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HEADLINES
Wednesday,
June 30, 2010
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On
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The CCH HIPAA Privacy Guide June 2010 update includes:
- Requirements for the Department of Health and Human Services under the Patient Protection and Affordable Care Act (PPACA) to support the use of health information technology (HIT), including (1) integrating the respective reporting mechanisms for the Medicare Physician Quality Reporting Initiative (PQRI) and the electronic health record (EHR) meaningful use incentives no later than January 1, 2012 and (2) establishing standards and operating rules for typical electronic transactions between insurers and providers;
- Two programs for certifying technology for EHR modules proposed by the Office of the National Coordinator (ONC) for Health Information Technology;
- A message from the director of the ONC describing progress in establishing a Nationwide Health Information Network for exchange of health information;
- An OCR chart summarizing key features of about 50 federal laws and regulations addressing “Confidentiality, Privacy and Security."
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Health Care Compliance Professional’s Manual Highlights
Endorsed by the Health Care Compliance Association, the Health Care Compliance Professional’s Manual and written by HCCA board members and other experienced compliance practitioners, provides insights on legislative and regulatory matters, offers guidance on applying the laws and regulations, and includes practical compliance solutions. Report 24 (June 2010), includes the following revised chapters:
- “Health Care Fraud and Abuse Laws,” updated by Ritu Kaur Singh, Esq. reflects recent enforcement activities and changes to the law mandated by the Fraud Enforcement Recovery Act of 2009 and the Health Information Technology for Economics and Clinical Health Act.
- “False Claims Act and Qui Tam Suits,” updated by Ritu Kaur Singh, Esq., reflects recent activity and changes to the law mandated by the Fraud Enforcement Recovery Act of 2009 and the Patient Protection and Affordable Care Act.
- “An Overview of Federal Antitrust Laws and Enforcement Policies,” revised by Bevin M.B. Newman, JD., updates discussions of antitrust laws and adds recent antitrust enforcement actions related to the health care industry.
- “Developing, Delivering, and Positioning Compliance Education and Training,” updated by Donnetta Horseman, MA, CHC, CIPP, CCE, provides additional information on training staff, including tips and examples.
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Headlines
CMS issues advance notice of background check program
CMS provided advance notice that it
will issue a solicitation for federal matching grants to all states
and the U.S. territories for a multi-year "National Background
Check Program for Patient Protection" for direct patient access
employees of several long-term care (LTC) facilities and providers.
The program, implemented under the Patient Protection and Affordable
Care Act (PubLNo 111-148) and Health Care and Education Reconciliation
Act (PubLNo 111-152), will assist states and territories that desire
to institute or upgrade their systems of employee background checks
to include checks of all pertinent registry sources in all states
in which a potential employee has lived, to check state and federal
criminal records, and to use the FBI fingerprinting system in order
to ensure that employees hired to serve the vulnerable LTC populations
do not have criminal or registry past histories that make them unfit
to be hired. States and territories are subject to several
major requirements to participate in the program. For instance, LTC
facilities and providers must obtain state and national criminal history
background checks on prospective employees. These checks must include:
- a search of abuse and neglect registries of the current
state and other states in which the prospective employee lived;
- state criminal history records;
- records of state proceedings that may contain disqualifying
information; and
- federal criminal history records, including a fingerprint
check using the FBI Integrated Automated Fingerprint Identification
System.
States and territories are also required to
describe and test methods to reduce duplicative fingerprinting, including
providing for the development of a “rap back” capability
so that employees once hired, who subsequently are convicted of new
crimes, are immediately made known to the employing facility or provider. CMS
plans to offer a national conference call once the solicitation is
issued and ongoing technical assistance to all participating states
to assist with implementation of their programs. CMS will also offer
the development and collection of data that will be later used by
the Office of the Inspector General when it conducts an evaluation
of the program. CMS matching funds will become available
on award and throughout federal fiscal year 2012, according to the
three-to-one match amount awarded to each participant. CMS
Memorandum to State Survey Agency Directors, No. S&C-10-21-NH,
May 28, 2010, Health Care Compliance Reporter.
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OIG anti-fraud initiatives enhanced under PPACA
The Chief Counsel of the Office of
Inspector General (OIG) testified on the new initiatives promulgated
under the Patient Protection and Affordable Care Act (PPACA) (PubLNo
111-148) that aim to combat fraud, waste, and abuse in the health
care system. Expansion of HHS authority. Under
PPACA §6401, the HHS Secretary is required to, among other things:
(1) establish procedures for screening providers and suppliers participating
in Medicare, Medicaid, and the Children’s Health Insurance Program
(CHIP); and (2) determine the level of screening according to the
risk of fraud, waste, and abuse with respect to each category of provider
or supplier. The Secretary is authorized to impose additional screening
measures based on risk, including fingerprinting, criminal background
checks, multi-state database inquiries, and random or unannounced
site visits. PPACA also authorizes the Secretary to require
providers and suppliers to adopt, as a condition of enrollment, compliance
programs that meet a core set of requirements, to be developed in
consultation with OIG. In addition, PPACA requires skilled nursing
facilities and nursing facilities to implement compliance and ethics
programs, also in consultation with OIG. Reporting
requirements. The new law imposes a number of reporting requirements
on various entities, including drug manufacturers, nursing facilities,
and program integrity contractors. In an effort to investigate financial
relationships and potential conflicts of interests between health
care companies and physicians, PPACA §6002 requires all U.S.
manufacturers of drug, device, biologics, and medical supplies covered
under Medicare, Medicaid, or CHIP to report information related to
payments and other transfers of value to physicians and teaching hospitals.
This information will be made available on a public web site. Section
6101 requires nursing facilities and skilled nursing facilities to
report ownership and control relationships. This reporting requirement
will help ensure that corporate owners and investment companies that
own nursing homes do not provide substandard care, deny responsibility,
and leave underfunded shell companies to take the blame. HCFAC
funding. PPACA provides additional funding to enable the OIG
to expand current enforcement and oversight efforts. The Health Care
Fraud and Abuse Control (HCFAC) Program, designed to coordinate federal,
state, and local law enforcement activities with respect to health
care fraud and abuse, has returned more than $15.6 billion to the
federal government through audit and investigative recoveries. HCFAC-funded
activities will receive $10 million per year for 10 years in fiscal
years (FYs) 2011 through 2010 under PPACA, and an additional $250
million spread across FYs 2011 through 2016 under the Health Care
and Education Reconciliation Act (PubLNo 111-152). Testimony
of OIG Chief Counsel before the House Committee on Ways and Means,
Subcommittees on Health and Oversight, June 15, 2010, Health
Care Compliance Reporter.
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Nonprofit’s financial aid arrangement permissible, OIG
A nonprofit, charitable organization’s
proposed arrangement to assist financially needy individuals diagnosed
with certain diseases would not constitute grounds for the imposition
of civil monetary penalties. The organization was created to establish
grant programs to provide aid to financially needy patients, including
Medicare and Medicaid beneficiaries, who have been diagnosed with
Multiple Sclerosis, cancer, or rheumatoid arthritis. Under the proposed
arrangement, the organization would establish a separate fund for
each of the diseases, and a fourth fund for genetic testing. The
availability of the grant program would be published on the organization’s
web site and to medical providers and pharmacies that typically treat
patients with the specified diseases. Patients would apply for assistance
by completing a grant application that would include the patient’s
diagnosis, proof of income, and other financial disclosures. Patients
must be under the care of a physician and already undergoing treatment
for a specified disease at the time of application to be eligible
for assistance, but patients would be free to change providers, suppliers,
or medications without losing eligibility for aid. For
a patient to qualify for assistance under the proposed arrangement,
the medication must have been prescribed as part of an approved course
of treatment for one of the specified diseases, and must not be for
an off-label use. The organization would not refer applicants to,
recommend, or arrange for the use of any particular medication, test,
practitioner, provider, or supplier; patients would have complete
freedom of choice in such matters. The organization would
solicit donations from the general public, such as individuals, foundations,
and corporations, including pharmaceutical manufacturers. All donations
would be in the form of cash or cash equivalents. Donations
could not be earmarked for patients using a specific medication, patients
requiring a specific genetic test, or genetic tests associated with
a particular specified disease. The organization’s discretion
to use the donations would be absolute, independent, and autonomous.
Further, no health plan or donor would be able to exert any influence
or control over the proposed program. The OIG concluded
that the design and administration of the proposed arrangement would
interpose an independent, bona fide charitable organization
between donors and patients in a manner that would effectively insulate
beneficiary decision-making from information attributing the funding
of their benefit to any donor. Thus, it appeared unlikely that donor
contributions would influence any beneficiary’s selection of
a particular provider, practitioner, supplier, test, or product. OIG
Advisory Opinion, No. 10-07, May 26, 2010, Health Care Compliance
Reporter.
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Ambulatory surgical center waiting area requirements clarified
The Centers for Medicare & Medicaid
Services (CMS) recently clarified its requirements for ambulatory
surgical center (ASC) waiting areas, including: (1) the prohibition
on the sharing of waiting areas with other entities, (2) the requirement
that waiting areas meet Life Safety Code (LSC) requirements, and (3)
the availability of waivers for existing ASCs that share a waiting
area with other building occupants when compliance with the LSC requirements
is not feasible. Under the Medicare ASC regulations, an
ASC is a distinct entity that operates exclusively for the provision
of surgical services. As a result, an ASC may not share space, including
its waiting area, with another entity when the ASC is open. The waiting
area must be a distinct area set aside for patients and families,
outside of the areas used to prepare patients for their procedures,
perform procedures, or recover from procedures. An ASC
must also comply with the provisions under the National Fire Protection
Association edition of the LSC, which require, among other things,
the ASC to be separated from other tenants by walls that have at least
a one-hour fire resistance rating, and its doors to be constructed
of not less than 1.75 inches thick solid-bonded wood core or the equivalent
and equipped with positive latches. A number of existing
ASCs have, however, misinterpreted the requirement for ASCs to be
separated from other tenants and occupancies. As a result, they may
not have walls with the requisite rating of at least one-hour fire
resistance, and therefore may have been cited for a lack of adequate
separation under the LSC. Accordingly, CMS is authorized to waive
specific provisions of the LSC if compliance would cause unreasonable
hardship and if the waiver would not adversely affect the health and
safety of the patients. While operating under an approved
waiver, the ASC must assure that fire protection for the waiting area
is appropriate for the occupancy for which it was designed. In addition,
in order for the ASC to be a distinct entity, the ASC’s patients
and visitors using the waiting area must be separated from other occupants
in a shared waiting area by a temporary partition, unless the ASC
is “temporally” distinct from the other occupancy. CMS
Memorandum to State Survey Agency Directors and State Fire Authorities,
No. S&C-10-20-ASC, May 21, 2010, Health Care Compliance Reporter.
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On The Front Lines
Mandatory Reporting of Elder Abuse in PPACA Creates Additional Risk and Compliance Burdens for Long-Term Care Providers
by H. Carol Saul and Allen B. Roberts
Many of us who focus on the healthcare industry are
familiar with the financial “carrot” dangled before whistleblowers
who report alleged false claims by filing qui tam lawsuits. One portion
of the Patient Protection and Affordable Care Act (PPACA) now will
function not as a whistleblower carrot, but as a “stick,”
imposing significant penalties against individuals who fail to report
a reasonable suspicion of a crime against a long-term care resident
or other individual receiving services from a long-term care facility.
Long-term care facilities and those who arrange for long-term care,
as well as their employees and contractors, should understand their
new obligations, the additional risks and the compliance steps which
are necessary to reduce that risk. Subtitle H of PPACA, titled the “Elder
Justice Act of 2009,” amends Title XX of the Social Security
Act to establish a federal elder justice program. It represents the
culmination of a nearly decade-long effort for increased federal regulation
of elder abuse. First introduced in 2003, an elder justice bill was
passed by the Senate Finance Committee four times, and by the House
of Representatives once. Despite strong efforts of the Elder Justice
Coalition to get a bill through both houses of Congress, those efforts
were unsuccessful until Senator Blanche Lincoln, D-Arkansas, led successful
efforts to include it in the federal heathcare reform bill. The
Elder Justice Act, which was signed into law on March 23, 2010, authorizes
block grants to states for social services; provides funding for adult
protective services; establishes an advisory board on elder abuse,
neglect and exploitation; and provides for Ombudsman Program grants,
as well as grants and incentives for long-term care staffing. From
a compliance and employment law perspective, however, it is Section
6703(b)(3) of the Elder Justice Act, titled “Reporting to Law
Enforcement of Crimes Occurring in Federally Funded Long-Term Care
Facilities,” that should be carefully noted. This section mandates
reporting of suspected crimes in federally funded long-term care facilities.
Every “covered individual” with respect to any long-term
care facility that receives at least $10,000 in federal funds annually
under the Social Security Act is subject to the reporting requirements
in Section 6703(b)(3).
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