Wednesday, October 9, 2019

Brief Blog: CMS Announces New Anti Kickback Proposals; Make Value Based Care Easier

Separate but related:

See a Seema Verma blog on wider program integrity efforts from September here, and a CMS Program Integrity "Request for Information" (due Nov. 20, but worth reading even if you missed the deadline) here.

On October 9, 2019, CMS and OIG announced several hundred pages of pending proposed rulemaking intended to lighten coordination of care barriers for value-based care, such as ACO's.  

The rules were published in a website version, which is prior to both the "public inspection" copy at and the official Federal Register publication, which typically follows in 5-15 days.

Associated Press summarizes as follows:
Azar said the idea is to encourage hospitals, doctors and other service providers to enter into formal “value-based arrangements,” in which they collaborate to improve care for patients and commit to delivering measurable results. 
For example, a hospital may send a kidney patient home with technology to monitor critical health indicators and automatically transmit back any signs of problems. Under existing rules, such an arrangement could be interpreted as the hospital providing the patient an illegal “inducement” to continue using its services.
The original rulemaking for ACO's faced some conflicts with similar kickback laws.  Also on the program integrity front, a few weeks ago CMS released final rulemaking for program integrity, generally making it easy to kick abusive providers out and keep them out (here).

See links below:
  • CMS press release, including additional links about anti kickback statute (AKS) and Stark Law, here.
  • OIG proposed rulemaking:
    • OIG Federal register version, October 17, here.
    • 84 Fed Reg 55694-55765 (72pp), 10/17/2019.
    • Comment to 12/31/2019.
    • Focus on "anti-kickback"
  • CMS proposed rulemaking:
    • CMS Federal Register version, October 17, here.
    • 84 Fed Reg 55766-55847 (82pp), 10/17/2019.
    • Comment to 12/31/2019.
    • Focus on "self-referral"
  • CMS Fact Sheet on Self-Referral changes, here.
  • OIG Fact Sheet on Safe Harbor changes, here.
  • Coverage at Associated Press here.
  • Coverage at Reuters, here.
  • Coverage at Lexology, here.  
  • National Law Review here (McDermott), here (Drinker Biddle).
  • Wilson Sonsini here, Greenberg Traurig here
  • Wynne et al. at Health Affairs, here.
  • Mintz produced a three-part series of the proposes rules:
Note that in September 2019, CMS released new regulations making it hard for fraudulent providers to use CMS as a revolving door through a facade of name changes or corporate shells; here.

Trump Name Watch

Some CMS press releases very prominently feature the President's name, including in headlines. (E.g., this week, see "Trump Administration Empowers Nursing Home Residents," here.) 

In contrast, this lengthy press release only mentions the President's name in passing ("Regulatory reform has been a key piece of President Trump's agenda.")  

Press Release Extract

These are examples of problems that the new amendments are intended to fix:

"Below are examples involving coordinated care, value-based care, data sharing, and patient engagement activities that, depending on the facts, could currently be difficult to fit under existing protections and could potentially be protected by the Stark Law, Anti-Kickback Statute, or Civil Monetary Penalties Law proposals if all applicable conditions are met:
Hospitals and physicians could work together in new ways to coordinate care for patients being discharged from the hospital. The hospital might provide the discharged patients’ physicians with care coordinators to ensure patients receive appropriate follow up care, data analytics systems to help physicians ensure that their patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions. 
A physician practice could provide smart pillboxes to patients without charge to help them remember to take their medications on time.  The practice could also provide a home health aide to teach the patient and the patient’s caregiver how to use the pillbox.  The pillbox could automatically alert the physician practice and caregiver when a patient misses a dose so they could follow up promptly with the patient.   
A local hospital could improve its cybersecurity and the cybersecurity of nearby providers that it works with frequently.  To do so, it could donate, for free, cybersecurity software to each physician that refers patients to its hospital.  The hospital and the physicians often share information about their patients, so it is important that there are no weak links that might compromise everyone else.  The software would help ensure that hackers cannot attack the physician’s computers.  Improving each physician’s cybersecurity would help prevent hackers from spreading the attack to other physicians and the hospital. 
To improve health outcomes for patients with end-stage kidney disease, a nephrologist, dialysis facility, or other provider could furnish the patients with technology that is capable of monitoring the patient’s health and two-way, real-time interactive communication between the patient, facility, and physician.  In addition, the facility could equip the physicians with data analytics software to help them monitor patients’ health outcomes. 
In an effort to coordinate care and better manage the care of their shared patients, a specialty physician practice could share data analytics services with a primary care physician practice."