FDA/Food & Drug Administration
Comparison of Presidential Candidates’ Health Care Proposals
Health Care
September 22, 2008

Cynthia E. Berry
Leah Mendelsohn Stone

As part of their campaigns for the presidency, both Senator McCain and Senator Obama have outlined health care reform proposals that aim to provide access to affordable health care. The candidates’ plans differ on how they would achieve their stated objectives.



New Stark Rules Bring Major Changes - 08/08
Health Care
August 27, 2008

Sandra K. Herron

On August 19, 2008, the Centers for Medicare and Medicaid Services published the latest changes to the Stark Law. The Stark Law regulates the types of arrangements into which physicians may enter. Violations of the Stark Law bring hefty civil fines and penalties.



Expansion of Competitive Bidding Program for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Health Care
January 15, 2008

Alan K. Parver
Leah Mendelsohn Stone

The Centers for Medicare & Medicaid Services announced on January 8 the seventy Metropolitan Statistical Areas and eight product categories that will be involved in the second phase of competitive bidding for durable medical equipment, prosthetics, orthotics, and supplies.



Congress Passes New Ethics, Lobbying, and Earmark Requirements - 08/20/07
Health Care & Advocacy & Government Relations
August 20, 2007

Cynthia E. Berry

Before recessing for the month of August, the U.S. House of Representatives and the U.S. Senate passed the "Honest Leadership and Open Government Act" (S. 1), which would tighten ethics guidelines, restrict lawmakers' interactions with lobbyists, increase lobbying disclosure, and impose new requirements on earmarking of federal funds.



President Releases FY 2008 Budget - 02/06/07
Health Care
February 6, 2007

On Monday, President Bush sent his $2.8 trillion fiscal year (FY) budget to Capitol Hill, which preliminary analyses show includes $66 billion in savings from Medicare and $6.8 billion from Medicaid and the State Children's Health Insurance Program (SCHIP).



Fall Elections May Bring Increased Oversight of the Medicare Program - 10/30/06
Health Care
October 30, 2006

Alan K. Parver

Representative Fortney "Pete" Stark, Ranking Minority Member for the House Ways and Means Health Subcommittee recently identified areas in health law and policy that could draw the attention of a Democratically-led Congress.



CMS Releases Quality Standards for DMEPOS Suppliers - 08/22/06
Health Care
August 22, 2006

Alan K. Parver

On August 14, 2006, the Centers for Medicare and Medicaid Services (CMS) issued quality standards for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Read details in our alert.



Inspector General Issues First Open Letter - 05/03/06
Health Care
May 3, 2006

On April 24, 2006, the Inspector General of the Department of Health and Human Services issued guidance encouraging providers to voluntarily disclose violations of the physician self-referral law and the Anti-Kickback Statute. This guidance is Daniel Levinson's, the Inspector General, first Open Letter to Health Care Providers. This guidance relates his perspectives on compliance, the resolution of health care fraud cases, corporate integrity agreements, and the OIG's Provider Self Disclosure Protocol. This letter also introduces a new voluntary disclosure initiative that supplements prior guidance issued in 1998.



Electronic Medical Records on the Fast Track - 10/10/05
October 10, 2005

This Health Care Update discusses a new series of Health and Human Services regulations that will accelerate the use and the implementation of electronic medical records ("EMR") and electronic prescribing.



OIG Demonstrates Increased Willingness to Allow Physician Malpractice Insurance Subsidies - 01/12/05
Health Care
January 12, 2005

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) is the Federal agency that is charged with enforcing the Federal Medicare/Medicaid Anti-Kickback Statute, which makes it a criminal offense to knowingly and willingly offer, pay, solicit or receive any remuneration for referrals of items or services paid by Federal health care programs. In the past, OIG has expressed a deep distrust of arrangements in which hospitals or other entities subsidize malpractice insurance premiums for physicians. In the agency's view, physicians are potential referral sources and subsidies could be considered payments to influence referrals to hospitals. The OIG's first departure from this position was the creation of a safe harbor for obstetrical malpractice insurance subsidies on November 19, 1999. The safe harbor provision permits hospitals and other entities in rural or urban underserved areas to pay for some or all of the obstetrical malpractice insurance premiums for obstetrical practitioners, including physicians and certified nurse midwives. However, at the time, it was not clear that the agency would allow such subsidies in other areas.



Department of Health and Human Services Task Force Releases Report on Prescription Drug Importation - 12/23/04
December 23, 2004

Cynthia E. Berry

In this edition of the Advocacy & Government Relations Client Alert we discuss the final report (released on December 21) of the Department of Health and Human Services Task Force on Drug Importation. Reiterating that access to safe and affordable prescription drugs is an important policy goal, the Task Force concluded that drug importation would be costly to implement, provide little overall savings and, if not restricted to commercial importation from Canada, could be dangerous to consumers. The Task Force advised that all aspects of achieving safety, quality and cost-effectiveness must be comprehensively examined before imported drugs can be considered safe.



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