Practices

Health Law Practice

See the Big Picture.

The health industry is a complex system, and reimbursement is the lifeblood. Reduction in payments from governmental and commercial payors affects providers, suppliers, manufacturers, and all others across the health care continuum.

Regulatory approval and accreditation is the heart of the system. For many, delay in licensure and other regulatory approvals can threaten financing and corporate viability. Accreditation of residency training programs is essential to the vitality of academic medical centers and teaching hospitals.

Restructuring is a fact of life in this dynamic system. Our clients are frequently involved in mergers, acquisitions, joint ventures, and strategic affiliations to achieve and maintain viability and a leadership position in the marketplace.

Mintz Levin’s health law attorneys work on the most complicated and sensitive legal matters, from managing government investigations with potential civil, administrative, and criminal liability, to structuring multi-million dollar corporate transactions.  Our cross-disciplinary approach equips Mintz Levin attorneys to solve problems throughout the industry, enabling our clients to focus on what counts:  providing cost-effective, quality patient care.

Practice Broadly, Focus Strategically

  • Accreditation, Licensing and Certification
  • Antitrust
  • Clinical Trials, FDA and Research
  • Contracting
  • Corporate Governance
  • Due Diligence
  • Fraud and Abuse
  • Government Investigations/Litigation
  • Graduate Medical Education Program Accreditation
  • Health Care Compliance/Regulatory Counseling
  • Health Care Reform
  • Mergers, Acquisitions, Financings and Joint Ventures
  • Privacy and Security/HIPAA Compliance
  • Reimbursement
  • Tax-Exempt Organization Issues

Our health law attorneys represent for-profit and nonprofit companies that provide health care or who service the health industry. Our clients include:

  • Ambulatory Service Providers
  • Assisted Living/Life Care Communities
  • Behavioral Health Companies
  • Biotech Manufacturers/Suppliers/ Distributors
  • DME Manufacturers/ Suppliers/Distributors
  • Diagnostics Companies
  • Dialysis Providers
  • Emergency Transportation Services
  • Health Care IT Suppliers/Distributors
  • Home Health Agencies
  • Hospice Providers
  • Health Systems/Academic Medical Centers/Hospitals
  • Laboratories
  • Lenders/Investors/Underwriters
  • Long Term Care/SNF Facilities
  • Managed Care Organizations
  • Medical Device Manufacturers/ Suppliers/Distributors
  • Medicare/Medicaid Managed Care  Plans
  • Part D Plans 
  • Pharmaceutical Manufacturers/  Suppliers/Distributors
  • Pharmacies
  • Pharmacy Benefit Managers
  • Physicians/Physician Practices/Allied  Health Providers
  • Retail Clinics
  • Tissue Banks

Minimize Operating Pain.

Health industry executives and governing boards rely on Mintz Levin to help address the complex operational issues on their leadership agendas. We deliver an A-team of lawyers and government relations professionals with a track record of making the system work. Many of our attorneys have served as in-house counsel or have held government positions. Using diverse perspectives and skills, we help health industry clients to address and solve regulatory, business, financial, transactional, and operational problems and challenges every day.

Mintz Levin’s Health Law Practice has received national recognition for its accomplishments, particularly in the legal and health industry media.  Our dedicated team consists of over 30 full-time health law attorneys.  One of the most respected health care industry publications, Modern Healthcare, cites Mintz Levin among the top 15 largest health care law firms in the U.S., and the American Health Lawyers Association granted Mintz Levin an Award of Excellence based on the size of its Health Law Practice.  Chambers USA: America’s Leading Lawyers for Business 2010 recognized Mintz Levin’s Health Law Practice in Boston, New York, and Washington, D.C., as well as Nationwide for the East Coast, and lists six Mintz Levin Health Law attorneys as leaders in their field. Over the past several years, Nightingale’s Healthcare News has named Mintz Levin Health Law attorneys to its lists of Outstanding Healthcare Fraud and Compliance Lawyers, Outstanding Hospital Lawyers, Outstanding Healthcare Transaction Lawyers, Outstanding Young Healthcare Lawyers, and Outstanding Healthcare Antitrust Lawyers.  Five of our Health Law attorneys were selected for the 2011 edition of The Best Lawyers in America.  Massachusetts and New York Super Lawyers also identified five Mintz Levin attorneys as leading health law lawyers.

Stay Fiscally Fit.

Faced with inadequate reimbursement, aging facilities, and patient demand for new technologies and treatments, many hospitals and other health care providers are hard-pressed to find enough capital to meet their future needs. Funding sources for capital projects are changing, and funds from traditional sources (such as tax-exempt and taxable bonds, equity, debt financing, philanthropy, and equipment leases) have dropped sharply. Despite these trends, capital is available—even to health care entities with challenging or distressed financial profiles.

Mintz Levin lawyers help health industry clients determine what is possible and create strategies to make it happen. For some, we structure joint ventures and strategic alliances with payors, management companies, and providers. For emerging health industry companies, we help find venture capital and other private and institutional financing, arrange corporate research and marketing partnerships, and secure technology and intellectual property licensing that leverage additional sources of available capital. Our clients rely on us to expand their business and the reach of the services they provide.

Since 2006, Mintz Levin has completed over 130 health industry mergers and acquisitions totaling over $45 billion; venture capital deals totaling over $1 billion; 51 strategic collaborations totaling $1.6 million; and 168 other financings totaling nearly $8 billion.

Give Back to the Community.

Mintz Levin encourages all attorneys to provide pro bono legal services to the community, and believes that an organized, firm-sponsored program is critical to enabling its lawyers to undertake such efforts.  The legal services furnished through Mintz Levin’s pro bono program are wide-ranging, and clients include needy individuals as well as groups who are fighting poverty, homelessness, and domestic violence; seeking civil rights, economic justice, and access to health care; and addressing other acute social needs.  As a signatory to the Pro Bono Institute's Pro Bono ChallengeSM, Mintz Levin has committed to dedicating 3% of all billable hours on pro bono matters.

For example, Mintz Levin has provided legal and strategic advice to The Kenneth B. Schwartz Center since its inception.  Founded in 1995 by Kenneth B. Schwartz, a highly respected attorney in Mintz Levin’s Health Law Practice, shortly before his death from lung cancer at age 40, The Schwartz Center is dedicated to strengthening the relationship between patients and caregivers in the changing health care system.  Mintz Levin’s service to The Schwartz Center has included board participation, the development of its bylaws, advice on trademark issues, assistance with contract matters, other strategic advice, and government relations representation.  Over the past year alone, more than 40 Mintz Levin attorneys have devoted over 1500 hours to this pro bono representation.    

Please click here for a pdf of our Health Law brochure.

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Publications

ML Strategies Health Care Reform Update (5/23/11)

5/23/2011



ML Strategies Health Care Reform Update (5/16/11)

5/16/2011



ML Strategies Health Care Reform Update (5/9/11)

5/9/2011



Health Care Reform Advisory: ACO Fraud & Abuse Provisions

5/6/2011



ML Strategies Health Care Reform Update (5/2/11)

5/2/2011



Health Care Reform Advisory: How ACOs Will Use and Disclose Protected Health Information While Complying with HIPAA

4/27/2011



Health Care Reform Advisory: Understanding the Implications of Proposed Legal Structure Requirements of Accountable Care Organizations

4/15/2011



ML Strategies Health Care Reform Update (4/11/11)

4/11/2011



Health Care Reform Alert: CMS and OIG Issue Joint Notice, Solicit Comments Related to Waivers of Fraud and Abuse Provisions for Accountable Care Organizations

4/6/2011



Health Care Reform Advisory: U.S. Department of Labor Issues Sixth Set of Frequently Asked Questions under the Patient Protection and Affordable Care Act

4/6/2011



Health Care Reform Alert: IRS Issues Guidance on W-2 Reporting of Health Care Costs

4/5/2011



ML Strategies Health Care Reform Update (4/4/11)

4/4/2011



Tom Crane speaks at AHLA Institute on Medicare & Medicaid Payment Issues

4/1/2011



ML Strategies Health Care Reform Update (3/27/11)

3/27/2011



Health Care Enforcement Defense Advisory: HHS Boosts State Health Care Enforcement Authorities

3/23/2011



ML Strategies Health Care Reform Update (3/20/11)

3/20/2011



ML Strategies Health Care Reform Update (3/13/11)

3/13/2011



ML Strategies Health Care Reform Update (3/6/11)

3/6/2011



ML Strategies Health Care Reform Update (2/28/11)

2/28/2011



Health Law Alert: CMS Final Rule Strengthens Framework to Prevent Health Care Fraud

2/25/2011



CMS Finalizes Regulations Intended to Strengthen Program Integrity

2/23/2011
Karen S. Lovitch, Carrie A. Roll, Rachel M. Irving, Katina W. Lee and Ellyn L. Sternfield
BNA's Health Care Fraud Report

ML Strategies Health Care Reform Update (2/20/11)

2/20/2011



Private Equity's Interest in Non-Profit Hospitals: What's Next

2/14/2011
Stephen M. Weiner and Daria Niewenhous
HealthLeaders Media

Life Sciences Alert: FDA Releases Criteria for Responsible Officer Prosecutions

2/14/2011



ML Strategies Health Care Reform Update (2/13/11)

2/13/2011



ML Strategies Health Care Reform Update (2/6/11)

2/6/2011



Health Care Reform Advisory: Graduate Medical Education Reimbursement Final Rule Under PPACA Offers Relief for Hospitals

2/3/2011



Electronic Health Record Donations: Best Practices to Minimize Liability

2/2011
Theresa C. Carnegie and Karen S. Lovitch
G-2 Compliance Report

ML Strategies Health Care Reform Update (1/28/11)

1/28/2011



Thomas S. Crane Gives Presentation at AdvaMed's Medical Technology Learning Institute

1/26/2011



Mo V. Spilton And False Claims Penalties

1/25/2011
Ellyn L. Sternfield
Law360

Life Sciences Advisory: FDA to Begin Revamping the 510(k) Medical Device Review Program

1/25/2011



ML Strategies Health Care Reform Update (1/21/11)

1/21/2011



Health Care Reform Advisory: CMS Proposes New Hospital Value-Based Purchasing Program

1/18/2011



OUTLOOK 2011: Permissive Exclusions, Increase in Oversight Expected for 2011

1/12/2011

BNA's Health Care Fraud Report

ML Strategies Health Care Reform Update (1/12/11)

1/12/2011



Employee Benefits Advisory: Departments of Labor and Health and Human Services Issue Joint Guidance under the Affordable Care Act and MHPAEA

12/29/2010



ML Strategies Health Care Reform Update (12/17/10)

12/17/2010



Health Care Enforcement Defense Alert: DOJ and HHS Announce Efforts to Obtain Proactive Data Mining Tools to Supplement Anti-Fraud Efforts

12/17/2010



Health Care Enforcement Defense Advisory: Federal Compliance Blitz: Enforcement Challenges Ahead for Labs and Pathologists

11/23/2010



Health Care Reform Alert: New Health Plan Notices Required Under Health Care Reform

11/15/2010



Health Care Reform Alert: Stark Law Update: CMS Finalizes Rule Regarding Disclosure Requirements for Certain In-Office Ancillary Services

11/4/2010



Health Care Reform Alert: How Health Care Reform Adversely Impacts Executive Health Care and COBRA Subsidy Arrangements

11/2/2010



Health Care Reform Advisory: U.S. Department of Labor Issues Two Additional Sets of Frequently Asked Questions under the Affordable Care Act

10/25/2010



Health Care Reform Advisory: Department of Labor Issues Q&As Regarding Selected Provisions of the Affordable Care Act

10/13/2010



Health Care Reform Advisory: CMS Issues Proposed Rule Addressing Enhanced Program Integrity Requirements

9/30/2010



Thomas S. Crane Gives Speech at AHLA/HCCA Fraud and Compliance Forum

9/28/2010



Health Care Reform Alert: CMS Implements Self-Referral Disclosure Protocol Process to Self-Disclose Stark Law Violations

9/27/2010



Health Care Reform Advisory: Health Care Remains Front and Center Despite Packed Legislative Calendar

9/16/2010



Health Care Reform Advisory: Massachusetts Takes the Next Step: An Interim Step Toward Payment Reform?

9/8/2010



Health Care Enforcement Defense Advisory: The Game Has Changed: Medicare and Medicaid Overpayments

9/1/2010



Health Care Reform Advisory: NAIC, AHIP, HHS Push MLR Regulations Forward

8/24/2010



Health Care Reform Advisory: Health Reform Implementation Moves Forward Despite Continued Opposition

8/17/2010



Health Law Advisory: New Proposed HIPAA Rules May Benefit Researchers

8/9/2010



Health Care Reform Advisory: IRS, DOL, and HHS Issue Guidance on Preventive Care under Health Care Reform

7/28/2010



Health Care Reform Advisory: The Impact of Health Care Reform on Graduate Medical Education Reimbursement

7/23/2010



Health Law Alert: Federal Money for EHR Meaningful Users in Closer Reach

7/21/2010



Employment, Labor and Benefits and Health Law Advisory: Finally! HHS Issues Proposed Rule Implementing Changes to the HIPAA Privacy, Security and Enforcement Rules under HITECH

7/13/2010



Health Care Reform Alert: Update: U.S. Department of Labor Issues Model Notices Applicable to Child Coverage, Lifetime Limits, and Patient Protection

7/2/2010



The Ten Compliance Commandments for Medical Device Manufacturers

7/2010
Jennifer E. Williams
HCCA Compliance Today

Health Care Reform Alert: New Health Care Reform Regulations Address Pre-Existing Conditions, Lifetime and Annual Coverage Limits, Restrictions on Rescission, and Patient Protections

6/30/2010



Health Care Reform Advisory: Reminder: Applications under the $1 Billion Qualifying Therapeutic Discovery Project Program Due July 21, 2010

6/30/2010



Employment, Labor and Benefits Advisory: Hospitals and Medical Service Providers Take Note: You May be Subject to OFCCP Jurisdiction and Not Even Know It

6/21/2010



Health IT Alert: FCC Seeks Comments on Converged Communications and Health Care Devices; Schedules Public Meeting

6/18/2010



Health Care Reform Advisory: Departments of Treasury, Labor, and Health and Human Services Publish Interim Final Rules Implementing "Grandfather" Rules under Health Care Reform

6/16/2010



Health Care Enforcement and White Collar Defense Alert: SJC Limits Corporate Criminal Liability

5/27/2010



Health Care Antitrust Advisory: Assistant Attorney General Varney's Healthcare Antitrust Speech Emphasizes Health Insurance Industry Enforcement and Offers Supportive Remarks on Clinical Integration

5/26/2010



Health Care Reform Advisory: How to Apply for a Billion-Dollar Tax Credit and Grant Opportunity - New Guidance from the IRS

5/25/2010



Health Care Reform Advisory: HHS Issues "Early Retiree Reinsurance Program" Guidance

5/18/2010



Health Care Enforcement Defense Alert: Fraud and Abuse Enforcement: Big Recoveries in 2009; Big Plans for 2010

5/17/2010



Health Care Reform Advisory: Agencies Issue Guidance on Health Care Reform's New Child Coverage Rules

5/13/2010



Health Care Reform Advisory: CMS Kicks Off Program Integrity Rulemaking Process

5/7/2010



Health Care Reform Advisory: Update on the Billion-Dollar Tax Credit and Grant Opportunity: What Life Sciences Companies Can Do Now to Prepare

4/29/2010



Health Care Reform Advisory: Medicare in the 21st Century: Achieving Quality and Efficiency Through Payment and Service Delivery Reforms

4/27/2010



Health Care Reform Advisory: Bringing Health Care Technology Home—Senate Holds First Hearing on the National Broadband Plan and Health IT

4/26/2010



Medicare in the 21st Century: Achieving Quality and Efficiency Through Payment and Service Delivery Reforms

4/23/2010
Thomas S. Crane, Karen S. Lovitch, Stephen M. Weiner, Katina W. Lee and Tara E. Swenson
BNA's Medicare Report

Health Care Reform Advisory: The "Employer Responsibilities" Requirement of The Patient Protection and Affordable Care Act: A View from the Weeds

4/22/2010



In Vitro Diagnostics: The Complete Regulatory Guide

4/21/2010
Hope S. Foster, Sarah A. Kaput and Jennifer E. Williams
The Food and Drug Law Institute

Health Care Reform Advisory: FAQs: Health Care Reform and Employee Benefits

4/14/2010



Employment, Labor and Benefits Alert: Health Care Reform Amendments to FLSA Require Break Time and Private Place for Nursing Mothers to Express Milk

4/13/2010



Risky Business: Health Care Reform's Fraud-Fighting Provisions Increase the Potential for Liability for All in the Health Care Industry

4/7/2010
Thomas S. Crane, Brian P. Dunphy, Hope S. Foster, Sarah A. Kaput, Karen S. Lovitch, Jennifer E. Williams
BNA Health Care Fraud Report

The HITECH Act: Is Your Organization Ready for Implementation?

4/2010
Karen S. Lovitch, Stephen R. Bentfield and Dianne J. Bourque
G-2 Compliance Perspectives

Health Law and Employee Benefits Alert: HHS Announces Delay in Enforcement of HITECH Rules as Applied to Business Associates

3/26/2010



Health Care Reform Advisory: Assessing the Impact of Federal Health Care Reform on Employers and Employer-Sponsored Group Health Plans

3/24/2010



Health Care Reform Advisory: Health Care Endgame

3/15/2010



Health Law Alert: Massachusetts Department of Public Health Issues Guidance Document IV To Clarify the Pharmaceutical and Medical Device Manufacturers Code of Conduct

3/4/2010



Health Care Enforcement Defense Group Alert: Fighting Health Care Fraud - This Time, It's Personal

2/3/2010



Employee Benefits and Executive Compensation / Health Law Advisory: Complying with the HIPAA Privacy and Security Mandates under the HITECH Act: A Field Guide for Benefits Brokers and Consultants and other Business Associates

1/20/2010



Health Care Reform Advisory: Meaningful Use = Meaningless Dollars?

1/15/2010



Health Care Reform Advisory: Emergency Care - Will Health Care Reform Come to the Rescue?

1/11/2010



DOJ Criminal Chief's Recent Speech Foreshadows Increased FCPA Prosecutions and Reminds Companies to Implement and Follow Best Practices

1/7/2010



Health Care Reform Advisory: The Medical Home — A New Foundation for Health Care

1/4/2010



Health Care Reform Advisory: Comparative Effectiveness Research Proposals — Potential Implications for Stakeholders

1/4/2010



Health Care Reform Advisory: CMS Issues Proposed Rule on Meaningful Use of EHR Technology

1/4/2010



Health Care Reform Advisory: Assessing the Impact of Federal Health Care Reform on Employers and Group Health Plans

12/31/2009



Health Care Reform Advisory: Solidarity in a Sea of Dissent - Consistencies Between the House and Senate Bills' Provisions Targeting Fraud and Abuse

12/28/2009



Health Law and Communications Alert: FCC Issues Public Notice Seeking Comment On Broadband Infrastructure and Health IT

11/23/2009



Technology Allowing Patients to Participate in Own Health Care

11/17/2009
Doug Sherwin
The San Diego Daily Transcript

Health Law / Employee Benefits and Executive Compensation Alert: HHS Issues Interim Final Rule Implementing Civil Penalty Provisions of HITECH Act

11/4/2009



Health Care Enforcement Defense Group Alert: Senate Hearing and Proposed Legislation Focus on Health Care Fraud

10/29/2009



Employee Benefits and Executive Compensation / Health Law Advisory: Department of Health and Human Services Issues Proposed Regulation Updating the HIPAA Privacy Rule for Changes under the Genetic Information Nondiscrimination Act of 2008

10/23/2009



Employee Benefits and Executive Compensation / Health Law Advisory: DOL, Treasury and HHS Issue Joint Interim Final Rule under Title I of the Genetic Information Nondiscrimination Act of 2008 (Relating to Group Health Plans and Health Insurance Issuers)

10/16/2009



Employee Benefits and Executive Compensation / Health Law Advisory: HHS Issues Rules Relating to Breach Notification and Related Items under the HITECH Act

8/26/2009



Privacy and Security Alert: Analysis of Amendments to Massachusetts Data Security Regulations

8/19/2009



Health Law Washington Beat: Recent Health Industry News - Issue 13

8/3/2009



The Health Care Fraud Enforcement Juggernaut Continues

7/29/2009



Health Law Washington Beat: Recent Health Industry News - Issue 12

7/17/2009



Health Care Enforcement Defense Practice Group Advisory: The Temperature is Changing in the Health Care Industry

7/13/2009



Health Law Washington Beat: Recent Health Industry News - Issue 11

7/1/2009



Health Care Fraud Alert: HEAT in Action

6/26/2009



Health Law Washington Beat: Recent Health Industry News - Issue 10

6/2/2009



Health Law Advisory: Vermont Passes Sweeping Regulation of Pharmaceutical Marketing Activities

5/28/2009



Health Care Fraud Alert

5/21/2009



Health Law Washington Beat: Recent Health Industry News - Issue 9

5/14/2009



Health Law Washington Beat: International Edition - Issue 2

5/7/2009



Health Law Advisory: Federal Court Upholds Vermont Law Restricting the Sale and Use of Prescriber-Identifiable Data

5/4/2009



Health Law Washington Beat: Recent Health Industry News - Issue 8

4/30/2009



Health Law Advisory: Federal Court Holds that It Lacks Jurisdiction to Hear Challenge to the New Definition of "Entity" Under the Stark Law Regulations

4/30/2009



Health Law Alert: Identity Theft Red Flag Program Compliance Deadline Rapidly Approaching

4/23/2009



Health Law Advisory: Review of the Massachusetts Marketing Code of Conduct for Pharmaceutical and Medical Device Manufacturers

4/13/2009



Health Law Washington Beat: Recent Health Industry News - Issue 7

4/6/2009



Health Law Client Advisory: A Win for PBMs: Federal Court Holds D.C.'s Access Rx Act Preempted by ERISA

4/1/2009



Health Law Client Alert: OIG Narrows Scope of Permissive Self-Disclosures and Imposes a Floor on Kickback Settlement Amounts

3/25/2009



Health Law Washington Beat: Recent Health Industry News

3/23/2009



Health Law Washington Beat: International Edition Issue 1

3/18/2009



Health Law Client Alert: Massachusetts DPH Releases Final Rules for Pharmaceutical and Medical Device Manufacturers' Conduct

3/13/2009



Health Law Washington Beat: Recent Health Industry News

2/26/2009



Health Law and Health Information Technology Alert: Electronic Health Record Legislation Passed As Part of President's Stimulus Package

2/10/2009



Health Law Washington Beat: Recent Health Industry News

2/9/2009



Health Law Alert: OMIG Publishes Regulations for Mandatory Compliance Programs

1/28/2009



Health Law Washington Beat: Recent Health Industry News

1/27/2009



Health Law Alert: OHRP Publishes New Registration Requirements for IRBs

1/16/2009



Health Law Advisory: CMS Finalizes Medicare Part D Negotiated Pricing Regulation and Additional Remaining Revisions to Medicare Advantage and Part D Programs

1/13/2009



Health Law Washington Beat: Recent Health Industry News

1/12/2009



Gainsharing Arrangements: A Review of the Governing Law and CMS's Proposed New Stark Exception

1/2009
Garrett G. Gillespie and Brian P. Dunphy
HFMA Massachusetts-Rhode Island Chapter, Mass Media (Volume XXXVI Issue 2)

Health Law Alert: TRICARE Announces Implementation of Medicare's Outpatient Prospective Payment System

12/23/2008



Health Law Washington Beat: Recent Health Industry News

12/19/2008



IMS Health Inc. v. Ayotte - What Does it Mean for the Health Care Industry

12/18/2008
Jennifer Williams and Heather Westphal
BNA Health Law Reporter

Crisis Communications

12/2008
Daria Niewenhous and Nancy Sterling
Oncology Issues

Health Advisory: CMS Moves Forward with a Modified Disclosure of Financial Relationships Initiative

9/9/2008



Health Law Alert: PhRMA Issues New Marketing Code Effective January 2009

7/10/2008



Key Issues in Physician Employment Contracts

7/2008
Nili S. Yolin and M. Daria Niewenhous
Oncology Issues

Employee Benefits Advisory: Updated Employer's Guide to the 2006 Mass. Health Care Reform Act

5/19/2008



Pre://view '08

2/8/2008



Stark III

1/2008
M. Daria Niewenhous and Sarah Whipple
Oncology Issues

Self-Disclosure of Overpayments and Violations of Healthcare Laws

1/2008
Thomas S. Crane
Journal of Health & Life Sciences Law

Physician Self-Referrals

12/17/2007
Margaret D. Kranz, Andrew B. Roth
New York Law Journal

Stark Phase III Regulation

9/26/2007
Mintz Levin's Health Law Practice
Bureau of National Affairs

OIG Issues Advisory Opinion on Joint Venture Buy-Outs

9/2007
M. Daria Niewenhous, Deborah Daccord, and Melissa O'Neill
Oncology Issues

Health Antitrust Advisory: FTC Rules Evanston Northwestern Merger Violated Antitrust Law

8/8/2007



Health Antitrust Alert: FTC Staff Takes Positive Second Look at MedSouth's Clinical Integration

6/22/2007



Health Advisory: CMS Proposes Mandatory Disclosure of Financial Relationships Between Hospitals and Physicians

6/22/2007



Health Alert: OIG Withdraws Proposed "Substantially in Excess" Rule

6/21/2007



Employee Benefits and Executive Compensation Alert: Health Connector Issues Four Final Rules Implementing Key Features of the Massachusetts Health Care Reform Act

6/21/2007



Employee Benefits and Executive Compensation Advisory: An Employers' Guide to the 2006 Massachusetts Health Care Reform Act

5/15/2007



Communications and Health Care Article: Radio Frequency Medical Devices at the Intersection of FCC, FDA and Privacy Concerns

4/3/2007



Clinical Trials Expand Medicare PET Coverage: While OIG Scrutinizes Billing in 2007

4/1/2007



Health Care Presentation: Repayments and Disclosures: Whether, Which, When and How Much

3/21/2007



Health Care Article: Tennessee Settlement Shows Failure to Refund Overpayments Can Be a Crime

2/28/2007



Health Care Presentation: Off-label Marketing of Prescription Drugs and Devices, the False Claims Act and the Impact of Medicare Part D

2/27/2007



Healthcare Alert: Release of Proposed Medicare Advantage (MA) Capitation Rates for 2008

2/21/2007



Healthcare Alert: Hearing on Fraud and Abuse Issues in Pharmaceutical Pricing

2/13/2007



Healthcare Alert: Release of Final 2008 Medicare Advantage Applications

2/2/2007



Health and Communications and IT Advisory: Grants Available for Telehealth and Telemedicine from the FCC

1/25/2007



Health Advisory: New CMS Rules Impact Hospital Operations

12/1/2006



Privacy Article: RFID use in health care raises privacy questions.

11/28/2006



Health Care Article: New Incentives for States to Modify or Enact Whistleblower Laws

11/1/2006



Health Alert: New York State Legislature Passes Sweeping Health Care Fraud Reform Legislation

9/18/2006



Medical Device Advisory: FCC Proposes Medical Device Radiocommunications Services

9/8/2006



Health Care Article: OIG Clarifies Role of Patient Assistance Programs under Medicare Part D

9/1/2006



Health Care Article: Changes to Off-Label Prescribing Practices Under Medicare Part D

7/1/2006



Health Alert: Senate Health, Education, Labor and Pensions Committee Releases Details of Comprehensive Drug Safety Bill

6/19/2006



HealthCare Article: CMS Final Rule Overhauls Medicare Enrollment Process

6/2/2006



Health Alert: CMS Issues Final Part D Guidance on Controlling Fraud, Waste, and Abuse

5/1/2006



Health Alert: Massachusetts Enacts Landmark Health Care Reform Bill: An Overview of H. 4850, An Act Providing Access to Affordable, Quality, Accountable Health Care

4/21/2006



Health Alert: CMS Proposes New Process for Notification of Hospital Discharges

4/7/2006



Health Care Article: CMS's Final E-Prescribing Rule

4/1/2006



Health Alert: CMS Issues Final 2007 Medicare Part D Formulary Guidelines

3/29/2006



Health Alert: CMS Issues Proposed 2007 Part D Guidelines on Formularies and Enrollee Transition

3/1/2006



HealthCare Article: Medicare Appeals Process: It's New But Is It Improved?

2/15/2006



Health Alert: CMS Issues Guidance on Controlling Fraud, Waste, and Abuse for Medicare Part D Sponsors

2/14/2006



HealthCare Article: Medicare Part D Update

1/1/2006



Health Care Article: Drug Reimbursement Issues Surrounding the Implementation of Medicare Part D, What community Cancer Centers Need to Know.

1/1/2006



Long Term Care Article: Medicare Part D and Long Term Care: The Reimbursement and Operation Issues

7/30/2005



HealthCare Article: Arrangements Between Hospitals and Hospital-Based Physicians

6/1/2005



HealthCare Article: Overhaul of the Medicare Appeals Process: Are Providers and Suppliers Prepared?

5/6/2005



LTC Matters: Restructuring of the Medicare Appeals Process: Are Long Term Care Providers Ready?

5/1/2005



HealthCare Article: Use Caution When Undertaking a Joint Venture

4/30/2005



Health Advisory: Pharmacogenomic Data Submission in New Drug Applications, Investigative New Drug Applications, and Biologics License Applications

4/21/2005



LTC Matters: New Medicare Part D - A Prescription for Industry-wide Change

3/15/2005



Health Care Article: The Right Motivation: With careful drafting, pay for performance pushes quality and efficiency.

3/14/2005



Health Client Advisory: CMS Publishes Final Regulations on Part D Prescription Benefit

2/2/2005



Benefits Advisory: The Final (and Proposed) IRS, DOL and HHS HIPAA Portability Regulations

1/31/2005



Health Article: Effective and Compliant Records Management Policies for Health Care Providers and Suppliers

11/25/2004



Best Practices for Home Health Care Association Financial Managers, a Presentation by Mintz Levin Health Attorney Ellen Janos

10/14/2004



Health Presentation: Fraud and Abuse Issues Involving Pharmaceutical Products and Medical Devices

9/27/2004



Health Law Advisory: Tax-Exempt Hospitals Face Class-Action Lawsuits Challenging Charity Care and Billing Practices

7/1/2004



LTC Matters: Department of Labor Issues Final Overtime Rule

5/7/2004



Health Article: Stark Phase II Final Rule - Summary and Analysis

4/14/2004



LTC Matters: Effective and Compliant Records Management Policies for Long Term Care Providers

2/2/2004



Health Memorandum: Medicare Prescription Drug Improvement and Modernization Act of 2003 - An Analysis for Medical Device Manufacturers

12/19/2003



Health Advisory: New Medicare Provisions to Promote Improvement in the Management of Chronically Ill Patients

12/10/2003



Health Advisory: The New Medicare

12/3/2003



Health Alert: Congress Passes Major Medicare Reform Bill

11/26/2003



Health Advisory: CMS Final Rule Clarifies Hospital Responsibilities Under EMTALA

9/12/2003



Health Advisory: Recently Passed House and Senate Medicare Reform Bills Would Significantly Affect Health Care Providers

7/25/2003



LTC Matters: Federal Agencies Hold Hearings on Antitrust Issues in Health Care: Long Term Care Session Focuses on Competition Dimensions of Quality Care

7/21/2003



Health Advisory: New Final HIPAA Regulations Emphasize Flexibility

6/2/2003



LTC Matters: Recruitment of Foreign Health Care Workers: A Solution to the Staffing Shortage

5/28/2003



Health Advisory: OIG Issues New Guidance on Pharmacy Issues and Joint Ventures

5/14/2003



Health Client Alert: HIPAA Compliance Regulations Now in Effect

4/15/2003



LTC Matters: Litigation Buyout Insurance: Removing Pending Legal Actions from the Deal

3/28/2003



LTC Matters: Maximizing Medicare Reimbursement Through Effective Claims Management

1/1/2003



LTC Matters: Avoiding the Malpractice Lawsuit: Managing Relationships as a Risk Management Strategy

11/1/2002



LTC Matters: Some Congressional Momentum, but Federal Medical Tort Reform Unlikely

9/1/2002



Health Advisory: The HIPAA Privacy Regulations- The Final Chapter (Or is it?)

8/1/2002



LTC Matters: Government Investigations: Are You Prepared?

4/5/2002



LTC Matters: Government Investigations- Are You Prepared?

4/1/2002



Health Advisory: The HIPAA Privacy Regulation- The Never-Ending Story

4/1/2002



Business Advisory: IRS Issues Proposed Regulations and Closing Agreement Procedures for Hospital Acquisition Bonds

4/1/2002



LTC Matters: Fisher v. Network Software Associates- A New Chapter in Successor Liability for Health Care Companies

3/1/2002



Intellectual Property Advisory: Payment for New Health Care Technologies- The Long and Winding Road

3/1/2002



Intellectual Property Advisory: Medical Device Patents- An Important Business Asset

3/1/2002



LTC Matters: Arbitration Agreements: Keeping It Out of the Courtroom

2/1/2002



LTC Matters: Consumer Protection Claims: Provider Liability on the Increase

1/1/2002



Health Advisory: "OIG Announces 'Kinder, Gentler' Enforcement Tactics"

11/1/2001



Health Paper: "Health Care Provider Perspectives on False Claims Act Enforcement"

6/17/2001



Health Advisory- Medical Research, HIPAA and FDA Standards

5/1/2001



Health Advisory: Drug Benefit, HCFA Reform Tops Congressional Health Agenda

3/1/2001



Health Advisory: HHS, Reviving Gainsharing and Bayer Settlement

2/1/2001



Health Article: Stark II Final Rule-- Summary and Analysis

1/24/2001



Litigation Publication: Massachusetts Non-Profit Organizations: Supp. 2001, Chapter 16: Special Issues for Health Care Non-Profits

1/1/2001



Health Advisory: New Federal Privacy Rules Mandate Major Changes in Health Care

1/1/2001



Health Advisory: Medicaid Drug Rebate Law Celebrates First Decade as Federal Prosecutors Provide First Close Look at Implementation

12/1/2000



Health Presentation: E-Health Commerce: Enforcement and Compliance Issues from the Health Care Fraud and Abuse

11/2/2000



Health Article: Fundamentals of Qui Tam Avoidance: Keeping the Whistle Away From Potential Whistleblowers

11/1/2000



Health Advisory: Tax-Exempt Institutions, Huge Potential Liabilities From IRS Acquisition/Refunding Audits

11/1/2000



Health Advisory: HCFA Begins Clinical Trial Coverage: Investigators May Soon Face More Fraud Claims

9/1/2000



Health Advisory: HCFA, Supreme Court and the White House

6/1/2000



Health Advisory: Focus- Human Clinical Trials- Clinical Trial Issues Suddenly Loom

6/1/2000



Health Advisory: Whistleblower Suits Continue Without Government Intervention But the Supreme Court Limits Actions Against Providers

5/1/2000



Health Advisory: FDA Announces New Regulatory Requirements for Certain PET Drugs; All Production to be Treated as Manufacturing

4/1/2000



Health Advisory: Internet Pharmacies and Health Care

2/1/2000



Health Advisory: Slow Train Coming- OIG Issues New Anti-Kickback Safe Harbors, Clarifies Others: Expanded Coverage of Discount Safe Harbor Opens New Window for Incentive Arrangements: Better Late than Never

1/1/2000



Resources

Current DevelopMintz

Center for Health Law & Policy
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Health Care Reform:
Analysis & Perspectives

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