The Move to Self-Reporting Continues: Self-Referral Disclosure Protocol

health law complianceBy: James Saling

The Center for Medicare and Medicaid Services (CMS) issued proposed Self-Referral Disclosure Protocol (SRDP) forms and revisions to the regulations on May 6, 2016. This was an additional step in the move for providers to self-report violations of the Stark Law.  Part of the revisions to the regulations came as a result of the final overpayment rule issued earlier this year on February 11, 2016 (60 Day Rule). CMS expects that the SRDP forms will facilitate faster review of a self-disclosure and make it easier for providers to report violations.

The SRDP was established as a result of the Affordable Care Act and is a tool for resolving Stark Law compliance issues. One of the problems with the SRDP is the time that self-disclosures worked their way through the system.  Some self-disclosures have yet to be resolved and were initially made years ago. Continue reading

The First False Claims Act Involving the Affordable Care Act (ACA) 60 Day Repayment Rule

By: Valerie Shahriari

While the False Claims Act (FCA) has been in existence for years, many providers do not know that the rule was extended in 2010.  As part of the Affordable Care Act (ACA), Congress created the “60 Day Rule” and extended the False Claims Act liability to health care providers who fail to report and return overpayments within 60 days of identification if that overpayment came from a federal program (i.e., Medicare and Medicaid).  United States ex rel. Kane et al. v. Healthfirst, Inc., et al (Case No. 1:11-cv-02325) (S.D.N.Y. August 3, 2015) is the first case in which the federal government intervened on an alleged violation of the 60 Day Rule.  Continue reading

The Affordable Care Act on Trial Again in King v. Burwell

bcbs lawsuitBy: Jackie Bain

The Affordable Care Act is heading back to the Supreme Court this Spring.  The issue presented to the Supreme Court on this occasion is whether the IRS is authorized promulgate regulations to extend tax credit subsidies for coverage purchased through Federal Government’s Health Care Exchange.

The Affordable Care Act allows individuals who purchased health coverage through State-established Health Care Exchanges to subsidize a portion of that coverage through the form of refundable tax credits.  The United States treasury directly pays each eligible taxpayer to offset the cost of the taxpayer’s insurance premium.  However, a majority of States (including Florida) have elected not to establish their own Health Care Exchanges.  In order to provide coverage to persons in these States, the Federal Government set up its own Health Care Exchange marketplace.  Continue reading

Physicians’ Participation in the Open Payments Program: As if the Anti-Kickback Statute Wasn’t Enough !

sunshine act scope

 

By: David Hirshfeld

By now we are all too familiar with the commandment “Thou shaltneither pay nor receive, nor solicit the payment or receipt, of anything of value in exchange for referring an individual to a person for the furnishing of an item or service for which payment may be made by a Federal health care program.”  Many of us have restructured, redefined, contorted and construed our arrangements so that they fit neatly within a statutory Safe Harbor to the anti-kickback legislation.  Then, in the name of “Patient Protection,” comes the Open Payments Program (also known as the “Physician Payment Sunshine Act”).

Continue reading

Hospital Physician Alignments are Tenuous

integration1Hospitals, particularly those heading ACO development efforts, are quick to say things like “One day, all physicians will be employed by hospitals.”  Though there is clearly some wisdom under that statement, it’s also a remarkable leap of faith.

Three things are clear in this era of healthcare reform:  (1) healthcare will be provided to more, but with less; (2) there will be a growing move over time to pass financial risk to providers; and (3) those businesses in a position to control both costs and quality (and some say patient satisfaction) are in a position to both survive and even do better than ever.

This leaves the door wide open as to the form of the business that can succeed.  Is it a single specialty mega practice?  Is it a multi specialty medical practice?  How about a hospital? Continue reading

Ordering and Referring Providers: CMS Just Won’t Take No for an Answer. Form 855-O.

By: David Hirshfeld, Esq.

More and more of our seasoned clients are opting out of Medicare, and the younger ones are simply not enrolling.  The scale seems to have finally tipped so that the potential liability of being a Medicare provider outweighs the benefits.  So many providers are avoiding Medicare participation, that the Affordable Care Act and CMS have implemented the issuance of “Ordering and Referring Provider Numbers” through CMS Form 855-O.

As of May 1, 2013, physicians and other providers (collectively “Providers”) who bill Medicare must list the NPI of the ordering/referring Provider on their claim forms in order to be paid for the technical component of imaging services, the technical component of clinical laboratory services, durable medical equipment and/or home health services.  An issue arises when the referring/ordering Provider does not participate with Medicare, and does not have an active NPI.

The Affordable Care Act provides a solution by allowing Providers to enroll in Medicare for the sole purpose of ordering or referring covered services for their Medicare patients, even though the ordering/referring Provider cannot bill Medicare for the services (s)he provides.  This limited enrollment is accomplished through CMS Form 855-O.

Providers who have opted-out of Medicare by filing the required affidavit and entering into acceptable patient contracts do not have to submit Form 855-O as they have NPIs, even though they are not allowed to bill under them during their opt-out period.

Why Compliance Plans Make Sense

Clipboard with Checklist and Red PenHas your practice implemented a compliance program or considered improving an existing one?  Is it really necessary?  Prior to the Patient Protection and Affordable Care Act (ACA), the necessity for physician practices to develop compliance plans was merely voluntary.  However, the ACA will now require physician practices to have a fraud and abuse compliance plan in place as a condition of continuing to participate in Medicare or Medicaid programs.  Because the government first published guidelines in the year 2000 for the voluntary use of compliance plans in physician practices and has subsequently enacted a mandate in the ACA for compliance plans, many physician practices are proactively implementing them.  While this compliance plan mandate may be viewed by physicians as yet another administrative burden and expense to the practice, it can have many benefits as well.  Implementing an effective compliance program can have the result of not only reducing liability risks, but can also allow a practice to reap monetary benefits.  In fact, it could be more costly for the practice not to have one! Continue reading

The Preventionists Are Coming!

paul-revereThe popular conception in healthcare is that (1) a new law was passed, (2) it changed everything, and (3) in a bad way.  Over time, however, it should get clearer that, while there was a law passed, the law alone is not driving changes to our healthcare system: it’s our own demographics and behavior.  Most of the tax dollars currently fueling our healthcare system (and arguably our economy) are tied to an aging Boomer population that are soon to drop off the income producing cliff into the Medicare population.  Bye bye income earners; hello ridiculous public healthcare expenditures.  Though it is true that the timing for expanding public spending on healthcare (with the federal mandates aimed at employers and Medicaid eligibility expansion) could not be more poorly timed, the situation is more of a “Perfect Storm” than a surgical strike.

The financial stress of our changing population and of a historic utilization based healthcare system is causing our healthcare system to morph in every way.  “Health insurance,” with increasing cost, copays and deductibles and reduced benefits, is quickly ceasing to look like your father’s 80/20 major medical plan and starting to look more like catastrophic coverage.  Fee for service compensation is fast becoming “spoken” out of existence.  There are more “pay for performance,” “case rate” and other outcome and risk based compensation models than you can shake a stick at.  The simple truths are: payers have to deliver more with less; and patients have to bear more and more of their healthcare expenses. Continue reading

Discounted Fee Organizations Have Surprising Regulation

percentageThe idea of an organization which provides discounted fees to patients is not a new concept.  Organizations like independent physician associations (IPAs), even accountable care organizations (ACOs) and simpler discounted fee plans will be surprised to know that Florida may require them to be licensed by the  Office of Insurance Regulation (OIR), even though they do not handle pre payments and do not collect premiums.  That’s perhaps the most startling aspect of the regulations—there is no financial risk involved, and yet Florida law seems to require regulation.

Pursuant to Fla. Stat. 636.202(2), a “discounted medical plan organization” means an entity which, in exchange for fees, dues, charges, or other consideration, provides access for plan members to providers of medical services and the right to receive medical services from those providers at a discount.  A “discount medical plan” means a business arrangement or contract in which a person, in exchange for fees, dues, charges, or other consideration, provides access for plan members to providers of medical services and the right to receive medical services from those providers at a discount.  Fla. Stat. 636.202(1).  A discount medical plan does not include any product regulated under chapter 627, chapter 641, or part I of chapter 636 (governing Prepaid Limited Health Service Organization).  Fla. Stat. 636.202(1), which of course is no comfort to providers looking to garner or protect market share by discounting services or by creating a collection of discount services providers, which is typical of IPAs and “networks.”

Before doing business in Florida as a DMPO, an entity must be legally organized in a compliant way and must be licensed by the OIR as a discount medical plan organization or be licensed by the office pursuant to chapter 624 [Florida Insurance Code], part I of this chapter [Prepaid Limited Health Service Organization], or chapter 641 [HMO, Prepaid Health Clinic]. Fla. Stat. 636.204(1) emphasis added.  Each discount medical plan organization must at all times maintain a net worth of at least $150,000.

Providers looking to provide discounted fee arrangements in a simple and effective manner many be surprised to know how complex that endeavor in fact is.  Moreover, the discounts will likely (and ironically) have to be reduced in order to bear the state licensure and financial viability fees.  Go figure!

HIPAA Omnibus Final Rules and Penalties

On Friday January 25, 2013, the Department of Health and Human Services published the Final Rule modifying the HIPAA privacy, security, enforcement, and breach notification rules under the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the Genetic Information Non-Discrimination Act (“GINA”) as well as other modifications to the HIPAA rules. (See 45 CFR Parts 160 and 164, Federal Register Volume 78 Number 17.)

The omnibus rule actually contains four final rules. The first final modifications to HIPAA which were mandated by “HITECH” include modifications intended to improve the Rules which were issued as a proposed rule on July 14, 2010 include six modifications.

The first omnibus final rule includes direct liability modifications for business associates of covered entities for compliance with certain HIPAA privacy and security rule requirements. Strengthening of limitations on the use and disclosure of protected health information, expanded individuals’ rights to receive electronic copies of their health information, modification and redistribution of entities privacy practices protocols, modification of individual authorization forms and other requirements to facilitate research and disclosure of child immunization proof to schools as well as to enable access to decedent information and lastly the enforcement rules have been modified to address violations such as non-compliance with HIPAA rules due to willful neglect.

The second omnibus final rule adopts changes to the HIPAA enforcement rule that increase the civil monetary penalties in a tiered manner.

The third omnibus final rule involves the breach notification for unsecured protected health information under the “HITECH” act. This rule replaces the prior rules “harm” threshold with a more objective standard.

Finally, the fourth rule prohibits most health plans from using or disclosing genetic information for underwriting purposes.

These final rules take effect this month on March 26, 2013. Covered business entities and business associates must comply with the applicable requirements by September 23, 2013. The penalties for violating the final rules are now as follows:

TABLE 2 – CATEGORIES OF VIOLATIONS AND RESPECTIVE PENTALTY AMOUNTS AVAILABLE

Violation Category – Section 1176 (a)(1)

Each Violation

All such violations of an identical provision in a calendar year

(A)  Did Not Know(B)   Reasonable Cause

(C)   (i)Willful Neglect-Corrected

(C) (ii) Willful Neglect-Not Corrected

$100-$50,0001,000-50,000

10,000-50,000

50,000

$1,500,0001,500,000

1,500,000

1,500,000

Providers need to be aware of the penalties for violating the rules as we most recently reported to you the office of civil rights will not hesitate in sanctioning providers for violating the Act in amounts in excess of $1.5 million.