The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the … Continue Reading
On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general opposition … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
On December 4, the U.S. Supreme Court granted certiorari in Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, raising the question of whether “implied certification” liability is permissible under the False Claims Act and, if so, under what circumstances. Under the implied certification theory, defendants are presumed to have certified that they … Continue Reading
Recently, the Centers for Medicare & Medicaid Services (CMS) released final regulations under the physician self-referral law known as the Stark Law. We previously discussed the topic here, on our Health Industry Washington Watch blog here and in a American Health Lawyers Association Weekly article “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole … Continue Reading
As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark Law. The provisions of the final rule are effective on January 1, 2016, except for certain changes on calculating ownership percentages for … Continue Reading
As previously discussed here on our Health Industry Washington Watch blog, CMS is publishing a notice extending by 30 days the comment period for its July 16, 2015 proposed rule entitled “Reform of Requirements for Long-Term Care Facilities.” The revisions of the “Proposed Rule” indicate an increased cost of $729 million in the first year … Continue Reading
As previously discussed on our Health Industry Washington Watch blog, the Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law. However, even with changes, the regulations will remain highly complex, with major implications for health care providers … Continue Reading
On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a proposed rule that would institute several changes to the health care program civil monetary penalty (CMP) regulations. Under the proposed rule, the OIG would have the expanded authority to enforce significant CMPs on providers and suppliers in a variety of scenarios.
Reed Smith has prepared a Client Alert summarizing and analyzing the Proposed Rule, including the various scenarios under which CMPs could be issued under the proposed regulations as well as the changes in technical language proposed by OIG to more clearly define the scope of CMP regulations.… Continue Reading
On December 11, 2013, CMS released an advance notice of proposed rulemaking soliciting comments on specific practices for which civil monetary penalties may or may not be imposed for failure to comply with Medicare Secondary Payer reporting requirements. Among other issues, CMS is seeking comments and proposals on mechanisms and criteria that it would use to evaluate whether and when it would impose penalties for noncompliance with Medicare Secondary Payer reporting requirements.… Continue Reading
On June 30, 2012, the Pennsylvania Department of Public Welfare ("DPW") issued final regulations revising its process and standards for reviewing requests to enroll new nursing home beds in Pennsylvania's Medical Assistance ("MA") (i.e., Medicaid) program, and transfers of MA beds between existing nursing facilities. The new regulations suggest that DPW's restrictive approach to gaining approval for new MA beds will continue.… Continue Reading
On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services ("CMS") released its long-awaited proposed rule to implement the provisions of the Affordable Care Act ("ACA") relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program ("MDRP").… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has recently updated the information on its website with respect to the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), Section 111 "Mandatory Insurer Reporting" requirements. The recent updates cover (1) a revised implementation timeline for certain liability insurance (including self-insurance) total payment obligation to claimant settlements, (2) revised guidance on claims involving exposure, ingestion, and implantation issues, (3) upcoming improvements to the Medicare Secondary Payer (MSP) program, (4) a new exception for certain settlements paid into a qualified settlement fund and (5) a new way for certain injured Medicare beneficiaries to satisfy their past and future MSP obligations.… Continue Reading
On Friday, October 7, 2011, the Centers for Medicare & Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") (collectively, the "Agencies") announced they were soliciting nominations from sponsors of medical devices to participate in the Agencies' parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the "Notice"), with an effective date of November 10, 2011, although the Agencies began accepting nomination submissions October 7.… Continue Reading
In an "Alert" dated November 9, 2010, the Centers for Medicare and Medicaid Services (CMS) has published a revised implementation timeline applicable to liability insurance (including self-insurance) "responsible reporting entities" (RREs) under Section 111 of the Medicare, Medicaid and SCHIP Extension Action of 2007 (MMSEA). Specifically, the obligation to report "total payment obligation to claimant" (TPOC) amounts subject to the reporting requirement has been extended from the first calendar quarter of 2011 to the first calendar quarter of 2012. Moreover, under the revised implementation timeline, only TPOC amounts established on or after October 1, 2011 (instead of October 1, 2010) must be reported. Earlier reporting (i.e., reporting prior to the first calendar quarter of 2012), and reporting of TPOC amounts established prior to October 1, 2011 is now optional. CMS has also delayed the staggered phase-out of its interim threshold dollar amounts for TPOC amounts that liability insurance (including self-insurance) and workers' compensation RREs must report by one year.… Continue Reading
This post was also written by Robert J. Hill and Jennifer A. Goldstein. In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). In this analysis, … Continue Reading
We want to alert our manufacturer clients to the potential importance of a specific provision included in our analysis of the recent health care reform legislation. As we note at page 108 of our memorandum:
Medicaid Exclusion from Participation Relating to Certain Ownership, Control, and Management Affiliations (Sec. 6502)
[T]his provision requires Medicaid agencies to exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that: (1) has failed to repay overpayments during the period as determined by the Secretary; (2) is suspended, excluded, or terminated from participation in any Medicaid program; or (3) is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.… Continue Reading
On May 20, 2009, the President signed into law the Fraud Enforcement and Recovery Act of 2009 ("FERA"), which will implement significant changes to the federal False Claims Act ("FCA"). The amendments to the FCA will significantly expand the scope of FCA liability, provide for new investigative tools, and make it easier for qui tam relators to bring and maintain FCA suits on behalf of the government...… Continue Reading
Recent posts on www.lifescienceslegalupdate.com include:
"Current Issues Under The Civil False Claims Act: Worthless Services, Off-Label Use, and More" which briefly identifies relevant criminal and civil provisions relating to these issues, and then focuses more closely on recent uses of the civil False Claims Act ("FCA") in government investigations of health care providers, suppliers, and manufacturers, including a section on state false claims legislation. Finally, it discusses the issue of distinguishing overpayments from false claims and provide information on the voluntary disclosure program of the Office of the Inspector General ("OIG") of the Department of Health and Human Services (HHS). https://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/offlabel-use/current-issues-under-the-civil-false-claims-act-worthless-services-offlabel-use-and-more/
...and "Life Sciences Industry Members Who Contract With Government Should Note Recent Amendment to the Federal Acquisition Regulation" which discusses an amendment to the Federal Acquisition Regulation ("FAR") to establish: (1) mandatory disclosure requirements for certain violations of federal criminal law and the False Claims Act; (2) requirements for contractors to establish and maintain specific internal controls to detect, prevent, and disclose improper conduct in connection with the award or performance of any government contract or subcontract; and (3) new causes for suspension and debarment. See 73 Fed. Reg. 219, 67,064 (Nov. 12, 2008). https://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/life-sciences-industry-members-who-contract-with-government-should-note-recent-amendment-to-the-federal-acquisition-regulation/… Continue Reading
The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following: FDA Transparency Task Force Toll-Free Numbers for Adverse Events Reporting Generic Drugs … Continue Reading
President Bush has signed into law S. 2499, the “Medicare, Medicaid, and SCHIP Extension Act of 2007.” Most notably, the legislation postpones for six months a 10.1% across-the-board cut in Medicare physician payments that was scheduled to go into effect January 1, 2008.… Continue Reading
