Life Science Compliance Update

January 25, 2017

Final Common Rule - Sixteen Agencies Update Regulations on Individuals Who Participate in Human Research

Trials-protecting

The Department of Health and Human Services (HHS), along with fifteen other federal agencies, issued a final rule updating regulations that safeguard individuals who participate in research. The rule updates current regulations, known as the “Common Rule,” which has been in place since 1991, and finalizes a September 2015 proposal. The rule does not become effective until January 19, 2018, although cooperative research is not required to be compliant until January 20, 2020.

Since the Common Rule was promulgated, the volume and landscape of research involving human subjects have changed considerably. Research with human subjects has grown in scale and become more diverse. Examples of developments include: an expansion in the number and types of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques to study human biospecimens; and the growing use of electronic health data and other digital records to enable very large datasets to be rapidly analyzed and combined in novel ways. However, these developments have not been accompanied by major change in the human subjects research oversight system.

HHS notes that the rule seeks to strengthen “protections for people who volunteer to participate in research” while balancing administrative burden, particularly for low-risk research.

According to HHS, more than 2,100 comments were received and as such, the final rule contains a number of significant changes from the proposed rule. Proposed policies that were ultimately not adopted include:

  • The final rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
  • To the extent that some of the NPRM proposals relied on tools or standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance. Examples of items that were not included in the final rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.
  • The final rule does not expand the policy to cover clinical trials that are not federally funded.
  • The final rule does not adopt the NPRM’s proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards.
  • The final rule does not adopt the proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.

Some of the significant changes made to the Common Rule include:

  • Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
  • Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
  • Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

An HHS press release on the rule is available here.

January 11, 2017

HHS Releases Regulations on Alternative Pay Models in Last Weeks of Current Administration

Rules

Despite Republicans’ call for a suspension on new rules, the Department of Health and Human Services (HHS) pushed regulations regarding Medicare and Medicaid alternative pay models and insurance exchange stability out the door in the final weeks of the Obama administration. It is likely that the administration wanted to put final touches on changes to demonstrations, which test pay and delivery reforms in Medicare and Medicaid. However, the next administration might undo some of the biggest demonstrations for which the Centers for Medicare & Medicaid Services (CMS) published rules in December because they apply to policies most Republicans oppose.

Alternative Payment Models

CMS in December published regulations on mandatory bundled-pay demonstrations for cardiac and joint-replacement services and announced a demonstration that pays bonuses to accountable care organizations for reducing Medicaid spending on beneficiaries enrolled in both Medicare and Medicaid.

The new APMs include three episode payment models (EPMs) for episodes of care surrounding an acute myocardial infarction (AMI), coronary artery bypass graft (CABG), and surgical hip/femur fracture treatment excluding lower extremity joint replacement (SHFFT). HHS chose the AMI, CABG, and SHFFT models because the agency believes those EPMs will allow hospitals to engage in effective care redesign, by:

  • increasing post-hospitalization follow-up and medical management for patients;
  • coordinating across the inpatient and post-acute care spectrum;
  • conducting appropriate discharge planning;
  • improving adherence to treatment or drug regimens;
  • reducing readmissions and complications during the post-discharge period;
  • managing chronic diseases and conditions that may be related to the EPMs' episodes;
  • choosing the most appropriate post-acute care setting; and
  • coordinating between providers and suppliers such as hospitals, physicians, and post-acute care providers.

The EMPs will be tested for five years, with the first performance year beginning July 1, 2017.

The federal government is letting states share in Medicare savings for the first time, which offsets what states lose when CMS shares Medicaid savings with providers. That model, called the accountable care organization Track 1 +, aims to get more physicians to accept the risk of penalties for poor performance.

Insurance Exchange Stability

HHS also published regulations aimed at stabilizing the exchange-plan market. The final rule maintains several changes to the Affordable Care Act's (ACA) permanent risk adjustment program and adds a provision to reduce the statewide average premium used in the risk-transfer formula.

This final rule comes after health insurance companies across the United States requested steep premium increases time and time again, claiming that providing coverage for a sicker patient population with the implementation of the ACA has contributed to the substantial financial losses appearing in their earnings reports.

The final rule also lowers the fee for state-based exchanges seeking to use the Healthcare.gov platform to 2 percent in 2018, and dedicates 3 percent of the 3.5 percent user fee for other federally facilitated market states to education and outreach efforts. CMS also set 2018 certification deadlines for qualified health plans. The final 2018 letter to federally facilitated market issuers mostly keeps the same time-frame despite issuers' assertions that the process should be delayed until at least summer to account for uncertainty.

The current administration’s goal is for a stronger risk pool, enrolling younger – typically healthier – younger adults. These changes may be a step in that direction.

January 06, 2017

A Review of CMS' Hospital Compare Website

Hospitalcompare

As we reported, in July CMS released its first-ever hospital quality star ratings on its Hospital Compare website. The overall star ratings are based on 64 quality measures grouped under three process categories—effectiveness of care, efficient use of medical imaging, and timeliness of care—and four outcomes categories: mortality, patient experience, readmissions, and safety of care. Many of the hospitals widely considered to be the nation’s best were unable to achieve a five-star rating.

Unfairly punishes hospitals

According to a recent analysis, this star rating system rewards hospitals that serve mostly affluent patients and punishes those serving the poor. The research by Bloomberg BNA compares star ratings of hospitals, indicating a correlation between high star ratings and high household income, and a corresponding correlation between low ratings and low income.

Critics of the rating system point out that low-income patients are more likely to have difficulty accessing transportation for both routine primary care and post-discharge follow-up care. That can and does affect readmission rates, which are a key component of quality ratings. Critics of the system also point to anomalous results such as the consistently low ratings of academic medical centers, which are generally considered among the nation’s best hospitals and which are often located in low income urban areas. 

As published by Bloomberg BNA:

Bloom

 

Bloom2

Outcome reporting issue

As reported in Health Affairs, CMS calculated and published star ratings for hospitals that had sufficient data to report on as few as three quality domains, including some hospitals that only had data from one clinical outcome domain. The fewer the clinical outcome domains a hospital reports, the less that hospital’s overall star rating is actually tied to performance on patient outcomes. Based on the July 2016 release of hospital compare data, 40 percent of the 102 hospitals that received a five-star rating did not have the minimum data necessary to report on either mortality or readmissions. Of those, 20 performed at only the national average on patient safety. Are all the shining stars here an accurate representation of quality?

This inconsistent value matrix leads to a wide performance divide among five-star hospitals. As shown by the Health Affairs research, among the 30 five-star hospitals that had sufficient data to report only the minimum number of quality domains required—three out of a total of seven (red bars)—14 had performed higher than the national average on only one quality domain, 15 performed above average on two domains, and a single hospital excelled at those three quality domains. Hospitals that reported all seven quality domains (yellow bars), however, needed at least three quality domains with above national average performance to receive a five-star rating:

3

MedPAC: Change the program

In October, the Medicare Payment Advisory Commission (MedPAC) sent a letter to CMS raising concerns about the agency's methodology for calculating hospital quality star ratings. Specifically, MedPAC is concerned the ratings do not fully consider the intrinsic health risks that patients bring to hospitals, therefore creating an output score that is not “apples-to-apples”. For example, at one-star hospitals, an average of 78 percent of admissions were admitted through the emergency department. At five-star hospitals, only 36 of admissions were admitted through the emergency department. One-star hospitals treat a higher share of more severe cases from emergency rooms.

MedPAC is also concerned regarding overlapping quality payment and reporting programs.

The Commission asks CMS to align the star rating methodology as much as possible with existing CMS programs, like the Hospital Value-based Purchasing program, which scores hospitals on a set of quality and cost measures and redistributes payments from lower- to higher-performing hospitals. This may perhaps be the only way for CMS to save the program and correct the methodological challenges that currently call into question the utility of the hospital star ratings.

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