News & Analysis as of

OIG's 2015 Work Plan Highlights Departmental Priorities

Each year the Department of Health and Human Services, Office of the Inspector General (OIG) issues its Work Plan to identify for the provider community the key fraud and abuse issues on which it will focus on in the coming...more

Report Shows CMP Enforcement Actions On the Rise Against Part C and Part D Sponsors

A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013....more

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

Risks of Over-Medicating Residents and Potential Liability Under the FCA

According to the Complaint, Country Villa Watsonville East Nursing Center (now Watsonville Nursing Center) and Country Villa Watsonville West Nursing and Rehabilitation Center (now Watsonville Post-Acute Center) “persistently...more

CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that...more

OIG Reports that Two MACs are Responsible for $4 Million in Overpayments for Outpatient Drugs

According to two reports issued by OIG on July 25, the Medicare Administrative Contractors (MACs) for Jurisdictions 13 and 14 made overpayments of approximately $2.7 million and approximately $1.3 million, respectively, for...more

Health Headlines: Also in the News - July 2014 #3

CMS Revises Medicare Advantage and Part D Prescription Drug Plan Prior Authorization Requirement for Hospices – On July 18, 2014, CMS released a revised a memorandum outlining responsibility for drug payments for hospice...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

Health Headlines: Also in the News - June 2014 #4

CMS Holds Medicare Advantage and Prescription Drug Oversight and Enforcement Conference – On June 24, 2014, CMS offered an in-person program that instructed Medicare Advantage and Part D providers as to how they could...more

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

No More He-Said-She-Said: Revised Regulations Allow CMS to Request Records Information Directly from any Person or Entity Involved...

The Centers for Medicare & Medicaid Services (CMS) on May 19, 2014, adopted a final rule that significantly revised Medicare Advantage (MA) and Part D prescription drug benefit program regulations (the “Final Rule”). One of...more

CMS Announces Final Regulatory Changes to Medicare Advantage and Part D

- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year. - New requirements for the reporting and return of Medicare Advantage and Part D...more

CMS Changes to Medicare Advantage and Prescription Drug Benefit Programs for Contract Year 2015

On May 19, 2014, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule, published in the Federal Register on May 23, 2014, that sets forth changes to requirements for Medicare Advantage (“MA”) and...more

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The Office of the Inspector General (OIG) for HHS recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (OIG Report) in which it recommended that CMS implement changes to the way...more

CMS Issues Pared-Down Final Rule on Medicare Part D and Medicare Advantage

CMS recently issued a Final Rule with respect to the Medicare Part D and Medicare Advantage programs (the “Final Rule”) implementing certain Affordable Care Act provisions. The Final Rule follows a January 10, 2014 Notice of...more

CMS Scaled Back Changes to the Medicare Part D Prescription Drug and Medicare Advantage Programs, but Some Important Revisions...

On May 19, 2014, the Centers for Medicare & Medicaid Services ("CMS") released a final rule ("Final Rule") completing changes to the Medicare Program's outpatient prescription drug benefit ("Part D") program and the Medicare...more

DMEPOS Competitive Bidding Program: CMS Begins to Move Toward Nationwide Implementation and Seeks Public Comments Regarding...

The Centers for Medicare & Medicaid Services ("CMS") recently announced that the agency is seeking public comments as it moves toward nationwide implementation of the Medicare Durable Equipment, Prosthetics, Orthotics, and...more

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

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

Senate Finance Committee Urges CMS Not to Reduce “Protected Classes” Under Part D

In a February 5, 2014 letter signed by every member of the Senate Finance Committee (13 Democrats; 11 Republicans), Committee members “strongly urge[d]” CMS not to finalize proposed Part D changes that would reduce the number...more

CMS Clarifies Broad Scope of Hospices' Payment Responsibility for Part D Drugs

In a December 6, 2013 memorandum [PDF] to all Medicare hospice providers and Part D plan sponsors, CMS expressed concern that drugs covered under the Part A hospice benefit are being billed to Part D inappropriately....more

CMS Proposes Far-Reaching Changes to the Medicare Part D Prescription Drug Benefit Program and the Medicare Advantage Program

On January 10, 2014, the Centers for Medicare & Medicaid Services ("CMS") published a proposed rule ("Proposed Rule") setting forth sweeping changes to the Medicare Program's outpatient prescription drug benefit ("Part D")...more

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