Prescription Drugs

News & Analysis as of

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

Minnesota Session Ends With Governor Threatening Veto

The Minnesota legislature concluded its business last evening with Governor Mark Dayton threatening to veto a $17 billion public education funding bill – a threat he carried through with earlier today. The governor issued the...more

Sweet Home No More, Innovator Liability Leaves Alabama

On May 1, 2015, Alabama Gov. Robert Bentley signed into law a bill to “provide that a manufacturer is not liable ... for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by state...more

Senator Asks Department of Veteran Affairs to Break Patents on Hepatitis C Drugs

Last week, in a letter addressed to the Secretary of the U.S. Department of Veteran Affairs, Senator Bernard Sanders (I-VT) urged Secretary Robert McDonald to use his authority as Secretary "to break the patents on Hepatitis...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

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more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

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...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

Health Care Update - May 2015 #2

In This Issue: - 340B Drug Discount Program Guidance Nearing Finish Line - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

Health Alert (Australia) - May 11, 2015

In This Issue: Judgments, Legislation; and Reports and Publications. Excerpt from Legislation: Commonwealth - 5 May 2015 - Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue...more

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...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

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...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

Republican HELP Committee Members Request FDA to Step Up Finalizing Biosimilars Guidances and Transparency

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar...more

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...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

Special Update: OPA Sends 340B Program Omnibus Guidelines to Office of Management and Budget

On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...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

Illusory Economic Loss Theory Held “Absurd” – Class Action Dismissed

As anyone can tell from our class action scorecards (federal and state), plaintiffs have not done very well lately – lately being the last couple of decades – with class actions involving alleged injuries caused by...more

Alabama Governor Signs Bill Quashing Innovator Liability Claims

On May 1, 2015, Alabama Governor Robert Bentley signed SB80, which expressly bars liability claims against manufacturers that did not design or make the product that a plaintiff actually ingested or used. While at first...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - May 2015

- A Cautionary Tale: Takes One to Know One - Treatment with Drugs - Treatment with Exercise - Treatment with Modalities - Treatment with Injections - Quality Control for Pain Relief - Excerpt from Introduction:...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

OMB Reviewing New HRSA 340B Omnibus Guidelines

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. ...more

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