As previously reported, President Obama has signed into law the 21st Century Cures Act (PL 114-255), which is intended to spur the discovery and availability of new medical treatments. Reed Smith has prepared a client alert summarizing the major drug, device, and biologic development and approval provisions contained in the Cures Act. The
Drugs
FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products
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:
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Donald Trump Proposes Prescription Drug Importation as Element of Health Reform Plan
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…
Committees to Examine Administration’s HHS Budget Proposal, Other Health Policy Issues Next Week
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…
CMS Finalizes 2016 HCPCS Update
CMS has posted its final Level II HCPCS application determinations for 2016, addressing applications for new and revised codes for DMEPOS, surgical supplies, drugs, biologicals, radiopharmaceuticals, and radiologic imaging agents.
Energy and Commerce Health Subcommittee Advances Mental Health, Medicaid, Synthetic Drug Legislation
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
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HHS Schedules November 20 Pharmaceutical Forum on Innovation, Access, Affordability and Better Health
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.
GAO Calls for Expanded State Reporting on Medicaid Prescription Drug Fraud Controls
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…
Energy & Commerce Committee Approves Bipartisan Health Bills
On July 29, 2015, the House Energy & Commerce Committee approved the following bipartisan bills that aim to improve health care for newborns, infants, and children:
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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 rule published May 23, 2014, Part D sponsors must deny a pharmacy claim for a Part D drug if…
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 intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.…
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. 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…
Obama Administration Announces Plan to Combat Antibiotic Resistant Bacteria
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:
- Slow the emergence of resistant bacteria and prevent
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GAO Calls for Expanded HHS Efforts to Reduce Antipsychotic Drug Use in Community Settings
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…
FDA to Host Clinical Outcome Assessments Public Workshop (April 1)
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 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. According to CMS, prices for the top Part B drugs decreased by 0.6% on average compared…
CMS Schedules May 2015 Meetings on HCPCS Applications
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…
Upcoming House Hearing on 340B Program (March 25)
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…
Final Medicare Advantage/Part D Rule for Contract Year (CY) 2016
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
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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 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.
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