Prescription Drug Coverage

News & Analysis as of

GAO Report Concludes Prescribing Incentives Exist at 340B Hospitals

According to a report released July 6, 2015 by the Government Accountability Office (GAO), hospitals that qualify to participate in the 340B Drug Pricing Program by virtue of their serving a disproportionate share of...more

Health Update - July 2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

GAO Recommends Congress Reduce Incentives for Prescribing 340B Drugs

The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more

GAO Report Examines Hospital Financial Incentives to Prescribe 340B Drugs to Medicare Beneficiaries

The Government Accountability Office (GAO) has issued a report examining financial and other characteristics of hospitals that participate in the 340B Drug Pricing Program, focusing on disproportionate share hospitals (DSH)...more

Part D Woes, According to the OIG

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

What does "will be insured" actually mean?

Balancing obligations to provide health and life insurance benefits to retirees with other legitimate business needs can be tricky. Although retirees depend on the benefits, employers may need to modify benefit plans for...more

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

Dentists Who Write Prescriptions Must Make a Decision: Enroll in Medicare or Opt-Out

If you are a dentist who writes prescriptions to Medicare beneficiaries for drugs covered under Medicare Part D, this article contains important information for you and your patients regarding your new enrollment requirements...more

CMS Proposes Overhaul of Medicaid and CHIP Managed Care Rules

On May 26, 2015, the Centers for Medicare and Medicaid Services (CMS) released a notice of proposed rulemaking (NPRM) to overhaul the regulations governing Medicaid managed care and make conforming changes to the rules that...more

NDRC Issued Opinions and Notice on Drug Price Reform

On May 4, 2015, the National Development and Reform Commission (“NDRC”) and seven agencies including the National Health and Family Planning Commission and the Ministry of Human Resources and Social Security jointly published...more

The Saga Continues: CMS Further Delays Enforcement of Medicare Enrollment Requirements for Prescribers of Part D Drugs

The Centers for Medicare & Medicaid Services (CMS) on June 1, 2015, published its “Medicare Part D Prescriber Enrollment Requirement Update” (Update). The Update further delays—until June 1, 2016—enforcement of the regulatory...more

CMS Guidance on Beneficiary MA Drug Plan Disenrollments by Long Term Care Facilities

CMS has released guidance for long term care (LTC) facilities, including nursing facilities and skilled nursing facilities, on beneficiary disenrollments. According to the guidance, “CMS continues to see an unacceptable...more

HHS Revises, Delays Medicare Enrollment Requirements for Part D Prescriptions

The Affordable Care Act authorized the Department of Health and Human Services (HHS) to require a physician, dentist or other healthcare provider to be enrolled in the Medicare program before they can issue a prescription...more

CMS Issues Interim Final Rule Reaffirming Requirements for Prescribers of Part D Drugs

The Centers for Medicare & Medicaid Services (CMS) on May 6, 2015, published an interim final rule with comment period (Interim Rule) modifying the regulatory requirement that health care professionals enroll in or opt out of...more

340B ‘Mega-Guidance’ Arrives at OMB

On May 6, 2015, the Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. ...more

CMS Issues Interim Part D Rule Expanding Beneficiary Access to Covered Drugs

On May 1, 2015, CMS issued an interim final rule with comment period revising certain requirements related to beneficiary access to covered Part D drugs. This interim final rule modifies a prior final rule published on May...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

Important Recommendations from the MedPAC March Report to Congress, Part One

Each March, the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) is tasked with reporting to Congress on the current state of the Medicare fee-for-service (“FFS”) payment systems, the Medicare Advantage...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

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But...more

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as...more

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...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

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