Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

Contact  |  View Bio  |  RSS

Latest Posts › Healthcare

Share:

Will State Action on Biosimilars Thwart Anticipated Savings for Private and Government Health Care Programs?

Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more

6/4/2015 - Biologics Biosimilars Healthcare Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

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

4/10/2015 - Biosimilars Cancer CMS Healthcare Medicaid Medicare Medicare Part B Medicare Part D New Guidance Pharmaceutical Pharmaceutical Manufacturers

CMS Call Letter: Pharmacy Network Implications

As part of our continuing series on CMS’s 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks. In the Call Letter, CMS raises concerns about preferred...more

3/4/2015 - CMS Healthcare New Guidance Pharmacies

CMS Finalizes Policy Rules For Medicare Parts C and D

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year...more

2/17/2015 - CMS Final Rules Healthcare Medicare Medicare Advantage Medicare Part C Medicare Part D

Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more

11/5/2014 - Affordable Care Act CMS Healthcare Healthcare Reform HHS Medicare Medicare Part D OIG

CMS Proposes Major Changes to Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

CMS Proposes Major Rule Changes to Increase Payment Accuracy and Improve Program Integrity in Medicare Part C and Part D

On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more

3/10/2014 - CMS Healthcare Medicare Medicare Part C Medicare Part D Pharmaceutical Prescription Drugs

Record Numbers for Medicare Fraud Task Force Prosecutions in 2013

On January 27, 2014, the U.S. Department of Justice issued a press release announcing that its Medicare Fraud Task Force had “set record numbers for health care prosecutions in Fiscal Year 2013.” ...more

1/30/2014 - DOJ Fraud Healthcare Healthcare Fraud Medicare

What Do the Proposed Changes to Medicare Parts C and D Mean For Your Business?

On January 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs. If...more

1/23/2014 - Healthcare Healthcare Reform Medicare Medicare Part C Medicare Part D

HHS Announces That ACA Exchange Plans Are Not “Federal Health Care Programs”

In a surprising move late last week, HHS Secretary Kathleen Sebelius announced that qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) insurance exchanges are not “federal health care programs”...more

11/5/2013 - Affordable Care Act Anti-Kickback Statute Health Insurance Exchanges Healthcare HHS Qualified Health Plans

Caution: Risk Adjustment Hurdles Facing Plans and Providers Under the Affordable Care Act

January 1, 2014 is fast approaching and regulators, payor organizations, providers, and many other interested parties are working to implement, operationalize, and participate in the state-based American Health Benefit...more

7/22/2013 - Affordable Care Act Deadlines Delays Employer Mandates Health Insurance Exchanges Healthcare Pay or Play Shared Responsibility Rule

OIG Issues Favorable Advisory Opinion Regarding Tiered Rebate Program

Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the “Requestor”) tiered rebate program (the “Proposed Arrangement”)....more

7/2/2013 - Healthcare Medical Devices OIG Rebates Safe Harbors

Will “Skinny” Health Care Plans Help Employers Escape Hefty Penalties?

Recent stories in the media on low-cost or “skinny” group health care plans may have some employers thinking their prayers have been answered. Under the Affordable Care Act, those who don’t offer health insurance coverage to...more

6/24/2013 - Affordable Care Act Employer Group Health Plans Healthcare Penalties

Is Data Mining Coming to a State Medicaid Fraud Control Unit Near You?

Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in...more

6/5/2013 - Data Mining Federal Funding Fraud Healthcare HHS Medicare

14 Results
|
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×