On March 22, 2013, a new Ohio law will go into effect that seeks to clarify who must notify a patient that his or her physician’s employment has been terminated. Under Ohio Revised Code Section 4731.228, the “health care entity” that employs a physician is now responsible for notifying the physician’s patients that the physician’s … Continue Reading
On June 27, 2012, the U.S. Senate passed (by a vote of 92-4) the Food and Drug Administration Safety and Innovation Act, a bill primarily designed to let the U.S. Food and Drug Administration (“FDA” or “Agency”) collect user fees from prescription drug and medical device manufacturers to help fund the Agency. The House of … Continue Reading
We already know our John Kirsner as a frequent speaker and blogger regarding how CMS’ Accountable Care Organization regulations would impact health care delivery. Seeing Modern Healthcare’s Joe Carlson recognize him as such is further affirmation that Squire, Sanders, & Dempsey is building on its well deserved reputation as thought leaders in the future of … Continue Reading
On Friday, April 8, Peter Pavarini and I co-presented a webinar overviewing the ACO regulations from a legal perspective. We were part of a three-firm “task force” that came together to analyze the rules and provide guidance to our clients and friends. In addition to Squire Sanders, Paul Lee and others from Strategic Health Care and … Continue Reading
In commentary to the proposed regulations, CMS has committed to coordinate with other Federal agencies on various issues that relate to the Shared Savings Program. This includes coordination with the FTC and DOJ (the “Antitrust Agencies”) with respect to antitrust issues. This coordination is shown through CMS’s intention to incorporate the FTC/DOJ Proposed Statement on … Continue Reading
I agree with my colleagues that CMS appears to be looking to the industry to guide them on waiver development, as well as other details of the Medicare Shared Savings Program. CMS intends to grant waivers that would apply uniformly to all ACOs, ACO participants and ACO providers/suppliers participating in the Medicare Shared Savings Program. … Continue Reading
Does anyone else feel that the proposed waiver regulations don’t go far enough? Do you think they allow providers to engage in flexible arrangements that deliver value to the government? The key is how the government has limited the waiver proposals mostly only to the shared savings distributions. That seems too narrow, although I think … Continue Reading
The proposed CMS rules for accountable care organizations have only been out a few hours and even the speediest readers are still plowing through them, but a few initial observations are in order: CMS is admitting it needs more than the usual amount of public comment to craft final rules. Perhaps this was intentional but … Continue Reading
Discussions among physicians and physician groups contemplating the formation of an ACO can raise concerns under antitrust laws, particularly when those physicians or physician groups are considered competitors in the market. In the absence of contradictory guidance in the forthcoming ACO rules, it is important that physicians engaging in such discussions abide by the following … Continue Reading
Last month the California Department of Public Health (“CDPH”) issued privacy breach fines to seven California health facilities. Six California hospitals and one nursing home were assessed administrative penalties and fines totaling $792,500 after a determination that the facilities failed to prevent unauthorized access to confidential patient medical information. The agency is concerned that violations … Continue Reading
