Bridgette Wiley

Bridgette Wiley

Mintz Levin

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HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more

6/23/2015 - Civil Monetary Penalty CMS Drug Pricing HRSA Medicaid Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Section 340B

Government Announces Health Care Fraud “Takedown”

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712...more

6/19/2015 - Anti-Kickback Statute Health Care Providers Healthcare Fraud Home Health Care Home Healthcare Workers Medicare Medicare Fraud Strike Force Medicare Part D Nurses Physicians

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: June 2015

Trends & Analysis: ..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case...more

6/8/2015 - Anti-Kickback Statute Clinical Trials False Claims Act Hospitals Medical Devices Qui Tam Whistleblower Protection Policies Whistleblowers

Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to...more

6/8/2015 - CMS Healthcare Providers Managed Care Contracts Medicaid

3 Key Take Aways from AHLA’s Institute on Medicare and Medicaid Payment Issues

Last week I attended the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland. Taking a comprehensive approach to reimbursement issues, the program offered a variety of...more

4/3/2015 - Data Collection Healthcare Healthcare Fraud Medicaid Medicare Professional Conferences

CMS Call Letter: Medicare Advantage Contracting Considerations

As a final addition to our series on the 2016 Draft Call Letter, we highlight some of the MA contracting issues raised by the Centers for Medicaid and Medicare Services (“CMS”). Specifically, CMS (1) recommends Medicare...more

3/9/2015 - CMS Healthcare Managed Care Contracts Medicare Medicare Advantage

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

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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