Bridgette Wiley

Bridgette Wiley

Mintz Levin

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CMS Issues Rewards and Incentive Guidance to MA Plans

On December 4, 2014, CMS issued additional guidance regarding rewards and incentives programs (“RI Programs”). This guidance elaborates on whether an RI Program can target members with specific diseases, whether rewards can...more

12/19/2014 - CMS Healthcare Incentives New Guidance

D.C. Circuit Upholds Contraceptive Coverage Mandate

Last week, a unanimous three-judge panel of the D.C. Circuit upheld the religious accommodation to the Affordable Care Act’s (“ACA”) contraceptive coverage mandate (Priests for Life v. HHS, D.C. Cir. No. 13-5368, Nov. 14,...more

11/21/2014 - Affordable Care Act Contraceptive Coverage Mandate DOL Employer Mandates HHS Reasonable Accommodation Religious Freedom Restoration Act

The Contraception Coverage Controversy Continues…

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more

10/31/2014 - Affordable Care Act Burwell v Hobby Lobby Contraceptive Coverage Mandate Contraceptives DOL Employer Mandates FDA First Amendment HHS Religious Exemption Religious Freedom Restoration Act SCOTUS

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

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...more

10/24/2014 - Co-payments Coupons Health Insurance Healthcare Medicare Medicare Part D OIG Pharmaceutical Pharmaceutical Manufacturers Pharmacies Physicians Prescription Drugs

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

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

10/16/2014 - False Claims Act Healthcare Medicare Part D Pharmaceutical Pharmacies Prescription Drugs Qui Tam

Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide...

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of...more

9/4/2014 - Affordable Care Act Contraceptive Coverage Mandate FDA Healthcare HHS Religion Religious Exemption TPAs

Keeping Legal Advice In-House: Protecting the Attorney-Client Privilege

Given that laboratories operate in a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with the many laws and regulations that govern the laboratory industry. Luckily the...more

5/30/2014 - Attorney-Client Privilege Corporate Counsel False Claims Act Whistleblowers

Notice to Plans and PBMs: Pay for Contraceptive Services and Maybe We Will Pay You Back

As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no...more

2/18/2014 - Affordable Care Act Benefit Plan Sponsors Contraceptive Coverage Mandate Contraceptives Employee Benefits FDA Healthcare HHS

OIG Plans to Fight Fraud, Waste, and Abuse While Promoting Quality, Safety, and Value in 2014

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for Fiscal Year 2014 on January 31, 2014. The Work Plan provides insight into the OIG’s priorities by providing...more

2/12/2014 - Fraud Fraud and Abuse HHS OIG Strategic Enforcement Plan UDAAP

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

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