Key Regulatory Topics for Women’s Health Businesses | McGuireWoods LLP

Regulatory factors continue to be an location women’s well being businesses have to handle, as talked about through an April 14, 2022, webinar offered by McGuireWoods health care attorneys Kayla Marty and Tim Fry. Widespread spots of concentrate for women’s well being providers include: procedures to apply alternative payment products, ancillary company line growth, executing multistate advancement and navigating outdoors physician interactions.

1. As additional payors have an desire in option payment products, women’s health and fitness companies have financial possibilities leveraging clinical efficiencies. The webinar talked over numerous different payment designs, ranging from particular person amount impacts based on internet site of services, to bundled payment preparations aimed at the complete continuum of being pregnant treatment. No matter of the option payment design, the discussion centered on the importance of getting ready for alternative payment model implementation.

   Tips for these preparations provided: (i) investigating the models out there from payors in a marketplace (ii) participating experienced staff to deal with the choice payment product (iii) mapping out the preferred financial influence of the option payment design, due to the prospective economic hazard (iv) comprehending the business’s referral styles to assure it is a superior candidate for the alternate payment product (v) guaranteeing the company has appropriate know-how and facts to observe results and referral pathways and (vi) examining regulatory pitfalls and reporting necessities linked with the choice payment design.

   In addition, practices ought to make sure they recognize their high quality metrics as payors will want to see how this kind of types make improvements to care. Failure to implement the steps above may perhaps present danger of the substitute payment design possessing unwanted financial or regulatory repercussions to the women’s well being organization.

2. Compensating medical professionals for ancillary solutions triggers federal and point out laws, these that women’s well being providers require to be very careful when acquiring ancillary treatment alignment tactics. Most women’s wellbeing platforms look for to incorporate ancillary services, which include companies their doctors are seriously concerned in as element of a patient’s conventional care shipping. For case in point, mammography providers are protected by Medicare. But even groups with minimal to no Medicare affected individual census — e.g., obstetrician groups that emphasis on young affected person populations — may well confront scrutiny below the federal Health practitioner Self-Referral Law or Stark Law, the Doing away with Kickbacks in Recovery Act (EKRA), the Anti-Kickback Statute or point out law equivalents.

   Since of these regulatory strictures, team tactics ordinarily are unable to compensate doctors primarily based on their referrals for ancillary services. Alternatively, within just team procedures, in addition to productiveness-centered payment, ancillaries will want to be split in a Stark Law-compliant earnings-sharing pool. (For additional dialogue of these policies, see preceding McGuireWoods webinars and content.) These rules demand care and intentionality in making this sort of payments. In addition, for bigger platforms with many tactics, significantly investor-backed platforms, indirect payments by way of a management entity can build challenges that ought to be reviewed and thought of.

3. Such alignment difficulties can problem cross-border development strategies. Many women’s overall health platforms are investing in pricey genetic tests equipment, which can be difficult for a one apply to support purchasing (specially if the platform has a lot more than a person exercise in the identical condition). These expenses are a single purpose women’s well being doctors might be interested in partnering with larger platforms. Nonetheless, genetic tests is generally subject to federal rules even with no govt payors (see EKRA), as effectively as point out law regulation.

   Therefore, platforms need to have to contemplate thoroughly how to devote in these types of laboratory equipment, when adhering to these regulatory frameworks. This may well indicate producing regional supergroups that cross point out borders, which can enable the benefit of aligning ancillary compensation as reviewed in the preceding paragraph in a single team while including supplemental geographic scope. Other alternatives involve machines-sharing arrangements and lab possession by the buyers only (i.e., not aligning payment with the referring doctors).

   Depending on the specific parameters of the system and the organization targets, various methods can appear into play, but generally, women’s wellness platforms need to be intentional and thoughtful here as they develop outside of a single state or follow.

4. Outside medical professional relationships are commonplace in the women’s well being subsector and pose exclusive worries for women’s health and fitness practices. The webinar discussed many styles of medical doctor interactions that could exist outside a physician’s team practice. These incorporate (i) doctor investments in laboratories, imaging facilities, ambulatory surgical procedures facilities or birthing centers (ii) doctor consulting and speaking associations with pharmaceutical or clinical unit providers (iii) doctor arrangements with hospitals through clinical director or get in touch with protection agreements and (iv) pro witness roles.

   Just about every of these relationships possibly creates regulatory and business enterprise considerations. Immediate investments in ancillary products and services, in unique, can pose risk below federal fraud and abuse legal guidelines (these kinds of as the Anti-Kickback Statute and Stark Law), as properly as identical fraud and abuse guidelines at the point out level. Company criteria of medical doctor outdoors actions, this kind of as conflicts of fascination and the time needed for these kinds of outdoors activities, were also addressed.

   Lastly, the webinar covered various techniques for women’s overall health corporations to evaluate outdoors medical professional interactions without having removing them. These provided creating a pathway for regulatory and financial review that is distinct and quite applied, and applying conflict-of-interest procedures to ensure the entity has a system to on a regular basis keep track of, audit and evaluate exterior actions.