Monday, April 29, 2013

The Doctor Is Out, But the PA Will See You Now

On March 25, 2013, Governor Steve Beshear signed House Bill 104, a bill that will change how Physician Assistants (“PAs”) practice in the Commonwealth. Under former law, a PA had to be directly supervised by a doctor in the first eighteen months of their medical practice. Kentucky had the longest supervision requirement of any state in the U.S.

The new law establishes that from July 2013 to May 2014, physicians will be required to be on-site as newly-graduated PAs provide care for the first three months of practice. On June 1, 2014, this requirement will be eliminated altogether. In addition, PAs may perform services in a location separate from their supervising physician; this is possible because supervisors may now “supervise” via telecommunication.

Thursday, April 25, 2013

Antitrust Agencies Continue Pursuit of
Improper Joint Contracting by Providers

The Federal Trade Commission ("FTC") and the Department of Justice’s Antitrust Division ("DOJ") continue to pursue competing providers that are not clinically or financially integrated but nevertheless attempt to jointly negotiate contracts with payors.

In January of this year, DOJ pursued price-fixing charges against an independent physicians association ("IPA") allegedly including 350 competing chiropractors in Oklahoma. DOJ alleged that the IPA comprised 45 percent of the chiropractors in Oklahoma. Allegedly, from 2004 to 2011, the IPA negotiated seven payor contracts that fixed prices for chiropractic services. DOJ found particularly troubling a mandatory membership agreement that, among other things, required members to suspend any existing contracts with payors upon joining the IPA and that required members not to accept a reimbursement rate below a stated rate. The IPA's website also supported DOJ's position that the IPA was not clinically or financially integrated as the website stated that members could continue as "an individual practice while associating with other chiropractors to increase contract-negotiating power." As a result, DOJ charged that the IPA was engaged in price-fixing in violation of Section 1 of the Sherman Act. The IPA entered into a settlement agreement prohibiting any future negotiations with payors on behalf of its members.

Monday, April 8, 2013

OIG 2013 Work Plan Gives
Direction for Physicians

The government’s healthcare fraud prevention and enforcement efforts recovered a record $4.2 billion in taxpayer dollars in Fiscal Year 2012, up from nearly $4.1 billion in FY 2011. Over the last four years, the administration’s enforcement efforts have recovered $14.9 billion, up from $6.7 billion over the prior four-year period.  During 2012, the Department of Justice opened 885 new civil healthcare fraud investigations, with 1,023 civil fraud matters pending at the end of the year.  The DOJ also reported a record 647 whistleblower lawsuits and recovered $3.3 billion from lawsuits filed by whistleblowers.

On the criminal side, the DOJ opened 1,121 new criminal healthcare fraud investigations with 2,032 healthcare fraud criminal investigations pending at the end of FY 2012.  The DOJ filed criminal charges in 452 cases involving 892 defendants during that time.

Friday, April 5, 2013

House Bill 1 Revisited: Kentucky
General Assembly Amends “Pill Mill” Bill

In a 2012 Special Session, the Kentucky General Assembly passed House Bill 1, also known as the “pill mill” bill, to rein in the over-prescribing of prescription drugs and the diversion of prescription drugs.

Following passage of House Bill 1, and its being signed into law by Governor Beshear, the Cabinet and various licensure boards issued regulations implementing House Bill 1’s requirements.  After emergency regulations were promulgated, Governor Beshear’s office held a series of stakeholder meetings.  Governor Beshear’s office, as well as various licensure boards, recognized that House Bill 1 and the implementing regulations would require amendment and refinement to address concerns raised by the provider community and other stakeholders.  During the 2013 Regular Session of the General Assembly, some of these concerns were addressed in House Bill 217, which amended portions of House Bill 1.

Monday, April 1, 2013

More on the Final HIPAA Omnibus Rule

To follow up our previous blog on the Final Omnibus Rule (“Rule”) regarding HIPAA and HITECH, 78 Fed.Reg. 17, Part II, 5566-5702 (Jan. 25, 2013), which modifies 45 CFR Parts 160 and 164, we will now discuss the changes to the Breach Notification Rule. The modifications will greatly reshape how Covered Entities and Business Associates view a breach.

New “Breach” Standard
Previously, breach was defined as the “acquisition, access, use, or disclosure of protected health information (“PHI”) in a manner not permitted under [the Privacy Rule] which compromises the security or privacy of the PHI.” Compromising the security or privacy of PHI meant “posing a significant risk of financial, reputational, or other harm to the individual.” 45 CFR §164.402 (emphasis added). The problem, according to HHS, was that some covered entities interpreted the “risk of harm” standard as higher than HHS intended.

HHS Issues Final HIPAA Omnibus Rule

The U.S. Department of Health and Human Services (“HHS”) recently announced its issuance of the highly-anticipated regulations or Final Omnibus Rule (“Rule”) relating to the modification of the HIPAA Privacy, Security, and Enforcement rules under the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”). 78 Fed.Reg. 17 Part II (January 25, 2013) modifying 45 CFR Parts 160, 162, 164. The Final Rule, 78 Fed.Reg. 17 Part II, 563 pages in length, makes significant changes of which all providers need to be aware. A complete examination of the sweeping changes cannot be done in one article, so we will make a general summary of the most important changes.

The new HIPAA Rule extends certain provisions of the HIPAA Privacy, Security, and Breach of Notification Rules to Business Associates (“BA”). This means that a BA is now legally accountable for compliance with HIPAA rules.