James Bailey is the new CMS Medicare Pharmaceutical and Technology Ombudsman, a role Congress established in the 21st Century Cures Act to help expedite resolution of industry Medicare reimbursement concerns. The Ombudsman’s office is charged with fielding questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers, and other stakeholders regarding Medicare coverage, coding, and payment … Continue Reading
This month, Congressional committees held a number of hearings that focused on health policy issues, including the following: House Energy & Commerce Committee hearings on the drug supply chain and patient brokering/addiction treatment fraud. Senate Health, Education, Labor, and Pensions (HELP) Committee hearings on the cost of prescription drugs and implementation of the 21st Century … Continue Reading
The Energy and Commerce Subcommittee on Health has scheduled an October 11, 2017 hearing to discuss how covered entities use the 340B drug pricing program. A second Subcommittee hearing on October 11 will consider proposals from House members on ways to address the opioid crisis. On October 17, the Senate Health, Education, Labor, and Pensions … Continue Reading
Several recent Congressional hearings have focused on health policy issues. For instance, the House Energy and Commerce Committee held hearings on Food and Drug Administration regulation of over-the-counter drugs and Public Health Service Act health workforce programs. The Senate Finance Committee held hearings on the Graham-Cassidy health insurance reform bill, CHIP funding reauthorization, and health … Continue Reading
Two Congressional committees are holding hearings this week on FDA user fees: a March 21 Senate Health, Education, Labor, and Pensions Committee hearing and a March 22 Energy and Commerce Subcommittee on Health hearing. In addition, on March 22, 2017, the House Oversight Subcommittee on Health Care is holding a hearing on “Examining the Impact … Continue Reading
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 alert is … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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.… Continue Reading
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 House Democrats. … Continue Reading
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.… Continue Reading
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 … Continue Reading
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:… Continue Reading
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 the physician … Continue Reading
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. … Continue Reading
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 … Continue Reading
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 the … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 to … Continue Reading
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; and … Continue Reading
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 … Continue Reading
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 D … Continue Reading
