Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Ebola Update–CDC Issues New Protocols

Posted in Accreditation, Licensing & Certification, Hospitals & Health Systems

Written By: Rachel Irving Pitts

Copyright 2014, American Health Lawyers Association, Washington, DC. Reprint permission granted.
This post was originally written for an email alert to the Regulation, Accreditation, and Payment (RAP) Practice Group of the American Health Lawyers Association. Our thanks to AHLA for permission to reprint here. 

The response to Ebola continues to evolve as additional resources for providers and the public have been made available over the last several days. The Joint Commission (TJC) launched an Ebola Preparedness Resources webpage, which hosts TJC’s relevant internal resources and links to “credible, useful outside resources,” including the Centers for Disease Control and Prevention (CDC). While stressing that the CDC remains a primary source of information regarding Ebola, TJC is providing these resources in response to providers’ expectations for guidance, and asking providers to focus on infection prevention by performing a comprehensive evaluation of their practices and providing ongoing infection prevention education, training, and assessment. Non-compliance with infection prevention standards (hand hygiene, use of personal protective equipment (PPE), sterilization, and disinfection) is a persistent issue encountered by TJC when it surveys its accredited hospitals. The Ebola Preparedness Resources webpage includes educational podcasts, infographics, and articles on infection prevention and control and managing contagious patients, along with New England Journal of Medicine and Journal of the American Medical Association articles about Ebola, media coverage, and links to external resources–including the CDC’s “Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing).”

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HHS Announces $840 Million Initiative to Improve Patient Care and Lower Healthcare Costs

Posted in Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Physicians

Written by: Carrie A. Roll and Andrew J. Shin

Last week, the Department Health and Human Services (HHS) announced that it will invest $840 million over the next four years to support 150,000 clinicians through a combination of incentives, tools, and information to encourage clinicians and other health care providers “to move from volume-driven systems to value-based, patient-centered, and coordinated health care services.” CMS Deputy Administrator for Innovation and Quality and Chief Medical Officer Patrick Conway said the initiative is expected to save between $1 billion and $5 billion over four years and could result in reducing five million avoidable hospitalizations. Mr. Conway described the initiative as “part of a larger strategy for health system transformation.”

As noted in the announcement, the initiative is one part of a strategy advanced by the Affordable Care Act (ACA) to further the goal of putting quality care first and prioritizing efforts to reduce healthcare costs. Under ACA, the Center for Medicare & Medicaid Innovation (CMMI) received $10 billion to develop and test new health care delivery models as part of an effort to move away from the traditional fee-for-service model, improve quality of care, and lower costs.

Some stakeholders believe this newest initiative is the next logical step following on the heels of the massive $1 billion Partnership for Patients campaign that included over 3,700 hospitals in various quality-improving initiatives. Responding to some criticism that the majority of efforts from the Obama Administration have been focused on hospitals, the Transforming Clinical Practice Initiative (TCPI) targets smaller practices through peer-based learning networks that include physicians, physician assistants, nurse practitioners, and clinical pharmacists. Interestingly, eligible applicants for TCPI are more similar to those who were able to participate in the Partnership for Patients, as opposed to individual clinical practices themselves.

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Managing Antitrust Risks in Pre-Transaction Planning

Posted in Health Care Reform, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Payors & PBMs, Pharma & Medical Devices, Physicians, State & Federal Audits, Investigations & Litigation

Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”).  In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation.  Health care antitrust enforcers continue to closely scrutinize health care transactions in order to ensure that new health care delivery systems do not enhance or create market power or otherwise harm consumers.  As such, there are certain steps deal counsel should take in order to effectively manage and minimize potential antitrust risks in transactions with competitors.

In part one of a three part series, my colleagues, Dionne Lomax and Farrah Short, offer a planning checklist for transactions with potential competitive concerns.  Click here to read the full article.

Office for Human Research Protections Releases Draft Guidance

Posted in Clinical Trials & Research/FDA, Hospitals & Health Systems

Written by: Kate Stewart

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”).  The Draft Guidance addresses how researchers evaluate and characterize the risks to participants in research comparing current standards of care and how those risks are expressed in informed consent documents.

As comparative effectiveness research becomes more common, driven in part by funding under the Affordable Care Act, questions have arisen regarding whether the risks of undergoing a specific standard of care constitute research risks that must be considered by Institutional Review Boards (“IRBs”) and disclosed to study participants. The Draft Guidance follows OHRP’s 2013 compliance oversight determination letter, and subsequent controversy, regarding the informed consent process in the Surfactant, Positive Pressures, and Oxygenation Randomized Trial (“SUPPORT”).

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Ebola Exclusions from Commercial Insurance Policies

Posted in Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices

Written by: Heidi Lawson and Scott Rader

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses.  This week we note that some business insurers are beginning to specifically exclude ebola-related losses from their standard commercial insurance policies.  This raises what might seem to be an obvious question:  are ebola-related losses currently covered by standard business interruption provisions (in which case it would seem redundant for an insurer to specifically add this coverage) or are they currently excluded (in which case it would seem unnecessary for an insurer to specifically exclude it)?  But these apparently opposite reactions can be seen as reflecting a common theme among insurers:  because ambiguities in an insurance contract typically are construed in most jurisdictions against an insured, insurers prefer for their policies to be as explicit as possible (particularly when it comes to exclusions) to ensure that policyholders cannot make a claim for coverage as a result of an ambiguity.  The tendency for insurers to do so highlights why insureds typically should retain counsel to review their policies to make sure their expectations about what will be covered are reflected by their policy’s language.  For more information about how this ebola exclusion could affect your business or for a more general review of your business’s insurance policies, please contact Scott Rader, Elizabeth Kurpis or Heidi Lawson.

NYS Department of Health Proposes Changes to Certificate of Need Process

Posted in Accreditation, Licensing & Certification, Hospitals & Health Systems

Written by:  Nili S. Yolin

On October 15, 2014, the New York State Department of Health (DOH) released proposed changes that will simplify the certificate of need (CON) process.   Specifically, the Department is proposing to require prior notice, rather than a CON application, for certain construction projects involving non-clinical infrastructure, the replacement of medical equipment, and facility repair and maintenance.

Health care facilities licensed pursuant to Article 28 of the Public Health Law are required to submit a CON application for everything from establishing or constructing new facilities to renovating existing facilities, from acquiring major medical equipment to adding or removing inpatient beds or services.  Construction projects subject to CON review can fall under one of three categories of review:

  • Full CON review (for proposals with a cost in excess of $25 million ($50 million for hospitals)), which involves the submission of detailed forms and schedules that include, among other things, the project’s financial feasibility and public need.  These CON applications are subject to review and approval by DOH’s Public Health and Health Planning Council (PHHPC), which makes a recommendation to the Commissioner.
  • Administrative Review (for proposals that have total project costs of up to $15 million), which also requires a CON application but does not require the recommendation of the PHHPC; and
  • Limited Review (for proposals with a total project cost of up to $6 million), which requires only the submission of a narrative description, cost, and if necessary, architectural engineering drawings or certification of the project.

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ML Strategies Posts Weekly Health Care Update on October 27, 2014

Posted in Health Care Reform, Payors & PBMs

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

The Ebola response that is being coordinated across several Federal Agencies is now becoming a serious State issue as well. From travel restrictions to funding for Ebola prevention, treatment, cures, etc., the range of issues facing policymakers and their effect on international business and public health have quickly become a seminal issue leading up to the midterms and a likely area of action during the “lame duck” session of Congress.

Other news we are following this week include a major investment in practice transformation from CMS, the newest demonstration that will leverage over $800 million to support and scale health care improvement.

Click here to read this week’s full Health Care Update.

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians

Written by: Bridgette A. Wiley

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers.  Copayment coupons are typically offered to commercially insured patients in order to reduce or eliminate out-of-pocket costs for specific brand name drugs with higher copays.  Since their inception, prescription drug copayment coupon programs have been a source of controversy – favored by brand manufacturers, physicians, and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers (PBMs).

Last month, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) followed through on its promise in the 2013 and 2014 Work Plans and released a Special Advisory Bulletin directly addressing pharmaceutical manufacturer copayment coupons. The bulletin and its companion report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” advise that coupon offerors will risk sanctions if they do not take appropriate steps to ensure that their coupons are not inducing the purchase of items or services paid for by Federal health care programs.  This includes, among other things, prescription drugs paid for by Medicare Part D.  Even though this bulletin is directed toward pharmaceutical manufacturers, it is important to note that it applies to any entity offering a copayment coupon, as well as pharmacies that accept such manufacturer coupons.

Theresa Carnegie, Carrie Roll, and I recently published an article on this topic in the Health Care Fraud Report published by Bloomberg BNA. The article, OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer Copayment Coupons, provides an overview of the copayment coupon controversy, examines the OIG Special Advisory Bulletin and companion report, and looks at potential alternatives to copayment coupon programs.

Fraud and Abuse Waivers for MSSP ACOs Extended Another Year

Posted in Accountable Care Organizations, Fraud & Abuse, Physicians, State & Federal Audits, Investigations & Litigation

Written by:  Stephanie D. Willis

Fridays are for fraud and abuse news-related releases, yet again.  Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule regarding applicable fraud and abuse law waivers for ACOs participating in the Medicare Shared Savings Program (MSSP).  Accordingly, the OIG extended the application of the waivers from the fraud and abuse laws stated in the November 2011 Interim Final Rule (IFR) for another year (until Nov. 2, 2015).  The waivers from the IFR essentially allow ACOs participating in the MSSP to test out innovative relationships among participating providers with a “pass” from the OIG and Centers for Medicare & Medicaid Services (CMS) with regard to their authority to enforce the Physician Self-Referral Law, the Anti-Kickback Statute(AKS), the Gainsharing Civil Monetary Penalty Law (CMP), and the Beneficiary Inducement CMP.

In the Notice, the OIG has acknowledged that it “would benefit from additional input from stakeholders” on the following four topics:

  1. How and to what extent ACOs are using the IFR’s waivers;
  2. Whether the IFR’s waivers currently serve the needs of ACOs and the Medicare program;
  3. Whether the IFR’s waivers “adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services;” and
  4. Whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.

The OIG has not established a deadline for receiving stakeholder comments.

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Mintz Levin’s Health Care Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Kimberly J. Gold

Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases.

The six featured cases are:

  • United States ex rel. Fox Rx, Inc. v. Managed Health Care Associates, Inc., No. 2:13cv6154 (C.D. Cal.) and United States. ex rel. Fox Rx, Inc. v. Managed Health Care Associates, Inc., No. 2:13cv8433 (C.D. Cal.), regarding two false claims allegations by a private Medicare Part D sponsor against pharmacy providers.
  • United States ex rel. Angel v. Alliance Rehabilitation LLC, No. 1:10cv2124 D.D.C.), regarding a $2.78 million settlement to resolve allegations of false claims for physical therapy services.
  • United States ex rel. Madany v. Shahab, No. 2:09-cv-13693 (E.D. Mich.), regarding false claims for home health services based on underlying Anti-Kickback Statute violations.
  • United States ex rel. Brown v. Holy Spirit Hospital of the Sisters of Christian Charity, No. 1:12-cv-1197 (M.D. Pa.), regarding false claims for diagnostic tests that were never performed and failure to report or repay overpayments.
  • United States ex rel. Mahmood v. Elizabethtown Hematology Oncology, PLC, et al., No. 3:11-cv-00376 (W.D. Ky.), regarding a $3.7 million settlement to resolve allegations of false claims for chemotherapy infusion treatments.

The Fox cases are significant because they illustrate that whistleblowers can come not only from their current and former employees, but also from their business relationships.  In the past, sponsors of Medicare Part D prescription drug plans have rarely served as relators, but Fox has brought multiple claims against pharmacy providers. One of Fox’s other cases was noted in our November 2013 Qui Tam Update.

In our Qui Tam Update series, we monitor recently unsealed FCA cases, identify trends in health care enforcement, and discuss noteworthy cases and developments. To receive the Qui Tam Update by email, subscribe here.