Impact of Sunshine Law on physicians

In response to growing concerns that physicians’ financial relationships with pharmaceutical and medical device companies create inappropriate conflicts of interest in research and patient care, Section 6002 of the Patient Protection and Affordable Care Act implements the Physician Payments Sunshine Act (the Sunshine Act).

The Sunshine Act requires manufacturers of drugs, biological products, medical supplies and medical devices to annually report payments made to physicians or teaching hospitals to the Secretary of the Department of Health and Human Services (the Secretary). The Secretary must make the reported data publicly available. The expectation is that increased transparency will deter inappropriate conflicts of interest and will increase confidence that physicians are disseminating unbiased information.

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Vigorous HIPAA Privacy Rule enforcement

With the announcements of Cignet’s $4.3 million civil monetary penalties and two recent resolution payments, HHS’ Office of Civil Rights sent a clear message that it is serious about enforcement of HIPAA’s Privacy Rule. Therefore, covered entities should ensure that they have a robust HIPAA compliance program including employee training, vigilant implementation of policies and procedures, internal audits and a prompt action plan to respond to incidents.

Background

The Health Insurance Portability and Accountability Act’s (HIPAA’s) Privacy Rule is a set of federal standards to protect the privacy of medical records and other health information maintained by covered entities. These standards provide patients with access to their medical records and with significant control over how their personal health information (PHI) is used and disclosed.

The U.S. Department of Health and Human Services (HHS) delegated Privacy Rule enforcement to HHS’s Office of Civil Rights (OCR). For violations occurring before Feb. 18, 2009, OCR may impose civil monetary penalties (CMP) of up to $100 for each such violation. That penalty may not exceed $25,000 per year for multiple violations of the identical Privacy Rule requirement in a calendar year.

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Feds set sights on executives in battle to curtail health-care fraud

As first appeared in Columbus Business First, May 20, 2011.

The federal government is waging an aggressive fight against health-care fraud and it is generally understood that a business caught engaging in any type of fraudulent activity can expect to be sanctioned.

Less well-known is the fact that the government has the power to sanction owners, officers and even employees of a business convicted of health-care fraud, even if the individuals themselves have not been convicted of any wrongdoing. The sanction consists of banning the individual from participating in federal health-care programs such as Medicare and Medicaid. The ban, called exclusion, effectively prohibits the excluded individual from working for a health-care provider that receives reimbursement from Medicare, Medicaid, or other federal health-care programs.

Last year, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services excluded a drug company executive from participating in federal health-care programs. The executive, Marc Hermelin, was excluded based on his company’s compliance problems with the Food & Drug Administration (FDA). At the time, he was the first pharmaceutical company official who had not been convicted of a crime to be excluded from federal health-care programs by the OIG.

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Health care reform and access to care health insurance exchanges, care health cooperatives, community insurance and Medicaid

Presenters:
Robert Harrison, Snow, Christensen & Martineau

The recent HiTech Amendments to HIPAA have increased the stakes for anyone who handles patient health information, including attorneys and law firms.  In these podcasts, Robert discusses health reform and access to care health insurances exchanges and access to care health cooperatives, community insurance and Medicaid.

These podcasts are part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

HIPAA and the new HiTech amendments (Part Two)

Overview of the privacy, security and breach notification rules

Presenters:
Karin M. Zaner and Jennifer S. Brownell, Kane Russell Coleman & Logan PC

Business associates and covered entities must comply with HIPAA's Privacy, Security and Breach Notification Rules. Anyone who is undertaking new compliance efforts or evaluating existing efforts must have a working knowledge of these three rules and their underlying aims. In this podcast, Karin and Jennifer generally review and discuss the purpose behind and the basic safeguards set out in the Privacy, Security and Breach Notification Rules, so that covered entities and business associates (including attorneys who are handling protected health information in the course of representing their clients) can begin to evaluate existing compliance efforts or craft new compliance policies and procedures.

This podcast is part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

HIPAA and the New HiTech Amendments (Part One)

What is protected and who is covered

Presenters:
Karin M. Zaner and Jennifer S. Brownell, Kane Russell Coleman & Logan PC

With the recent focus on health care reform, compliance with HIPAA's privacy and security requirements for handling patient health information is of paramount importance. The recent HITECH amendments to HIPAA have increased the stakes for anyone who handles patient health information, including attorneys and law firms.

HIPAA compliance is complex and challenging. In this podcast, Karin and Jennifer explain what exactly protected health information is and who comes under the definition of covered entity and business associate. The civil and criminal penalties for violations, which have now been extended to business associates, are also discussed. Listening to this podcast is a crucial first step to getting HIPAA compliance policies and procedures in place.

This podcast is part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

Fraud and abuse after the 2010 Health Care Reform Bill

Presenters:
John Meyers and Gary Michel, Ervin Cohen & Jessup LLP

The Health Care Reform Bill as signed by President Obama in March of 2010 affects fraud and abuse in the areas of the physician referral statute, the Federal anti-kickback statute, and the False Claim Act. In this podcast John Meyers and Gary Michel, both partners of Ervin Cohen & Jessup LLP, Beverly Hills, CA, discuss the major changes in these areas.

This podcast is part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

State demonstration projects rather than tort reform under the 2010 health care bill

Presenters:
Mark Marquardt, Nancy Paikoff and David Phillips of MacFarlane Ferguson & McMullen, P.A.

In 2010, Congress enacted a health care bill which made no changes to the current method of tort litigation. The language in the bill provides for demonstration grants to states over a five year period for the states to propose alternatives to current medical tort litigation. In this podcast, the presenting attorneys discuss how states may apply for grants, elements to be considered in the grants and how grants are to be reviewed.

This podcast is part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

Health industry specific tax provisions in health care reform

Presenters:
Mark Gilgus, Seigfreid, Bingham, Levy, Selzer & Gee, P.C.
Mark Thompson, Seigfreid, Bingham, Levy, Selzer & Gee, P.C.

The Patient Protection and Affordable Care Act included a number of health industry specific tax provisions. These are primarily designed to raise revenue from health insurers, pharmaceutical companies, and medical device manufacturers to help pay for the costs of increased access to health insurance and will be phased in over the next few years. Gilgus and Thompson highlight these revenue raisers, which will require significant regulations to implement.

This podcast is part of the Law Firm Alliance – 2010 Health Care Reform podcast series, which can be accessed in its entirety by clicking here.

CMS adopts more strict regulations for DMEPOS suppliers

On Aug. 26, the Centers for Medicare and Medicaid Services (CMS) issued new rules for suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The new rules consist of additions and revisions to the supplier standards in 42 C.F.R. §424.57. The rules take effect Sept. 27. and enhance Medicare enrollment standards and strengthen existing standards that suppliers must meet before being able to furnish equipment and supplies to Medicare beneficiaries. Among other things, the rules require the following:

  • Suppliers must be licensed to provide licensed services and cannot contract with an individual or an entity to provide the services.
  • Suppliers must permit CMS and the National Supplier Clearinghouse (NSC) to conduct onsite inspections to ascertain supplier compliance.
  • Suppliers are prohibited from using cell phones, beepers or pagers as the primary method of receiving calls or exclusively using call forwarding to forward a call to a cell phone, beeper or pager from the public or beneficiaries during posted hours of operation.
  • Suppliers cannot directly solicit patients, which includes, but is not limited to, a prohibition on telephone, computer, e-mail, instant messaging and internet coercive advertising.
  • Suppliers must obtain oxygen from a state licensed oxygen supplier (applies only in states that require oxygen licensure).
  • Suppliers are required to maintain ordering and referring documentation for a period of seven years from the date of service.  
  • Suppliers are prohibited from sharing a practice location with another Medicare supplier or provider (subject to certain exceptions).
  • Subject to certain exceptions, suppliers must be open to the public a minimum of 30 hours per week.
  • Suppliers must maintain a physical facility that measures at least 200 square feet (except for orthotic and prosthetic personnel providing custom fabricated orthotics and prosthetics in private practice). The location must be accessible during posted business hours to beneficiaries and to CMS, and must include a visible sign and posted hours of operation.

A supplier who does not meet the requirements of the new rules may lose its billing privileges in the Medicare program. In addition, failure to comply with the rules could result in an overpayment finding.