Medicare Part B

News & Analysis as of

The Soon-to-be Reality of Medicare Part B Reimbursements for Biosimilars

As the country’s largest health insurer, Medicare has immense influence on the health care market. In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, last month the...more

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

Also In The News - Health Headlines - April 2015

Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

Placing Medicare Beneficiaries Into "Observation Status" - Recent Second Circuit Decision Casts Doubt on Lawfulness of CMS...

The trend toward placing more Medicare beneficiaries into observation status in the hospital has come under increasing attack by patient advocates. Such patients are considered outpatients reimbursed by Medicare Part B rather...more

CMS Releases April 2015 Medicare Part B Drug ASP Update

CMS has posted its April 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts CMS will use to pay for Part B covered drugs for the second quarter of 2015....more

GAO Report Highlights Improper Medicare/Medicaid Payments

Despite the efforts of the Department of Health and Human Services (HHS) to combat fraud and contain costs in federal healthcare programs, Medicare’s fee-for-service program (Parts A and B) and Medicaid were two of the top...more

OIG Repeats Calls for Expanded Medicare Part B Drug Price Substitution Policy

The OIG has issued the latest in a long line of reports comparing Medicare Part B drug average sales prices (ASP) and average manufacturer prices (AMP), this time with a focus on 2013 pricing. By way of background, CMS has...more

Partial Relief for Employer Payment of Individual Insurance Premiums

In a recent notice, the Internal Revenue Service has tempered prior guidance that closed the door on employer arrangements for paying the cost of individual health insurance for employees. The IRS still views these premium...more

CMS Releases CY 2015 Outpatient PPS/Ambulatory Surgical Center Final Rule

On October 31, 2014, CMS issued its CY 2015 outpatient and ambulatory surgical center (ASC) PPS final rule. CMS finalized a net payment rate increase of 2.2 percent under the OPPS. This figure includes a 2.9 percent market...more

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

Health Care Reform Implementation Update

In the past week, CMS has released several advisories including updates to the rating system for nursing homes, premium and deductible information for Medicare Part B and Part D for 2015, Pioneer ACO results, payment dispute...more

District Court Rejects Hospitals' Challenge to CMS's Rebilling Policy

On September 17, the United States District Court for the District of Columbia ruled that it lacked jurisdiction over a challenge brought by the American Hospital Association (AHA) and several hospitals and systems (the...more

Health Reform + Related Health Policy News - September 2014, Issue 1

In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more

OIG Reports Medicare Part B Supplying and Dispensing Fees Significantly Higher Than Those Under Part D and Medicaid

According to a recently released report from the HHS OIG, pharmacies are reimbursed significantly more for dispensing drugs under Medicare Part B than they would be for dispensing the same drugs under Medicare Part D and...more

Court Dismisses AHA’s Challenge to CMS Billing Policy

On September 17, 2014, the U.S. District Court for the District of Columbia dismissed a lawsuit brought by the American Hospital Association (AHA), three individual hospitals, and two health care systems that challenged CMS’s...more

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more

New Clarifications Affect Physician and Hospital Medicare Part B Billing for Services Provided by Nursing and Other Staff...

CMS recently released rules changing the requirements for Medicare coverage of services furnished incident to a physician’s, NP’s, or PA’s services. Howard Sollins, Donna Senft and Susan Turner explain the effect of the...more

OIG Report Recommends Increased Scrutiny of Over 1000 Laboratories With Questionable Billing for Medicare Part B Clinical...

According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more

CMS Releases Proposed 2015 Physician Fee Schedule and Outpatient Prospective Payment System Rules

On July 3, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released its proposed Calendar Year (“CY”) 2015 Physician Fee Schedule (“PFS”) Proposed Rule, to be published in the Federal Register on July 11, 2014....more

OIG Report: Questionable Billing for Medicare Part B Clinical Laboratory Services

Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more

Quantifying and addressing improper payments for Medicare evaluation and management services

A review of Medicare Part B claims for evaluation and management (E/M) services conducted by the Office of the Inspector General (OIG) has found that the program paid $6.7 billion in improper payments in 2010. This figure...more

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The Office of the Inspector General (OIG) for HHS recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (OIG Report) in which it recommended that CMS implement changes to the way...more

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