ONC’s final rule on Information Blocking implements the 21st Century Cures Act and fleshes out what is and is not a prohibited information blocking practice. However, not all health care organizations and their vendors are on the hook for complying with this new regulation.
The 21st Century Cures Act and the ONC Final Rule define the scope of individuals and organizations – referred to as “Actors” — that are required to comply with Part 171 regulating information blocking practices. Section 171.101 specifically states that the Information Blocking requirements apply only to:
- Health Care Providers;
- Health IT developers of Certified Health IT; and
- Health Information Exchanges, and Health Information Networks.
For purposes of the Information Blocking Rule, “health care provider” is defined as having “the same meaning as health care provider set forth in 42 U.S.C. 300jj” of the Public Health Service Act. Under 42 U.S.C. 300jj, the scope of health care providers who/that fall within that definition include the following:
- hospitals;
- skilled nursing facilities;
- nursing facilities, or other long-term care facilities;
- home health entities;
- health care clinics;
- community mental health centers (as defined in 42 U.S.C. § 300x-2);
- renal dialysis facilities;
- blood centers;
- ambulatory surgical centers (as described in 42 U.S.C. § 1395l(i));
- emergency medical services providers;
- federally qualified health centers;
- rural health clinics;
- group practices;
- pharmacists;
- pharmacies;
- laboratories;
- ambulatory surgical centers (as described in §1395l(i)of the Public Health Service Act);
- physicians, as defined in 42 U.S.C. § 1395x to include the following:
- doctors of medicine or osteopathy;
- doctors of dental surgery or of dental medicine;
- doctors of podiatric medicine;
- doctors of optometry, but only if under the “care” of a physician;
- chiropractors;
- practitioners, as defined in 42 U.S.C. § 1395u(b)(18(C) to include the following:
- physician assistants (PA);
- nurse practitioner (NP);
- clinical nurse specialist;
- certified registered nurse anesthetist (CRNA);
- certified nurse-midwife;
- clinical social worker (CSW);
- clinical psychologist;
- registered dietitian or nutrition professional;
- therapists, defined to include PTs, OTs and qualified speech therapists;
- providers operated by, or under contract with, the Indian Health Service or by an Indian tribe, tribal organization, or urban Indian organization;
- covered entities defined under 42 U.S.C. § 256b to include a list of entities including, but not limited to, certain grant-funded family planning projects; entities receiving a grant relating to categorical grants for outpatient early intervention services for HIV disease; state-operated AIDS drug purchasing assistance program receiving financial assistance;
and
- any other category of health care facility, entity, practitioner, or clinician determined appropriate by the Secretary of HHS.
In the Preamble to the Final Rule, ONC noted that this definition of “health care provider” is different from the definition of ‘‘health care provider’’ under the HIPAA Rules. A significant number of commenters were in favor of using the definition of health care provider used in the HIPAA Rules. Other commenters suggested limiting the application of the Information Blocking Rule only to those health care providers using certified health information technology. Still other commenters suggested including additional categories such as community-based organizations that address social determinants of health (e.g., access to food, housing, and transportation) – which, were not included.
In response, ONC decided to retain the definition of ‘‘health care provider’’ as set forth in the 21st Century Cures Act, referencing the Public Health Service Act (PHSA) definition of the same term. ONC noted that the last clause of the health care provider definition of the PHSA gives the Secretary of HHS discretion to expand the definition to any other category determined to be appropriate. ONC also noted that it will consider whether the definition should be expanded in the future if the scope of health care providers subject to the information blocking provision does not appear to be broad enough in practice to ensure that the information blocking provision applies to all health care providers that might engage in information blocking. ONC concluded its responses to comments by confirming that “community-based organizations, as described by commenters, generally would not meet the health care provider definition unless they are also a type of individual or entity identified in the definition.”
On this last point, because “physicians,” “practitioners” and “therapists” are included and therefore required to comply with the Information Blocking Rule, even though certain entity-level organizations have been left out of the scope of the definition, their qualifying employees and other individual providers will be required to comply. This means that such employer-organizations — that otherwise fall outside the scope of the PHSA definition — will likely still need to facilitate compliance with the Information Blocking Rule in some capacity, at least with respect to such individual “health care providers” who they employ.
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