January 16, 2013

Selected Bills before New York State Senate Health Committee for the 2013 Session

A few bills of note for health care providers in New York were introduced in the New York State Senate with the opening of the 2013 legislative session.  Each of these bills was formally introduced on January 9 and referred to the Senate Health Committee.

  • An act allowing patients to see their laboratory results upon request

S.634-2013, available at http://open.nysenate.gov/legislation/bill/S634-2013

Senator Stavisky introduced a bill that would allow clinical laboratories to report test results to the patients tested.  The bill would amend the Public Health Law to create a new section 576-D, which would require clinical laboratories to report test results to patients upon request.  Laboratories would have to include disclaimers with these results that caution patients that the reports themselves are not medical advice, and that the reports do not replace communicating with one’s doctor.

  • The Safe Patient Handling Act

S.1123-2013, available at http://open.nysenate.gov/legislation/bill/S1123-2013

Senators Maziariz, Grisanti, Boncic, Kennedy, Montgomery, and Perkins introduced the bill.  S.1123, the “Safe Patient Handling Act,” which would apply to nursing homes and hospitals, would amend the Public Health Law and Education Law to create a new work group within the New York State Department of Health (“DOH”) to establish safe patient handling guidelines state-wide.  The work group would be required to generate a report for the Commissioner of Health by 2016.  § 2997-H(4).  Furthermore, the Commissioner would be tasked with promulgating new regulations concerning safe patient handling across the state.  § 2997(J)(1).  Facilities covered would have to file a compliance plan by July of 2017, which DOH would have to accept by July of 2018.  § 2997-J(3).

Continue reading →

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January 8, 2013

Eco-Friendly Cleaning Supplies in Nursing Homes and Adult Homes on Senate Agenda

The New York State Senate Health Committee will consider a bill that may ultimately require nursing homes, adult homes, senior centers, and other residential health care facilities to use environmentally-sensitive cleaning and maintenance products.  Senator Diaz will introduce the bill on January 9.

The bill, S.866-2013, would require the Commissioner of Health to create “guidelines and specifications” for the use of environmentally-sensitive cleaning supplies in covered facilities, which include nursing homes and adult care facilities.  § 1.  The act would become part of the Public Health Law and would be effective as of September 1st after the date the bill passes.  § 2.  The Department of Health would have to consult federal and other relevant environmental guidance documents concerning such supplies before issuing any guidelines.  § 1. Continue reading →

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January 7, 2013

HIPAA Enforcement for Breach Involving Less than 500 Patients

The U.S. Department of Health and Human Services (HHS) initiated a compliance investigation after the Hospice of North Idaho (HONI) reported to HHS that an unencrypted laptop computer containing the electronic protected health information (ePHI) of 441 patients had been stolen.

Pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH), if a breach of unsecured PHI involves less than 500 impacted individuals, a log of the unauthorized disclosure must be maintained and submitted to HHS on an annual basis.

As a result of the investigation, the HHS Office for Civil Rights (OCR) discovered that HONI had not conducted a risk analysis to safeguard ePHI, and did not have written policies or procedures to address mobile device security as required by the HIPAA Security Rule. The HONI agreed to pay the HHS $50,000 to settle the potential violations.

The settlement confirms that the OCR may conduct a compliance investigation in response to these required “self” disclosures.

This post is contributed by Charles Dunham.

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January 7, 2013

New York State Legislative Bill Mandating Direct Payment To Out Of Network Clinical Laboratory Providers

The New York State Senate and Assembly have introduced a bill (S.1083/A.636) to amend the Public Health Law (Section 4406) and the Insurance Law (Section 4084), in relation to reimbursement of out-of-network clinical laboratory providers by a commercial health benefit plan.

The bill would require commercial health benefit plans to make payment for laboratory services directly to the out-of-network provider and deem any payment to the enrollee as insufficient to satisfy the payment obligation.

An interesting provision within the proposed mandate is that the enrollee remains responsible for any applicable copayment, deductible or coinsurance. However, the provision does not expressly condition the direct payment upon the clinical laboratory’s collection of the copayment, deductible or coinsurance from the enrollee.

The bill will be referred on January 9, 2013 to the Senate Committee on Health and the Assembly Committee on Insurance.

This post is contributed by Charles Dunham.

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November 26, 2012

Quest’s Competitors File Lawsuit for Prohibited Arrangements with National Health Plans

Over the past several years, some commercial insurers have made a concerted effort to reduce costs associated with laboratory services, which physicians have increasingly relied upon in diagnosing and treating patients. In particular, insurers are concerned with the rise in laboratory services being performed out-of-network and the increased costs associated with such claims. Despite the imposition of higher premiums for out-of-network benefits, insurers are attempting to do indirectly – what they cannot do directly – to restrict the ability of health plan members to receive laboratory services from out-of-network providers.

A federal complaint was filed on November 14, 2012, in the Northern District of California that highlights the extent of such activities alleged to have been taken by Aetna, Inc., Blue Shield of California, and Blue Cross and Blue Shield Association in violation of federal and state law, and charges that such efforts are being initiated in concert with Quest Diagnostics Incorporated, the largest clinical laboratory provider in the nation. Rheumatology Diagnostics Lab., Inc. et al v. Blue Shield of Cal. Life & Health Ins. Co. et al, Case No. 12-5847 (November 14, 2012).

In short the complaint alleges that Aetna and Blue Shield, in order to receive capitated rate discounts on laboratory services, have conspired with Quest to direct all laboratory testing business to Quest by controlling referrals and reducing competition by the following: Continue reading →

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November 20, 2012

Health Planning Committee of the Public Health and Health Planning Council Proposes Significant Certificate of Need Redesign

The Health Planning Committee of the Public Health and Health Planning Council is proposing a significant Certificate of Need (“CON”) redesign. The Committee and Council are expected to make twenty-two (22) recommendations to the Department of Health next week, affecting the CON process.  Five of the recommendations refer to an initiative to shift towards regional planning for CON applications.

New entities – called Regional Health Improvement Collaboratives (“RHICs,” pronounced “Ricks”) – would be responsible for increasing patient experience of care, decreasing the per capita cost of care, reducing the disparities in coverage, and more effectively managing the health of New York’s citizens.  Continue reading →

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November 16, 2012

CMS Issues Section 1135 Waivers for New York and New Jersey

The Centers for Medicare and Medicaid Services (CMS) approved waivers for New York and New Jersey under Section 1135 of the Social Security Act.  The waivers ease certain legal requirements on healthcare providers who are serving those impacted by Sandy.  The Section 1135 waiver for New York is available here.  The waivers relax the rules for providers in areas like recordkeeping, patient relocation and billing in order to ensure that individuals enrolled in federal programs like Medicare and Medicaid receive the health care items and services that they need.  New York’s waiver is retroactive to Oct. 27. Continue reading →

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October 19, 2012

False Claims Act: Payment vs. Participation Regulations

In U.S. ex rel. Williams v. Renal Care Group, Inc. (Case No. 11-5779) (October 5, 2012), the Sixth Circuit Court of Appeals reversed a grant of summary judgment in favor of the United States on two main False Claims Act (FCA) claims relating to Medicare reimbursement of dialysis supplies. In doing so, the Court issued an important decision distinguishing the applicability of the FCA between noncompliance with payment and participation regulations.

The United States alleged, inter alia, that defendants violated the FCA by submitting claims which they knew were not in compliance with DME supplier standards set forth by statute and regulation relating to conditions of participation (i.e. to honor warranties, fill orders, and maintain an appropriate place of business), which impose independent sanctions and potential exclusion.

The Sixth Circuit reasoned that “[t]he False Claims Act is not a vehicle to police technical compliance with complex federal regulations.” As such, the Court agreed with the defendants that noncompliance with participation regulations does not render a claim materially false, irrespective of the whether the regulation is violated, because payment is not expressly or impliedly conditioned upon compliance with participation conditions.

This decision could have a further relevance in the context of Medicare and Medicaid provider audits for improper payments. In opposing audit tactics, our firm has always maintained that disallowances based on noncompliance with conditions of participation are unwarranted and inconsistent with the structure and purposes of the Medicare and Medicaid program. This decision adds support and justification to the validity of this argument in suggesting that payment is not expressly or impliedly conditioned upon compliance with participation conditions.

This post is contributed by Charles Dunham

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October 4, 2012

OMIG Releases Annual Report for Calendar Year 2011

Today, the New York State Office of the Medicaid Inspector General (“OMIG”) posted its 2011 Annual Report.  We will post a detailed analysis in the coming days. In the meantime, the report may be accessed here.

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October 1, 2012

New York State Allegedly Overbilled $15 Billion for State-Operated Facilities for Developmentally Disabled

On May 17, 2012, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a report that found Medicaid overpayments to New York State-operated developmental centers. The OIG concluded that, in 2009, State-operated  facilities for the developmentally disabled received $1.7 billion in Medicaid payments in excess of the reported costs of these facilities. The Medicaid rates paid to these New York State-operated facilities were ten times higher than the rates paid to private Intermediate Care Facilities in New York, which the OIG found comparable. The OIG determined that these overpayments had occurred for two decades and that they are still occurring in 2012. In fact, in fiscal year 2011, the daily payment rate to New York’s developmental centers was $5,118, which represented a 24 percent increase since 2009 and means that State-run developmental facilities are being paid approximately $1.9 million per year for each individual patient. This surprising increase was triggered by the formula for Medicaid payment rates for patients in developmental centers, which allows State-operated facilities to collect roughly two-thirds of the total Medicaid payment after an individual who has left the facility. Continue reading →

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