Monthly Archives: October 2014

CDC Publishes Updated Interim Guidance Regarding Potential Ebola Exposure

Posted by J. Nicole Martin on October 28, 2014
CDC, WHO / No Comments

According to the World Health Organization, the Ebola outbreak is “the biggest and most complex . . . in history,” and in August, the World Health Organization declared the Ebola outbreak in West Africa to be a “Public Health Emergency of International Concern.” Following news last week that New Jersey and New York each announced Ebola exposure and quarantine measures, on Monday, the CDC published updated interim guidance for the monitoring and movement of persons with potential exposure to the Ebola virus (“Guidance”). According to the CDC, the Guidance is updated to include the addition of the following:

  •  A “low (but not zero) risk” category;
  •  A “no identifiable risk” category;
  •  Modifications to the recommended public health actions in each of the high risk, some risk and low (but not zero) risk categories; and
  • Recommendations for specific groups and settings (i.e., healthcare workers providing care to Ebola patients in U.S. facilities and healthcare workers providing care to Ebola patients in countries with widespread transmission).

The CDC further explained that the Guidance provides a “framework for determining appropriate public health actions based on risk factors and clinical presentation.” The Guidance also includes a reference chart outlining recommended public health actions based on exposure category. The CDC correctly noted that primary jurisdiction to address this matter remains with state and local authorities. Under the Tenth Amendment to the U.S. Constitution, states have police power to protect the health (i.e., public health/infectious disease control, including quarantine) of its population.

As Ebola remains a “Public Health Emergency of International Concern,” it is likely that additional and/or updated Ebola guidance will be published by the CDC, as well as orders issued by other states and local authorities.

J. Nicole Martin

J. Nicole Martin

J. Nicole Martin is an associate and practices in the Health Care Practice Group. Nicole assists accountable care organizations, health care systems, long term care providers, behavioral and mental health providers, medical device manufacturers, physician practices and pharmacies with their compliance, regulatory and transactional needs. Nicole’s practice includes providing clients with counsel regarding HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws. Nicole also represents clients undergoing changes of ownership and changes of control, and assists them with the transactional, regulatory and compliance requirements necessary to finalize the transactions.

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CDC Publishes Revised Ebola Guidelines and Announces New Monitoring Program

Posted by J. Nicole Martin on October 23, 2014
CDC / No Comments

The CDC recently announced stricter guidelines on the use of personal protective equipment for United States healthcare workers providing healthcare services to patients with Ebola (“Guidelines”). According to the CDC, the Guidelines have three core principles:

  • All healthcare workers undergo rigorous training and are practiced and competent with personal protective equipment, including putting it on and taking it off in a systemic manner
  • No skin exposure when personal protective equipment is worn
  • All workers are supervised by a trained monitor who watches each worker putting personal protective equipment on and taking it off.

Continue reading…

J. Nicole Martin

J. Nicole Martin

J. Nicole Martin is an associate and practices in the Health Care Practice Group. Nicole assists accountable care organizations, health care systems, long term care providers, behavioral and mental health providers, medical device manufacturers, physician practices and pharmacies with their compliance, regulatory and transactional needs. Nicole’s practice includes providing clients with counsel regarding HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws. Nicole also represents clients undergoing changes of ownership and changes of control, and assists them with the transactional, regulatory and compliance requirements necessary to finalize the transactions.

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CMS Withdraws Proposed Medicare Secondary Payer Rule

Posted by Gregory M. Fliszar on October 17, 2014
CMS, Medicare / No Comments

On October 8, 2014, the Centers for Medicare & Medicaid Services (“CMS”) withdrew its Notice of Proposed Rule Making (“NPRM”) from the Office of Management and Budget that was to address how Medicare’s future interests should be protected pursuant to the Medicare Secondary Payer (“MSP”) Act (42 U.S.C. § 1395y(b)(2)) in workers’ compensation, liability (including self-insurance), automobile and no-fault insurance cases (see Notice).  While it is expected that CMS will submit another proposed rule, it does not seem likely that an ultimate final rule will be forthcoming anytime soon.

Although CMS has published guidelines for how to address claims in workers’ compensation cases where future medical expenses are claimed or released in a settlement judgment or other award, it has not released much guidance on addressing future medical expenses in liability, self-insurance, automobile and no-fault insurance cases.  The resulting lack of any clear guidance has resulted in many settlements being prolonged or even coming to a grinding halt as the parties differed over how—or whether— to address Medicare’s interest in future medical expenses.  It was hoped this would change after CMS released an Advance Notice of Proposed Rulemaking in June of 2012 addressing the issue of protecting Medicare’s interest in future medical expenses.  Yet, the recent notice that CMS has withdrawn its proposed rule is disappointing to the stakeholders, including claimants, insurers and attorneys looking for clarity and guidance from CMS on this issue.  Even without guidance addressing future medicals, parties to a settlement must still fulfill their MSP obligations, which include addressing Medicare’s interests in future medical expenses.

Gregory M. Fliszar

Gregory M. Fliszar

Greg Fliszar is member in the firm’s Health Law Group. Greg’s practice focuses on health law litigation and regulatory and compliance matters, as well as compliance with the Medicare Secondary Payer Act and HIPAA. Greg is also a licensed doctoral level clinical psychologist and was a clinical instructor of psychiatry at the MCP-Hahnemann School of Medicine.

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CMS Announces Program to Fund ACO Growth, Extends Fraud and Abuse Waivers

Posted by Chris Raphaely on October 16, 2014
Accountable Care Organizations, CMS, OIG / No Comments

The Centers for Medicare & Medicaid Services (“CMS”) announced a new initiative, the ACO Investment Model, on October 15, 2014.  Under the model, ACOs which are made up of “providers [who] lack adequate access to … capital” may receive additional funding from the CMS “to invest in infrastructure necessary to successfully implement population care management.” The eligibility criteria are as follows:

  • The ACO must be accepted into and participate in the Medicare Shared Savings Program. The ACO’s first performance period in the Medicare Shared Savings Program must have started in either 2012, 2013 or 2014 or will start in 2016.
  • The ACO has completely and accurately reported quality measures to the Medicare Shared Savings Program in the most recent performance year, if the ACO started in the Medicare Shared Savings Program in 2012, 2013 or 2014, excluding ACOs that will start in 2016.  The ACO has a preliminary prospective beneficiary assignment of 10,000 or fewer beneficiaries for the most recent quarter, as determined in accordance with the Shared Savings Program regulations.
  • The ACO does not include a hospital as an ACO participant or an ACO provider/supplier (as defined by the Shared Savings Program regulations), unless the hospital is a critical access hospital (CAH) or inpatient prospective payment system (IPPS) hospital with 100 or fewer beds.
  •  The ACO is not owned or operated in whole or in part by a health plan.
  •  The ACO did not participate in the Advance Payment Model.

Continue reading…

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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Skilled Nursing Facility Reaches Largest Failure of Care Settlement in DOJ History

Posted by J. Nicole Martin on October 13, 2014
DOJ, HHS, Medicaid, Medicare / No Comments

On Friday October 10, 2014, the Department of Justice (DOJ) and the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) jointly announced a $38 million settlement with a skilled nursing facility (SNF), Extendicare Health Services Inc. (Extendicare) and its subsidiary Progressive Step Corporation (ProStep). Extendicare owns and operates 146 SNFs in eleven states. Prostep offers Extendicare residents occupational, physical and speech rehabilitation services.

The settlement stemmed from allegations in two qui tam cases: United States ex rel. Lovvorn v. EHSI, et. al. C.A. 10-1580 (E.D. Pa); and United States ex rel. Gallick et al., v. EHSI et al., C.A. 2:13cv-092 (S.D. Ohio). The allegations were that Extendicare (1) “billed Medicare and Medicaid for materially substandard nursing services that were so deficient that they were effectively worthless”; and (2) “billed Medicare for medically unreasonable and unnecessary rehabilitation therapy services.” Continue reading…

J. Nicole Martin

J. Nicole Martin

J. Nicole Martin is an associate and practices in the Health Care Practice Group. Nicole assists accountable care organizations, health care systems, long term care providers, behavioral and mental health providers, medical device manufacturers, physician practices and pharmacies with their compliance, regulatory and transactional needs. Nicole’s practice includes providing clients with counsel regarding HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws. Nicole also represents clients undergoing changes of ownership and changes of control, and assists them with the transactional, regulatory and compliance requirements necessary to finalize the transactions.

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Prepare for Changes to CMS’ Five Star Quality Rating System for Nursing Homes

Posted by Dana Petrillo on October 10, 2014
CMS, Medicare / No Comments

Choosing a nursing home can be a daunting task for consumers who often have myriad questions regarding the quality of care available at the nursing homes in their areas. To help answer these questions, CMS has created the Nursing Home Compare website, which provides consumers with easy-to-compare ratings of nursing homes’ staffing, quality measures, and health inspections, as well as an overall rating, of each nursing home in the country. To help consumers make informed decisions about nursing home quality, CMS uses the Five Star Quality Rating System, by which CMS compares data from nursing home inspections, self-reports, and assessments.  Based on this information CMS calculates nursing homes’ star levels on a scale of one to five, with five stars being much above average and one star being much below average.

However, there has been concern over the accuracy of the self-reported data that CMS uses in calculating its star ratings. To improve the Five Star Quality Rating System, and to standardize the results, Congress recently passed the Improving Medicare Post-Acute Care Transformation Act (“IMPACT Act”). The IMPACT Act will require providers to submit standardized data to allow CMS to compare quality across different post-acute care settings, and will provide funding for the quarterly electronic submission of nursing home staffing information that is tied to payroll data. CMS will also increase both the number and type of quality measures used in the Five Star Quality Rating System. The first additional measure, starting January 2015, will be the extent to which antipsychotic medications are in use. Future additional measures will include claims-based data on re-hospitalization and community discharge rates. Continue reading…

Dana Petrillo

Dana Petrillo

Dana Petrillo joined Cozen O'Connor's Health Law Practice in 2014 as an associate in the Philadelphia office. Dana's experience includes ensuring clients’ compliance with federal and multi-state health care laws and regulations, including Medicare, Medicaid, licensure, HIPAA, STARK, Anti-Kickback, and False Claims Act laws and regulations.

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