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
The Medicare secondary payer ("MSP") law requires Medicare to be the "secondary" payer of health benefits for Medicare beneficiaries where another entity is the "primary" payer of health benefits. Determining whether another entity is "primary" and when Medicare is "secondary" has often been difficult due to the wide range of circumstances in which another party may be responsible for a Medicare beneficiary's health expenses, the number of potential parties involved, and the somewhat confusing terminology in the law itself. As a result, Congress enacted new rules to enhance the enforcement of the MSP law. Any entity that might pay settlements to Medicare-eligible plaintiffs that would cover any health expenses, or might otherwise compensate Medicare beneficiaries for health expenses as part of group health insurance, workers' compensation, or any other arrangement or plan, needs to become familiar with these new rules. Specifically, Congress now requires such entities to (1) register as a responsible reporting entity ("RRE"), and (2) electronically report information to the Centers for Medicare & Medicaid Services ("CMS").CMS will use this information to track and recover health expenses it incurred on behalf of Medicare beneficiaries but that another entity, as a primary payer under the existing MSP requirements, may be responsible for paying.… Continue Reading
On July 1, 2009, the Centers for Medicare & Medicaid Services ("CMS") proposed to relax its controversial position concerning physician supervision of hospital outpatient services. The hospital industry had recently been vocal in its objection to CMS's position, and the latest proposal signifies a potential important win for hospitals. If adopted, hospitals will be able to meet Medicare supervision requirements for outpatient services, without incurring some of the high costs necessary to ensure physician presence while those services are furnished.… 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
A lesser-known provision in the Medicare Program allows payment for “reasonable and necessary” items or services provided through clinical trials. At the same time, even for traditional reimbursement, the Centers for Medicare & Medicaid Services (CMS) increasingly is demanding evidence of effectiveness in the Medicare population, rather than simply in the general population, to support a … 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
