Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

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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

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

Fourth Circuit & FTC: State Dental Board Subject to Federal Antitrust Laws in Teeth-Whitening Case

The health care industry is familiar with the FTC’s enforcement presence for anticompetitive business practices in health care markets. But in a case involving the market for teeth-whitening services in North Carolina, it...more

6/14/2013 - Competition Dentists FTC

Is Data Mining Coming to a State Medicaid Fraud Control Unit Near You?

Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in...more

6/5/2013 - Data Mining Federal Funding Fraud Healthcare HHS Medicare

The Pressure Is On: Deadline for States to Pass False Claims Laws Looms

What’s at stake for states that fail to bring their false claims laws in line with new federal standards by the August 31 deadline? A 10% share from settlements of Medicaid fraud lawsuits which, considering the $4.2 billion...more

5/29/2013 - Deadlines False Claims Act Fraud Medicaid

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 P&T Committees

OIG Approves Gift Cards to Encourage Clinical Visits to Health Center

In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under...more

1/10/2013 - Anti-Kickback Statute Gift-Cards Medicaid Medicare OIG

OIG Approves Hospital’s Electronic Interface Arrangement

In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback...more

12/21/2012 - Anti-Kickback Statute Hospitals OIG Safe Harbors Sanctions

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes...more

12/13/2012 - OIG Pharmacies Software

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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