2021 National Survey on Prior Authorization Burden and Its Impact on Gastroenterology Practice.

INTRODUCTION: Prior authorizations (PAs) are intended to control prescription drug expenditures.
METHODS: One hundred fifty-six physician and advanced practice provider members of the American College of Gastroenterology completed a national survey to assess PA burden and impact.
RESULTS: One-half of PA requests relate to prescription refills. Greater than 50% of the respondents choose inferior treatments at least weekly because of perceived PA burden for preferred agents. One-half of the respondents reported a patient who experienced serious adverse events due to PA-related care delays. DISCUSSION: PA is an administrative burden that exhausts practice resources and may have a negative impact on patient care.

INTRODUCTION

We performed a national survey on the burden of prior authorizations (PAs) in gastroenterology practice and its impact on prescribing behavior and clinical care.

METHODS

A national cross-sectional survey was broadly distributed using several channels, including repeated e-mail and blog blast reminders, website, and social media, to facilitate a wide geographic and practice-type representation to >17,000 board-certified/board-eligible gastroenterology physician and advanced practice provider members of the American College of Gastroenterology (ACG) between September and October 2021. The survey instrument was developed over several meetings as a joint collaboration of members on the Practice Management Committee, US FDA-related matters committee, and Public Policy Council to formulate 3 thematic domains, including (1) PA burden (2), impact of PAs on clinical care recommendations, and (3) practice strategies to address PAs. The survey instrument was iteratively pilot tested and revised by committee members to establish content and face validity and evaluate test-retest reliability in a manner that improved completion time and comprehension while informing the order of questions (see Supplementary Digital Content, http://links.lww.com/AJG/C471). The Dartmouth-Hitchcock Institutional Review Board approved this study.

RESULTS

Demographics

One hundred fifty-six gastroenterology providers (1.0% of 17,000 ACG members who received the survey) completed the survey, including 151 gastroenterologists (a median of 20.0 years in practice [range 2.0–37.0]) and 5 advanced practice providers (a median of 10.0 years in practice [range 3.0–16.8]). A total of 262 respondents initiated the survey (59.9% completion rate) (Table 1). We included all responses to individual items when available, regardless of survey completion. Respondents represented 43 states plus Puerto Rico and a variety of practice types.

Table 1.

Survey respondent demographics

Prior authorizations burden

Overall, 93.8% of respondents (182/196) perceived a high or extremely high burden of PA requests (Figure 1). Respondents reported receiving a median number of 10 PAs in the previous 7 days (mean 16.4, range 2–50) and 2 written appeals or telephone peer-to-peer (P2P) requests (mean 4.0, range 0–40). Respondents processed almost all of these requests (median of 10 PAs processed in the previous 7 days, mean 14.6, range 0–150; median of 2 written appeals/P2P requests completed in the previous 7 days, mean 3.4, range 0–32). Perceived PA burden was high among respondents, regardless of employment arrangement, except equity partners in private practice (35.0% rated high or very high burden). This cohort also had the highest rate of having dedicated staff to process PAs (76.2% of practices) and the lowest proportion of inflammatory bowel disease specialists (4/36) among respondent cohorts.

Figure 1.

Burden of prior authorizations on gastroenterology practice.

Approximately one-half of all PA requests and written appeals/P2P requests received in the previous 7 days related to refill requests for a drug that the patient was already taking (median of 5/10 PA requests received related to refills [mean of 8.1/14.7 requests received]; median of 1/2 written appeal/P2P request received related to refills [mean of 2.56/4.0 requests received]).

Impact of PAs on clinical care recommendations

Of the 158 respondents, 57.6% (91) avoided talking about a preferred medication with their patients because of a high perceived likelihood of coverage denial at least once per week (with 31.7% of the respondents reporting doing so at least daily and 19.0% of the respondents reporting doing so multiple times per day) (Figure 2). Of the 158 respondents, 67.7% (107) reported that they encouraged patients to contact the insurer directly when pursuing prescription drug approval, in addition to or in lieu of the respondent's office contacting the insurer on the patient's behalf (with 39.3% of the respondents requesting this of patients daily and 20.9% of the respondents requesting this of patients multiple times per day).

Figure 2.

Impact of the prior authorization burden on clinical care recommendations. FDA, Food and Drug Administration.

Respondents were asked to consider situations during the previous 7 days in which they gave up on a PA and chose an alternative treatment (Figure 3). The alternative treatments were generally less effective, more costly to patients, less tolerable, and/or supported by a lower level of evidence. Respondents were then asked to consider situations during the previous 7 days in which they gave up at the appeals stage. The addition of this second stage of review by the insurer did not improve the likelihood of finding a superior alternative.

Figure 3.

Impact of the prior authorization burden on patient harm.

Impact of PAs on patient harm

Of the 160 respondents, 54.4% (87) reported that at least one of their patients suffered a serious adverse event (e.g., death, hospitalization, disability/permanent bodily damage, or other life-threatening event) due to delays in care delivery attributed to the PA process. Of respondents who recalled at least 1 serious adverse event, respondents recalled a median of 3 such situations in the preceding 12 months (range 0–20).

Practice strategies/resources to address PAs

Of the 158 respondents, 59.5% (94) reported hiring staff to work exclusively on PAs. In most cases, these staff were medical assistants (45.7% of the respondents; 43 of 158), while the remaining were nurses (23.4% of the respondents; 22 of 158) or pharmacists (11.7% of the respondents; 11 of 158). The perceived PA burden was high or very high among practices with (95.7%) or without (89.1%) dedicated staff to process PAs.

DISCUSSION

To our knowledge, this was the first national cross-sectional survey to assess the PA burden and impact conducted among gastroenterologists and affiliated advanced practice providers. Our survey revealed the significant administrative burden of the PA process to gastroenterologists. Our survey strongly suggests that the PA process leads to inferior care and harms patients from the perspective of experienced gastroenterologists who care for patients.

Addressing barriers to access for prescription medications in gastroenterology remains a priority (1–3). Ultimately, congressional action is needed to address root causes. The PA process should be realigned with its original mission of preventing misuse of high-cost medications in highly specific medically inappropriate situations (4,5). The impact of pharmacy benefits management practices on drug prices, and patient health outcomes should be carefully examined (6). Collaborating with individual patients and patient advocacy groups may be particularly helpful in meeting with insurance commissioners and state legislators to effectively advocate for changes to improve this patient-centered issue (7). Ultimately, “all politics is local”—professional society resources can help gastroenterologists be available as a resource for local political representatives to inform on patient needs (8).

Our limitations are typical of surveys, including low response limiting external generalizability and the potential for selection bias, specifically that those experiencing high PA burden might be more likely to respond.

Improving access to effective prescription drugs is a priority for gastroenterology professional societies and patients. Understanding the PA burden and its effects on practice is a major component of efforts to help gastroenterologists have the tools to support their practice, and, in so doing, be able to provide their patients with the best care possible.

CONFLICTS OF INTEREST

Guarantor of the article: Eric D. Shah, MD, MBA, FACG.

Specific author contributions: All authors were involved in study concept and design and interpretation of data. E.D.S.: authored the initial draft of the article and performed statistical analysis. All authors critically revised the article and approved the final copy.

Financial support: None to report.

Potential competing interests: E.D.S.: consulted for Bausch Health and GI Supply. S.T.A.: consulted for Eli Lilly.