Harvey Tettlebaum, a Husch Blackwell attorney specializing in healthcare law with an emphasis in post-acute care, contributed an article to the June 2013 issue of the Journal of Health & Life Sciences Law titled “Quality Measurements, Payment, and the Law: Disincentives to Physician-Patient Discussions of End-of-Life Care.” Here is the abstract of the article.
With …
An X-number, or “DATA-waived,” registration allows providers holding the registration to avoid U.S. Drug Enforcement Agency (DEA) registration requirements for narcotic treatment programs. A health care provider that possesses an unneeded X-number registration creates unnecessary regulatory burdens for the provider’s practice. Specifically, the DEA periodically makes unannounced site visits of all x-number registration holders. Even…
Are you worried about audits and investigations at your post-acute care facility? If not, you may need to be. Husch Blackwell attorneys Brian Bewley and Barb Miltenberger weighed in on this issue in Report on Medicare Compliance. The article discusses audits and investigations at post-acute care facilities and Bewley points out that home health and hospice…
The jury in the Tuomey case (U.S. ex rel. Drakeford v. Tuomey Healthcare Systems, Inc.) returned a verdict in favor of the government yesterday, May 8, 2013. As is well known, this is the re-trial of a case centered on a series of employment agreements that Tuomey Healthcare entered to allegedly capture referrals…
Mark D. Welker and Scott A. Behrens, Husch Blackwell attorneys in our Employee Benefits and Executive Compensation group, recently addressed key questions employers should ask themselves about Healthcare Reform. Existing guidance in this area is complicated, confusing, and incomplete in many respects. To access the key questions and examples of basic compliance hurdles and planning strategies, click
On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.
The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.
Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”
According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition.
If you have been struggling to figure out the risk assessment requirements of the Final HIPAA Omnibus Rule, then you are in luck. Join us for a webinar! Husch Blackwell attorneys Pete Enko and Peter Sloan along with Director of Information Management Consulting Deb Juhnke will present the Who, What, When, How and Why…
In August 2002, the United States Health and Human Services Office of Inspector General (HHS-OIG) issued a Special Advisory Bulletin relating to offering gifts and inducements to beneficiaries of Title XIX (Medicaid) programs. Since the States operate their Medicaid programs under the direction of HHS-CMS, it has generally been considered in the health law community…
Skilled nursing facilities have long been subject to civil money penalties (CMPs). Depending on where the facility is located, it could mean CMPs of hundreds of thousands of dollars or less than $10,000 (with a waiver) for the same type of deficiency. No longer. Effective April 1, 2013, Regional Offices (RO) for the U.S. Department of Health and Human Services, Centers for…
This post was prepared by Toni Blackwood and Tim Hilton, labor and employment attorneys at Husch Blackwell.
Following 12 months of public comment, U.S. Citizenship and Immigration Services (USCIS) issued a revised Form I-9 on Friday, March 8, 2013. The form has a new look, contains more specific instructions and solicits additional information. Although the form is available for use now, it becomes mandatory in May 2013.
Every U.S. employer is required to record on Employment Eligibility Verification Form I-9 the employment authorization and identity of every person hired in the U.S. High profile enforcement actions by Immigration and Customs Enforcement (ICE), growing employer experience with high administrative fines resulting from ICE I-9 audits, and the public debate over illegal immigration have combined to raise awareness in recent years of the importance of Form I-9 to all employers. These factors all make it vital that employers have a clear understanding of the form itself and how to complete it.
The new form contains additional data fields, such as those asking for the email address, telephone number (both optional) and foreign passport number for the employee in Section 1. The new form includes a prominent warning to new employees of the consequences of using false documents or making false statements when completing Form I-9. This is an important addition, as ICE has pursued remedies against individuals for using false documents and for making false claims of citizenship on Form I-9. There are also overall improvements in the form’s layout, making the employer’s Section 2 easier to read and understand. Perhaps the most obvious change is that the form has expanded to two pages.
