Health Law Advisor

In September 2024, a group of Washington, D.C., legislators introduced the Certificate of Need (CON) Improvement Act of 2024, B25-0948. If passed, the measure will reform the requirements and process for health establishments in the District to obtain CONs from D.C.’s State Health Planning and Development Agency (SHPDA).

Background

D.C.’s CON requirements were originally established in 1980 to ensure that access to health care services is available to all D.C. residents and to contain the costs of such health care services. D.C. regulators have more recently argued that D.C. was experiencing an overabundance of primary care providers, which has led regulators to apply the CON process in an overly broad manner to prevent a doctor on every block.^[1] The CON requirements have been applied in an inconsistent manner such that similarly situated providers may or may not have a CON depending on enforcement by regulators. Stakeholders within the D.C. community have contested the overly broad interpretation and enforcement of the CON law in D.C. and have argued that such interpretations are in fact creating provider shortages, increasing health care costs, and decreasing access to care.

In addition, the time and expense of complying with the CON requirements is enough of a barrier to potentially send independent physician practices across the border into Maryland and Virginia.^[2] Stakeholders have asserted that rather than decrease health care costs and increase access to care, the CON laws have had the opposite effect.

Lastly, the current requirements for institutional and physician providers to apply for a CON for even routine projects or activities is unnecessary and overly burdensome. For example, hospitals must wait months to a year following the CON process to get non-patient improvements like heating, ventilation, and air conditioning (HVAC). Furthermore, under the current interpretation by regulators, a physician group could subject itself to requiring a CON simply by hiring a non-owner physician or maintain a separate room to perform non-surgical procedures.

California’s legislature recently passed AB 3129, and it is awaiting Governor Gavin Newsom’s signature. While AB 3129 impacts several different provider types, this article focuses on its impact on Management Service Organizations (MSOs) and Physician Practice Management Companies (PPMCs) as the historically accepted structure for purposes of complying with the prohibitions on the corporate practice of medicine (CPOM). In its initial drafts, AB 3129 seemed highly focused on MSOs and the Friendly PC models for PPMs in the state.

While much of the early language regarding MSOs seems to have been shed from the bill, some ambiguity remains regarding whether, and in what contexts, sponsored MSOs will need to give pre-transaction notice to, or obtain the consent of, the California Attorney General (AG).  A later section of the bill highlights what will likely be CPOM enforcement priorities and is worth the close attention of all MSOs operating in the state.

On July 25, 2024, a federal “Health Over Wealth Act” was introduced in the U.S. Senate and House of Representatives. The bill would amend the Public Health Service Act, requiring the Secretary of Health and Human Services (HHS) to enforce certain transparency, accountability, and other requirements with respect to for-profit corporations that own health care systems.

S. 4804 was introduced by Senator Edward D. Markey (D-Mass), chair of the Health, Education, Labor, and Pensions Committee on Primary Health, and Retirement Security, before being referred to the Committee on Finance. H.R. 9156 was introduced by Representative Pramila Jayapal (WA-07), member of the House Judiciary Subcommittee on Health, Employment, Labor, and Pensions.

In April, we shared with you our thoughts on what to consider before opening in or investing in a medical spa, thinking about corporate structure, scope of practice, licenses and registrations, referral restrictions, HIPAA and data privacy, and more. This month, we’re focusing on how states are beginning to regulate in this area, so owners and operators can hit the ground running in terms of compliance—or relax and breathe deep, knowing they are ahead of the plan. 

In March 2024, the state of Rhode Island introduced S 2870, the Medical Spas Safety Act, providing (within the definition of “cosmetic medical procedure”) that:

• The performance of cosmetic medical services is the practice of medicine and surgery; and
• A cosmetic medical service shall be performed by a qualified licensed or certified non-physician only if the services have been delegated by a medical director, supervising physician, supervising physician’s assistant (PA) or supervising advanced practice registered nurse (APRN) who is responsible for onsite supervision of services performed.

Aesthetic services and the medical spa industry have continued to grow over the past few years as clients continue to demand the availability of such cosmetic services. In response, many providers and investors in the health care industry are seeing opportunities to open or invest in a medical spa.

Before opening or investing in a medical spa there are several key elements to be considered:

Corporate Structure

One of the first elements to consider when opening a medical spa is the corporate structure and ownership of the medical spa. Many jurisdictions have “Corporate Practice of ...

On March 13, 2024, Indiana Governor Eric J. Holcomb signed Senate Enrolled Act No. 9 (“SEA 9”) which will amend the Indiana Code with respect to notice of health care entity mergers and acquisitions.

The measure, effective July 1, 2024, adds a new Chapter 8.5 to the Indiana Code providing in Section 4(a) that “[a]n Indiana health care entity that is involved in a merger or acquisition with another health care entity with total assets, including combined entities and holdings, of at least ten million dollars ($10,000,000) shall, at least ninety (90) days prior to the merger or ...

On February 28, 2024, bipartisan legislation was introduced in the Connecticut General Assembly by the State Senate and House of Representatives that would require the executive director of the Office of Health Strategy to develop a plan concerning private equity firms acquiring or holding an ownership interest in health care facilities in the state.

Raised HB 5319, sponsored by Sen. Jeff Gordon (R) and Sen. Saud Anwar (D), was referred to the state’s Joint Committee on Public Health. A public hearing was held on March 6.

This legislation, and related bills around the country, are ...

On February 22, 2024, legislation was introduced in Minnesota’s House of Representatives that would prohibit private equity companies or real estate investment trusts (REITs) from acquiring or increasing any direct or indirect ownership interest those entities have in a health care provider after August 1, 2024.

H.F. No. 4206, authored by state Rep. Jessica Hanson and referred to the Commerce, Finance, and Policy Committee, would also prohibit private equity or REITs from acquiring or increasing any operational or financial control those entities have over a provider, after ...

As our December 2023 Insight noted, California’s SB 184 (enacted in June 2022) and accompanying regulations contain pre-transaction notice requirements by “specified health care entities” for certain “material change transactions” involving the provision of “health care services” in the state. SB 184, which takes effect on April 1, 2024, also established a state Office of Health Care Accountability.

While many transactions involving health care entities will already face the notice requirements of SB 184, AB 3129, introduced by California Assembly Member ...

Oregon’s Proposed HB 4130, which passed the Oregon House of Representatives on February 22, 2024, was at the desk of the Senate president when the 82nd Legislative Assembly adjourned sine die on March 7, 2024, thereby ending this legislation for this year. HB 4130 would have severely limited non-professional businesses from owning or controlling health-related entities through commonly used management models and, therefore, would greatly reduce physicians from seeking non-professional investors.

For those opposing the measure, the victory may only be temporary. The ...