Massachusetts
Massachusetts is one of eight states to require CONs within all six broad categories—hospital beds, beds outside hospitals, equipment, facilities, services and emergency medical transport. Massachusetts, however, calls its program a determination of need (DON) program. DONs function the same as CONs. Massachusetts maintains regulations that allow applicants to apply for an emergency DON if they are able to “convincingly demonstrate that the Proposed Project will address the Emergency Situation, and without issuance of a Notice of Determination of Need, that the public health will be measurably harmed.” 105 Mass. Code Regs. § 100.740(A).
Massachusetts’s COVID-19 Response
On March 24, 2020, Monica Bharel, Commissioner of the Massachusetts Department of Public Health, acting pursuant to the Governor’s public health emergency declaration, ordered the Department to reduce the burdens associated with the DON program. Order of the Comm’r of Pub. Health Regarding Determination of Need Approvals Related to COVID-19 (Mar. 24, 2020).44 The Department issued a memorandum describing an expedited DON application process in response to COVID-19. Memorandum from Margo Michaels, Massachusetts Pub. Health Director (Mar. 24, 2020).45 The Department then reviewed applications to determine whether the proposed project actually related to COVID-19 and whether the project was truly temporary in nature.
Application Process
In Massachusetts, the DON application process takes four months. 105 Mass. Code Regs. § 100.405(D). Applications can be submitted at any time and the application fee is $500 or 0.2% of the total value of the proposed project, whichever is greater. 105 Mass. Code Regs. § 100.405(B). Competitors can intervene in the application process and can offer evidence or argument as to why an application should be denied. 105 Mass. Code Regs. § 100.440(A).
Types of DONs in Massachusetts
| DON? | DON applies with expenditure of: | Temporary COVID-19 response: | |
| Hospital Beds | Yes | $0 – $19,293,096+ | Expedited Review |
| Beds Outside Hospitals | Yes | Any amount | Expedited Review |
| Equipment | Yes | $285,780 – $1,029,141+ | Expedited Review |
| Facilities/Buildings | Yes | $2,058,278+ | Expedited Review |
| Services | Yes | $0 – $31,467,725+ | Expedited Review |
| Emergency Medical Transport | Yes | Any amount | Expedited Review |
Massachusetts DONs in Detail
| Category | Types of DONs | Citation |
| Hospital Beds | Hospital beds. | Mass. Gen. Laws ch. 111 §§ 25C(a), 25B; 105 Mass. Code Regs. § 100.100 |
| Beds Outside Hospital | Clinic beds. Long-term care facility beds. Convalescent or nursing home beds. Rest home or a charitable home for the aged beds. Public medical institution beds. Beds in any institution for the developmentally disabled or mentally ill which is administered under Titles 18 and 19 of the Federal Social Security Act. | Mass. Gen. Laws ch. 111 §§ 25C(a), 25B; 105 Mass. Code Regs. § 100.100 |
| Equipment | Computerized tomographer. Magnetic resonance image scanner. Positron emission tomographer. Medical, diagnostic or therapeutic equipment over $400,000 acquired by a health care facility other than a hospital. | Mass. Gen. Laws ch. 111 § 25C(d); 105 Mass. Code. Regs. § 100.100; see Determination of Need-Required Equipment and Services Guidelines 4, (Mass. Dep’t of Pub. Health Jan. 2017);46 Mass. Gen. Laws ch. 111 §§ 25B (definition of “expenditure minimum with respect to substantial capital expenditures”), 25C(a) |
| Facilities/Buildings | Hospital. Clinic. Long-term care facility. Convalescent or nursing home. Rest home or a charitable home for the aged. Clinical laboratory. A public medical institution. Any institution for the developmentally disabled or mentally ill which is administered under Titles 18 and 19 of the Federal Social Security Act. | Mass. Gen. Laws ch. 111 §§ 25C(a), 25B; 105 Mass. Code Regs. § 100.100 |
| Ambulatory surgical center. | 105 Mass. Code Regs. § 100.730(A)(1) | |
| Services | Air ambulance. Megavoltage radiation therapy. | Mass. Gen. Laws ch. 111 § 25C(a), (d); 105 Mass. Code Regs. § 100.100; see Guidelines at 4 |
| Emergency Medical Transport | Air ambulance. | 105 Mass. Code Regs. § 100.100; see Guideline at 4 |
Massachusetts DON Exceptions
| No DON Required For: | Citation |
| No DON is needed for any substantial capital expenditure for construction related to the provision of inpatient services or for any substantial change in inpatient services if a substantial capital expenditure or such substantial change in services will be made by or on behalf of one of the following: An HMO or combination of HMOs providing inpatient services if: The HMO or combination of HMOs in the service area have a combined enrollment of at least 50,000 individuals; The facility to which the service is provided will be reasonably accessible to enrolled individuals; and At least 75% of the patients served will be enrolled in the HMOs. | Mass. Gen. Laws ch. 111 § 25C ½(1) |
| A healthcare facility if: It provides or will provide inpatient services; It will be controlled or leased (with 15 years remaining on the lease) by an HMO or a combination of HMOs which has in the service area of the HMOs a combined enrollment of at least 50,000 individuals; It will be geographically located so that services are reasonably accessible; and At least 75% of the patients who can be expected to receive such inpatient served will be enrolled in the HMOs. | Mass. Gen. Laws ch. 111 § 25C ½(2), (3) |
| A health care facility if: It will be a long-term care facility, an infirmary maintained in a town, a convalescent or nursing home, or a charitable home for the aged; It will be located in an under-bedded urban area; It provides a service to at least 70% of its patients as enrollees in Title XIV of the federal Social Security Act; It presents an adequate quality assurance program plan; and The need for such facility has been established. | Mass. Gen. Laws ch. 111 § 25C ½(4) |
| Basic biomedical research or applied medical research. | Mass. Gen. Laws ch. 111 § 25C(a); 105 Mass. Code Regs. § 100.726(A) |