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2008

Date Title
October 2, 2008

Ryan Haight Online Pharmacy Consumer Protection Act to Become Law

Type: On the Subject

October 1, 2008

FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis

Type: On the Subject

September 24, 2008

CMS Final Rules Affect Medicare Marketing, Implement MIPPA Changes

Type: On the Subject

September 16, 2008

Top 10 Intellectual Property and Regulatory Legal Issues for Biotech Start-Ups

Type: On the Subject

September 2, 2008

CMS Adopts Changes to EMTALA Regulations in Final 2009 Inpatient IPPS Rule

Type: On the Subject

August 21, 2008

FDA Confirms Its View on Generic Drug Label Carve-Outs

Type: On the Subject

August 19, 2008

Massachusetts Enacts Pharmaceutical and Medical Device Disclosure Law

Type: White Papers

August 11, 2008

CMS Finalizes Stark Rule Changes in Final 2009 Inpatient PPS Rule

Type: On the Subject

August 6, 2008

OIG Issues Favorable Ambulatory Surgery Center Advisory Opinion

Type: On the Subject

July 18, 2008

Congress Approves Medicare, Medicaid Changes

Type: White Papers

July 18, 2008

IRS Issues Miscellaneous Guidance on Health Savings Accounts

Type: On the Subject

July 16, 2008

2009 Medicare Physician Fee Schedule

Type: White Papers

July 15, 2008

PhRMA Revises Code on Interactions with Healthcare Professionals

Type: White Papers

July 14, 2008

CMS Revisits the Diagnostic Test Anti-Markup Rule

Type: On the Subject

July 14, 2008

DEA Issues Proposed Regulations for E-Prescribing of Controlled Substances

Type: On the Subject

July 10, 2008

Proposed Stark Exception Covers Pay-for-Performance and Gainsharing Programs

Type: White Papers

June 18, 2008

Massachusetts Enacts Comprehensive $1 Billion Life Sciences Initiative

Type: On the Subject

May 29, 2008

Merck Settles Vioxx® Litigation with State Attorneys General: an Analysis

Type: White Papers

May 27, 2008

CMS Proposes Changes to EMTALA Requirements

Type: On the Subject

May 19, 2008

CMS Proposed Rule Revisits PBM Pricing Arrangements, Proposes Other Medicare Advantage and Part D Program Changes

Type: On the Subject

April 30, 2008

Election Year Activities for Section 501(c)(3) Organizations: Frequently Asked Questions

Type: White Papers

April 2008

International News, Issue 1, 2008

Type: International News

April 29, 2008

FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions

Type: On the Subject

April 29, 2008

OIG Issues Draft Supplemental Compliance Program Guidance for Nursing Facilities

Type: On the Subject

April 25, 2008

CMS Includes Additional Stark Proposals in IPPS Proposed Rule, Requests Comments

Type: On the Subject

April 25, 2008

CMS Proposes Revisions and Expansion of the Stark “Stand in the Shoes” Concept

Type: On the Subject

April 25, 2008

OIG Improves the Viability of the Self Disclosure Protocol

Type: On the Subject

April 22, 2008

IRS Releases Draft Instructions to Revised Form 990

Type: White Papers

April 16, 2008

403(b) Plan Sponsors Subject to New Reporting and Audit Requirements

Type: On the Subject

April 14, 2008

Third Circuit Decides Long-Awaited Antidepressant Drug Labeling Preemption Cases

Type: On the Subject

April 11, 2008

Secretary of HHS Recognizes Interoperability Standards for Lab Results, Biosurveillance and Consent Management

Type: On the Subject

April 3, 2008

Treasury Releases Final Regulations on Intermediate Sanctions/Standards for Exemption

Type: On the Subject

February 29, 2008

IRS Releases Expanded Governance Guidelines for Exempt Organizations

Type: On the Subject

February 28, 2008

AAMC/AAU Joint Advisory Committee Issues New Guidelines on Managing Conflicts of Interest

Type: On the Subject

February 28, 2008

Supreme Court Holds That FDA Premarket Approval of Class III Medical Device Preempts State Tort Law

Type: On the Subject

February 21, 2008

Ownership of Biological Samples and Clinical Data II: U.S. Supreme Court Denies Certiorari in the Catalona Decision

Type: On the Subject

February 19, 2008

FDA Releases Draft Guidance on Dissemination of Reprints of Peer Reviewed Journal Article

Type: On the Subject

January 22, 2008

FDA Issues Proposed Regulations on Supplemental Applications for Labeling Changes

Type: On the Subject

 

2007

Date Title
December 28, 2007

Congress Approves Medicare, Medicaid, SCHIP Changes

Type: On the Subject

December 17, 2007

CMS Publishes Final Rule for Medicare Advantage and Medicare Part D

Type: On the Subject

November 19, 2007

CMS Delays Stark Law “Stand in the Shoes” Rule for AMCs

Type: On the Subject

November 16, 2007

2008 Physician Fee Schedule Regulations Include Anti-Markup and IDTF Rule Changes

Type: On the Subject

October 15, 2007

FDA Oversight of Clinical Trials

Type: On the Subject

October 1, 2007

IRS Announces Revisions to Draft Revised Form 990

Type: On the Subject

September 20, 2007

Key Reviews for Compliance with Stark Law Phase III Regulations

Type: On the Subject

September 13, 2007

Joint Commission Approves Controversial Revisions to MS.1.20

Type: On the Subject

September 2007

CMS Publishes Phase III Stark Law Rule

Type: White Papers

August 29, 2007

Drug Enforcement Administration Compliance for University and Health System Research Facilities

Type: On the Subject

August 24, 2007

Internal Revenue Service Follows 2006 Audits of Tax-Exempt Bond Issues with Compliance Check

Type: On the Subject

August 24, 2007

Lessons from the Evanston Northwestern-Highland Park Hospital Merger Enforcement Action

Type: On the Subject

August 22, 2007

Final 403(b) Regulations Offer Planning Opportunities and Some Surprises for Plan Sponsors

Type: On the Subject

August 16, 2007

House Legislation Would Halt Physician-Owned Hospitals

Type: On the Subject

July 20, 2007

Community Benefit Debate Escalates

Type: On the Subject

July 19, 2007

Ambulatory Surgery Center Payment Changes Finalized

Type: On the Subject

July 11, 2007

CMS final decision on reconsideration of the Clinical Trials NCD: Maintains status quo.

Type: On the Subject

July 10, 2007

Proposed Medicare Rule Would Restrict Permitted Business Arrangements

Type: White Papers

July 9, 2007

Medicare Coordinated Retiree Health Care Plans Remain a Viable Plan Design

Type: On the Subject

July 2007

International News, Issue 2, 2007

Type: International News

June 26, 2007

New Rules for Residency Rotations to Non-Provider Sites

Type: On the Subject

June 13, 2007

Internal Revenue Service on Section 501(c)(3) Organizations and Political Activity

Type: On the Subject

June 6, 2007

New Proposed Rules for Medicare Advantage and Part D Programs

Type: On the Subject

June 2007

Update from Germany - June 2007

Type: On the Subject

May 31, 2007

May 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators

Type: On the Subject

May 24, 2007

The Massachusetts Health Care Reform Act–What Employers Need to Know

Type: On the Subject

May 7, 2007

HIPAA and Wellness Program Regulations Revised

Type: On the Subject

May 1, 2007

IRS Releases FAQs Clarifying 2006 Form 990 for Exempt Organizations

Type: On the Subject

April 18, 2007

2008 Inpatient PPS Update Includes New Obligations to Disclose Physician Ownership and Emergency Response Capabilities to Patients

Type: On the Subject

April 2007

International News, Issue 1, 2007

Type: International News

March 14, 2007

IRS Sharpens Focus on Tax-Exempt Organization Compensation

Type: On the Subject

February 26, 2007

Deregulation of the German Health Care Service Sector Opens Investment Opportunities

Type: On the Subject

February 13, 2007

CMS Issues Changes to IDTF Enrollment Rules - Block Leasing and Other Shared Imaging Arrangements May Need Restructuring

Type: On the Subject

February 5, 2007

IRS Gives Mixed Signals on Revised Exempt-Organization Annual Reporting Procedures and the Form 990

Type: On the Subject

January 16, 2007

Converting an ASC to a Hospital-Based Site

Type: On the Subject

 

2006

Date Title
December 19, 2006

CMS Releases Guidance for Compliance Policies on Medicaid Anti-Fraud Laws

Type: On the Subject

December 14, 2006

Changes on the Horizon for Health Savings Accounts

Type: On the Subject

December 12, 2006

Congress Approves Medicare, Medicaid Changes

Type: On the Subject

December 2006

International News, Issue 3, 2006

Type: International News

November 9, 2006

New IRS Workplan

Type: On the Subject

November 2006

Monetizing Medical Device Research

Type: White Papers

October 10, 2006

Donating Health Information Technology: Final Regulations Compete with H.R. 4157 for Public Policy Control

Type: White Papers

October 5, 2006

Deadline Looms for New Compliance Policies on Medicaid Anti-Fraud Laws

Type: On the Subject

September 15, 2006

Senate Finance Committee Hears Testimony on Standards for Hospital Tax Exemption

Type: On the Subject

September 11, 2006

Charity-Related Provisions of the Pension Protection Act of 2006: Significant New Rules and Restrictions

Type: White Papers

September 2006

International News, Issue 2, 2006

Type: International News

August 11, 2006

Final Specialty Hospital Report Released

Type: On the Subject

August 10, 2006

Ambulatory Surgery Center Payment Changes Proposed

Type: On the Subject

August 8, 2006

Registered Nurses Challenge Their Hospitals’ Participation in Surveys of Nurses’ Wages, Salaries, and Benefits as Violations of Federal Antitrust Laws

Type: On the Subject

August 7, 2006

New Exceptions, Safe Harbors Proposed for Donations of E-Prescribing and Electronic Health Records

Type: On the Subject

July 25, 2006

CMS Announces Reconsideration of Clinical Trial Billing Policy

Type: On the Subject

July 21, 2006

New Regulations for Advanced Medical Communication Devices - Part 2

Type: On the Subject

July 18, 2006

New Regulations for Advanced Medical Communication Devices

Type: On the Subject

June 7, 2006

New CMS Coverage Policy for Cardiac Rehabilitation

Type: On the Subject

May 30, 2006

IRS Compliance Check Surveys Frequently Asked Questions

Type: On the Subject

May 23, 2006

IRS Pursues Audits of 1997 and 1998 Health Care Tax-Exempt Bond Issues

Type: On the Subject

May 10, 2006

Interim Specialty Hospital Report Concerns All Hospitals

Type: On the Subject

May 1, 2006

Ownership of Biological Samples and Clinical Data: Catalona Decision Announced

Type: On the Subject

April 10, 2006

IRS Announces Community Benefit Audits for Hospitals

Type: On the Subject

February 2, 2006

Hospital Fair Billing and Collection Practices Act Proposed for Illinois Hospitals

Type: On the Subject

February 1, 2006

House Gives Final Approval to Deficit Reduction Act of 2005

Type: On the Subject

January 31, 2006

Proposed Tax-Exempt Hospital Responsibility Act Creates Charity Care Requirements

Type: On the Subject

 

2005

Date Title
December 2, 2005

Update on IRS Exempt Organization Compensation Review

Type: On the Subject

November 21, 2005

Donating Health Information Technology to Physicians

Type: White Papers

November 4, 2005

American University: Board v. CEO v. Board

Type: On the Subject

October 31, 2005

Continued Pressure on Hospital Tax-Exempt, Nonprofit Status

Type: On the Subject

October 13, 2005

IRS Issues Draft of Revised Form 990 for Public Comment

Type: On the Subject

October 12, 2005

Corporate Minute-Taking: A General Counsel’s Guide

Type: On the Subject

October 11, 2005

CMS and OIG Propose New Stark Law Exceptions and Anti-Kickback Safe Harbors for E-Prescribing and EHRs

Type: On the Subject

September 30, 2005

U.S. Congress Announces New Investigations into University Spending on Clinical Research

Type: On the Subject

September 9, 2005

Proposed Department of Treasury intermediate sanctions regulations give guidance to avoid revocation of tax-exempt status

Type: On the Subject

August 23, 2005

OIG Advisory Opinion Offers New Insights for Academic Medical Center Arrangements

Type: On the Subject

August 11, 2005

New Federal Requirements for Investigating and Managing Allegations of Research Misconduct

Type: On the Subject

July 22, 2005

State Action Doctrine Immunizes Public Hospital and the Commercial Payor from Antitrust Claim

Type: On the Subject

June 29, 2005

Medicare 2006 SNF PPS Payment Update Proposes Significant Changes; Long-Term Care Pharmacies Part D Plan Arrangements for January 1, 2006

Type: On the Subject

June 24, 2005

Framework of New Nonprofit Oversight Legislation Taking Shape

Type: On the Subject

June 16, 2005

New Focus and Heightened Scrutiny of Travel and Entertainment Policies and Practices of Nonprofits

Type: On the Subject

June 2, 2005

New Congressional Scrutiny of Hospital Tax-Exempt Status

Type: On the Subject

May 18, 2005

Proposed Self-Referral Ban Casts Chill on Specialty Hospitals

Type: On the Subject

April 18, 2005

IRS Exempt Organizations Compensation Audits—Update and Strategy

Type: On the Subject

April 14, 2005

Another Year of Medical Resident FICA Refund Claims Due April 15, 2005

Type: On the Subject

April 6, 2005

Sweeping Legislative Changes for Nonprofits Move Closer to Reality

Type: On the Subject

March 7, 2005

Health: Key Issues Under Medicare’s Final Prescription Drug Rule

Type: On the Subject

March 1, 2005

A General Counsel’s Guide to Avoiding the Healthcare Antitrust Minefield

Type: On the Subject

 

2004

Date Title
December 16, 2004

The New Form 1023: What Does It Mean For Charitable Organizations?

Type: On the Subject

December 15, 2004

Medicare Prospective Payment System for Inpatient Psychiatric Hospitals and Units

Type: On the Subject

November 23, 2004

Administrative Law Judge Upholds U.S. Federal Trade Commission’s Complaint against North Texas Specialty Physicians

Type: On the Subject

November 18, 2004

IRS Issues Long-Awaited Guidance on 403(b) Annuities for Tax-Exempt Organizations

Type: On the Subject

November 8, 2004

Encouraging a Responsible Aprroach to Consumer-Driven Health Care

Type: White Papers

November 4, 2004

Increasing FDA Oversight Over Clinical Research

Type: On the Subject

October 12, 2004

EPA New England Increases Enforcement Efforts for Healthcare Facilities

Type: On the Subject

October 5, 2004

Election Year Activities for Section 501(c)(3) Organizations: Frequently Asked Questions

Type: On the Subject

September 29, 2004

OSHA Interpretation Regarding Commercially Sold Medical Kits

Type: On the Subject

September 27, 2004

The FTC and the Department of Justice Provide New Guidance: Antitrust Enforcement Against Health Care Providers To Remain A Top Priority

Type: White Papers

September 22, 2004

CMS Proposes Rule on Medicare’s New Drug Benefit

Type: On the Subject

September 2, 2004

Catholic Health Care & Education: New Era of Litigation Demands Increased Vigilance by Religious Institutes

Type: On the Subject

July 20, 2004

Catholic Health Care: Importance of Effective Corporate Structure: Archdiocese of Portland Bankruptcy Filing

Type: On the Subject

June 25, 2004

IRS and Congress Target Exempt Organizations’ Executive Compensation Practices

Type: On the Subject

June, 2004

Best Practices: Nonprofit Corporate Governance

Type: White Papers

June 15, 2004

Corporate Responsibility: Spitzer v. Grasso: Compensation-Related Governance Issues for Not-for-Profits

Type: On the Subject

June 8, 2004

Health Litigation: A General Counsel's Guide to Avoiding "Obstruction of Justice" Liability

Type: On the Subject

May 27, 2004

CMS Revises Medicare Program Integrity Manual: Work of Program Safeguard Contractors and Data Mining Fully Implemented

Type: On the Subject

May 18, 2004

New Metropolitan Areas Shuffle the Deck

Type: On the Subject

May 13, 2004

IRS Revenue Ruling Approves Tax-Exempt Organization Participation in Ancillary Joint Ventures

Type: On the Subject

April 28, 2004

Law of Tissue Banks and Stem Cells in Flux

Type: On the Subject

April 27, 2004

Medicare Hospice Benefit: Growth and Opportunities

Type: On the Subject

April 19, 2004

Phase II of the Final Stark II Regulations

Type: On the Subject

April 7, 2004

Massachusetts Appeals Court Decision Casts Doubt on the Tax-Exempt Status of Hospital Affiliated Medical Practices

Type: On the Subject

April 2, 2004

IRS Developments Impact the FICA Tax Treatment of Medical Residents

Type: On the Subject

March 30, 2004

CMS Issues Long-Awaited Phase II Stark Regulations

Type: On the Subject

March 22, 2004

CMS Creates Broad Exception to Medicare Reassignment Prohibition

Type: On the Subject

February 19, 2004

New Illinois Rules Regulate In-House Counsel

Type: On the Subject

January 21, 2004

Medicare Act Impacts Sub-Acute and Post-Hospital Providers

Type: On the Subject

January 16, 2004

Competitive Edge: New Law Requires Pharmaceutical Companies to Notify Agreements with the U.S. Antitrust Regulators

Type: On the Subject

January 14, 2004

New Law Changes Massachusetts’ HMO Statute

Type: On the Subject

January 7, 2004

More Rural Health Care Providers Eligible for Telecom Funding

Type: On the Subject

 

2003

Date Title
December 8, 2003

U.S. Congress Creates New Geographic Reclassification Opportunity for Hospitals

Type: On the Subject

December 3, 2003

Impact of the Medicare Prescription Drug Act on Plan Sponsors

Type: On the Subject

November 26, 2003

Congress Approves Medicare Prescription Drug and Modernization Act of 2003

Type: On the Subject

November 21, 2003

FDA’s Authority to Restrict Importation of Prescription Drugs from Canada Upheld

Type: On the Subject

November 18, 2003

Deal Reached on Medicare Prescription Drug Benefit

Type: On the Subject

October 31, 2003

JCAHO Publishes New Hospital Credentialing Standards for Telemedicine

Type: On the Subject

September 23, 2003

OIG Proposes to Define “Charges” and “Substantially in Excess”

Type: On the Subject

September 17, 2003

Over-the-Counter Drugs May Now Be Reimbursable

Type: On the Subject

September 16, 2003

EMTALA Final Regulations

Type: On the Subject

July 2, 2003

New OIG Pharmaceutical Compliance Guidance Raises Questions About Financial Relationships

Type: On the Subject

May 28, 2003

HIPAA Final Security Regulations Released

Type: On the Subject

May 27, 2003

HHS Issues Interim Rule Regarding Enforcement of Violations of the Administrative Simplification Provisions of HIPAA

Type: On the Subject

May 15, 2003

OIG Special Bulletin Raises Questions Concerning Some Health Care Contractual Joint Ventures

Type: On the Subject

April 10, 2003

OSHA Issues Ergonomic Guidelines for the Nursing Home Industry

Type: On the Subject

April 3, 2003

FICA Medical Resident Update and April 15th Filing Deadline

Type: On the Subject

February 20, 2003

Community Code Directive Safeguards Public Health

Type: On the Subject

February 14, 2003

Patent Strategies in the European Union for the Pharmaceutical Industry

Type: On the Subject

Winter 2003

International News Volume 5, No. 1, Winter 2003

Type: International News

 

2002

Date Title
December 18, 2002

CMS Targets Hospitals with High Outlier Payments

Type: On the Subject

October 2002

FTC Health Care Workshop: What Physicians, Hospitals and Pharmaceutical Companies Need to Know

Type: On the Subject

October 2002

HIPAA Privacy Issues for Employers Who Sponsor Group Health Plans

Type: On the Subject

October 2002

Summary of Draft OIG Compliance Guidance for Pharmaceutical Manufacturers

Type: On the Subject

July 2002

IRS Approves New Health Plan Design

Type: On the Subject

June 4, 2002

Changes Proposed to Provider-Based Status Rules

Type: On the Subject

March 29, 2002

DHHS Attempts to Reduce Administrative Burdens Of HIPAA Privacy Rule

Type: On the Subject

March 2002

New JCAHO Accreditation Standards for Hospitals

Type: On the Subject

February 7, 2002

CMS Revamps Medicare Enrollment Process and Forms

Type: On the Subject

January 2002

U.S. Department of Health and Human Services Invites Comments for Reducing Regulatory Burdens

Type: On the Subject

 

2001

Date Title
December 26, 2001

Congress Extends HIPAA Standard Transaction Compliance Deadline

Type: On the Subject

December 2001

U.S. Office for Human Research Protections (OHRP) Increases Emphasis on Regulatory Compliance

Type: On the Subject

November 2001

HHS OIG Responds to Complaints About Corporate Integrity Agreements

Type: On the Subject

September 2001

Expanded Medicare Reimbursement for Telehealth May Create New Opportunities

Type: On the Subject

June 27, 2001

National Physician Supervision Requirements Established for Diagnostic Tests

Type: On the Subject

May 16, 2001

Final Health Information Privacy Rules: Implications For Hospital Fundraising Activities

Type: On the Subject

May 16, 2001

The Final Stark Rule: Implications For Academic Medical Centers

Type: On the Subject

May 2001

HCFA Proposes Medicare Geographic Reclassification Changes

Type: On the Subject

April 13, 2001

"Thompson Announces""No Delay"" To HIPAA Privacy Rules"

Type: On the Subject

February 23, 2002

Final Health Information Privacy Rules

Type: On the Subject

February 8, 2001

Intermediate Sanctions: A Guide to the Temporary Regulations

Type: On the Subject

January 26, 2001

HCFA Issues Phase I of the Final Stark II Rule

Type: On the Subject

January 2001

Medicare Legislation: Geographic Reclassification Changes

Type: On the Subject

 

2000

Date Title
December 21, 2000

Congress Approves Medicare Changes

Type: On the Subject

December 13, 2000

DOL Makeover for Health Benefit Plans’ Claims Procedures and Summary Plan Descriptions

Type: On the Subject

August 2000

E-SIGN: What Awaits the Healthcare Industry?

Type: On the Subject

July 7, 2000

OIG Issues Draft Compliance Program for Individual and Small Group Physician Practices

Type: On the Subject

June 21, 2000

Supreme Court Expands Prosecutors' Health Care Fraud Arsenal

Type: On the Subject

June 14, 2000

IRS Scrutinizes Hospital Mergers; Threat to Tax Exempt Bond Financings

Type: On the Subject

May 2000

Health Care Financing Administration Proposes to Ease Medicare Geographic Reclassification

Type: On the Subject

April 14, 2000

The Final Provider-Based Status Rule

Type: On the Subject

April 2, 2000

Protective Refund Claims Provide Valuable but Inexpensive Benefits to Hospitals

Type: On the Subject

McDermott Will & Emery

McDermott Will and Emery