Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

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Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to...more

3/16/2016 - CMS Drug Pricing Medicare Part B PHRMA Prescription Drug Coverage

Amidst the Raucous Debate in D.C., States Quietly Take Action on Rising Prescription Drug Prices

Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would...more

2/16/2016 - Ballot Measures CMS Drug Pricing Gilead Sciences HHS Medicare Part D Pharmaceutical Industry Presidential Elections Price Transparency Proposed Legislation

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

2/12/2016 - Affordable Care Act CMS Drug Pricing Fair Market Value Final Rules Medicaid Pharmaceutical Industry Pharmacies

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

12/9/2015 - AstraZeneca Biosimilars CMS DOJ Drug Pricing FDA Approval HRSA Kickbacks Kmart Novartis Pharmaceutical Industry Pharmacies Section 340B Value-Based Purchasing

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 Industry

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 Abandons Certain Controversial Provisions in its Proposed Medicare Part D Rule

Following an onslaught of criticism, CMS told Congress today that it will not move forward with certain controversial provisions of its proposed rule on the Medicare Advantage and Medicare Part D prescription drug program. ...more

3/11/2014 - CMS Medicare Medicare Advantage Medicare Part D

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 Industry 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 Industry Prescription Drugs

CMS Proposes Major Changes to Medicare Parts C and D

On January 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

1/22/2014 - CMS Medicare Medicare Part C Medicare Part D

CMS Declares Third Party Payment of QHP Premiums Not OK

On the heels of HHS’s recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback...more

11/6/2013 - Affordable Care Act Anti-Kickback Statute CMS HHS Premiums Qualified Health Plans Third-Party

CMS Issues Star Ratings for the 2014 Plan Year

On October 11, 2013, CMS posted the 2014 Medicare Health Plan Quality and Performance Ratings, which are commonly referred to as “Star Ratings.” CMS released the 2014 Star Ratings several days later than originally...more

10/15/2013 - CMS Health Plan Sponsors Medicare Ratings Sponsors

Court Rejects Urologists’ Appeal to Overturn Regulatory Changes to Stark Law

The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services (CMS) illustrates. The Council for Urological Interests, a...more

6/20/2013 - CMS Physician-Owned Distributors Stark Law

2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes

After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more

4/17/2013 - Beneficiaries CMS Controlled Substances Medical Reimbursement Plans Medicare Advantage Modification Pharmacies Point of Sale Terminals Prescription Drugs Waivers

OIG Report Critical of P&T Committee Oversight

In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees...more

3/12/2013 - CMS Conflicts of Interest Medicare OIG

Medicare Star Ratings – What Plan Sponsors Need to Know By Theresa C. Carnegie and Roy M. Albert

Originally published in BNA’s Medicare Report, 11/30/2012. On Oct. 12, the Centers for Medicare & Medicaid Services published its 2013 Medicare Health Plan Quality and Performance Ratings, also called ‘‘Star Ratings’’...more

12/3/2012 - Affordable Care Act CMS Medicare

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