United States: Forty-Five Days And Counting For Current HHS Leadership: Implications For Rulemaking

Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration. A perusal of the Federal Register reveals that in the wake of the election, federal agencies are issuing proposed and final rules at a swift pace.

So it may be wise to consider what HHS rules have been published, and what rules could still be acted on by the Office of Management and Budget (OMB) and published before the inauguration of the new administration. And we also need to consider what action Congress may take on those rules.

Recently Published Rules

In recent days, HHS agencies have published several new proposed rules.

  • On November 22, 2016, CMS published a Proposed Rule to amend the procedures governing pass-through payments in Medicaid Managed Care. The rule was published with a 30-day comment period, meaning it is unlikely that the present CMS leadership will be in a position to finalize this rule
  • On November 30, 2016, CMS published Proposed Rules to revise existing rules governing Medicaid and CHIP eligibility and enrollment, and the appeals process related to that eligibility and reenrollment. Many of the changes would align appeals processes across Medicaid and exchange plan eligibility. The 60-day comment period for these rule changes assures that decisions on any finalization will fall to new CMS leadership.
  • On December 7, 2016, OIG published the long awaited Final Rules on HHS-OIG Safe Harbors Regarding Beneficiary Inducement and Gainsharing. The Proposed Rules were first issued in October 2014, and among other things addressed the breadth of the statutory beneficiary inducement safe harbor, excluding beneficiary incentives that "promote access to care and pose a low risk of harm to patients and federally funded health care programs," from the definition of prohibited remuneration. After more than 18 months of comment review, the final rules were submitted to OMB in mid-August 2016, OMB review was completed on November 16, 2016, and OIG went ahead with publication. One change in the final rules was the distinction that OIG draws between beneficiary inducement that "removes obstacles to compliance with treatment," which qualifies for the safe harbor, as opposed to beneficiary inducement that "rewards treatment adherence" which does not qualify for the safe harbor.
  • On December 7, 2018 OIG also published a Final Rule revising HHS-OIG's Civil Monetary Penalty Rules impacting Medicare and State Health Care Programs. This Final Rule was submitted to OMB mid-August 2016, and review was completed by OMB on November 16, 2016. Changes of note in this rule include methodologies for calculating penalties, including penalties for overpayments.

Rules That May Still Be Published

Proposed and final rules, and certain types of agency guidance, must be reviewed by the OMB before the agency can publish the rules in the Federal Register. The OMB Office of Information and Regulatory Affairs is reporting daily on the status of OMB review of rules.

There are several key HHS provisions that OMB is still reviewing. There is still time for OMB to complete review, and for the Agency to elect to go forward with publication before the new administration takes office. These provisions include:

  • The 340B Program Omnibus Guidelines, which HHS-HRSA forwarded to OMB for review on September 1, 2016. We blogged on these Guidelines when first proposed in the fall of 2015. Given the controversial nature of the Guidelines, and the uncertainty as to their enforceability, conventional wisdom is that even if OMB completes review, HRSA may elect not to issue the Guidelines. Stay tuned on this one.
  • Also from HHS-HRSA, Final Rules on 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations. Unlike the Omnibus Guidelines, HRSA actually does have statutory rule-making authority for these rules, and it is more likely that if OMB review is completed, the rules will actually be issued. OMB received these rules from HRSA on October 21. 2016.
  • A Proposed Rule from HHS that, per its title, would revise the procedures for appeals of payment and coverage determinations to Administrative Law Judges involving items and services furnished to Medicare beneficiaries, enrollees in MA and PDP plans, as well as appeals of Medicare beneficiary and entitlement determinations. Given the significant backlog of appeals that exists, one might think these rule revisions would be of the highest priority, but OMB did not receive the proposed rule for review from HHS until November 18, 2016. Review is pending.
  • From HHS-CMS, a Proposed Rule on Medicaid Supplemental Payments and Accountability. This Proposed Rule has been at OMB since July 19, 2016 and is still pending OMB review. Even if it passes out and is published, there is no likelihood the rule would be finalized before the new administration takes office.
  • A Final Rule from HHS-OIG, revising OIG's Exclusion Authorities. The rule was not forwarded to OMB for review until October 27, 2016.
  • And as evidence that CMS is not standing pat, in the last week it forwarded two new rules for OMB review: an Interim Final Rule impacting the Conditions of Coverage for ESRD facilities was submitted to OMB on December 2, 2016, and a Final Rule on CY 2018 Notice of Benefit and Payment Parameters was submitted on December 5, 2016.

Congress and the Congressional Review Act

Congress is already telegraphing its intent to closely scrutinize any rules adopted in the waning days of the present administration. On November 17, 2016, the Congressional Research Service published a Memorandum with the title: Major Obama Administration Rules Potentially Eligible to be Overturned under the Congressional Review Act in the 115th Congress. As noted in the Memorandum, the Congressional Review Act gives Congress the authority to adopt "disapproval resolutions" the effect of which would be to overturn any rules or regulations adopted within 60 days prior to the present Congress' adjournment. The Act only applies to final rules/regulations; proposed rules or guidance can be withdrawn at the new Administration's discretion.

The Memorandum lists a number of rules which could be overturned through such a resolution. One would assume the list could be supplemented with any rules adopted after November 17th, including those listed above.

What Comes Next?

An ancient Chinese saying which roughly translates to: May you live in interesting times can be viewed alternatively as a blessing or a curse. Whether a blessing or curse, this much is true: the next few months are going to be quite interesting for those of us who closely follow health care law and policy.

The knee-jerk expectation of some is that the incoming Administration will simply withdraw all of the proposed regulations discussed above, and consider action under the CRA to rescind all the final rules. That is far from certain. The next administration will have to carefully decide which regulations they want to significantly alter and which they may want to let move forward through the process. Having no regulations on each of these subjects is may not be realistic.

While we cannot give you much in the way of certainly, we can say we will be following developments and blogging as appropriate. We hope you will follow us on this journey.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Ellyn Sternfield
Rodney L. Whitlock
In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.