News & Analysis as of

CMS Releases April 2015 Medicare Part B Drug ASP Update

CMS has posted its April 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts CMS will use to pay for Part B covered drugs for the second quarter of 2015....more

OIG Repeats Calls for Expanded Medicare Part B Drug Price Substitution Policy

The OIG has issued the latest in a long line of reports comparing Medicare Part B drug average sales prices (ASP) and average manufacturer prices (AMP), this time with a focus on 2013 pricing. By way of background, CMS has...more

Final Medicare Advantage/Part D Rule for Contract Year (CY) 2016

CMS has published a final rule revising Medicare Advantage (MA) and Part D prescription drug benefit regulations for CY 2016. Among other things, the final rule...more

CMS Takes a Measured Approach to Medicare Advantage and Part D Plan Payment Rates and Policy Changes for 2016

Increased Part D Drug Costs Set the Stage for Higher Beneficiary Premiums - The Advance Notice (“Advance Notice”) of Methodological Changes for Calendar Year (“CY”) 2016 for Medicare Advantage (“MA”) Capitation Rates,...more

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting...more

OIG Reports Lack of Oversight on Hospital Use of Compounded Drugs

On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more

The Overuse of Antipsychotic Drugs in Nursing Homes

Many nursing homes are improperly prescribing antipsychotic drugs to patients even though federal law restricts their use. Almost 300,000 nursing home residents are currently receiving antipsychotic drugs normally used to...more

Health Headlines: Also in the News - December 2014

CMS Extends Comment Period for Home Health Conditions of Participation Proposed Rule – As previously reported, on October 9, 2014, CMS published in the Federal Register a Proposed Rule that would revise the home health...more

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

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