QUESTION: Our Medical Staff Bylaws require all bylaws amendments to be accomplished at an officially called, in-person meeting. As a result, we have been compiling revisions for months (years?) because of the logistics involved in getting this done. The issue has now come to a head because we have revisions that really have to get into our Bylaws in preparation for an upcoming survey. Do medical staffs really still vote on bylaws amendments in meetings? No one shows up for meetings any more — even before the complications created by the current pandemic! Is this still a current practice? Should it be?
ANSWER: In our experience working with medical staffs across the country, the answer has pretty clearly become no. While it was traditional for big things — like bylaws amendments and voting on medical staff officers — to occur in in-person medical staff meetings, that tradition has been changing significantly over the past decade. The negative spin on the move away from in-person voting is that people have stopped showing up for meetings — there just isn’t enough time in the day for all of the patient care issues that have to be addressed to then make time for medical staff citizenship obligations. However, what we hear most often is the positive side of this coin — which is that by moving away from in-person meetings to take action, which, no matter when they are held (early morning, lunchtime, or late afternoon/evening) will exclude some portion of the medical staff, it is a way to get the input of a much more board cross-section of the medical staff. The reality is that folks have more time to read an email that includes the proposed amendment and a description of the rationale than they to do attend a meeting.
We have also worked with a number of medical staffs that have opted to “open forum” meetings to discuss proposed bylaws amendments (generally when there is a comprehensive revision process underway), but then conduct the actual vote through email or other electronic ballot — again, attempting to reach as many members of the medical staff as possible.
QUESTION: I thought I saw something recently about the Stark and Safe Harbor Regulations being changed? Did I hallucinate after eating too much Halloween candy?
ANSWER: Well, you may have been hallucinating, but it wasn’t about the Stark and Safe Harbor Regulations. On October 9, 2019, CMS issued a proposed rule to modernize and clarify the Stark regulations and, at the same time, the OIG published proposed amendments to the Anti-Kickback Safe Harbor regulations. Comments will be accepted through December 31, 2019.
The proposed amendments to the Stark regulations would:
- create new, permanent exceptions to the Stark Law for value-based arrangements;
- solicit comments about the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service;
- provide additional guidance on several key requirements that must often be met in order for physicians and healthcare providers to comply with the Stark Law, including how to determine if compensation is at fair market value;
- provide guidance on a wide range of other technical compliance issues; and
- propose a new Stark exception for donations of certain cybersecurity technology.
The revisions proposed by the OIG to the Anti-Kickback safe harbors apply to certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others and add protections under the anti-kickback statute and civil monetary penalty (“CMP”) law that prohibit inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care.
The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (“EHR”) arrangements, warranties, local transportation, and personal services and management contracts. The proposed rule would also add a new safe harbor related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis.
Do you want to know more? HortySpringer partners Henry Casale and Dan Mulholland went over these proposals in detail earlier this month in a Special Audio Conference and told everyone what they should be doing right now to get ready for them. You can order a recording of that audio conference here.