On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions to stakeholders, covering such topics as:
Continue Reading FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes should be enacted in connection with repealing and replacing “ObamaCare.” Specifically, the plan states that Congress must:

Remove barriers to

On February 9, 2016, President Obama is scheduled to submit his proposed fiscal year 2017 budget to Congress.  Two Congressional committees have planned hearings to examine provisions of the proposed budget involving the Department of Health and Human Services (HHS), with HHS Secretary Sylvia Mathews Burwell testifying.  Specifically, the House Ways and Means Committee has

On November 4, 2015, the House Energy and Commerce Health Subcommittee approved the following health policy bills:

  • HR 2646, the Helping Families in Mental Health Crisis Act – includes a series of reforms intended to improve federal mental health research, screening, and treatment programs, some of which have met with strong opposition from

On November 20, 2015, the Department of Health and Human Services (HHS) is hosting a public forum in Washington DC to explore pharmaceutical innovation, access, affordability and better health. While attendance is by invitation only, an invitation can be requested by contacting hhspharmforum@mitre.org. There will also be a live webcast of the event.

In light of continuing indicators of potential prescription-medication fraud and abuse in state Medicaid programs, the Government Accountability Office (GAO) has reviewed federal and state pharmacy-related policies and processes to prevent and detect such abuses. The GAO identified two potential controls that are not included in CMS’s current reporting requirements: (1) lock-in programs for noncontrolled

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 intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.

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. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by

On March 27, 2015, the Obama Administration released its National Action Plan for Combating Antibiotic Resistant Bacteria (NAP), a five-year, government-wide plan to address the spread of resistant bacteria. The main components of the strategy, which identifies roles for the public and private sectors, are as follows:

  1. Slow the emergence of resistant bacteria and prevent

The Government Accountability Office (GAO) has issued a report examining the extent to which antipsychotic drugs are prescribed for older adults with dementia in nursing homes and other settings. The GAO found that, according to Medicare Part D data, about one-third of older adults with dementia who spent more than 100 days in a nursing

On April 1, 2015, the FDA is hosting a workshop entitled “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” The workshop will update the public on ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs. The workshop will also

CMS has announced that it is holding series of meetings in May 2015 to discuss pending  Healthcare Common Procedure Coding System (HCPCS) applications. The meeting dates are as follows:

May 7 & 8 — Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents
May 21 & 22 — Supplies and Other
May 27 — Durable Medical Equipment (DME) and Accessories

The House Energy and Commerce Subcommittee on Health will hold a hearing on Thursday, March 5, 2015 on “Examining the 340B Drug Pricing Program,” focusing on the functionality of the program and the extent to which it meets its goal of improving access to prescription drugs for needy patients at facilities serving these populations. Scheduled

CMS has published a final rule revising Medicare Advantage (MA) and Part D prescription drug benefit regulations for CY 2016. Among other things, the final rule:

  • Implements a statutory provision requiring MA and Part D contracts to provide the right to “timely”’ inspection and audit and allowing CMS to require MA organizations or Part

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 proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) during expected debate in the coming months on Medicare physician fee schedule (MPFS) reform legislation or during future budget negotiations. The following is a summary of the major Medicare, Medicaid, and related policy proposals contained in the FY 2016 budget proposal.
Continue Reading Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions