans must cover hospitalizations in order to satisfy minimum value under the ACA. The guidance, which will be followed up by proposed regulations, states the agencies “believe that plans that fail to provide substantial coverage for in-patient hospitalization services or for physician services” do not meet minimum value requirements.

Other Federal Regulatory Initiatives

CMS Innovation Center Webinar: On November 10th, the Centers for Medicare & Medicaid Services (CMS) Innovation Center will hold a webinar to provide an update on the work of the Center and the models being tested to improve care for patients, communities, and lower costs. Dr. Patrick Conway, CMS Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, will be the lead presenter in the webinar.

New Members of the Health IT Policy Committee: HHS Secretary Burwell announced the appointment of a new member to the Health Information Technology Policy Committee (HITPC) and renewed appointments for three members of the Health IT Standards Committee (HITSC). The new appointment is Anjum Khurshid, director of the health systems division of the Louisiana Public Health Institute.

HHS Survey on Health Coverage: The HHS Assistant Secretary for Planning and Evaluation (ASPE) released the findings of a survey of health insurance coverage for 2013 and 2014. Among other things the survey finds that, as of June 2014, 10.3 million nonelderly Americans, age 18 to 64, gained health insurance coverage since the beginning of the ACA open enrollment.

HRSA Awards Mental Health and Substance Abuse Funding: The Health Resources and Services Administration (HRSA) announced $51.3 million in ACA funding to support 210 health centers in 47 states to establish or expand behavioral health services for nearly 440,000 people.

ONC Data Sheds Light on Attestation Rates: The Office of the National Coordinator for Health IT (ONC) released a data analytics update on the 2014 attestation experience. The update shows that 4,656 doctors and other eligible providers and 258 hospitals had attested to Stage 2.

CDC Releases Monitoring Guidance for Ebola: The CDC released updated monitoring and movement guidance defining four risk levels based on degree of exposure to Ebola. The guidance helps to ensure a system is in place to quickly recognize symptoms that may necessitate a person be routed to medical care.

Other Health Care News

Study of Marketplace Insurance Premiums: The Robert Wood Johnson Foundation and the Urban Institute released a study of public filings from 17 states and Washington, DC of marketplace insurance premiums in early approval states. The report finds that premium increases will be low, with 10 states increasing only 5 percent, 2 states increasing more than 5 percent, and 6 states seeing premium reductions.

Specialty Providers Press NAIC on Access: The Alliance of Specialty Medicine sent a letter to the National Association of Insurance Commissioners (NAIC) regarding draft policy models for individual and small group market health insurance coverage. The Alliance urged NAIC to ensure consumers have access to specialists without suffering high out-of-pocket costs.

WHO Recommends Overdose Policies: The World Health Organization, estimating that 69,000 people die a year from opioid overdose, advised that those likely to witness an overdose incident, such as family members, should be given access to the opioid antidote naloxone and trained in its use. The FDA approved use of naloxone injectors for family use in April 2014.

Survey of ICD-10 Preparation: The American Health Information Management Association and the eHealth Initiative released a survey of health delivery organizations and clinicians finding that 65 percent of respondents indicated that they could begin end-to-end testing prior to the fourth quarter of 2015 but that there remain concerns that revenue will decrease during the first year of ICD-10 compliance.

Georgetown University Survey of Children’s Insurance: Georgetown University’s Center for Children and Families found that in 2013, for the first time in five years, children’s health uninsured rates did not drop. The 2013 rate was 7.1 percent, compared to 7.2 percent in 2012. Since 2008, the number of uninsured children has shrunk from 6.9 million to 5.2 million.

Upcoming Congressional Hearings

Senate

On November 12th, The Senate Appropriations Committee will hold a hearing on the U.S. Government response to the Ebola outbreak.

House

On November 13th, the House Committee on Foreign Affairs will hold a hearing titled, “Combating Ebola in West Africa: The International Response.”

ARTICLE BY

Joseph P. Hammang, PhD
Alexander Hecht
Andrew J. Shin
Abby Matousek
OF
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Ebola and Bribery in Liberia?

steptoe-johnsonlogo

With today’s newscasts full of stories about a second Dallas healthcare worker contracting the Ebola virus, people are focused on this woman and the 75 other Dallas healthcare workers (and their pets!) being monitored for symptoms. So what does this have to do with our usual subject of international corruption? Plenty, as it turns out.

More than 4,000 people in Africa have died from the virus. The international community has put on a full court press to contain the virus. But families in Liberia, which is at the epicenter of the epidemic,are reportedly bribing retrieval teams to let them keep their loved ones’ bodies and give them traditional burials. Traditional Liberian funerals include surviving relatives washing the body and keeping it around for a wake that sometimes lasts days, while family and friends stop by to kiss the corpse before it is buried in a shallow grave in the family grave plot nearby.

The Liberian government has ordered that bodies be collected and cremated, and sends retrieval teams out to collect the bodies. But according to news reports, grieving relatives are paying $40 to $150 for death certificates that don’t show Ebola as the cause of death. Having Ebola carries a stigma in Liberia, and it is important to some families that they don’t have to admit that Grandma had the disease. The Liberian government has said that the retrieval teams do not have the authority to issue death certificates, but for $40, they are doing so anyway.

Half of the Ebola deaths have happened in Liberia, so one can imagine the confusion of a young man who lived next door to an Ebola victim. He told the Wall Street Journal that the government tells its citizens to call the body retrieval teams and not to touch the bodies themselves, but then the teams come and don’t insist on taking the corpses. “They told us not to bury the bodies. They told us to call. But now I am not sure if they are the ones trying to eradicate this virus or to make it grow.”

So a small bribe still carries the day in some locations, even in the face of a catastrophic dilemma. Companies doing business, or contemplating doing business, in west Africa are understandably wary of doing so now, and that’s the last thing this impoverished area needs.

Improving Medicare Post-Acute Care Transformation (IMPACT) Act to be Signed into Law

Drinker Biddle Law Firm

The Improving Medicare Post-Acute Care Transformation Act of 2014, known as the IMPACT Act, passed the House on September 16th. It was introduced in the House by Ways and Means Chairman Dave Camp (R-MI) and in the Senate by Finance Committee Chairman Ron Wyden (D-OR) on June 26, 2014. The Senate voted to approve the legislation on Thursday, September 18, meaning it will now be sent to President Obama for his signature.

The IMPACT Act establishes requirements for post-acute care (PAC) providers to report and share standardized assessment data, including patient assessments, quality measures, and information about resource use. The bill gives various facilities between two and just over four years to implement processes that allow them to report different kinds of data. The legislation also directs the Medicare Payment Advisory Commission (MedPAC) to evaluate payment systems that consider individual characteristics rather than just the type of facility at which a patient is treated. The new data to be reported will help illustrate facility performance and could help determine if a payment system that takes patient outcomes into account is preferable.

Additionally, the bill directs the Secretary of Health and Human Services (HHS) to conduct two studies using additional data to determine what effect, if any, socioeconomic and other factors have on quality and resource use measures.  To learn more, read the District Policy Group bill summary, written by Legislative Assistant Sarah Williams here.

Read a summary from the Library of Congress here.

ARTICLE BY

Ilisa Halpern Paul
OF
Drinker Biddle & Reath LLP

Privacy, Behavioral Health and Hospital Regulations: Recent Developments in Wisconsin Law [VIDEO]

vonBriesen

In recent months, the Wisconsin legislature has passed several bills relating to health information privacy, treatment of behavioral health patients, and regulation of hospitals. Please view this webcast that will provide a summary of the legislative action and tips for complying with the new law.

http://player.vimeo.com/video/90057974

Health Law Check-Up Webcast: Recent Developments in Wisconsin Law

Article By:

Meghan C. O’Connor
Ralph V. Topinka
Of:
von Briesen & Roper, S.C.

Happy National Healthcare Decisions Day: Why an Advance Directive is a Crucial Part of Estate Planning

Varnum LLP

Today is a day that, until recently, I wasn’t aware had any independent significance other than being April 16. However, April 16 is – and has been for the past seven years – National Healthcare Decisions Day. You can see the website dedicated to this purpose here: www.nhdd.org

Planning with an advance directive for health care decisions is only one piece of the larger estate planning puzzle. But it is a crucial component of any estate plan, and far too few people take the advice of their doctors or lawyers to implement their own advance directives. Some polls suggest only 30% of the population has implemented an advance directive.  However,this clip from NPR tells the story of La Crosse, Wisconsin, where over 96%  of the population has an advance directive. This has had at least two very important results: first, individuals are able to receive the medical care they want at a time when they cannot express their opinions; and second, medical costs for end of life care in La Crosse are far below the national average.

At a minimum, a carefully crafted advance directive will inform your family members about your wishes for your health care in the event you cannot make your own decisions. You can ensure that your family and your health care professionals know what you intend. You can avoid the need for the cost and hassle of a guardianship proceeding in probate court. And you can avoid unwanted medical procedures. The bottom line: an advance directive is an important part of ensuring that you receive the care you want when you cannot make your own decisions.

Article By:

Christopher J. Caldwell
Of: 
Varnum LLP