Articles Posted in Health Law

On April 7, 2011 CMS held a telephone conference for hospitals to answer questions on the recently released Accountable Care Organizations proposed rule and to provide further instruction on the submission of comments to CMS for consideration.

The CMS representatives stated that more information regarding the Centers for Medicare and Medicaid Innovation Center would also be provided soon. This statement arose in light of questions regarding possibilities for ACOs that are not quite ready for the Shared Savings Program. The representatives did reiterate that, pursuant to the statute, ACOs will not be able to participate in more than one shared savings program. The representatives further stated that the required organizational structure for ACOs wishing to participate in other programs might not necessarily be the same as for the Medicare Shared Savings Program.

CMS representatives also discussed the fact that primary care services provided by rural health clinics or federally qualified health clinics would not be considered in the patient attribution process because CMS does not collect sufficient data in claims from these organizations to determine whether the services are “primary care”.

On March 31, 2011, CMS released the proposed rule implementing the Medicare Shared Savings program and establishing the requirements for Accountable Care Organizations (ACOs) that wish to participate in this program.  The following is a list of some of the highlights from this Proposed Rule.

1. The proposed rule contemplates two models: a “one-sided” model in which providers do not share risk and a “two-sided” model in which providers share in risk and realize greater return on the shared savings.

2. ACOs must commit to participate in the shared savings program for three years.  Providers who select the “one-sided” option will need to agree to share risk in their final year of participation.  If an ACO wants to terminate early, they will need to give a 60 day notice to CMS, as well as a notice to beneficiaries, and will forfeit a portion of previously earned shared savings that was withheld by CMS.

The OIG recently issued a favorable opinion concerning (1) the waiver of patient cost sharing amounts, without regard to patient need and (2) providing limited lodging and transportation for all patients of a network of pediatric charity hospitals.  The requestors were pediatric non-profit charity hospitals which currently provide free services to very sick and injured children.

The Requestors have not billed for their services in the past, but were seeking a favorable determination so that they could begin to bill on an “insurance only” basis without billing the patients or families for copayments, deductibles or other cost sharing amounts.  They would also continue to provide free services to uninsured patients and would not make decisions as to which families could receive the service based on insured status.

The OIG concluded that the Insurance-Only Billing would not lead to a risk of improper billing since the hospitals historically have not charged the patients or their families for services.

The Affordable Care Act requires that all home health and hospice services be initiated by an in-person encounter with the patient and their physician in order to be covered under Medicare.  This requirement began January 1, 2011, but CMS has announced that it will not begin enforcing the requirement until April 1, 2011.  CMS has further stated that the delay in enforcement will not be further extended beyond April 1, 2011.

If you have any questions or concerns about complying with these new regulations, or any other regulations, please contact one of our attorneys at 248-544-0888 or www.Wachler.com. 

The final rule changed several elements from the proposed rule.  One changed feature under the final rule is that one entity will be responsible for testing EHRs, and another entity will be responsible for certifying the EHRs.  No single entity will be allowed to perform both activities.

Other changes involve the process for accrediting the testing and certifying entities.  Those entities that were approved to test and certify records under the temporary program will not automatically be accredited under the permanent program and will have to meet any criterion required under the permanent program.  The permanent program is scheduled to begin January 12, 2012.

If you have any questions or concerns regarding certification of EHRs, or any compliance issues, please contact one of our attorneys at 248-544-0888 or visit www.Wachler.com for more information. 

Due to confusion surrounding whether an IDTF was considered a “mobile” or “fixed-base” delivery structure, the DAB has explicitly stated that there are two types of mobile IDTFs.  Mobile IDTFs can either be “portable units” or a “mobile facility or unit.”  The difference between the two definitions is that a “portable unit” is one that transfers equipment to different fixed locations for diagnostic testing, while a “mobile facility or unit” is a vehicle that travels to different locations to treat patients inside the vehicle.

The DAB further clarified that rules on shared practice space between IDTFs and another Medicare enrolled provider.  These entities may share a location, but there is a clear distinction between clinical and non-clinical space.  The DAB specified that the sharing of common hallways, waiting rooms, and reception areas is permissible.  But the sharing of clinical space or diagnostic equipment is still strictly prohibited.

If you have any question or concerns regarding compliance with current CMS regulations, please contact one of our attorneys at 248-544-0888 or visit www.Wachler.com for more information.