Prescription Drugs Centers for Medicare & Medicaid Services

News & Analysis as of

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...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 Posts July 2015 Medicare Part B Drug Payment Files

CMS has released the July 2015 update to the Medicare Part B average sales price (ASP) files. CMS notes that prices for the top Part B drugs increased by 0.5% on average compared to the previous quarter, and prices changed...more

Washington Healthcare Update

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...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

Washington Healthcare Update

This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

Health Care Update - May 2015 #4

In This Issue: - House Energy and Commerce Unanimously Advances 21st Century Cures Legislation - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional...more

21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace...more

CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

CMS Updates Part D Prescribing Regulations

CMS published an interim final rule with comment period (IFC) on May 6, 2015 that modifies a previously-adopted regulatory requirement regarding qualifications to prescribe Part D drugs. By way of background, under a final...more

Also In The News - Health Headlines - May 2015 #2

CMS Publishes Corrected Comment Deadline for FY 2016 IPPS and LTCH Proposed Rule; Comments Due by June 16, 2015 – On May 5, 2015, CMS published in the Federal Register a corrected comment period for the FY 2016 Medicare IPPS...more

CMS Changes Medicare Prescriber Enrollment Requirements

On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,...more

New Data on Part D Prescription Drugs Available

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare...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

Also In The News - Health Headlines - May 2015

New Medicare Prescription Drug Cost Data Available – On April 30, 2015, CMS announced the availability of new, privacy-protected data on Medicare Part D prescription drugs prescribed by physicians and other health care...more

CMS Amends Medicare Part D Program Integrity Regulations to Facilitate Beneficiary Access and Expand Coverage for Pharmacist...

On May 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule with comment period (“IFC”) that amends Medicare program integrity regulations requiring prescribers to either enroll in...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

The Soon-to-be Reality of Medicare Part B Reimbursements for Biosimilars

As the country’s largest health insurer, Medicare has immense influence on the health care market. In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, last month the...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....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

CMS Announces Key 2015 Compliance Priorities for Federally Facilitated Exchange Plans

The Centers for Medicare & Medicaid Services (“CMS”) recently announced its 2015 key priorities for compliance reviews of qualified health plans (“QHPs”) offered in the federally facilitated marketplaces (“FFMs”). Through a...more

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million...more

Washington Healthcare Update

This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute...more

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

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