The New Jersey Department of Human Services ("Department") has sent letters to numerous pharmaceutical manufacturers demanding rebate payments under the Work First New Jersey General Public Assistance/Medicare Part D Wraparound Drug Rebate Program ("GA Rebate Program"). The Department is seeking to collect payments from manufacturers that have chosen not to participate in the GA Rebate Program and thus never entered into a GA Rebate Program agreement with the Department ("Rebate Agreement"). In addition, for some manufacturers that have entered into Rebate Agreements, the Department is now seeking payments for time periods prior to the effective dates of those Rebate Agreements.… 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
Despite the many years since enactment, counseling health care clients on the broad and complex federal physician self-referral law, commonly called the Stark Law, will become increasingly difficult. Although originally enacted in 1989 to create “bright line” to demark improper physician self-referred laboratory services, and expanded in 1993 to cover a wide range of “designated … Continue Reading
On September 23, 2010, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement provisions of the Affordable Care Act (ACA) designed to strengthen provider and supplier screening requirements under the Medicare, Medicaid, and Children's Health Insurance Program (CHIP). According to CMS, the Proposed Rule is intended to ensure "that only legitimate providers and suppliers are enrolled in Medicare, Medicaid, and CHIP, and that only legitimate claims will be paid."
Among many other things, the Proposed Rule would: apply screening tools, including unannounced site visits, background checks, and fingerprinting, based on the level of risk associated with different provider and supplier types; impose a $500 application fee on certain providers and suppliers; authorize temporary moratoria on enrollment of certain types of new providers and suppliers; require Medicare and Medicaid payments to be suspended upon credible allegations of fraud; and update various Medicaid screening requirements. Comments on the proposed rule will be accepted until November 16, 2010.
Our full alert provides an analysis of the proposed rule.… 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
On March 5, 2010, the Office of Pharmacy Affairs published a Final Notice allowing covered entities to use multiple contract pharmacies in order to supplement "in-house" pharmacy services or to increase patient access to 340B drugs. This Final Notice replaces "Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services (61 Fed. Reg. 43,549) and all other previous 340B Program guidance regarding non-network contract pharmacy services.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has issued new "Telemarketing FAQs" to supplement the Office of Inspector General's (OIG) recent revisions to its Special Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers. As you may recall, in January 2010, the OIG amended the Special Fraud Alert to add a warning about suppliers contacting a beneficiary before the supplier receives written beneficiary consent, as it may violate the statutory provision that prohibits Durable Medical Equipment (DME) suppliers from making unsolicited telephone calls to Medicare beneficiaries regarding the furnishing of a Medicare-covered item. Specifically, the OIG stated that it "has also been made aware of instances when DME suppliers, notwithstanding the clear statutory prohibition, contact Medicare beneficiaries by telephone based solely on treating physicians' preliminary written or verbal orders prescribing DME for the beneficiaries." According to the OIG, the "physician's preliminary written or verbal order is not a substitute for the requisite written consent of a Medicare beneficiary."
In response to this new language, Reed Smith contacted the OIG to discuss the adverse impact this policy would have on timely beneficiary access to medically necessary equipment ordered by a physician, since some suppliers call a beneficiary to arrange for equipment deliveries upon receiving an initial physician verbal order. The OIG has just sent us a copy of new CMS Telemarketing FAQs that seek to clarify certain aspects of the revised Special Fraud Alert...… Continue Reading
Last week, in my capacity as president of the American Health Lawyers Association, I attended the first National Summit on Health Care Fraud, a joint undertaking by the U.S. Department of Health and Human Services and the U.S. Department of Justice. The conference brought together private sector leaders, law enforcement personnel, and health care experts as part of the Obama Administration's coordinated effort to fight health care fraud. This was the first national gathering on health care fraud between law enforcement and the private and public sectors.… Continue Reading
CMS is preparing to re-launch its controversial competitive bidding program for Medicare suppliers of certain types of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Under competitive bidding, only suppliers who are successful bidders will be eligible to furnish certain categories of DMEPOS to Medicare beneficiaries in certain geographic areas (with very limited exception). Under competitive bidding, successful bidders will be paid based on the median of the winning suppliers' bids for each of the selected items in the region, rather than the Medicare fee schedule or supplier bid amount. This will be CMS's second attempt to institute DMEPOS competitive bidding, after the first round of bidding was blocked by Congress last year because of widespread concerns about how the program was implemented. Reed Smith's Life Sciences and Health Industry Alert, "CMS Prepares to Re-Launch Medicare DMEPOS Competitive Bidding--Tips for Potential Bidders," highlights seven steps suppliers can take now to prepare for the coming bidding period based on the lessons learned during the first round of bidding.… Continue Reading
On February 12, 2009, the Internal Revenue Service (the "Service") released its long-awaited Hospital Compliance Project Final Report (the "Report"). The Service commenced the Hospital Compliance Project in 2006 by sending out comprehensive questionnaires to 544 tax-exempt hospitals. The questionnaires focused primarily on hospitals' current practices with respect to community benefits and executive compensation. The Report details the data the Service compiled from the 487 respondent hospitals and the 20 hospitals selected for examination from that group. The Report did not provide any conclusions on whether the federal tax rules regarding community benefits and executive compensation should be changed. IRS officials' and lawmakers' initial interpretation of the Report and its findings, however, suggests that exempt hospitals should expect significant scrutiny of the community benefit and compensation information that they provide on the revised IRS Form 990 and that stricter requirements may be forthcoming.… Continue Reading
This post was also written by Lorraine Mullings Campos. On March 17, 2009, the Department of Defense (DoD) issued a final rule to implement a provision of the 2008 National Defense Authorization Act (NDAA). In the final rule, the DoD takes the position that the NDAA requires pharmaceutical manufacturers to provide discounted drug prices based on … Continue Reading
On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading
Centers for Medicare & Medicaid Services ("CMS") [http://www.cms.hhs.gov/] states that on February 4, 2009 the parties involved in the protest of the award of the Recovery Audit Contractor ("RAC") contracts settled the protests filed with the GAO.
The settlement means that the stop work order has been lifted and CMS will now continue with the implementation of the RAC program.
Under the program, the four RACs will contract with subcontractors to supplement their efforts. PRG-Schultz, Inc. will serve as a subcontractor to HDI, DCS and CGI in regions A, B and D. Viant Payment Systems, Inc. will serve as a subcontractor to Connolly Consulting in region C. Each subcontractor has negotiated different responsibilities in each region, including some claim review.
According to the CMS Notice [http://www.cms.hhs.gov/RAC/01_Overview.asp#TopOfPage], the RAC in each jurisdiction is as follows:
Region A: Diversified Collection Services (DCS)
Region B: CGI
Region C: Connolly Consulting, Inc.
Region D: HealthDataInsights, Inc.
All correspondence, websites and call centers will be in the name of the RACs listed above.… Continue Reading
This post was written by Jason M. Healy. By now, most Medicare providers have heard about the Medicare Recovery Audit Contractor (RAC) demonstration and that it is currently being rolled out nationwide as a permanent program. On November 4, 2008, however, CMS imposed an automatic stay on the RAC program after two unsuccessful bidders for … Continue Reading
This post was also written by Robert J. Hill and Kathleen McGuan. I. INTRODUCTION On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”).1 Among many other things, MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) … Continue Reading
Articles in This Issue: Provider Networks and Joint Ventures: Avoiding Antitrust Scrutiny Through Clinical Integration Stark II, Phase III Final Rule In the Spotlight: Fraud and Abuse Health Law 101: Fraud and Abuse Recent Reed Smith Publications Click here to read the Spring 2008 issue of Health Law Monitor.… Continue Reading
I. INTRODUCTION On April 30, 2008, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule to implement the Fiscal Year 2009 Hospital Inpatient Prospective Payment System (the “IPPS proposed rule”). 73 Fed. Reg. 23528. The IPPS proposed rule includes possible changes to certain provisions of the federal Physician Self-Referral Law, or “Stark … Continue Reading
Calendar year 2008 has begun where 2007 ended, by presenting us with a number of legal developments impacting the provision of outpatient surgical care. Keeping up with such developments is a challenge for those of us whose careers revolve around representing outpatient surgical facilities. Keeping up for those who actually own and/or operate such facilities … 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
I. INTRODUCTION On January 8, 2008, CMS announced the second phase of Medicare competitive bidding for durable medical equipment (“DME”), prosthetics, orthotics, and supplies (“DMEPOS”). In this second round, competitive bidding will be implemented in 70 areas, including the nation’s largest cities. The complete list of areas can be found at Appendix 1. With very … Continue Reading