In the wake of the Hobby Lobby ruling with respect to the Affordable Care Act's contraceptive coverage mandate, the Administration (which already has taken steps to fund contraception for employees affected by their employers' exemption) is attempting also to deal with the issue by a recently-published DHHS regulation setting forth the procedures that "religious" employers might follow to gain exemption from having to provide contraceptive coverage in their sponsored health plans. The proposed rule covers both religious not-for-profits and closely held ...
By Adam Solander, Ali Lakhani and Wenxi Li
The increasing prevalence of mobile technology in the healthcare sector continues to create compliance concerns for physician practices and other health care entities. While the Office of Civil Rights (OCR) of the Department of Health and Human Services, has traditionally focused on technology breaches within larger health systems, smaller physician practices and health care entities must also ensure that their policies and practices related to mobile technology do not foster non-compliance and create institutional risk.
By Patricia Wagner, Ali Lakhani and Jonathan Hoerner
On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency's Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 ("Breach Report"). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.
Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services ...
By Constance Wilkinson, Alan Arville, and Jonathan Hoerner
On July 23, 2014, the Health Resources and Services Administration ("HRSA") issued an "interpretive rule" entitled "Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program" (the "Interpretive Rule").[1] The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program (the "Final Rule").[2]
By way of background, the 340B ...
Our colleagues at Epstein Becker Green released a client alert: "Medicare's Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies," by Emily E. Bajcsi and Serra J. Schlanger.
Following is an excerpt:
On July 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Home Health Prospective Payment System ("HH PPS") for calendar year 2015 ("Proposed Rule"). The Proposed Rule would update the HH PPS payment ...
The Office of the Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf). The OIG's permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant's response to the ...
The Controversy - 2012 Rulemaking Attempts
Roughly two years ago, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services ("CMS") published final regulations announcing two controversial rule changes addressing hospital governance. The industry was taken by surprise, to say the least, as neither of these requirements had been in the proposed rule. The changes, promulgated as amendments to the Governing Body Condition of Participation (CoP) included (i) the requirement that a hospital's board include at least one member of ...
It is not only the weather outside that is frightful! The traditional Medicare administrative appeals process operates along a strict timetable that, in recent months, has been absolutely "snowed in" by the avalanche of requests for appeals hearings by Administrative Law Judges (ALJs) and significant administrative delays extending far beyond normal processing backlogs. These delays affect providers across the Medicare spectrum, including those who are contesting adverse coverage and reimbursement decisions, as well as those who are contesting overpayment ...
Last week, the 2014 340B Coalition Winter Conference was held in San Diego, California (the "Winter Conference"), where representatives from the Health Resources and Services Administration ("HRSA") of the United States Department of Health and Human Services ("HHS"), the Office of Inspector General ("OIG") of HHS, and industry stakeholders (including Epstein Becker Green) presented on current developments with the 340B drug discount program (the "340B Program"). A brief summary of the 340B Program, including contract pharmacy arrangements, can be found ...
Our colleagues at Epstein Becker Green have issued a client alert: "OIG Issues Updated Guidelines for Evaluating State False Claims Acts: Is More State Litigation on the Horizon?," by George B. Breen, Wendy C. Goldstein, and Daniel C. Fundakowski.
Following is an excerpt:
On March 15, 2013, the U.S. Department of Health and Human Services' Office of Inspector General ("OIG") released the Updated OIG Guidelines for Evaluating State False Claims Acts ("2013 Guidelines), which replaces the original version released in 2006.
The 2013 Guidelines describe OIG's methodology for ...
Our colleagues at Epstein Becker Green have issued a client alert: "Key Compliance Actions for the New HIPAA Privacy Regulations," by Patricia M. Wagner, Pamela D. Tyner, and Leah A. Roffman.
Following is an excerpt:
As noted in previous Epstein Becker Green health reform alerts, on January 25, 2013, the long-awaited final omnibus rule (“Omnibus Rule”) issued by the U.S. Department of Health and Human Services was published in the Federal Register. The Omnibus Rule makes sweeping changes to the privacy and security regulations under the Health Insurance Portability and ...
Our colleagues at Epstein Becker Green have issued a client alert: "CMS Issues Final Regulations on Federal 'Sunshine' Law for Manufacturers and GPOs," by Amy K. Dow, Wendy C. Goldstein, Kim Tyrrell-Knott, Sarah K. diFrancesca, David C. Gibbons, Daniel G. Gottlieb, and Natasha F. Thoren.
Following is an excerpt:
On February 1, 2013, the Centers for Medicare & Medicaid Services issued long-awaited final regulations with a lengthy preamble relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the "Physician Payment Sunshine Act." This health ...
Our colleagues Mark E. Lutes, Robert J. Hudock, and Patricia M. Wagner have issued an alert on modifications to the HIPAA privacy, security, and enforcement rules. Following is an excerpt:
On January 17, 2013, the Department of Health and Human Services released the highly anticipated, 563 page, Health Insurance Portability and Accountability Act (“HIPAA”) regulations (the “Final Rule”) that have been delayed for over 3 years. The Final Rule will be published in the Federal Register on January 25, 2013. The Final Rule addresses many of the compliance issues and ...
The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.
First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for ...
by Jason B. Caron, O. Benton Curtis III, Anjali N.C. Downs, and Jennifer K. Goodwin
Almost two years after the passage of the Patient Protection and Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule regarding overpayments to providers and suppliers, as provided for under Section 6402(a) of the ACA. To date, regulators, courts, clients, and members of the bar have interpreted the requirements of Section 6402(a) in various ways. The proposed rule provides CMS's view on this matter, and, given that CMS is proposing a ...
by Wendy C. Goldstein and Kathleen A. Peterson
On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.
The FDA has a longstanding policy of permitting ...
by Sarah K. Giesting, Wendy C. Goldstein, Kathleen A. Peterson, and Natasha F. Thoren
On December 14, 2011, the Centers for Medicare & Medicaid Services issued long-awaited proposed rules (“Proposed Rules”) related to the federal Physician Payment Sunshine Act applicable to pharmaceutical, medical device, biological and medical supply manufacturers and group purchasing organizations (“GPOs”). The Proposed Rules outline CMS’s proposals regarding implementation of the Physician Payment Sunshine Act and seek comments regarding these proposals. This health ...
by René Y. Quashie and Lynn Shapiro Snyder
As the health care industry analyzes the recently released final rule and related guidance regarding the Medicare Shared Savings Program (“MSSP”) for accountable care organizations (“ACOs”), it is important for the industry to also pay attention to key deadlines related to initiatives being implemented by the Center for Medicare and Medicare Innovation (“CMMI” or “Innovation Center”) within the Centers for Medicare & Medicaid Services (“CMS”).
While the MSSP ACO initiative is a permanent Medicare program, CMMI ...
by Ross K. Friedberg, Shawn M. Gilman, Mark E. Lutes, David E. Matyas, René Y. Quashie, Serra J. Schlanger, Carrie Valiant, Dale C. Van Demark, and Lesley R. Yeung
On October 20, 2011, the Centers for Medicare & Medicaid Services ("CMS") released its final rule ("Final Rule") implementing the voluntary Medicare Shared Savings Program ("Program") for accountable care organizations ("ACOs"). The Program was established by Section 3022 of the Patient Protection and Affordable Care Act. The Final Rule was released in conjunction with revised antitrust guidance from the Federal ...
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Recent Updates
- DOJ’s Final Rule on Bulk Data Transfers: The First 180 Days
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