Legal Insights and Perspectives for the Healthcare Industry

We invite you to join us on Wednesday, November 20, for our second installment of the Fast Break: Regulatory Sprint series. In a recent Health Law Scan post, we discussed the two proposed rules by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services (HHS) calls the “Regulatory Sprint to Coordinated Care Initiative.”

Last month, we held Part 1 of the series, which highlighted CMS’s proposed rule on Stark Law Changes. This month, Katie McDermott, Matthew Hogan, and Jake Harper will discuss the OIG’s proposed rule on the Anti-kickback and beneficiary inducement Civil Money Penalty changes.

Register for the webinar now.

You can also check out a recent Bloomberg Law article the presenters wrote on “OIG Proposed AKS Safe Harbors For Patient Incentives – Getting Patients Involved.”

Several lawyers from our healthcare industry team recently attended HLTH in Las Vegas. HLTH provided a showcase for innovative ideas, platforms, and programs embracing the concept of “patient-centered care.”

This year’s event offered particular focus on innovations addressing the social determinants of care, elements of daily life that create barriers to receiving health services. As one executive of a large hospital system mentioned, they were reframing the institution’s vision around “health” and not “healthcare.” From programs in states partnering with ride-share apps to ensure Medicaid beneficiaries made their appointments, to highly integrated medical record and patient communication platforms designed to meet patients in their own space, there were numerous examples of business opportunities and legal challenges.

In Part 2 of a two-part Morgan Lewis series for Bloomberg Law on the proposed Stark Law and anti-kickback statute (AKS) rules, Kathleen McDermott, Matt Hogan, and Jacob Harper examine the safe harbors and exceptions aimed at empowering patients to manage their healthcare. Noting that value-based care can only be achieved when patients no longer sit on the sidelines, the authors ask whether the proposed AKS safe harbors are bold enough, and conclude there may be more that the Office of the Inspector General and the Centers for Medicare & Medicaid Services could do.

Read the full Bloomberg Law article >>

The Office of the Inspector General and the Centers for Medicare and Medicaid Services recently published a pair of proposed rules aimed at encouraging the adoption of value-based payment and care. In Part 1 of a two-part Morgan Lewis series for Bloomberg Law, Al Shay, Donna Clark, and Banee Pachuca unpack the proposed Stark Law exceptions and anti-kickback statute safe harbors that share similarities but differ in design when it comes to protecting physician compensation arrangements that advance value-based care. Potential challenges presented by the proposed rules with respect to obtaining safe harbor protection, encouraging payor participation, and absorbing downside financial risk are also addressed.

In addition, Al and Donna will be joining Jake Harper to talk about the Stark Law changes in more detail during our October 30 Fast Break—make sure to register!

Read the full Bloomberg Law article >>

We invite you to join us on Wednesday, October 30, for Part 1 of our two-part Fast Break: Regulatory Sprint webinar. In a recent Health Law Scan post, we highlighted two rules proposed by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services calls the “Regulatory Sprint to Coordinated Care Initiative.” In Part 1 of this Fast Break, Donna Clark, Albert Shay, and Jacob Harper will discuss the CMS’s proposed rule on Stark Law changes. Stay tuned for Part 2 when we discuss the OIG’s proposed rule on Anti-Kickback Statute and Civil Money Penalty changes.

Register for the webinar now.

Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two proposed rules that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

The HHS Regulatory Sprint identifies four lanes to better coordinate care:

  • Improving a patient’s ability to understand his/her treatment plans and be empowered to make decisions
  • Increasing providers’ alignment on end-to-end treatment
  • Providing incentives for providers to coordinate and collaborate care with their patients
  • Encouraging information sharing among providers, facilities, and other stakeholders in a manner that facilitates efficient care while preserving and protecting patient access to data

We hope you were able to join us for last month's Fast Break on the Physician Fee Schedule proposed rule. If not, you missed a great session featuring Eric Knickrehm discussing the important changes the proposed rule would have on Medicare Part B. 

Eric provided an overview of the most important aspects of the proposed rule, which was published on August 4, 2019. A number of these changes highlight CMS's increasing emphasis on preventive and low acuity care. For instance, CMS has continued to incentivize Transitional Care Management services and Chronic Care Management services to ensure that patients who were either recently hospitalized or are very likely to be hospitalized have effective care management to avoid further hospitalization.

We address more than a dozen key proposals from the CMS outpatient prospective payment system (OPPS) and ambulatory surgical center payment systems proposed rule in a recent LawFlash. Chief among them is the agency’s bold new proposal for a broad price transparency program. Other notable proposals include continuing payment reductions for 340B drugs and grandfathered off-campus provider-based departments, both the subject of pending litigation in federal court. CMS is soliciting public input on a multitude of proposals from this rule, and comments are due September 27, 2019. Hospitals will want to carefully assess these changes and consider submitting comments before these proposals become final rules.

Read the full LawFlash > >

Two OIG inspection reports detailing the results of onsite hospice surveys during a five-year period ending three years ago in 2016 build on the body of hospice industry evaluations conducted by the OIG, garnering significant negative press attention. Many in the hospice industry believe the OIG reports lack balance and focus excessively on the negative findings associated with a small minority of hospices. In light of CMS’s concurrent initiative to put “patients over paperwork” and reduce regulatory burdens on providers, OIG’s call for enhanced regulatory oversight and expanded reporting requirements for hospice may strike some industry watchers as out of step with the administration’s efforts to reduce unnecessary red tape, but OIG sticks to its watchdog role.

Read the LawFlash

For those providers—and there are more than a few—that believe the administrative and regulatory burdens associated with participating in the Medicare and Medicaid programs negatively affect their ability to furnish high-quality, cost-effective healthcare, now is the time to make your voice heard! On June 11, the Centers for Medicare & Medicaid Services (CMS) and the US Department of Treasury released a request for information (RFI) on Reducing Administrative Burden to Put Patients Over Paperwork. The RFI invites patients, their families, the medical community, and other healthcare stakeholders to submit comments on how CMS can reduce administrative, regulatory, and subregulatory burdens on providers. The goal of the initiative is to clear away needlessly complex, outdated, or duplicative requirements, allowing practitioners to spend more time with patients and less time on cutting through the red tape.