House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following: A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay,” the first of three planned hearings on prescription drug costs. A … Continue Reading
Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues. Today President-elect Trump’s transition team released … Continue Reading
A number of recent Congressional hearings have focused on health policy issues, including: Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and the safety of cosmetics. A House Judiciary Committee hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine.” … Continue Reading
A number of Congressional committees have recently considered legislation and/or held hearings on various health policy proposals. The Ways and Means Committee approved seven bills related to health care coverage and tax policy, including various bills to: expand access to health reimbursement arrangements and health savings accounts; ease employer insurance coverage mandates for students and … Continue Reading
A number of recent Congressional hearings have focused on health policy topics, including the following: A House Energy and Commerce Subcommittee on Health hearing on “Medicare Access and CHIP Reauthorization Act of 2015: Examining Physician Efforts to Prepare for Medicare Payment Reforms.” A House Judiciary Constitution and Civil Justice Subcommittee hearing on oversight of the False … Continue Reading
The Senate Special Committee on Aging recently held a hearing on the status of efforts to find a cure for Alzheimer’s disease, and the panel plans an April 27, 2016 hearing to examine prescription drug price increases. In addition, the House Education and Workforce Subcommittee on Health plans an April 14 hearing entitled “Innovations in … Continue Reading
Congressional committees have held hearings recently on various health policy issues, including: Energy and Commerce Committee hearings on CMS implementation of the Medicare physician fee schedule reform provisions included in the Medicare Access and CHIP Reauthorization Act (MACRA), financing and delivery of long-term care, and the public health response to the Zika virus. A Ways … 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
The Senate HELP Committee is holding a January 28, 2016 hearing on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.” Separately, on February 4, the House Committee on Oversight and Government Reform has scheduled a hearing on “Developments in the Prescription Drug Market: Oversight.” Other recent Congressional health policy hearings have included … Continue Reading
CMS has posted the payment amounts that will apply to Medicare Part B covered drugs for the first quarter of 2016. According to CMS, prices for the top Part B drugs increased by 0.9% on average compared to the previous quarter, with prices for 17 of the top 50 drugs decreasing and four remaining the … Continue Reading
A number of recent Congressional hearings have focused on health policy issues, including the following: A Senate Special Committee on Aging hearing titled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines.” A Senate Health, Education, Labor & Pensions Committee hearing on “Opioid Abuse in America: Facing the Epidemic and Examining Solutions.” A … Continue Reading
Several Congressional hearings are scheduled next week and into December on health policy issues, including: A November 17 Senate Finance Committee hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” A November 17 House Judiciary Subcommittee on Regulatory Reform hearing on “The State of Competition in the Pharmacy Benefit Manager and Pharmacy … 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
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
The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading
Recent Congressional health policy hearings have addressed the following issues: The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on generic drug pricing; The House Oversight and Government Reform Committee focused on its concerns associated with transparency in passage and implementation of the Affordable Care Act in a hearing featuring CMS Administrator Marilyn … Continue Reading
CMS has posted the January 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the first quarter of 2015. CMS notes that prices for the top Part B drugs decreased by 0.1 % on average … Continue Reading
The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 … Continue Reading
The Government Accountability Office (GAO) has released data comparing retail prescription drug prices paid by the Department of Defense (DOD), Medicaid, and Medicare Part D for a sample of 78 high-utilization/high-expenditure drugs. In general, the GAO determined that Medicaid paid the lowest average net prices for both brand-name and generic drugs in the sample based … Continue Reading
The OIG issued a report today entitled “Inconsistencies in States’ Reporting of the Federal Share of Medicaid Drug Rebates.” States are eligible for higher federal financial participation (FFP) rates for certain Medical Assistance services, such as those related to family planning, Indian Health Services, and breast and cervical cancer care. Based on prior work, the … Continue Reading
CMS has released the average sales price (ASP) files that will be used to pay for Medicare Part B drugs for the third quarter of 2014. According to CMS, “average drug prices in the market remain relatively stable,” with prices for the top Part B drugs increasing by 1.8% on average.… Continue Reading
In an email today to stakeholders, CMS announced that it will not be finalizing the ACA Medicaid federal upper payment limits (FUL) for multiple source drugs in July 2014, as previously intended. CMS attributes the change to a delay in providing detailed guidance to the states in preparation for implementation. CMS expects to announce a … Continue Reading
On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG's expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted.
Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG's proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.… Continue Reading
The OIG recently offered recommendations to CMS on how to update Medicare payments to end stage renal disease (ESRD) facilities for drugs used by dialysis patients. Based on a review of ESRD drug prices in the first quarter of 2012, the OIG concluded that independent dialysis facilities can purchase ESRD drugs for less than the … Continue Reading
