This year has been a challenging one for healthcare providers. Just to recall, a few of the challenges in 2015 were; the final implementation of ICD-10; two multi-million dollar Civil False Claims settlements involving physician-hospital relationships in Florida; elimination of the annual battle over the sustainable growth rate; and the apparent end of Florida’s cap on non-economic damages. Next year promises to be more of the same, and here are four of the issues that likely will be the focus of physicians’ attention.

1. The Office of Civil Rights (“OCR”) has been promising to randomly audit providers’ compliance with HIPAA-HITECH. OCR already has been criticized by the OIG for failing to ensure that Covered Entities and Business Associates compliance and, in its 2016 Work Plan, this agency has announced that it intends to determine “the adequacy of the Office of Civil Rights oversight over the security of electronic protected health information.” Thus, it is likely that OCR’s random auditing efforts will begin in early 2016.

OCR plans to select Covered Entities and Business Associates without any prior notice. Those selected will be required to produce evidence of HIPAA-HITECH compliance within a very short period of time (i.e., 20 days). Physicians and healthcare providers should make sure that their HIPAA-HITECH programs are compliant and up-to-date now, instead of trying to play catch-up after receiving notice of an audit.

2. Accountable care organizations (“ACO”) are a fundamental element of the Medicare Shared Savings Program (“MSSP”) and achievement of the “triple aim.” In fact, ACOs are so critical to achieving the triple aim that CMS and the OIG created 5 waivers for actions and arrangements that otherwise could be prohibited under the Stark Law and the Federal health care programs’ Kickback Prohibition.

These waivers, which have been finalized, provide ACOs and those forming ACOs with a great deal of latitude to form arrangements that otherwise may not be permitted. The waivers address: (i) pre-participation arrangements, (ii) participation arrangements, (iii) shared services distributions, (iv) physician self-referral, and (v) beneficiary incentives. These waivers are likely to create more interest in ACOs. However, because of the risk associated with not satisfying all of a waiver’s requirements, reviewing a proposed arrangement with experienced legal counsel will continue to be a wise course of action.

3. In January, Medicare began covering and paying for “chronic care management”, CPT code 99490. Unlike most of the services covered under this program, CPT code 99490 reimburses a provider or healthcare professional $43.12 for a 20 minute non-face-to-face encounter with a beneficiary. Chronic care management provides an additional source of fee-for-service revenue for physicians and is a key element of many population health management efforts (an important function for ACOs). It seems likely that CMS will take additional steps to promote the use of this new benefit.

4. The OIG’s 2016 Work Plan indicates that it will continue focusing on home health. The OIG observed that in prior studies the agency found that one in four home health agencies had engaged in “questionable billing practices.” This agency expects to review home health agencies’ billing practices further during 2016.

Most home health agencies rely on independent physicians for patient referrals, and certify and recertify each patient’s plan of treatment. It seems likely that the OIG’s examination of home health agencies’ billing practices will include reviewing their relationships with these physicians; the agency’s skepticism regarding the legitimacy of many of these relationships should not come as a surprise. Home health agencies and the physicians with whom they have relationships, therefore, should have their relationships carefully reviewed by competent legal counsel before the OIG starts asking questions.

If the past is any indication, 2016 promises to be a year of further change, challenge, and opportunity for all healthcare providers.