Med Law Blog

http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE1007.pdf

| Posted By Michael Cassidy In Medicare & Reimbursement | 0 Comments | Permalink

CMS APPROVES THREE NATIONAL ORGANIZATIONS TO

ACCREDIT SUPPLIERS OF ADVANCED IMAGING SERVICES

MRI, CT AND PET SCANS AMONG SERVICES TO BE AFFECTED

The Centers for Medicare & Medicaid Services (CMS) is designating three national accreditation organizations – the American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and The Joint Commission (TJC) - to accredit suppliers furnishing the technical component (TC) of advanced diagnostic imaging procedures.  The accreditation requirement will apply only to the suppliers furnishing the imaging services, and not to the physician’s interpretation of the images.

As required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), all suppliers of the TC of advanced imaging will have to become accredited by an accreditation organization designated by the Secretary of Health and Human Services by Jan. 1, 2012.  The accreditation requirement applies to physicians, non-physician practitioners, and physician and non-physician organizations that are paid for providing the technical component of advanced imaging services under the Medicare Physician Fee Schedule.

MIPPA specifically defines advanced diagnostic imaging procedures as including diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging such as positron emission tomography (PET).  The details of the accreditation organization selection process went through notice and comment rulemaking in the calendar year 2010 Physician Fee Schedule rule.

“While advanced diagnostic imaging procedures can be useful in identifying health problems that might otherwise require surgery, the rapid growth in their use raises important questions of quality and safety,” said Barry Straube, M.D., CMS chief medical officer and director of the CMS Office of Standards and Quality.  “The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide.”

To be designated, the accrediting organizations had to demonstrate that they were experienced in the advanced diagnostic imaging area, and that their accreditation requirements met or exceeded the standards set out in MIPPA, including requirements for:

·         Qualifications of non-physician personnel performing the imaging;

·         Qualifications and responsibilities or medical directors and supervising physicians;

·         Procedures to ensure the safety of the individuals furnishing the imaging procedure and of the persons to whom the services are furnished;

·         Procedures to ensure the reliability, clarity, and accuracy of the technical quality of the diagnostic images produced by the supplier;

·         Procedures to assist the beneficiary in obtaining his/her imaging records on request; and

·         Procedures to notify CMS of any changes to the imaging modalities subsequent to the accrediting organization’s decision.

In addition, the accrediting organizations were required to develop a plan for reducing the burden and cost of accreditation to small and rural suppliers.  The accrediting organizations are also required to provide CMS with detailed information about their survey processes.

MIPPA specifically excluded from the accreditation requirement certain imaging services such as x-rays, ultrasound, and fluoroscopy procedures.  The law also excludes from the CMS accreditation requirement diagnostic and screening mammography, which are subject to quality oversight by the Food and Drug Administration under the Mammography Quality Standards Act.

CMS will issue further guidance to suppliers about meeting the accreditation requirements.  CMS plans to undertake a provider education outreach program to ensure that all affected suppliers understand the requirements and are able to comply with them prior to the Jan. 1, 2012, accreditation deadline.

For more information, please see the CMS Web site at: www.cms.hhs.gov/medicareprovidersupenroll .

| Posted By Michael Cassidy In Medicare & Reimbursement | 0 Comments | Permalink

On January 28, the Senate approved legislation that will increase the federal debt limit to $1.9 trillion. Included in this legislation was a provision to reinstate "pay-go" rules mandating that Congress must offset any future increased spending with corresponding spending reductions or revenue increases.  This bill also provides Congress a 5 year exemption from these pay-go rules to address the Medicare physician payment cut. However, this provision does not provide any funding. The current freeze on the 2009 Medicare conversion factor is scheduled to expire on Feb. 28. Any solution still requires House and Presidential approval.
 

| Posted By Michael Cassidy In Medicare & Reimbursement | 0 Comments | Permalink

Contributed by Paul J. Welk, Esq.

412.594.5536, pwelk@tuckerlaw.com

In a letter dated January 27, 2010, the American Medical Association, American Veterinary Medical Association, American Osteopathic Association and American Dental Association wrote to the Federal Trade Commission ("FTC") asking that the FTC make it clear that in light of a recent court decision, the Red Flags Rule will not be applied to such professionals. The letter also briefly summarizes why the above referenced associations are making this request.

| Posted By Michael Cassidy In Legal News | 1 Comments | Permalink

New Data Bank Regulations Implement

Social Security Act §1921 - MMPPA §5(h)

The Medicare and Medicaid Program Protection Act (MMPPA) added Soc. Sec. §1921. This law expanded state licensure reporting obligations to match those already in place for the Healthcare Integrity and Protection Data Bank (HIPDB), which became active in 1999. These regulations will make reporting of adverse actions by state licensure and certification authorities nearly identical for NPDB and HIPDB, but does not change current NPDB reporting obligations for hospitals, healthcare entities, medical practice payers or other reporting entities.

One critical issue was the definition of what must be reported, and providing sufficient protection to physicians in order  to guard against reports by entities that provided no due process protections. Although HRSA and HHS rejected the proposal of emulating the immunity due process requirements of HCQIA, the definition of "formal proceeding" was revised to state as follows:

"Formal proceeding means a proceeding held before a state licensing or certification authority, peer review organization, or private accreditation entity that maintains defined rules, policies or procedures for such a proceeding."

| Posted By Michael Cassidy In Credentialing and Peer Review | 1 Comments | Permalink

The Department of Health and Human Services has published proposed regulations for the National Practitioner Data Bank (NPDB).  The new regulations are intended to incorporate Section 1921 of the Social Security Act, which was enacted as part of the Medicare and Medicaid Patient and Program Protection Act of 1987 (MMPPA). 

These proposed regulations were first published on March 21, 2006. Over the next several weeks we will provide summaries of the major changes. 

| Posted By Michael Cassidy In Medicare & Reimbursement | 0 Comments | Permalink

Contributed by Scott R. Leah, Esq.

sleah@tuckerlaw.com, 412.594.5551

In a recent case, several physicians challenged the ability of a medical practice to restrict their ability to practice medicine in accordance with a noncompetition agreement that they had signed. The physicians argued that the agreements were void as they violated state law on restricting the ability of physicians to practice medicine.

The Montana Supreme Court noted that the Montana law in question was not violated so long as the noncompetition agreement places only a reasonable restriction on the rights of a physician to practice medicine.

In that case, the noncompete did not absolutely bar the physicians from practicing medicine in the geographic area, but rather reduced the amount of their partnership interest that they would receive upon departure if they chose to practice medicine in that geographic area.

The Supreme Court reversed the trial court's granting of summary judgment to the departing physicians, holding that the trial court should have allowed for a factual determination as to whether that restriction was "reasonable."

| Posted By Michael Cassidy In Legal News | 0 Comments | Permalink

The case of Cowell v. Good Samaritan Community Health Care, a state court case in Washington, provides guidance on two of the four elements of HCQIA immunity, i.e. that the action was reasonably taken in the furtherance of quality health care and the necessary substance to establish a reasonable investigation. 

Dr. Cowell raised an unusual argument to defeat HCQIA immunity. She alleged that the conduct which was the subject of the peer review investigation caused no harm to patients, therefore, an adverse peer review action designed to eliminate that conduct obviously did not serve to further quality health care. 

As noted in the BNA Health Care Reporter, “The court found these arguments “misdirected” because they focused on whether Cowell actually harmed patients and whether the defendants’ actions actually improved health care at the hospital. The court said that HCQIA is not dependent upon those facts; the professional review need not result in actual improvement in health care – it need only be directed to actions reasonably believed to further quality.”

Dr. Cowell also complained about three instances which she believed established the lack of a reasonable investigation. The court responded by quoting the famous excerpt from Singh vs. Blue Cross/Blue Shield of Massachusetts, which states that physicians are entitled to “a reasonable investigation under the Act, not a perfect investigation.”

| Posted By Michael Cassidy In Credentialing and Peer Review | 0 Comments | Permalink

The stalled healthcare reform initiative leaves the Medicare Physician Fee Schedule problem of the Sustainable Growth Rate (SGR) imposed 21.5% reduction as a stand alone separate issue. The physician fee schedule decrease was postponed for 2 months by an Obama addition to a defense approriation bill, with the expectation that a long term solution would be included in the healthcare reform legislation. That looks unlikely now. Below is the AMA lobbying response to that issue.

eVoice^® Alert

Jan. 20, 2010

Keep your patients, your practice at forefront of Congress' decision on SGR

As the U.S. Senate returns to Capitol Hill today—and continues its deliberations on the floor—now is the time to act.

The 21 percent Medicare physician payment cut that had been scheduled to take effect this month has been delayed until March 1, giving us a short window of opportunity. Now is our chance to help permanently repeal Medicare's sustainable growth rate (SGR) formula. Connect with your senators today by calling (800) 833-6354 and tell them to pass legislation to permanently repeal the SGR formula.

Continuing this game of "kick the can" harms the stability and security of the entire Medicare system and the millions of seniors and military families it is intended to serve. That's why the AMA has made it abundantly clear to members of Congress and the White House that the days for Band-Aids are over. Mobilizing grassroots networks across the country, the AMA has begun an aggressive advertising and publicity campaign this month—and developed a new television ad—to make sure patients and likely voters are aware of and can help address this problem.

But senators need to hear directly from you—America's physicians. Call the AMA's toll-free grassroots hotline at (800) 833-6354 today, and please encourage your colleagues to do the same. An AMA physician flier (PDF) can direct them on how they also can help repeal the Medicare SGR formula.

Time is running out. Call for the future of your practice and the patients in your care.

| Posted By Michael Cassidy In Medicare & Reimbursement | 0 Comments | Permalink

The Health Information Technology for Clinical Health Act (the "HITECH" Act) provides economic incentive for the adoption and meaningful use of health information technology and qualified Electronic Health Record systems ("EHR"s). A physician, other professional, or hospital shall be deemed to be a meaningful EHR user if:

This sounds great. But, the amount of information "out there" on meaningful use is overwhelming and it seems that the medical community is struggling with what it is and how it can be implemented. To this end, a commentator on "meaningful" use wrote a succinct, yet compelling, critique of "meaningful use." John’s post on the EMR and HIPAA blog may be found here: <http://www.emrandhipaa.com/emr-and-hipaa/2010/01/19/some-pointed-thoughts-on-meaningful-use/> (last accessed January 20, 2010).

 lkim@tuckerlaw.com or 412.594.3915

| Posted By Michael Cassidy In Electronic Health Records | 0 Comments | Permalink