News & Analysis as of

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

Manatt on Health Reform: Weekly Highlights - November 2015 #2

With the election of a new Governor, the future of Kentucky’s Marketplace and Medicaid expansion is uncertain; CMS questions Iowa on its Medicaid managed care transition timeline; and the Supreme Court agrees to hear a case...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more

Washington Healthcare Update

Elections for Speaker of the House and Potential Changes at Ways and Means Committee - Rep. Paul Ryan (R-WI) announced Tuesday (Oct. 20) that he will run for the House Speaker position if the major House Republican...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

MedPAC Convenes to Discuss Open Payments, Payment for Post-Acute Care, and Other Issues

On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more

Washington Healthcare Update

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

Sandoz’s Zarxio® Launches with 15% Wholesale Discount

On September 3, 2015, Sandoz Inc. (“Sandoz”) announced that it launched the first biosimilar in the United States, Zarxio® (filgrastim-sndz). Sandoz began marketing Zarxio® following a Federal Circuit Order to permit it to...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Washington Healthcare Update

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Also In The News - Health Headlines - July 2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

Blog: CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more

Blog: 2014 Open Payments Infographic

Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49...more

Blog: Minimal Media Interest to Date in Recently-Released Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released last week the 2014 Open Payments data, the first release of data reported by applicable manufacturers and group purchasing organizations (GPO) for a full calendar...more

2014 CMS Open Payments Data Released

On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

Washington Healthcare Update

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

CMS Posts July 2015 Medicare Part B Drug Payment Files

CMS has released the July 2015 update to the Medicare Part B average sales price (ASP) files. CMS notes that prices for the top Part B drugs increased by 0.5% on average compared to the previous quarter, and prices changed...more

Washington Healthcare Update

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

Also In The News - Health Headlines - May 2015

New Medicare Prescription Drug Cost Data Available – On April 30, 2015, CMS announced the availability of new, privacy-protected data on Medicare Part D prescription drugs prescribed by physicians and other health care...more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

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