News & Analysis as of

Medicare Part D

Holidays Come Early as CMS Proposes to Significantly Narrow Training Requirements Under Medicare Advantage and Part D Plan...

by Reed Smith on

A recent Centers for Medicare & Medicaid Services (CMS) proposed rule (the Proposed Rule) would mark the end of a heavily criticized and frequently revised compliance program training requirement currently imposed on Medicare...more

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more

Recent Congressional Actions Bring Drug Pricing Debate Back Into National Spotlight

by Holland & Knight LLP on

In late October, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011; H.R. 4138), which would allow the Department of Health and Human Services (HHS)...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans face a Friday deadline to approve a stopgap budget bill to avert a government shutdown, delaying until later this month key decisions on healthcare priorities like renewing children’s insurance and...more

CMS Issues Wide-Ranging Proposed Rule on Medicare Managed Care (Part C) and Prescription Drug Plans (Part D)

by King & Spalding on

On November 16, 2017, the Centers for Medicare & Medicaid Services(“CMS”) published for public inspection a proposed rule that would impact a variety of Medicare Part C and Part D program provisions. The proposed rule, ...more

Third Circuit Confirms Government Knowledge Can Defeat Scienter and Materiality Requirements for False Claims Act Liability

by Jones Day on

The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid...more

Capitol Hill Healthcare Update

by BakerHostetler on

Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities. That...more

CMS Proposes Key Changes to the Medicare Advantage Program

by Hogan Lovells on

On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify requirements for the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more

CMS Proposes Changes to Medicare Advantage, Part D Programs for 2019

by Reed Smith on

CMS has issued a proposed rule to update the Medicare Advantage (MA) program and Part D prescription drug benefit rules for contract year 2019. The proposed rule would, among many other things: Implement a Comprehensive...more

CMS Releases Major MA/Part D Proposed Rule

by Hogan Lovells on

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

CMS Releases CY 2019 Proposed Rule for Medicare Advantage and Part D

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the...more

CMS Releases Broad-Ranging Medicare Advantage and Part D Proposed Rule

by McDermott Will & Emery on

CMS released a broad-ranging proposed rule for the Medicare Advantage and Part D Programs on Thursday, November 16, 2017. The proposed rule addresses a broad and diverse range of MA and Part D regulatory requirements,...more

Health Care E-Note - October 2017

by Burr & Forman on

Health care providers are constantly receiving requests for copies of patient medical records. Some requests come by way of the patient exercising his/her right to access his/her medical records, some come by way of patient...more

Now Is the Time to Review Your Medicare Options

Are you happy with your current Medicare plan or plans? Now is the time to think about whether you are in the right plan or whether a new plan could save you money. Medicare's Open Enrollment Period, in which you can enroll...more

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

OIG Work Plan – September 2017 Update

by Baker Ober Health Law on

Beginning in June 2017, the OIG began making monthly Work Plan updates. These monthly updates create some practical challenges for health care providers and compliance professionals trying to make operational and compliance...more

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

by Baker Ober Health Law on

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

October 15th Deadline: Medicare Part D Notice Of Creditable (Or Non-Creditable) Coverage

by Fraser Trebilcock on

UPDATED: September 19, 2017 – Employers who offer prescription coverage to any Medicare Part D eligible employees (whether or not retired), or Medicare Part D Medicare-eligible spouses or dependents, you must provide those...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Blog: OIG Releases August Work Plan Items

by Cooley LLP on

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The August updates released this week include 4 new Work Plan items:...more

Opioid Epidemic Declared a National Emergency; Proposed Law Calls for Mandatory E-Prescribing of Controlled Substances to Curb...

by Dorsey & Whitney LLP on

Today, in a move that is widely supported by those in both political parties and across the country, President Trump declared the opioid epidemic a national emergency. Doing so will allow for additional resources to be used...more

Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed

by Blank Rome LLP on

As Congress continues to grapple over healthcare reform, there are many uncertainties. However, one thing is clear: as government healthcare funding shrinks, federal and state enforcement agencies will continue to target...more

DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

by Foley & Lardner LLP on

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal...more

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