Congress Passes Legislation Providing Protection to States that Have Legalized Medical Marijuana

On August 19, 2013, the U.S. Department of Justice issued its current Guidance Regarding Marijuana Enforcement, which effectively deferred enforcement under the Controlled Substances Act, 21 U.S.C. § 811 et. seq. (the “CSA”) with respect to medical marijuana to those states “that have enacted laws legalizing marijuana in some form and that have also implemented strong and effective regulatory and enforcement systems to control the cultivation, distribution, sale, and possession of marijuana.”

On December 13, 2014, Congress passed government spending bill, H.R. 83 (the “Act”), which included provisions that appear to further insulate the participants in the medical marijuana industry in states that have legalized medical marijuana from enforcement under the CSA.   In particular, the Act provides that the funds made available to the Department of Justice pursuant to the Act may not be used to prevent those states that have enacted medical cannabis legislation “from implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana.” Continue reading

CMS Bringing Star Ratings to Home Health

The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

According to CMS, the star rating system allow consumers to identify differences in quality and use the information when selecting a health-care provider

Star ratings are currently provided for nursing homes, physicians and Medicare Advantage plans.  Ratings for dialysis facilities and hospitals  are in the works as well.

The proposed star rating system would be based on 10 of the process, outcome and patient experience of care quality measures on the Home Health Compare website. Home health agencies would be rated from one to five stars on the quality measures. Star ratings have been and continue to be the subject of much controversy in other sectors of the Medicare provider landscape.

CMS plans to solicit stakeholder feedback on the proposed star rating methodology, including the measures proposed for inclusion.  Home health providers should keep their eyes and ears open to CMS pronouncements on the ratings system and be sure they participate in feedback to the agency as the process develops.

For more information on CMS’ star rating system, home health services and Medicare, please feel free to contact Ari Markenson at amarkenson@duanemorris.com or 212.692.1012.

Clinical trial sponsors can be liable for inadequate consent forms

Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so.  Federal law imposes several specific items to be included in the consent form.  Where all pertinent risks, benefits and alternatives have been disclosed, and the patient signs the form, the patient is said to have given “informed consent.”

A patient injured in a clinical trial studying a new therapy for Parkinson’s Disease sued the manufacturer of the equipment used in the procedure.  In addition to a claim of negligent design and manufacture of the equipment itself, the patient asserted that the manufacturer, as the sponsor of the clinical trial, was negligent in drafting and approving the informed consent documents that the patient signed to participate in the clinical trial.  Can a manufacturer be liable for an improperly drafted consent form? Continue reading

Duane Morris Holds Post Acute Care Roundtable Event 12/11/14

On December 11, 2014, Duane Morris held a Post-Acute Care Roundtable event in our New York office entitled “What Will It Take to Survive as a Long-Term Care Facility in the Next 5 to 10 years?”

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The event was a panel discussion moderated by NY Health Group Partners, Ari Markenson and Jerry Levy. The panel included a distinguished group of long-term care experts in New York, including:

Richard Herrick, President and Chief Executive Officer, New York State Health Facilities Association

Marc Zimmet, President, Zimmet Healthcare Services Group, LLC

Chris McCarthy, CPA, Partner, O’Connor Davies, LLP

Scott James, Managing Director, Cain Brothers & Company, LLC

The panel held a very engaging discussion of the challenges and opportunities that will face the New York long-term care provider community in the coming years.  Reimbursement, managed care, management and leadership, value and quality and access to capital issues dominated the discussion.

Duane Morris’ Post-Acute Roundtable is a planned series of networking and educational events focusing on the post-acute care industry. For more information, please feel free to reach out to Ari Markenson Jerry Levy or Susan Kayser, partners in our Health Care Practice and Long Term Care and Senior Services Group.

The IMPACT ACT of 2014 – New Enforcement and Oversight for Hospice Providers

The IMPACT Act of 2014 (“IMPACT”) was signed into law on October 6, 2014. It includes two significant enforcement and oversight changes for Medicare hospice providers among other post-acute care policy changes.

IMPACT increases the frequency of survey and certification inspections for hospice providers. It mandates that hospices undergo a certification inspection no less frequently than once every 36 months. Previously, the frequency of inspections was left up to the State Agencies performing the inspections.

IMPACT requires medical review of hospice programs with a high percentage of patients who receive care for 180 days or more. CMS is required to set a threshold percentage or number of patients receiving care for more than 180 days that will trigger medical review.

The increased frequency of certification inspections and the focus on long-stay patients are intended to address long standing concerns, voiced by the OIG in several reports, that hospices were not receiving sufficient oversight and that there were too many abuses of the hospice benefit by providers who were servicing patients with questionable diagnoses or certifications of terminal illness.

For more information on the IMPACT ACT of 2014, hospice, Medicare or the OIG, please feel free to contact Ari Markenson at amarkenson@duanemorris.com or 212.692.1012.

7th Circuit Clarifies FCA Fraud Standard

In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy.  The principal claims in the case, Grenadyor v. Ukrainian Village Pharmacy, Inc., were that the pharmacy’s practice of soliciting and keeping its base of mostly Ukrainian customers by providing gifts of caviar and Russian language TV Guides, as well as waiving co-pays, amounted to kickbacks in violation of the federal (and several state) anti-kickback statutes.

Judge Richard A. Posner, the author of the court’s opinion, revealed his distaste for the relator early in the opinion by describing him as a “bounty hunter”.  The court rejected most of the relator’s claims because he had failed to identify a single patient who received gift bags worth more than the de minimis $50, even though the relator had amended his complaint ostensibly to correct this deficiency, and had not alleged that the pharmacy intended to offer kickbacks when it certified to the government that it would abide by Medicare and other federal laws. Continue reading

OIG 2015 Work Plan – Hospice

Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will review and evaluate during the year. This post is one in a series that will outline the OIG’s activities, in 2015, for a specific industry sector – Hospice.

Hospices in Assisted Living

The OIG remains focused on what it believes are inappropriate hospice services being provided to certain types of geriatric patients. As a result, it will review the extent to which hospices serve Medicare beneficiaries who reside in assisted living facilities (ALFs). It is going to take a look at length of stay, levels of care received, and common terminal illnesses of beneficiaries who receive hospice care in ALFs.

Hospice General Inpatient Care

The OIG, in prior work, has suggested that the general inpatient care level of care is used inappropriately and too often. It is going to look at the appropriateness of hospices’ general inpatient care claims and the content of election statements for hospice beneficiaries who receive general inpatient care. It will also review hospice medical records to address concerns that this level of hospice care is being misused.

For more information on the OIG’s 2015 Work Plan and priorities, hospice services and Medicare, please feel free to contact Ari Markenson at amarkenson@duanemorris.com or 212.692.1012.

OIG 2015 Work Plan – Home Health

Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to  the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will review and evaluate during the year. This post is one in a series that will outline the OIG’s activities, in 2015, for a specific industry sector – Home Health.

Prospective Payment System Requirements

A prior OIG report found that one in four home health agencies (HHAs) had questionable billing. With this new initiative the OIG is going to review HHA compliance with various aspects of the home health PPS, including the documentation required to support claims.

Employment of Individuals with Criminal Convictions

OIG is going to review the extent to which HHAs employed individuals with criminal convictions and whether or not employees with potentially disqualifying convictions were employed by HHAs.

For more information on the OIG’s 2015 Work Plan and priorities, home health services and Medicare, please feel free to contact Ari Markenson at amarkenson@duanemorris.com or 212.692.1012.

OIG 2015 Work Plan – Skilled Nursing Facilities

Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will review and evaluate during the year. This post is one in a series that will outline the OIG’s activities, in 2015, for a specific industry sector – skilled nursing facilities (SNF).

Medicare Part A Billing

The OIG remains concerned about the high levels of therapy services being provided in the SNF setting despite its understanding that beneficiary characteristics have remained unchanged in FYs 2011 to 2013. It is going to continue to evaluate how CMS changes have and will effect these billing patterns.

Part B Services During Nursing Home Stays

The OIG is going to evaluate what it believes are questionable billing patterns associated with nursing homes and Medicare providers for Part B services provided to nursing home residents during non-Part A stays. A series of studies will examine several broad categories of services, such as foot care. Continue reading