Fig. 1 There are various steps involved in getting a regulation passed into law.
Source: National Journal


Published 11/1/2018
Shreyasi Deb, PhD, MBA

The Regulatory Side of Lawmaking Can Be Confusing

AAOS advocates before federal and state legislative, regulatory, and executive agencies to improve musculoskeletal care for patients. Although many people are familiar with the Congressional legislative process, fewer understand the development of regulations. Regulations are standards and rules adopted by administrative agencies that govern how laws will be enforced.

AAOS focuses primarily on influencing the Department of Health and Human Services (HHS) regulations at the federal level. With 11 operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies, HHS is one of the largest federal departments. It has nearly 80,000 employees and an annual budget of more than $1 trillion. In addition, its numerous agencies, specialized groups, and centers regulate healthcare services, research, and delivery. An AAOS regulatory policy team closely follows regulations that are relevant to musculoskeletal care and physician practices (Fig. 1).

After a proposed regulation is approved by the Office of Management and Budget (OMB), it goes back to the submitting agency in preparation for publication and is published chronologically in the Federal Register. The regulations also are organized by topic in a separate publication called the Code of Federal Regulations. The publication of regulations lays out the federal officers in charge of the proposed rule; the method for submitting comments (usually due within 60 days); and the details of the proposed regulation, including cost-benefit analysis and sometimes the impact on the federal budget.

After the agency receives comments, it finalizes the regulation and sends the final rule to the OMB for a second review. The final, approved rule is then submitted to Congress and the Government Accountability Office and published in the Federal Register. Any objections from the executive or legislative branches are sorted before publication. The White House, however, can ask to review regulations any time during the rulemaking process. It is rare, but Congress can pass a resolution of disapproval, and the White House can veto a finalized rule. The judiciary branch can get involved on legal questions once a regulation has been finalized and brought into effect.

How to make regulatory advocacy more effective

Regulatory advocacy is procedurally different than legislative advocacy. Regulatory agencies are bound by requirements from the Administrative Procedure Act, as well as by the agency’s own ethics and legal oversight. Federal regulators are extremely limited in terms of the audiences they may interact with and the timing and content of such discussions. For example, federal agency staff will meet with the public once a proposed rule has been published, but they can only listen and are prohibited from commenting in any way. Also, such verbal feedback from the public is considered informal, and only formal written comments following the announced process are considered by an agency.

Fig. 1 There are various steps involved in getting a regulation passed into law.
Source: National Journal
Fig. 2 AAOS members can become regulatory advocates for the profession and their colleagues through several avenuese.
Source: National Journal

There are four primary ways regulatory advocacy can be more effective:

  1. Advocates write meaningful comments that are directly relevant to the regulation or rule at hand.
    Regulatory agencies receive innumerable comments, especially if the regulation has a broad impact, and can consider only the more substantive comments. The AAOS Office of Government Relations (OGR) often finds its comments quoted or responded to in final rules. For example, the Centers for Medicare & Medicaid Services (CMS) accepted AAOS’ proposals to make orthopaedic surgeons the final arbiter of the setting of care once total knee arthroplasty (TKA) was moved out of the Medicare Inpatient Only (IPO) list and to leave the development of clinical practice guidelines to experts such as physicians and researchers. Another example is AAOS’ relentless and cogent comments and in-person meetings with CMS staff that led to the cancelation of the mandatory Surgical Hip/Femur Fracture Treatment (SHFFT) model under Medicare.
  2. A high volume of commentators influences a regulatory policy change.
    OGR often would help develop comments from a large group of stakeholders and partners to improve the volume of comments on a specific issue. In 2017, OGR did a similar push in response to the annual Medicare Inpatient Prospective Payment System rule to change the Medicare Severity–Diagnostic Related Group (MS-DRG) for ankle arthroplasty from MS-DRG 470 to the higher-paying MS-DRG 469.
  3. Provide alternative policy ideas.
    Offering solutions rather than simply raising concerns is likely to augur a better response from regulators. For example, AAOS is currently working with CMS on the development of educational materials for interpreting last year’s Medicare regulation that removed TKA from the IPO list. When several stakeholders misunderstood the rule, AAOS approached CMS clinical quality staff to develop information that can be widely disseminated via CMS information vehicles.
  4. Use social media campaigns and other information sessions, which can publicize a group’s perspectives.
    AAOS regularly uses Twitter, press releases, and focused interviews with members that appear in the trade press to communicate its public stance on various issues. For example, when after months of relentless advocacy actions, CMS withdrew the mandatory SHFFT model and made the Comprehensive Care for Joint Replacement (CJR) model partially voluntary, AAOS issued a celebratory press release and highlighted continuing concerns with the CJR model.

AAOS members as regulatory advocates

There are various avenues through which AAOS members can become regulatory advocates for the profession and the AAOS fellowship (Fig. 2). First and foremost, they can interact with regulatory agency staff at conferences, at AAOS’ internal meetings, and through specific issue-based requests for group calls and in-person meetings. Health policy regulators like to hear from physicians, and AAOS staff often facilitate meetings among AAOS members and regulatory agency leaders.

Members also can volunteer on various agency-led advisory committees if nominated by AAOS via the internal Committee Appointment Program. A current example is the CMS-sponsored Episode-based Cost Measures for Musculoskeletal Care, which is developing Merit-based Incentive Payment System’s cost category measures.

Even after a regulation has been finalized, advocates can bring forth their concerns to agencies and work toward a solution. An example is the recent rule that updated the previously fully mandatory CJR model to partially voluntary. This was the result of active advocacy by AAOS members and staff. Often a strategy of last resort, members can even directly ask Congressional members and staffers to make use of their regulatory oversight responsibilities, such as urging Congress to pass or update legislation so that regulators must undertake rulemaking.

In conclusion, the regulatory space has become highly active in the past few years. It is important that the AAOS fellowship take an active interest in regulatory policymaking and get involved in helping agencies develop policies that are beneficial for patients.

Shreyasi Deb, PhD, MBA, is senior manager of health policy in the AAOS OGR.