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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April 29, 2008	FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions Type: On the Subject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

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