Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

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Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

7/29/2015 - Biosimilars FDA Notification Requirements Orange Book Pharmacies Pharmacist

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

IRS Ruling Permits Inclusion of “Friendly PCs” in Consolidated Federal Income Tax Returns

On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the...more

2/19/2015 - Corporate Practice of Medicine Corporate Taxes IRS Management Companies Physicians Private Letter Rulings

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

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

10/21/2014 - Affordable Care Act Ambulance Providers Anti-Kickback Statute CMP Law Gainsharing Hospitals OIG Pharmacies Physicians Proposed Regulation Safe Harbors

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more

10/10/2014 - Ambulance Providers Anti-Kickback Statute Cost-Sharing Medicare Part D OIG Proposed Regulation Safe Harbors

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

8/13/2014 - Drug Manufacturers Generic Drugs Marketing OIG Pharmaceutical Prescription Drugs

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 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

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

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

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

OCR Guidance to Address HIPAA Marketing Turmoil

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services (“HHS”) has committed to issuing guidance by September 23rd (the compliance date for...more

9/13/2013 - Compliance Deadlines HHS HIPAA HIPAA Omnibus Rule Marketing OCR

HIPAA Marketing Rules Prompt First Amendment Challenge

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

9/11/2013 - ACOs First Amendment Free Speech HIPAA HIPAA Omnibus Rule Hospital Readmission Marketing Medicare Advantage Pharmaceutical Prescription Drugs

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more

8/8/2013 - Ancillary Agreements Civil Monetary Penalty GAO HHS Medicare OIG Stark Law

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

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