Bridgette Keller

Bridgette Keller

Mintz Levin

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Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

8/22/2016 - Appeals Commerce Clause Proposed Rules Sherman Act State Action Immunity State Medical Board Statute of Limitations Telemedicine

New Materials Help Covered Entities Comply with Nondiscrimination Rules

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557...more

7/25/2016 - Affordable Care Act Covered Entities Grievance Process HHS Non-Discrimination Rules OCR Section 1557

New Rules for ACOs in the MSSP

CMS issued a final rule, published in the Federal Register on Friday, June 10, 2016, updating how the performance of ACOs participating in the Medicare Shared Savings Program (MSSP) is measured and compensated. This rule is...more

6/16/2016 - ACOs Benchmarking CMS Final Rules Medicare Medicare Shared Savings Program

Massachusetts Establishes Road-Map for New ACO Program

Massachusetts Secretary of Health and Human Services, Marylou Sudders, held a public meeting earlier this week to receive feedback on the proposal of the Executive Office of Health and Human Services (EOHHS) to overhaul the...more

4/22/2016 - ACOs HHS State Medicaid Programs

Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more

3/31/2016 - Clinical Laboratory Testing CMS Final Rules PAMA Sunshine Act

CMS Releases 2017 Advance Notice and Draft Call Letter

Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017...more

3/1/2016 - CMS Employer Group Health Plans Medicare Advantage Medicare Part D Prescription Drugs Star Ratings Substance Abuse Waivers

Groundbreaking Multi-Payer Alignment on Core Measures for Quality-Based Payments

For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense. Both public and private payers had their own proprietary reporting metrics,...more

2/24/2016 - CMS Health Care Providers HHS Medicaid Proprietary Information Provider Payments Quality of Care Standards

The Managed Care Industry – 2015 Year in Review

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016. Industry Consolidation – The Changing Landscape...more

1/6/2016 - ACOs Affordable Care Act Healthcare Hospital Mergers Managed Care Contracts MCOs Medicare Part D Provider Payments Shared Savings Program

HHS Drug Pricing Forum Highlighted in ML Strategies’ Health Care Update

This week’s ML Strategies Health Care Update highlights the recent Department of Health and Human Services (HHS) forum on prescription drug costs, which featured players from every corner of the industry, including top...more

11/25/2015 - Competition Congressional Investigations & Hearings Drug Pricing HHS Prescription Drugs Transparency

Government Finalizes Religious Accommodation, But What About Health Plans, TPAs and PBMs?

In a set of rules published last week, the government finalized a July 2010 interim final rule (“IFR”) related to coverage of certain preventive services and an August 2014 IFR regarding the definition of an eligible...more

7/21/2015 - Affordable Care Act Burwell v Hobby Lobby Closely Held Businesses Contraceptive Coverage Mandate Contraceptives DOL EBSA Employer Group Health Plans Exceptions Health Insurance HHS Injunctions IOM IRS Non-Grandfathered Health Plans OTC Pharmacies Religious Accommodation TPAs

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 Industry 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 (FCA) 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 Health Care 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 Industry 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 (FCA) Healthcare Medicare Part D Pharmaceutical Industry 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 (FCA) Whistleblowers

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