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.”

Law clerk Ariel Landa-Seiersen contributed to this blog post.

With bipartisan bills introduced in both the US House of Representatives and the US Senate on October 30, Congress appears ready to expand access to telehealth benefits for Medicare beneficiaries. The Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (CONNECT Act) may eliminate significant barriers Medicare beneficiaries currently face in accessing and utilizing telemedicine. The CONNECT Act acknowledges the potential for telehealth services to promote the “three pillars” of healthcare—expanding access, improving quality, and reducing spending—particularly at a time where healthcare workforce shortages make it difficult for many Medicare beneficiaries to access the care they need.

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

The US Department of Health and Human Services (HHS) recently announced more than $1.8 billion in funding to support the prevention and treatment of opioid addiction. This latest round of funding, authorized in conjunction with the continuing implementation of the 2018 SUPPORT Act, will be awarded by the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to states and local communities.

The CDC will provide more than $900 million to help state and local governments track overdose data “as closely to real-time as possible.” Packaged as a three-year cooperative agreement “to scale-up prevention and response activities,” the CDC will distribute $301 million in funding for the first year to states, localities, and some territories beginning in September 2019.

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 > >

Clearing the way for consideration by the US House of Representatives, the Ways and Means Committee has unanimously approved bipartisan legislation aimed at increasing drug price transparency by manufacturers and pharmacy benefit managers through enhanced reporting and accountability requirements.

In a rare show of bipartisanship, the House Ways and Means Committee recently approved HR 2113, the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act of 2019 (STAR Act) by a 40-0 vote. The STAR Act is the consolidated product of four House bills aimed at bringing transparency to drug price hikes and high launch prices, required reporting of product samples under the Physician Payments Sunshine Act (Sunshine Act), accountability by pharmaceutical benefits managers (PBMs), and accurate drug price reporting to the Medicare program. Key highlights of the legislative proposal follow below.

Daniel Levinson, the HHS Inspector General (IG), tendered his resignation to President Donald Trump on April 2, effective May 31. Mr. Levinson was the longest serving HHS-IG and under his leadership, the watchdog managed a wide array of oversight, including checks on the implementation of the Affordable Care Act. The HHS-OIG is the largest inspector general office among federal agencies helping to police over 200 HHS programs as well as the massive Medicare and Medicaid programs. The current Principal Deputy Inspector General Joanne Chiedi will become the acting IG on June 1.

Undoubtedly the next HHS-IG appointee will be a staunch advocate of fraud and abuse enforcement, and likely will have years of government audit or enforcement experience, as was the case with previous HHS IGs. It remains to be seen, however, if the appointee will also have private industry experience and will bring to bear deep knowledge of an evolving healthcare delivery system.