Prescription Drug Coverage

News & Analysis as of

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

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 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

Battle Over Cost of Drugs Ratchets Up

The battle over the rising costs of drugs, fueled by Gilead’s Hepatitis C drug Sovaldi that costs $84,000 for a 12 week treatment regimen, intensified this week. Critics of the cost have taken to referring to the drug as the...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

OIG Proposes Rule to Implement Expanded Civil Monetary Penalty Authority under the ACA

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations (Proposed Rule)....more

OIG Issues Proposed Rules on Its Exclusion and CMP Authorities

OIG has issued two proposed rules that would expand the agency’s ability to impose certain sanctions on entities and individuals involved with Federal health care programs. OIG’s first proposed rule—published in the Federal...more

Health Care Update

In This Issue: - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming Hearings and Markups -...more

CMS Proposes Significant Rate Cuts and Other Changes to Medicare Advantage and Prescription Drug Plans

The Advance Notice ("Advance Notice") of Methodological Changes for Calendar Year ("CY") 2015 for Medicare Advantage ("MA") Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter was released by the Centers...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

CMS Suggests Significant Changes to Medicare Part D and Medicare Advantage Prescription Drug Plans

The Centers for Medicare and Medicaid Services, CMS, recently issued a Proposed Rule that would initiate important changes to prescription drug plans under Medicare Part D and Medicare Advantage. Comments can be submitted...more

CMS Attributes Significant Out-of-Pocket Savings for Medicare Beneficiaries to Health Care Reform Efforts

On October 28, 2013, CMS announced that Medicare beneficiaries are realizing significant out-of-pocket savings as a result of health care reform efforts. The savings are based on cumulative savings in the prescription drug...more

Staying the Course: HHS Finalizes the Essential Health Benefits Regulations for 2014

The U.S. Department of Health and Human Services (HHS) Essential Health Benefits Final Rule and actuarial value regulations offer few surprises and much needed certainty to enable group health plans and health insurance...more

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