After multiple implementation delays, the Health Resources and Services Administration (HRSA) now seeks to move up the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). By way of background, HRSA most recently delayed implementation of the 2017 rule because the Trump Administration was “developing … Continue Reading
The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration. Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements … Continue Reading
The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) has issued a request for information (RFI) on ways to amend or add new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty statute, in order to foster arrangements that promote care … Continue Reading
The House Energy and Commerce Committee has approved by voice vote the following bipartisan bills addressing the Medicare Part B program: HR 3245, which would significantly increase various Medicare civil and criminal penalties under sections 1128A and 1128B of the Social Security Act. Sponsors of the bill note these penalties have not been updated in … Continue Reading
The House Energy and Commerce Subcommittee on Health has approved the following seven bipartisan bills addressing the Medicare Part B program: HR 3245, which would significantly increase various Medicare civil and criminal penalties under sections 1128A and 1128B of the Social Security Act, which sponsors note have not been updated in 20 years. Maximum penalties … Continue Reading
CMS has just corrected an error in a 2016 rulemaking that inadvertently called for a 10-fold increase in certain “Sunshine Act” civil monetary penalties (CMPs). Under section 1128G of the Social Security Act, applicable manufacturers must report annually to CMS any payments or other transfers of value to covered recipients. In addition, the statute requires … Continue Reading
The Department of Health and Human Services (HHS) is once again applying an inflation increase to maximum civil monetary penalty (CMP) amounts for HHS agencies and programs – less than five months after the last inflation hike and notwithstanding the Trump Administration’s recently-announced regulatory freeze. Specifically, in a final rule to be published on February … Continue Reading
The HHS Office of Inspector General’s (OIG) latest Semiannual Report to Congress highlights top audits, investigations, and enforcement activities for the period of April 1 to September 30, 2016 and summarizes overall accomplishments for fiscal year (FY) 2016. Notably, the OIG reports: Expected FY 2016 recoveries will exceed $5.66 billion, including nearly $1.2 billion in audit … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule to codify the OIG’s expanded authority under the Affordable Care Act (ACA) to impose civil monetary penalties (CMPs) on providers and suppliers under a variety of additional scenarios. For example, for failure to timely report … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule). … Continue Reading
The Office of Inspector General (OIG) has increased the value of permissible gifts that may be made to Medicare beneficiaries without running afoul of the civil monetary penalty (CMP) provision prohibiting beneficiary inducements (Social Security Act § 1128A(a)(5)). The statute provides for CMPs of up to $10,000 for offers or transfers to a Medicare or Medicaid beneficiary … Continue Reading
The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (which was part of the Bipartisan Budget Act of 2015). The magnitude of the individual CMP increases varies depending … Continue Reading
Today the Department of Justice published an interim final rule with request for comments that applies an inflation adjustment to civil monetary penalty (CMP) amounts assessed by the Department, as mandated by the Bipartisan Budget Act of 2015. Notably, the new maximum CMP for False Claims Act (FCA) violations under 31 U.S.C. 3729(a) is $21,563, … Continue Reading
The OIG has issued its Spring 2016 Semiannual Report to Congress, which describes significant enforcement and investigative activities relating to HHS programs during the first half of FY 2016 (October 1, 2015 – March 31, 2016). The OIG reports expected recoveries of more than $2.77 billion ($554.7 million in audit receivables and about $2.22 billion … Continue Reading
On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” While comments may be submitted on any aspect of the proposed rule, feedback … Continue Reading
On November 2, 2015, President Obama signed into law H.R. 1314, the “Bipartisan Budget Act of 2015” (BBA). The two-year, $80 billion budget/debt-ceiling deal is funded in part by several significant Medicare and Medicaid policies, including an extension of Medicare sequestration, changes to Medicare payment for services provided in “new” off-campus hospital outpatient departments (OPDs), … Continue Reading
The Bipartisan Budget Act of 2015 (H.R. 1314), signed into law by President Obama November 2, 2015, will increase the civil monetary penalties (CMPs) imposed under the Social Security Act (SSA) in addition to False Claims Act (FCA) penalties (among other civil penalties). Under an innocuous-sounding provision, entitled “Civil monetary penalty inflation adjustments,” the budget … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the Shared Savings Program” and “reduce burden on ACOs, ACO participants, and ACO providers/suppliers.” Specifically, the rule allows ACOs, ACO participants, … Continue Reading
Outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending. For instance, while the budget would provide $80 billion in discretionary spending sequestration relief over two years, it would extend Medicare sequestration for an additional year, … Continue Reading
Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes. Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading
On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” … Continue Reading
The OIG’s latest Semiannual Report to Congress describes significant investigative and enforcement activities relating to HHS programs and operations during the first half of FY 2015 (October 1, 2014 – March 31, 2015). The OIG reports expected recoveries of more than $1.8 billion during this period, consisting of nearly $544.7 million in audit receivables and about $1.26 … 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
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.… Continue Reading
