CMS Issues Final Rules Under Physician Sunshine Act 

The Physician Sunshine Act was enacted as part of the Affordable Care Act.  The Physician Sunshine Act requires drug, device, biological and medical supply manufacturers to make annual reports to the Department of Health and Human Services regarding payments or transfers of value to physicians and teaching hospitals and certain ownership interests that are held by physicians.  Manufacturers are subject to civil monetary penalties if they fail to comply with the reporting requirements.

 Data that is reported by manufacturers is required to be published on a public website.  An annual report must also be made to Congress and each state. 

CMS published proposed rules in 2011 which defined more precise obligations that manufacturers need to meet in order to comply with the requirements of the Physician Sunshine Act.  Just last week, CMS issued final regulations on the Physician Sunshine Act Law.  The Physician Sunshine Law as interpreted by the final regulations require applicable manufacturers to begin collecting required data by August 1, 2013 and to make their first data report to CMS by March 31, 2014.

The Final Rule provides further definition of terms that are necessary to determine compliance.  For example, the Final Regulations provide more complete definitions of applicable manufacturers and the types of drugs, devices, biological and medical supplies that are covered.  The Final Rules also provide clarification on the procedures and forms that manufacturers must use to report data.  The character of payments to be reported is also defined further.

The reporting requirements fall on the manufacturer.  However, physicians may be interested to know more details on the types of payments and activities that relate to them that would need to be reported by manufacturers.  Physicians are in the front lines of interactions with pharmaceutical and other sales representatives.  The Physician Sunshine Act has not changed the types of interactions that are permissible or prohibited.  However, even permissible arrangements with physicians will need to be reported by manufacturers and will be made publically available.

CMS Proposed Rule Would Simplify Ambulatory Surgery Center Radiologist Requirements 

On February 7, 2013, the Center for Medicare/Medicaid Services (“CMS”) released a proposed rule that contains regulatory provisions to promote program efficiency, transparency and burden reduction.  The proposed rule proposes reforming certain Medicare regulations that CMS has identified as unnecessary, obsolete or excessively burdensome on health care providers and suppliers. 

One significant rule that CMS is proposing be abandoned is the requirement that Ambulatory Surgery Centers (“ASC”) meet the full hospital requirements for radiology services.  The full requirement must correctly be met by ASCs even though ASCs are only permitted to provide radiologic services that are integral to the performance of surgical services provided at the ASC. 

CMS concluded in the proposed regulations that some of the hospital conditions of participation requirements which are applicable to ASCs are unduly burdensome and create unnecessary costs.  Particularly, this CMS is proposing that the requirement to have a radiologist supervise the provision of radiologic services be deleted from the ASC conditions of participation.  CMS states that the requirement was overly aggressive since ASCs did not provide radiologic services that are required for interpretation or diagnosis.  CMS cites the cost of privileging radiologists and paying radiologist fees for oversight of radiology studies that are limited to services that are integral to surgical procedure.

The proposed revision would keep the governing body of the ASC responsible for determining if there are any procedures being performed at the ASC, which would require review by a radiologist.  The surgeon performing the procedure would be expected to be privileged and trained the use of imaging as an integral part of the procedure.  However, the use of radiology in connection with surgical procedures does not require the services of a radiologist in most cases.

The revised requirements would permit supervision of radiologic services used in an ASC by a doctor of medicine or osteopathy who is not a radiologist but is a general member of the ASC’s medical staff.  CMS welcomes comments on these proposed regulations.

The Ruder Ware Health Care Industry Focus Group has done a great deal of work structuring Ambulatory Surgery Centers to comply with regulatory requirements.  Please feel free to contact us with any questions regarding the structure or operation of your Ambulatory Surgery Center.

Sources of Telemedicine Information on the World Wide Web

Because telemedicine is a developing field, many of the legal issues regarding telemedicine are

undeveloped. As courts and legislatures attempt to tackle these issues, experts will want to stay informed of these developments. Fortunately, there are a number of useful World Wide Web sites that address telemedicine and the attendant legal issues. Some of the most useful and informative sites are:

 US Government Resources

Federal Telemedicine Gateway

http://www.tmgateway.org/

Office for the Advancement of Telehealth

US Department of Health & Human Services

http://telehealth.hrsa.gov/

Telemedicine-Related Activities Report

US Food and Drug Administration

http://www.fda.gov/cdrh/telemed.html

Telemedicine Report to Congress, January 31, 1997

US Department of Commerce and Department of Health & Human Services http://www.ntia.doc.gov/reports/telemed/cover.htm

US Department of Defense Telemedicine

http://www.matmo.org/

Telemedicine Associations

American Telemedicine Association – atawiki – contains an abundance of telemedicine services in Wiki format.

American Medical Informatics Association

http://www.amia.org/

American Telemedicine Association

http://www.atmeda.org

MedWeb Plus: Telemedicine (1999).

http://www.medwebplus.com/subject/Telemedicine.html

Telemedicine Publications

Telehealth Magazine

http://www.telemedmag.com

Telemedicine Information Exchange

http://208.129.211.51/

http://tie.telemed.org

Telemedicine Today, http://www.telemedtoday.com

Telemedicine and Telehealth Networks, http://www.telemedmag.com

Indian Health Service http://www.ihs.gov

Telemedicine Links, http://www.jma.com.au/telelink.htm#networks

Telemedicine Information Exchange, http://208.129.211.51/

United States Department of Commerce and United States Department of Health and Human Services (1997).

State Telemedicine Programs and Resources

East Carolina University School of Medicine’s Telemedicine Page

http://www.telemed.med.ecu.edu/

Emergency Medicine and Primary Care Home Page

http://www.embbs.com/

MedWeb: Telemedicine Emory University

http://WWW.MedWeb.Emory.Edu/MedWeb/

Telemedicine Links John Mitchell & Associates

http://www.jma.com.au/telelink.htm#networks Includes links to telemedicine networks, telemedicine projects, telemedicine organizations, telematics, telemedicine journals, books, articles, bibliographies, terminology.

Rural Alabama Health Alliance Telemedicine

http://www.tmgateway.org/gateway/agencies/rus/501/

University of Iowa’s Virtual Hospital

http://vh.radiology.uiowa.edu/

University of Kansas Telemedicine

http://www2.kumc.edu/telemedicine/index.asp

University of Vermont Telemedicine

http://www.vtmednet.org./telemedicine/

Health Information Tennessee

http://web.utk.edu/~chrg/hit/index.htm

Other Useful Links

Prevention

http://www.cdc.gov/cdc.html

Healthcare on the Internet Index/Abstract

http://www.personal.psu.edu/faculty/e/p/epd103/hci/

National Center for Injury Prevention and Control

http://www.cdc.gov/ncipc/osp/mortdata.htm

Sig Med Pulse, ASIS Medical Informatics Newsletter

http://www.asis.org/SIG/SIGMED/newsletter/pulsev1n3.html

Telemedicine Report to Congress, January 31, 1997, http://www.ntia.doc.gov/reports/telemed/

United States Food and Drug Administration (1997).

Telemedicine-Related Activities Report, http://www.fda.gov/cdrh/telemed.html

United States Government (1998)

The Federal Telemedicine Gateway, http://www.tmgateway.org/gateway/

Online Telemedicine Resource Links

Telemedicine Resources • Http://telehealth.hrsa.gov (OAT)

• http:www.atmeda.org (Am. Telemedicine Assn.)

 • http://telehealth.hrsa.gov/jwgt/jwgt.htm

http://transition.fcc.gov/wcb/tapd/ruralhealth/

 http://www.rurdev.usda.gov/UTP_DLTResources.html

Telemedicine Credentialing By Proxy and Hospital Policies

Provider Credentialing requirements raise important considerations in any telemedicine arrangement. The facility where care is received, renders a diagnosis, or otherwise provides clinical treatment to a patient, must assure that a telemedicine practitioner is appropriately credentialed and privileged in compliance with their credentialing process, CMS rules, and the requirements of applicable accreditation organizations.  The process for credentialing telemedicine providers should be addressed by the governing body and reflected in medical staff bylaws and formal credentialing policies.

Credentialing standards have been somewhat streamlined since CMS adopted new regulations that were effective in June of 2011.  CMS rules now permit “credentialing by proxy” provided that several conditions are met.  It remains the responsibility of the board to determine when or if it wishes to rely on “credentialing by proxy” or whether it should apply full credentialing requirements on remote providers of telemedicine services.  Even though the process has been simplified, credentialing of providers who perform telemedicine services to patients of a hospital is still an extremely important responsibility of the hospital board.

Anesthesia Company Models and Advisory Opinion 12-06

As previously reported on this blog, the Department of Health and Human Services issued advisory opinion 12-06 in June 2012.  This advisory opinion has an impact on many relationships between physician groups, ambulatory surgery centers and providers of anesthesia services.

Generally, the advisory opinion addressed the permissibility of the “company model.”  Under the company model, a physician group who provides surgical services will establish a separate company and provide ownership interest to an anesthesia group.  This structure is created in order for the surgery group to take advantage of some of the revenues from anesthesia services.  The jointly held entity is the billing provider for the anesthesia component of the care.

Advisory opinion 12-06 addressed the company model and found that such a model was potentially a violation of the Medicare Anti-Kickback Statute.  However, the advisory opinion did not go so far as to say that all anesthesia models were impermissible.  Each circumstance must be looked at under its specific facts.  It is often possible to structure these arrangements to take advantage of an Anti-Kickback Statute Safe Harbor or to otherwise minimize the risk to an acceptable level.

There has been a lot of talk in the industry following the release of advisory opinion 12-06.  Many sources are saying that this advisory opinion completely abolished the ability of a surgery group to be involved in anesthesia service revenues.  It is important that providers have a clear understanding of the true implications of advisory opinion 12-06 and the structures that are still permissible without creating unacceptable risk under the Anti-Kickback Statute.

Ruder Ware health care has advised physician practices and anesthesia groups regarding the structuring of permissible arrangements.  We have also represented providers and payors with respect to other types of anesthesia billing and contract matters.  If you have questions regarding advisory opinion 12-06, or any other legal issue pertaining to health care law, please contact us through the contact information on this blog.

Telemedicine Private Reimbursement – More States Look at Private Payment Mandates

Much of the discussion surrounding telemedicine relates to factors that slow the implementation of its use.  One factor contributing to this is the lack of consistent and comprehensive reimbursement.  There is no systematic private payment across the country.  Many private payors refuse to cover telemedicine services.  Others do so on a limited basis.  The inconsistency makes the burden and costs high for providers who use telemedicine.

Some states have responded to this inconsistency by enacting laws.  As of the current date, 16 states have enacted some type of law mandating payment for health care services that are provided through use of telemedicine technologies.  Three states, Michigan, Maryland, and Vermont, added new laws to their books during 2012 that mandate some level of telemedicine reimbursement.

The American Telemedicine Association has reported that 8 additional states have introduced telemedicine reimbursement laws already in 2013.  Those states include Florida, District of Columbia, Connecticut, Mississippi, Nebraska, Indiana, South Carolina, and New Mexico.  Some of the listed states have introduced general requirements that telehealth be reimbursed without discrimination.  Others have addressed more limited coverage scope such as Indiana, which is considering coverage to home health agencies, federally qualified health centers and rural clinics.

It is uncertain what the final outcome of the recently introduced legislation will be.  It is also probable that more states will consider various forms of private payment requirements for telemedicine services.  We are likely to see more states address this issue over upcoming years as telemedicine gains more traction.