Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

Reference Chart of Proposed Amendments to Medicare Shared Savings Program

Posted in Accountable Care Organizations, Home Health & Hospice, Payors & PBMs, Physicians

Mintz Levin has prepared a chart of the proposed amendments to 42 C.F.R. Part 425 governing the Medicare Shared Savings Program.  This chart provides a summary of each proposed amendment and its potential impact.  Please also refer to our Advisory that provides an in-depth analysis of key provisions of the proposed changes and how they may impact current MSSP accountable care organizations created under the authority of the Affordable Care Act.

Health Care Enforcement in 2015: A Look Back at 2014 and Forecasting the Year Ahead

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

Written by: Bridgette A. Wiley

The US Department of Justice (DOJ), the Department of Health and Human Services’ Office of Inspector General (OIG), and other federal and state agencies continued to focus on health care enforcement as a top priority in 2014.  Companies in the health care industry were subject to steep monetary penalties and high dollar settlements, while individuals saw lengthy prison terms and the imposition of large fines, forfeiture, restitution, and settlements.

My colleagues Hope Foster and Bridget Rohde recap 2014 health care enforcement actions, highlight key takeaways, and forecast what to expect in 2015 in their recently published Health Care Enforcement Year in Review and Forecasting Report.  Hope and Bridget will also host a webinar on Thursday, February 5, 2015, from 12:00 – 1:00 EST to discuss the key enforcement trends of 2014 and their likely impact on the activities of these very active agencies in 2015.  Topics for discussion include:

  • The prioritization of cases against health care providers, including doctors, nurses, and other medical practitioners;
  • The expanding array of criminal charges leveled against companies and individuals to include not only health care fraud, anti-kickback statute violations and false statements, but also identity theft, money laundering, tax violations, and obstruction of justice;
  • The geographical reach of these actions, as DOJ continues to bring cases across the country;
  • The continued focus of the DOJ Civil Division on alleged provider and procedure fraud; and
  • The ongoing importance of qui tam relators in health care enforcement.

For more information about the upcoming webinar and to register, click here.

FTC Review of Medtronic Acquisition Focuses On Future Competition

Posted in Antitrust, Clinical Laboratories, Mergers, Acquisitions & Other Transactions, Pharma & Medical Devices

The Federal Trade Commission continues to analyze relevant products that have not yet been introduced into the market in its merger analysis.  In Medtronic Deal Highlights FTC Focus On Future Competition, we discuss the FTC’s recent review of Medtronic’s acquisition of Covidien, where the Commission looked over the horizon to see two apparent new entrants and took steps to ensure that even after the merger, there would still be two new competitors for the incumbent monopolist.  It is clear that the agency is continuing to look at remedying forward-looking competitive concerns rather than simply remedying the present overlaps and concerns that may plague a potential acquisition.

OIG Defends Its Hospital Compliance Reviews in Response to AHA Criticism

Posted in Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

Written by: Daria Niewenhous and Sarah Beth Smith

The Office of the Inspector General for the Department of Health and Human Services(“OIG”) responded to concerns expressed by the American Hospital Association (“AHA”) regarding the OIG’s hospital compliance reviews, particularly regarding Medicare Part A.  In a letter released publicly on January 22, 2015, the OIG defended its practices, describing the review of Medicare Part A payments as essential to ensuring that federal funds are spent appropriately.

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ML Strategies Posts Weekly Health Care Update on January 20, 2015

Posted in Health Care Reform, Pharma & Medical Devices, Physicians, Reimbursement, Telemedicine

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.

Highlights this week include the upcoming departure of CMS Administrator Marilyn Tavenner, and possible bi-partisan supported changes to the ACA that could relate to payment and delivery system reform, telehealth, health IT, and promoting the role of innovative health technology.

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

Massachusetts Senate Creates Special Committee on Marijuana

Posted in Health Care Reform, Hospitals & Health Systems, Pharmacies

Written by: Rachel Irving Pitts

The Massachusetts Senate has created a Special Senate Committee on Marijuana to assess the Commonwealth’s medical marijuana implementation, to examine marijuana legalization issues in other states, and to make recommendations for the Senate regarding any legalization or ballot initiative on the subject.  Jason Lewis – a Democrat from Winchester – will chair the special committee.  Mr. Lewis also chairs the Senate-House Joint Committee on Public Health.

In an Alert highlighting the various leadership and committee appointments recently announced by the Senate, ML Strategies points out that the creation of this commission is timely, as advocates are considering whether to put a question to legalize marijuana on the 2016 ballot.

To read more about the other Leadership and Special Committee Appointments, see the full ML Strategies Alert.

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

Posted in Clinical Trials & Research/FDA, Pharma & Medical Devices

Written by Ellen Janos

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).   This development is welcome news for the mHealth community.

What is an accessory?  The Draft Guidance considers an accessory to be an article that is intended for use with one or more parent devices and is intended to support, supplement, and/or augment the performance of one or more parent devices. While accessories were typically included in the same class as the parent device, the FDA now recognizes that some accessories can have a lower risk profile than that of their parent device and may warrant being regulated in a lower class. For these lower risk products, the Draft Guidance encourages the use of the FDA  de novo classification process to request risk-based classification of accessories of a new type.

The FDA is seeking comments on the Draft Guidance by April 15, 2015.

New York Passes Telemedicine Reimbursement Legislation

Posted in Payors & PBMs, Physicians, Reimbursement, Telemedicine

Written by: Nili S. Yolin

New York became the 22nd state to sign into law legislation that will require commercial and Medicaid plans to provide coverage of telehealth and telemedicine services.  The law, originally intended to take effect on January 1, 2015, will become effective on January 1, 2016.

In addition to providing definitions for telemedicine (two-way audio video communications, including video conferencing) and telehealth (telephone and remote patient monitoring), the new law defines the scope of eligible distant site providers to include not just physicians, physician assistants, and hospitals, but also dentists, home care and hospice agencies, nurses, midwives, podiatrists, optometrists, ophthalmic dispensers, psychologists, social workers, and speech language pathologists and audiologists.

Although the law does not place any restrictions on the site at which a patient is located at the time telemedicine or telehealth services are provided, it permits insurers to delineate appropriate settings for such services.

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Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

Written by: Ellyn L. Sternfield

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D billings resulted in falsely inflated claims to those programs. And once again, the qui tam case has survived a Motion to Dismiss.

In September of 2013, I blogged about qui tams based on usual and customary billings.  That blog post was prompted by a ruling in U.S. ex rel. Garbe v. K-Mart, that a qui tam Complaint alleging the chain pharmacy’s failure to use discounted pricing as the “usual and customary” price for medications in government program claims, was sufficient to pass muster under Rules 9(b) and 12(b)(6).

Pharmacy claim forms contain a required field for the pharmacy to submit its “usual and customary” price for the billed medication.  That price is often factored into the reimbursement formula for government-funded health care programs.  However, government programs each define how “usual and customary” price is determined, and when it comes to Medicaid, each state is free to define the term differently.  In some instances the term may be defined as inclusive of any discount offered (akin to a most-favored-nation clause), in other instances the term may be defined as an average charged to or paid by any payor, or in still other instances the term may be defined as the amount charged to or paid by any cash-paying customer.

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You’re Invited: Tips for Surviving a HIPAA Audit

Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Written by: Samantha P. Kingsbury

On Wednesday January 28th, my colleague Dianne Bourque (a member in Mintz Levin’s Health Law practice), will be presenting a webinar on how to survive a HIPAA audit.  As luck would have it, January 28th is also international Data Privacy Day.

With the New Year in full swing, the HHS Office of Civil Rights (“OCR”) is resuming its random audit program to assess compliance with HIPAA privacy, security and breach notification rules.  While Phase I of the OCR audit program involved on-site visits, OCR will conduct Phase II audits by performing desk review of documentation.  Findings during a Phase II audit can lead to enforcement and failure to comply can lead to the imposition of civil monetary penalties.

During this webinar, Dianne will discuss lessons learned from Phase I of the audit program and how best to incorporate those lessons into Phase II preparations.  She will also discuss how to identify and eliminate compliance gaps, in case you are chosen for an audit.

 Phase II audits can happen to covered entities and business associates alike.  Learn more about how you should be preparing and register for this webinar by clicking here.