Tag: health

The Healthcare Executive’s Simple Guide to FMV For Attorneys, C-Suite, Compliance, and Physicians

Health ABA adsThe ABA has developed a guide for healthcare executives: The Healthcare Executive’s Simple Guide to FMV For Attorneys, C-Suite, Compliance, and Physicians.  This guide has been developed to provide basic information on nearly every type of transaction or compensation arrangement that must adhere to the FMV standard.

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This guide will help healthcare executives navigate nearly every type of FMV opinion for transactions and compensation agreements. Readers will be able to quickly access pertinent material to help better understand and ensure a sound FMV analysis.

The Guide covers:
• Current regulatory environment and guidance behind FMV
• What to ask when engaging an appraiser to help ensure you will get a defensible opinion
• Value drivers behind over 20 of the most common facility transactions and agreement types
• Checklist when reviewing a FMV opinion and the Commercially Reasonable standard

 

CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act

Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate.

american health care actThe CHRONIC Care Act was developed by the Senate Finance Committee’s Bipartisan Chronic Care Working Group. If enacted, the bill would expand Medicare coverage of telehealth services in four ways:

  • Nationwide Coverage for Telestroke – Currently, Medicare will pay a physician for consulting on a patient experiencing acute stroke symptoms via telehealth only if the hospital where the patient is located is in a rural Health Professional Shortage Area (HPSA) or a county outside a Metropolitan Statistical Area (MSA). Under the CHRONIC Care Act, beginning in 2019, the geographic restriction would be eliminated and physicians would receive payment for telestroke consultations regardless of the hospital location.
  • Home Remote Patient Monitoring for Dialysis Therapy – Medicare requires that beneficiaries receiving home dialysis treatments have a monthly clinical assessment from their health care provider. Under current law, beneficiaries can only use telehealth to satisfy the clinical assessment requirement if the patient is at an authorized originating site (e.g., a physician office) located in a rural HPSA or a county outside an MSA. Beginning in 2019, beneficiaries could receive the required monthly clinical assessment from a freestanding dialysis facility or the patient’s home without geographic restriction.
  • Enhanced Telehealth Coverage for ACOs – The CHRONIC Care Act would apply the Next Generation ACO telehealth waiver criterion to the Medicare Shared Savings Program (MSSP) Track II, MSSP Track III, and the Pioneer ACO program. Specifically, the legislation would (i) eliminate the geographic component of the originating site requirement, and (ii) allow beneficiaries assigned to the approved MSSP and ACO programs to receive telehealth services in the home.
  • Increased Flexibility for Telehealth Coverage under Medicare Advantage Plans – Under current law, a Medicare Advantage (MA) plan may provide telehealth benefits beyond those that are currently reimbursed by Medicare. However, these enhanced telehealth services are not separately paid for by Medicare and MA plans must use their rebate dollars to pay for those services as a supplemental benefit. The CHRONIC Care Act would allow an MA plan to offer additional, clinically appropriate, telehealth benefits in its annual bid amount beginning in 2020.

The CHRONIC Care Act has been widely heralded by health care providers as a first step in removing barriers to providing telehealth services to Medicare beneficiaries. In a recent Senate Finance Committee hearing, health care providers voiced their support for greater coverage of telemedicine services. The Senate Finance Committee is in the process of marking up the bill.

This post was written by Carrie Roll of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Practicing Telemedicine Across State Borders: New Expedited Licenses Permit Physicians to Expand Practice

In a watershed moment for the expansion of telemedicine, the Interstate Medical Licensure Compact Commission is now processing applications to allow physicians to practice telemedicine across state lines with greater ease. Nineteen states have passed legislation to adopt the Interstate Medical Licensure Compact, which allows physicians to obtain a license to practice medicine in any Compact state through a simplified application process.  Under the new system, participating state medical boards retain their licensing and disciplinary authority, but agree to share information essential to licensing, creating a streamlined process.

The Federation of State Medical Boards’ President and CEO, Humayun Chaudhry, DO, MACP, called the Compact a “milestone” for medical regulation in the United States.  “The launch of the Compact will empower interested and eligible physicians to deliver high-quality care across state lines to reach more patients in rural and underserved communities. This is a major win for patient safety and an achievement that will lessen the burden being felt nationwide as a result of our country’s physician shortage.”

States currently participating in the Compact are Idaho, Montana, Wyoming, Nevada, Arizona, Utah, Colorado, South Dakota, Kansas, Minnesota, Iowa, Wisconsin, Illinois, Mississippi, Alabama, West Virginia, Pennsylvania, New Hampshire, and Nebraska.  Seven additional states have proposed legislation to adopt the Compact, including Washington, D.C.

Most states require a physician to obtain a license to practice medicine in each state where the patient is located at the time of the physician-patient encounter.  Prior to adoption of the Compact, obtaining licensure in a given state was an oppressive task, requiring the physician to complete lengthy applications, submit required documentation, pay fees, and pass examinations.  This proved to be a burdensome restriction for physicians practicing telemedicine, where patients may be located in any state at the time of the physician-patient encounter.  Licensing requirements were identified as a significant barrier to the expansion of telemedicine, prompting introduction of the Compact.

Physicians are eligible to apply for the Compact license if they possess a full and unrestricted license to practice medicine in a Compact state and have not been disciplined by any state medical board, among other requirements.  To apply, the physician must designate a Compact state as the “state of principal licensure” and select the other Compact states in which they would like to become licensed.  The state of principal licensure will verify the physician’s eligibility and provide credential information to the Interstate Commission.  The Interstate Commission then collects applicable fees and transmits the physician’s information to the additional states, where the licenses will then be granted.

Participation in the Compact creates another pathway for licensure, but does not otherwise change a state’s existing Medical Practice Act.  Physicians located in a state that has not adopted the Compact may still obtain licensure in other states through the ordinary licensure process.

This post was written by Marki Stewart at Dickinson Wright PLLC.

Office for Civil Rights (OCR) to Begin Phase 2 of HIPAA Audit Program

Mcdermott Will Emery Law Firm

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security and breach notification standards (HIPAA Standards) as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Unlike the pilot audits during 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR will conduct Phase 2 Audits of both covered entities and business associates.  The Phase 2 Audit Program will focus on areas of greater risk to the security of protected health information (PHI) and pervasive noncompliance based on OCR’s Phase I Audit findings and observations, rather than a comprehensive review of all of the HIPAA Standards.  The Phase 2 Audits are also intended to identify best practices and uncover risks and vulnerabilities that OCR has not identified through other enforcement activities.  OCR will use the Phase 2 Audit findings to identify technical assistance that it should develop for covered entities and business associates.  In circumstances where an audit reveals a serious compliance concern, OCR may initiate a compliance review of the audited organization that could lead to civil money penalties.

The following sections summarize OCR’s Phase 1 Audit findings, describe the Phase 2 Audit program and identify steps that covered entities and business associates should take to prepare for the Phase 2 Audits.

Phase 1 Audit Findings

OCR audited 115 covered entities under the Phase 1 Audit program, with the following aggregate results:

  • There were no findings or observations for only 11% of the covered entities audited;
  • Despite representing just more than half of the audited entities (53%), health care providers were responsible for 65% of the total findings and observations;
  • The smallest covered entities were found to struggle with compliance under all three of the HIPAA Standards;
  • Greater than 60% of the findings or observations were Security Standard violations, and 58 of 59 audited health care provider covered entities had at least one Security Standard finding or observation even though the Security Standards represented only 28% of the total audit items;
  • Greater than 39% of the findings and observations related to the Privacy Standards were attributed to a lack of awareness of the applicable Privacy Standard requirement; and
  • Only 10% of the findings and observations were attributable to a lack of compliance with the Breach Notification Standards

The Phase 2 Audit Program

Selection of Phase 2 Audit Recipients

Unlike the Phase 1 Audit Program, which focused on covered entities, OCR will conduct Phase 2 Audits of both covered entities and business associates.  OCR has randomly selected a pool of 550–800 covered entities through the National Provider Identifier database and America’s Health Insurance Plans’ databases of health plans and health care clearinghouses.  OCR will issue a mandatory pre-audit screening survey to the pool of covered entities this summer.  The survey will address organization size measures, location, services and contact information.  Based on the responses, the agency will select approximately 350 covered entities, including 232 health care providers, 109 health plans and 9 health care clearinghouses, for Phase 2 Audits.  OCR intends to select a wide range of covered entities and will conduct the audits between October 2014 and June 2015.

OCR will notify and send data requests to the 350 selected covered entities this fall.  The data requests will ask the covered entities to identify and provide contact information for their business associates.  OCR will select the business associates that will participate in the Phase 2 Audits from this pool.

Audit Process

OCR will audit approximately 150 of the 350 selected covered entities and 50 of the selected business associates for compliance with the Security Standards, 100 covered entities for compliance with the Privacy Standards and 100 covered entities for compliance with the Breach Notification Standards.  OCR will initiate the Phase 2 Audits of covered entities by sending the data requests this fall and then initiate the Phase 2 Audits of business associates in 2015.

Covered entities and business associates will have two weeks to respond to OCR’s audit request.  The data requests will specify the content, file names and other documentation requirements, and the auditors may contact the covered entities and business associates for clarifications or additional documentation.  OCR will only consider current documentation that is submitted on time.  Failure to respond to a request could lead to a referral to the applicable OCR Regional Office for a compliance review.

Unlike the Phase 1 Audits, OCR will conduct the Phase 2 Audits as desk reviews with an updated audit protocol and not on-site at the audited organization.  OCR will make the Phase 2 Audit protocol available on its website so that entities may use it for internal compliance assessments.

The Phase 2 Audits will target HIPAA Standards that were sources of high numbers of non-compliance in the Phase 1 Audits, including:  risk analysis and risk management; content and timeliness of breach notifications; notice of privacy practices; individual access; Privacy Standards’ reasonable safeguards requirement; training to policies and procedures; device and media controls; and transmission security.  OCR also projects that Phase 2 Audits in 2016 will focus on the Security Standards’ encryption and decryption requirements, facility access control, breach reports and complaints, and other areas identified by earlier Phase 2 Audits.  Phase 2 Audits of business associates will focus on risk analysis and risk management and breach reporting to covered entities.

OCR will present the organization with a draft audit report to allow management to comment before it is finalized.  OCR will then take into account management’s response and issue a final report.

What Should You Do to Prepare for the Phase 2 Audits?

Covered entities and business associates should take the following steps to ensure that they are prepared for a potential Phase 2 Audit:

  • Confirm that the organization has recently completed a comprehensive assessment of potential security risks and vulnerabilities to the organization (the Risk Assessment);
  • Confirm that all action items identified in the Risk Assessment have been completed or are on a reasonable timeline to completion;
  • Ensure that the organization has a complete inventory of business associates for purposes of the Phase 2 Audit data requests;
  • If the organization has not implemented any of the Security Standards’ addressable implementation standards for any of its information systems, confirm that the organization has documented (i) why any such addressable implementation standard was not reasonable and appropriate and (ii) all alternative security measures that were implemented;
  • Ensure that the organization has implemented a breach notification policy that accurately reflects the content and deadline requirements for breach notification under the Breach Notification Standards;
  • Health care provider and health plan covered entities should ensure that they have a compliant Notice of Privacy Practices and not only a website privacy notice;
  • Ensure that the organization has reasonable and appropriate safeguards in place for PHI that exists in any form, including paper and verbal PHI;
  • Confirm that workforce members have received training on the HIPAA Standards that are necessary or appropriate for a workforce member to perform his/her job duties;
  • Confirm that the organization maintains an inventory of information system assets, including mobile devices (even in a bring your own device environment);
  • Confirm that all systems and software that transmit electronic PHI employ encryption technology or that the organization has a documented the risk analysis supporting the decision not to employ encryption;
  • Confirm that the organization has adopted a facility security plan for each physical location that stores or otherwise has access to PHI, in addition to a security policy that requires a physical security plan; and
  • Review the organization’s HIPAA security policies to identify any actions that have not been completed as required (e.g., physical security plans, disaster recovery plan, emergency access procedures, etc.)
ARTICLE BY

Patrick Callaghan
Daniel F. Gottlieb
Edward G. Zacharias
Of:
McDermott Will & Emery

Hobby Lobby: The Supreme Court’s View and Its Impact

Proskauer

For the second time in two years the United States Supreme Court (the “Court”) hasruled against the Obama Administration with respect to elements of the Affordable Care Act (the “ACA”).  In a 5-4 decision announced today in Burwell v. Hobby Lobby Stores, Inc.  (“Hobby Lobby”) (f/k/a Sebelius v. Hobby Lobby Stores, Inc.), the Court ruled that the federal government, acting through Health and Human Services (“HHS”), overstepped its bounds by requiring faith-based private, for-profit employers to pay for certain forms of birth control that those employers argued contradicted their religious beliefs, in violation of the Religious Freedom Restoration Act of 1993 (“RFRA”).

In Hobby Lobby, the Court found that for-profit employers are “persons” for purposes of the RFRA.  The Court, assuming that the government could show a compelling interest in its desire to provide women with access to birth control, ultimately held that the government could have met this interest in a less burdensome way.

Background

Among its many insurance mandates, the ACA requires non-grandfathered health insurance plans to cover “preventive services” at no cost to participants.

As part of its implementation of the ACA, HHS added 20 contraceptives that were required to be included as preventive services, including four that may have the effect of preventing a fertilized egg from developing.

Hobby Lobby argued that requiring the company to pay for or provide pills and procedures that they believe terminate life—so-called abortifacients—intrudes intrudes on their religious beliefs.   Hobby Lobby sued HHS, asserting that requiring them to pay for or provide abortifacients violated their First Amendment rights to freedom of religion and also violated the RFRA.

The RFRA provides that the federal government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest.  The Administration argued, however, that neither Hobby Lobby nor Conestoga or any other for-profit, faith-based employer was a person for purposes of the RFRA or the First Amendment.

The Decision

Writing for the majority, Justice Samuel Alito held that private—as opposed to publicly traded—employers could be considered “persons” for the RFRA.  The Court noted that the law imposed a substantial burden on religious beliefs, requiring the owners of Hobby Lobby to engage in conduct that “seriously violates their sincere religious beliefs.”

The Court noted that for the government to prevail it needed to demonstrate a compelling state interest and that its application was the least restrictive means to achieve its goals.  The Court assumed (with Justice Kennedy providing the swing vote in his concurrence) that the government does, in fact, have a compelling interest to, among other things, promote “public health” and “gender equality” by providing contraceptive coverage for women. However, the Court found that even assuming a compelling interest there were less restrictive alternatives for the government. The government could, the four-person majority noted, simply provide these benefits to all, without charge to the individuals; in his concurrence, Justice Kennedy questioned this, and noted the Court’s opinion does not decide this issue.  But Kennedy and the four-person majority agreed the government could extend the accommodation it made religiously affiliated employers:  they do not have to provide the benefit but their insurers or third-party administrators would without charge to either the employers or the employees.

Because there are less restrictive alternatives, the Court found that HHS had violated the RFRA as applied to these faith-based, for profit, private employers.

The Impact

The Hobby Lobby ruling has a direct impact on a relatively small number of employers—as a percentage of total employers across the country there are very few that can be considered faith-based employers.

However, the ruling is significant in that it signals an ongoing willingness by the Court to exercise its checks-and-balances power.  The Court indicated it may not provide the Administration much leeway in its implementation of the ACA, when implementation impacts and is limited by other federal rights.

The ruling may also be significant for certain religious-affiliated non-profit employers who are operating under the accommodation discussed above.  By identifying the accommodation as a less restrictive alternative, the Court may be signaling it believes that the exception HHS provided them suffices to meet any concerns they may have.  The Court, however, noted it was not deciding this issue, and the “government-pay” approach tendered by four justices may provide a possible opening for relief for the religious-affiliated non-profit employers.

Finally, the Hobby Lobby decision should stand as a reminder that while there may be differences of opinion about specific rules and requirements under the ACA, and some of those differences may be decided against the government, the law itself is not going away.  Employers need to continue to monitor new developments and implement strategies for complying with the ACA.

Article By:

Peter J Marathas, Jr
Stacey Cerrone
Robert W Rachal
Of:
Proskauer Rose LLP

Proposed Health Information Technology Strategy Aims to Promote Innovation

Sheppard Mullin 2012

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with theOffice of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”

This report, entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework”, was mandated by Section 618 of the Food and Drug Administration and Innovation Act, and establishes a proposed blueprint for the regulation of health IT.  The FDA, ONC and FCC (the Agencies) noted that risk and controls on such risk should focus on health IT functionality, and proposed a flexible system for categorizing health IT and evaluating the risks and need for regulation for each category.

The Agencies set out four key priority areas: (1) promote the use of quality management principles, (2) identify, develop, and adopt standards and best practices, (3) leverage conformity assessment tools, and (4) create an environment of learning and continual improvement.

The Agencies are seeking public comment on the specific principles, standards, practices, and tools that would be appropriate as part of this regulatory framework.  In addition, the Agencies propose establishing a new Health IT Safety Center that would allow reporting of health IT-related safety events that could then be disseminated to the health IT community.

The Agencies also divided health IT into three broad functionality-based groups: (1) administrative, (2) health management, and (3) medical device. The Agencies noted that health IT with administrative functionality, such as admissions, billing and claims processing, scheduling, and population health management pose limited or no risk to the patient, and as a result no additional oversight is proposed.

Health IT with health management functionality, such as health information and data exchange, data capture and encounter documentation, provider order entry, clinical decision support, and medication management, would be subject the regulatory framework proposed in the report.  In addition, the FDA stated that a product with health management functionality that meets the statutory definition of a medical device would not be subject to additional oversight by the FDA.

The report had a spotlight on clinical decision support (CDS), which provides health care providers and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.  The report concluded that, for the most part, CDS does not replace clinicians’ judgment, but rather assists clinicians in making timely, informed, higher quality decisions.  These functionalities are categorized as health management IT, and the report believes most CDS falls into this category.

However, certain CDS software – those that are medical devices and present higher risks – warrant the FDA’s continued focus and oversight.  Medical device CDS includes computer aided detection/diagnostic software, remote display or notification of real-time alarms from bedside monitors, radiation treatment planning, robotic surgical planning and control, and electrocardiography analytical software.

The FDA intends to focus its oversight on health IT with medical device functionality, such as described above with respect to medical device CDS.  The Agencies believe that this type of functionality poses the greatest risk to patient safety, and therefore would be the subject of FDA oversight.  The report recommends that the FDA provide greater clarity related to medical device regulation involving health IT, including: (1) the distinction between wellness and disease-related claims, (2) medical device accessories, (3) medical device CDS software, (4) medical device software modules, and (5) mobile medical apps.

The comment period remains open through July 7, 2014, and therefore the report’s recommendations may change based on comments received by the Agencies. In the meantime, companies in the clinical software and mobile medical apps industry should follow the final guidance recently published by the FDA with respect to regulation of their products.

In the meantime, health information technology companies should follow the final guidance recently published by the FDA with respect to regulation of their products.

Article By:

Stephanie L. Zeppa
Lauren Lewis
Of:
Sheppard, Mullin, Richter & Hampton LLP

FDA (Food and Drug Administration) Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated

Morgan Lewis logo

The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register and list products the with Agency and submit new products for premarket review.

On April 25, the U.S. Food and Drug Administration (FDA or the Agency) published a proposed rule (the Rule) in the Federal Register, establishing, for the first time, federal regulatory authority over electronic cigarettes (e-cigarettes), cigars, pipe tobacco, dissolvable tobacco products, and nicotine gels (deemed tobacco products).[1]

Key Takeaways from the Rule, if Finalized

The following would apply to the newly deemed tobacco products:

  • No sales to those younger than 18 years of age and requirements for verification by means of photographic identification
  • Requirements to include health warnings on product packages and in advertisements
  • Prohibition of vending machine sales unless in an adult-only facility

In addition, per the Rule, manufacturers of newly deemed tobacco products would be subject to the following requirements, among others:

  • Register with, and report product and ingredient listings to, the Agency
  • Market new tobacco products only after FDA review
  • Not make direct and implied claims of reduced risk unless FDA confirms (1) that scientific evidence supports the claim and (2) that marketing the product will benefit public health
  • Not distribute free samples

Background

The Tobacco Control Act provides FDA with the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products not named in the tobacco control statute (e.g., e-cigarettes) to be subject to the FD&C Act. Section 906(d) provides FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on access to, and advertising and promotion of, tobacco products if FDA determines that such regulation would protect public health.

The Rule would extend FDA’s existing authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to include e-cigarettes, cigars, pipe tobacco (including hookah [water pipe] tobacco), dissolvable tobacco products, and nicotine gels. This latter group of tobacco products, deemed by FDA to be subject to the Tobacco Control Act, was not named in such legislation.

Scope of the Rule

Broadly, the Agency has proposed the following two alternatives for the scope of the deeming provisions and, consequently, the application of the Rule:

  • Option 1 would extend the Agency’s authority to all tobacco products not previously regulated by FDA that meet the statutory definition of “tobacco product,”[2] except accessories of such products
  • Option 2 would extend the Agency’s authority to all tobacco products not previously regulated by FDA that meet the statutory definition of “tobacco product,” except premium cigars[3] and the accessories of products not previously regulated by FDA

FDA is seeking comment on the relative merits of Option 1 versus Option 2, based primarily on the public health consequences of adopting one option or the other.

The principal difference between the two options is the scope of cigar regulation. Under Option 1, all cigars would be covered. Under Option 2, only a subset of cigars (i.e., “everything but “premium” cigars) would be covered by the Rule.

As noted above, accessories of proposed deemed tobacco products are outside the scope of the Rule. FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or items that are intended or expected to be used by consumers in the consumption of a tobacco product. For example, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product (e.g., hookah tongs, bags, cases, charcoal burners and holders, cigar foil cutters, humidors, carriers, and lighters). However, e-cigarettes, and the components thereof, and hookah pipes are covered by the Rule.

Requirements; Implications for Retailers and Manufacturers

Generally, deemed tobacco products would be subject to the same FD&C Act provisions that apply to cigarettes. These include, but are not limited to the following:

  • Prohibition on selling (at a retail counter or via a vending machine) these products to persons under 18 years of age and verification by means of photographic identification related to the same
  • Enforcement action against products determined to be adulterated and misbranded
  • Required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products
  • Required registration and product listing for all tobacco products
  • Prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use
  • Prohibition on the distribution of free samples
  • Premarket review requirements

Display of Health Warnings on Deemed Tobacco Product Packages and Advertisements

The Rule would require the following health warning on packages of cigarette tobacco, roll-your-own tobacco, and deemed tobacco products other than cigars sold, distributed, or imported for sale within the United States: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” Regarding cigars, the Rule would require that any cigar sold, distributed, or imported for sale within the United States must bear one of the following warning statements on each product package:

  • “WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.”
  • “WARNING: Cigar smoking can cause lung cancer and heart disease.”
  • “WARNING: Cigars are not a safe alternative to cigarettes.”
  • “WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.”
  • “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”[4]

These warning statement requirements also apply to advertisements of cigarette tobacco, roll-your own tobacco, and deemed tobacco products, regardless of form, which could encompass retail or point-of-sale displays (including functional items, such as clocks or change mats), magazine and newspaper ads, pamphlets, leaflets, brochures, coupons, catalogues, posters, billboards, direct mailers, and Internet advertising (e.g., websites, banner ads, etc.).

New Requirements for Deemed Tobacco Products; Implications for E-Cigarettes and Hookahs

Significantly, the Rule would require manufacturers of deemed tobacco products to meet new additional requirements. In addition to the deemed tobacco products themselves, the scope of the Rule also includes components and parts sold separately or as parts of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include, but are not limited to, the following:

  • Air/smoke filters
  • Tubes
  • Papers
  • Pouches
  • Flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers)
  • Cartridges for e-cigarettes (including the liquid contained therein)

The Rule would require manufacturers of deemed tobacco products that were not on the market in the United States by February 15, 2007 to only market such products after FDA premarket clearance. The review process adopts a system similar to the medical device regulatory process. Manufacturers may submit either (1) a premarket tobacco product application (PMTA) to, and receive a marketing authorization order from, FDA or (2) a substantial equivalence (SE) report if the new product is substantially equivalent to a predicate product (i.e., a product commercially marketed in the United States as of February 15, 2007) at least 90 days prior to introducing or delivering for introduction into interstate commerce for commercial distribution of the product.[5]

A PMTA may require one or more types of studies, including chemical analysis, nonclinical studies, and clinical studies. To demonstrate substantial equivalence, an SE notice must compare a new product to a predicate product to demonstrate that the products have the same characteristics or, if there are differences between such products, that the differences do not raise different questions of public health.

The Agency intends to continue to allow the marketing of such products pending FDA’s review of either a PMTA or SE notice, presuming such application or notice is submitted within 24 months after publication of the final Rule. It is unclear whether most e-cigarette products commercially marketed in the United States could be eligible for an SE report or if they would be required to go through the PMTA process.

Although the PMTA and SE requirements do not take effect until 24 months after publication of the final Rule, we would expect manufacturers to begin, in the near term, to gather the necessary information and prepare the necessary applications/notifications to come into compliance. Those manufacturers that submit their PMTAs or SE reports early within the 24-month window presumably will receive clearance before the close of the window. Retailers should be aware of supply chain issues and possible disruptions in the marketplace because of the Rule and should work with suppliers to understand the continued availability of deemed tobacco products.

What Is Not in the Rule; No Impact on Internet Sales or Flavored Products

The Rule’s prohibition on sales from vending machines is not intended to impact the sale of any tobacco product via the Internet, and the Rule does not otherwise address Internet sales. Note, however, that state laws would continue to apply to Internet sales.

Moreover, the Rule does not restrict the sale of deemed tobacco products that are flavored. FDA specifically notes in the Rule that the prohibition against the use of characterizing flavors established in the Tobacco Control Act applies to cigarettes only (i.e., it does not apply to e-cigarettes, pipe tobacco, cigars, dissolvable tobacco products, or nicotine gels). However, FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors. FDA’s request for comments in this area is in response to the proliferation of products marketed as “little cigars” or “cigarillos” (allegedly to get around the flavored cigarette ban), but which the Agency has indicated are truly cigarettes.

Compliance Dates

The age restrictions in the Rule would take effect 30 days after publication of the final Rule, whereas the proposed health warning requirements would take effect 24 months after publication of the same. The PMTA and SE requirements would also take effect 24 months after publication of the final Rule.

Comments on the Rule

Interested parties are encouraged to submit comments on the Rule, identified by Docket No. FDA-2014-N-0189 and/or Regulatory Information Number (RIN) 0910-AG38 by July 9, 2014.

[1]. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 79 Fed. Reg. 23,142 (proposed April 25, 2014) (to be codified at 21 C.F.R. pts. 1100, 1140, 1143), available here.

[2]. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” FDA notes in the Rule that products falling within the FD&C Act’s definition of “tobacco product” may not be considered tobacco products for federal excise tax purposes. See 26 U.S.C. § 5702(c).

[3]. The Rule defines “premium cigars” as cigars that are wrapped in whole tobacco leaf; contain a 100% leaf tobacco binder; contain primarily long filler tobacco; are made by manually combining the wrapper, filler, and binder; have no filter, tip, or non-tobacco mouthpiece and are capped by hand; do not have a characterizing flavor other than tobacco; weigh more than 6 pounds per 1,000 units; and sell for $10 or more per cigar.

[4]. In 2000, in settlements with the Federal Trade Commission (FTC), the seven largest U.S. cigar manufacturers agreed to include warnings about significant adverse health risks of cigar use in their advertising and packaging. See, e.g., In re Swisher International, Inc., Docket No. C-3964 (FTC Aug. 25, 2000). Under the 2000 FTC consent orders, virtually every cigar package and advertisement is required to clearly and conspicuously display one of several warnings on a rotating basis. FDA is proposing to adopt these four cigar warning statements from the FTC consent orders, which the vast majority of cigars already use.

[5]. FDA states in the Rule that it is aware of new product category entrants into the market after the February 15, 2007 reference date and that the SE pathway may not be available to these newer products.

Article By:

Jonathan A. Havens
Anthony “Tony” Pavel
Kathleen M. Sanzo
Of:
Morgan, Lewis & Bockius LLP

Tri-Agency Health Information Technology Report Issued

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On Thursday, April 3rd, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (the “Report”).  The Report seeks to develop a strategy to address a risk-based regulatory framework for health information technology that promotes innovation, protects patient safety, and avoids regulatory duplication.

Congress mandated the development of the Report as part of the 2012 Food and Drug Administration Safety and Innovation Act, requiring the Food and Drug Administration (“FDA”), the Office of the National Coordinator for Health Information Technology (“ONC”), and the Federal Communications Commission (“FCC”) to coordinate their efforts to regulate Health IT.  Notably, the Report identifies and distinguishes between three types of Health IT: (i) health administration Health IT, (ii) health management Health IT, and (iii) medical device Health IT.

The recommendations in the Report include continued interagency cooperation and collaboration, the creation of a public-private safety entity—the Health IT Safety Center—and a risk based approach to the regulation of Health IT.  The Report emphasizes that the functionality of Health IT and not the platform for the technology (mobile, cloud-based, or installed software) should drive the analysis of the risk and the regulatory controls on Health IT.

In very good news for the Health IT community, the Report included a recommendation that, “no new or additional areas of FDA oversight are needed.”  The report emphasized that even if the functionality of health management Health IT meets the statutory definition of a medical device, the FDA will not focus its oversight attention in this area.  The Report gives additional guidance on clinical decision support (“CDS”) tools, clarifying that a number of CDS tools can be categorized as health management Health IT and do not require further regulation by FDA.  However, the Report noted that certain types of CDS tools that are currently regulated as medical devices by the FDA would continue to be so regulated.  These FDA-regulated CDS tools include computer aided detection and diagnostic software and robotic surgical planning and control tools.

The agencies intend to convene a public meeting on the proposed strategy within 90 days and to finalize the Report based on public input.

Of:

Ellen L. Janos

Kate F. Stewart
By:
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

The Department of Justice Continues to Bring the "Heat" in Pursuing Health Care Fraud

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The False Claims Act (31 U.S.C. §§ 3729 – 3733) (the FCA) penalizes individuals and companies (often government contractors) who defraud the government by either submitting a false request for payment or avoiding payment of an obligation to the government. In May 2009, the Department of Justice (DOJ) and Department of Health and Human Services jointly announced the formation of the Health Care Fraud Prevention and Enforcement Action Team, or the “HEAT” initiative, to specifically target fraud in the health care industry, and using the FCA as a primary tool.

 

According to the DOJ’s own estimates, the HEAT initiative has been successful. Indeed, the DOJ claims that in only five years, it has recovered more than $13.4 billion based on its pursuit of FCA and other claims against alleged perpetrators in the health care industry.

 

It is no shock based on those numbers that the DOJ remains as determined as ever to bring the “HEAT” against the health care industry. For example, on Feb. 25, 2014, the DOJ announced a $15.5 million settlement under the FCAagainst a chain of diagnostic testing facilities in New Jersey and New York. The DOJ alleged that the facilities falsely billed federal and state health care programs for tests that were not performed or not medically necessary and by paying kickbacks to physicians. Three whistleblowers received over $2.5 million in connection with the settlement.

 

On Feb. 10, 2014, the DOJ announced the settlement of FCA allegations against an addiction clinic, clinical lab, and two doctors in Kentucky for $15.75 million, approximately $12 million of which represent funds to be refunded to the federal government. The settlement arose out of allegations that the targets defrauded Medicare and Kentucky Medicaid by seeking reimbursement for unnecessary tests or tests that were more expensive than those performed.

 

These and other settlements demonstrate the DOJ’s ongoing commitment to aggressively pursuing allegations of fraud in the healthcare industry.

Article by:

Kathleen L. Matsoukas

Of:

Barnes & Thornburg LLP

 

Dewonkify – Risk Corridors Re: Affordable Care Act

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The Patient Protection and Affordable Care Act –commonly referred to as “the ACA”—is a law that reformed nearly twenty-percent of the economy through modifications to regulations and changes to existing law. Its primary goals were to expand health care coverage and control rising costs. Among a number of reforms, the ACA mandated that all citizens have health insurance for a minimum of nine months of the year (or face a penalty); allowed children to remain on their parents plan until the age of 26; created health insurance market places where anyone can shop for health insurance; and banned insurance companies from denying coverage on the basis of pre-existing conditions.

Word: Risk Corridors

Used in a sentence: “Risk corridors, a provision of the ACA, limits both the amount of money that a health-insurance plan can make and lose during the first three years it is sold on the new health-care exchanges. Related programs that mitigate risk for insurance companies are also being targeted by conservative Republicans.” –Rep. Tom Cole quoted in The Washington Post.

Definition: Risk corridors are a component of the ACA that limit the risk borne by qualified health plans on the insurance marketplaces. Risk Corridors are a mechanism to minimize the year-end losses of insurers who covered a disproportionate share of sicker, often older, insured customers. The federal government, through the Department of Health and Human Services, agrees to cover 50% of the excess costs borne by insurers if those costs exceeded premiums by 3-8%. In the event those losses amount to greater than 8%, the government will defray 80% of those losses. However, if insurance companies see similar gains then the situation is reversed and the federal government is the beneficiary of those excess funds. This is the risk adjustment portion of the ACA where “healthier” insurance companies help ones shouldering more expensive populations.

History: Ideally, insurance is a system whereby a company manages risk by distributing moneys from a sizeable portion of healthy participants—needing minimal to moderate medical services—to a much smaller portion of sicker participants that need a lot more medical services. This results in a margin or profit where premiums exceed the medical costs of the consumers participating in a given plan. This is a simplified way of explaining what actuaries do every year. They take consumers in a given plan and compare their likelihood to use medical services with the expected revenues from monthly insurance premiums and other out-of-pocket costs like yearly deductibles. However, the advent of the ACA brought on this new frontier of health insurance marketplaces where no one could be denied care due to pre-existing conditions: previous surgery, diabetes, HIV, cancers, benign tumors, hypertension, etc.

Although, risk was managed by mandating that everyone be covered, this did not completely allay the fears of private insurers. Actuaries remained nervous. Anyone from the individual market—usually those not eligible for Medicaid/Medicare or employer sponsored coverage—could enter the exchanges and purchase insurance coverage. This uncertainty could have resulted in excessive premiums to consumers. To mitigate that risk and help with the possibility that consumers would be sicker and older—and thus more likely to use many costly medical procedures—the authors of the law created risk corridors. This would be a temporary program to help insurers on the insurance market places for three years.

Article by:

José Woss

Of:

Drinker Biddle & Reath LLP