OIG reports that medicare could have saved $7 million with drug-substitution policy
March 5, 2013
The Centers for Medicare & Medicaid Services ("CMS") could have saved $7 million in Medicare Part B drug reimbursements in 2011 if a proposed drug-substitut...
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Reporting “Indirect Payments” Under the Sunshine Act: A Closer Look
March 4, 2013
One of the most challenging aspects of compliance with the Sunshine Act is accounting for "indirect payments" made through third parties. Many had...
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$85 billion in mandatory spending cuts begin today
March 4, 2013
Beginning today, March 1, 2013, the federal spending cuts known as the "sequester" go into effect. The $85 billion in cuts that begin today are just the...
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FDA issues proposed rule to change requirements for use of foreign clinical data
March 4, 2013
On February 25, the United States Food and Drug Administration ("FDA") issued a proposed rule to update the standards for FDA acceptance of data from clinical...
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Legislation to be Introduced in U.S. Congress to Count Hospital Observation Stays Toward Three-Day Mandatory Inpatient Stay For Post-Acute Skilled Nursing Facility Services
February 28, 2013
Senator Charles Schumer (D-NY) announced on February 20 his intent to introduce legislation in the U.S. Senate that would require Medicare to count hospital observation...
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States Decide Whether to Run Health Insurance Exchanges
February 27, 2013
February 15, 2013 marked the deadline for states to decide whether they will run state-based health insurance exchanges, partner with the federal government to run the...
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Medicare Overpays for Infusion Drugs
February 26, 2013
The federal government pays between 54% and 122% more than the market price for infusion drugs under Medicare Part B because the drugs' prices are typically based on...
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HHS Publishes Final Rule Implementing ACA Essential Health Benefits
February 25, 2013
On February 20, 2013, the U.S. Department of Health and Human Services ("HHS") issued a final rule adopting standards established under the Patient Protection...
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Congressional Budget Office Publishes Report Detailing Slowing of Growth in Projected Medicare and Medicaid Payments
February 22, 2013
The Congress Budget Office ("CBO") has published a report entitled "The Budget and Economic Outlook: Fiscal Years 2013 to 2023." In its...
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Food Safety Newsletter
February 22, 2013
FDA to Hold Public Meetings on Two Major Food Safety Proposed Rules
FDA Issues Final Rule on the Administrative Detention of Food Under the FSMA...
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Senate HELP Subcommittee Hearing Addresses 30 Million Uninsured
February 21, 2013
On January 29, 2013, the U.S. Senate Committee on Health, Education, Labor, and Pensions, Subcommittee on Primary Health and Aging held a hearing to discuss the provision...
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340B Drug Pricing Program Continues to be a Focus of Interest of Certain Members of Congress and the Pharmaceutical Industry
February 21, 2013
The Health Resources and Services Administration's ("HRSA") 340B Drug Pricing Program is back in the news. Under the 340B program, drug...
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FDA Extends Comment Period for Information Collection Provisions Associated with Two FSMA Proposed Rules
February 20, 2013
FDA has decided to extend the comment period for the information collection provisions associated with the proposed rules on "Current Good Manufacturing Practice...
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Wisconsin and Indiana Governors Decline to Expand Medicaid
February 20, 2013
On February 13, 2013, Republican Governors Scott Walker of Wisconsin and Mike Pence of Indiana stated that they do not support expanding Medicaid in their states. ...
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Supreme Court Trims Scope Of State Action Antitrust Defense: Mere Authorization by State Will Not Suffice
February 20, 2013
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The Supreme Court has trimmed back the "state action" antitrust defense that shields conduct authorized by a state from federal antitrust challenge. In a...
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