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Physician Payments Sunshine Act


Last December, we blogged about a proposed rule published by the Center for Medicare and Medicaid Services (“CMS”), concerning the Physician Payments Sunshine Act (the “Act”) that is part of the healthcare reform legislation, and the impact of the Act upon physicians.  Essentially, the Act requires drug and medical device manufacturers (“Manufacturers”) to collect information concerning payments, gifts or transfers of value they make to physicians that are worth more than $10, and to report such information to CMS on an annual basis.  In short, any drug company or medical device company that gives money or something else of value to a doctor shall have to report it to the federal government, including direct compensation and costs of Manufacturer-supported, physician-related research, consulting, and continuing medical education [Read More]
 
 
 
 

Solving Some Common Complaints of Hospital-Employed Physicians


Recently, I read an article discussing the most common complaints of hospital-employed physicians.  Before turning to these complaints and ways to address them, one common thread was an acknowledgment by many of the physicians interviewed for the article that they failed to undertake the necessary due diligence before entering into the hospital employment relationship– either because they rushed into the relationship without having their employment agreements carefully reviewed or because they failed to ask certain questions during their job interviews; and this lack of due diligence was as prevalent among older physicians as ones just coming out of their residency.

The most common general complaint of hospital-employed physicians was the loss of control over their professional lives, especially among those that were formerly in private practice.  However, in terms of specific complaints, the following appeared to be the most common:

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Final ACO Rule – Some Highlights For Physicians


Two weeks ago, the Centers for Medicare and Medicaid Services (“CMS”) issued the final rule (“Final Rule”) for accountable care organizations (“ACO’s”).  CMS released the Final Rule after receiving more than 1,300 comments to the proposed regulations (“Proposed Rule”) published more than seven (7) months ago.  As compared with the Proposed Rule, the Final Rule contains a number of revisions designed to encourage more physicians to become involved with ACO’s, including the following:

·       Physicians are not required to be meaningful users of electronic medical records (“EMR”) as a condition of participating in an ACO, although EMR is now a quality measure and is weighted higher than others.  Essentially, CMS elected not to add an extra requirement to ACO participation, preferring instead to permit participating physicians to discover and decide for themselves how best to manage patient data and other information in order to provide coordinated care for their patients.

·       Allows prospective assignment of patients to ACO’s on a quarterly basis, rather than using a retrospective method for selecting patients to participate in an ACO, as had been originally proposed.  In the Final Rule, prospective assignment of patients is permitted in order that physicians shall know in advance which patients are in an ACO, thereby enabling physicians and patients to partner together in order to better address health problems, both in terms of objectives and how to achieve them.  In this regard, it should be noted that, according to the Final Rule, only persons enrolled in the Medicare fee-for-service program may be assigned to an ACO.

·       Eliminates participant risk in the first of the two (2) ACO shared-savings’ models.  The Proposed Rule had required that, after the first two (2) years, an ACO choosing the one-sided model (i.e., shared savings among participants without any sharing of losses) would transition into the two-sided model (i.e., shared savings and losses) during the third year.  However, the Final Rule provides for shared savings among the participants in the one-sided model during the entire initial agreement period with no sharing of losses in the third year.  The two-sided model, where participants share savings and losses for the entire initial agreement period (the first “year” of the initial agreement for ACO’s starting in 2012 will be to 18 to 21 months) continues to include risk- or loss-sharing for participants, but also offers them larger potential rewards than they would have received under the Proposed Rule.

·       Reduces from 65 to 33 the number of quality measures ACO-participating physicians must report.  The Proposed Rule required providers to report on 65 quality measures in five (5) categories so as to enable CMS to assess the quality of care furnished by ACO’s.  In response to the comments it received – the majority of which favored utilizing fewer quality measures in order to reduce reporting burdens and attain more focused and meaningful improvements to the Medicare program – CMS reduced to 33 in four (4) categories the required number of quality measures subject to reporting.  These categories are as follows:  (i) patient/caregiver experience; (ii) care coordination/patient safety; (iii) preventive health; and (iv) at-risk population that includes subcategories of reporting requirements regarding the following disease states:  diabetes, hypertension, ischemic vascular disease, and coronary artery disease.

·       Ensures that all ACO’s shall receive a share of any first-dollar savings generated to Medicare once a minimum amount of savings is achieved, known as the Minimum Savings Rate (“MSR”).  The MSR is on a sliding scale, ranging from 3.9% for ACO’s with 5,000-5,999 beneficiaries to 2% for ACO’s with 60,000 or more beneficiaries.

Finally, it should be noted that the Department of Justice and the Federal Trade Commission have issued a joint “Final Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program.”  This Final Statement addresses the application and enforcement of antitrust laws for ACO’s and supplements the Final Rule.  While the Justice Department and FTC promise to monitor the impact of ACO’s in order to protect competitive markets, they shall not require a regulatory antitrust review of ACO’s as had been originally mandated.  

 
 
 
 

The Corporate Practice of Medicine (“CPOM”) Doctrine: Alive and Well in New Jersey


Last week, I served as a panelist/speaker for a nationally-broadcast webinar regarding the formation of physician multispecialty groups.  One of the topics addressed by this webinar—the one that prompted the greatest number of questions from the audience—was the CPOM doctrine. 

Essentially, the CPOM doctrine, which is found in the laws of many states, including New Jersey, prohibits unlicensed and lesser-licensed individuals, business corporations and other entities from employing physicians to practice medicine—all in an effort to ensure that only those entities owned and controlled by licensed professionals shall render healthcare services, subject to certain exceptions.  The CPOM doctrine also prohibits the division or splitting of professional fees between physicians and lay persons/lay entities and/or the payment for referrals. 

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FDA Plans to Regulate Mobile Medical Apps


Within the past week or so, the FDA has issued draft guidelines concerning mobile medical applications or “apps,” as they are more commonly referred to.  Medical apps are sold for devices such as Apple’s iPad and iPhone, Blackberry phones, and phones using Google’s Android software.

[Read More]
 
 
 
 

House GOP Budget Plan: Bad News for Providers


Earlier this week, I attended a breakfast meeting, featuring my local congressman who is a  Republican.  He devoted the majority of his remarks to the current budget debate taking place in Washington, and to defending the House GOP plan that, among other things, seeks to repeal the Affordable Care Act (“ACA”), and to overhaul Medicare and Medicaid, including  gradually eliminating Medicare coverage for those born in 1957 and later, and decreasing federal Medicaid spending.   [Read More]
 
 
 
 
 

Duane Morris Health Law

Reporting legal developments in the healthcare industry and the latest on the implementation of
the Healthcare Reform Act impacting providers, employers and physicians.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.