On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
HHS Issues Proposed Rule Regarding Program Integrity and the Exchanges
- State Exchanges: The proposed rule establishes oversight and financial integrity standards for state exchanges, including reporting and audit requirements. In particular, the rule focuses on establishing program safeguards to ensure that state exchanges have safeguards in place to avoid inaccurate eligibility determinations.
- FFE: The proposed rule also provides details regarding the oversight functions of the FFE, including records retention requirements and compliance reviews to be conducted by HHS, and proposes the bases and processes for imposing civil monetary penalties in the FFE, as well as for decertifying plans from participation therein.
Resolution of Grievances
The rule also establishes a process for resolving “cases” received by a QHP issuer operating in an FFE (i.e., grievances regarding the operation of the plan, other than advance benefit determinations). While these cases generally must be resolved within 15 days, “cases involving the need for urgent medical care” must be resolved no more than 72 hours they are received by the plan (unless a stricter state standard applies). Notably, a determination regarding benefit tiers or plan design may fall within HHS’ proposed definition of a “case” for these purposes, so long as it is not a claim denial, which is subject to a different process.
Correcting Improper Allocation of Premium Tax Credits and Cost-Sharing Reductions
The proposed rule specifies the actions a QHP must take if it does not provide the appropriate premium tax credit payments or cost-sharing reductions. Notably, the proposed rule prohibits QHPs from recouping excess funds paid on behalf of the individual or to a provider and requires QHPs to refund any excess payments made by enrollees within certain, specified time frames.
State Flexibility to Operate Just a SHOP Exchange
The proposed rule would allow states to operate just a SHOP exchange, leaving the operation of the exchange serving both the individual and small group markets to the federal government. To implement this change, HHS proposes to allow states that have received conditional approval to operate a state-based exchange to modify their proposal to offer just the SHOP exchange.
Moreover, those states that have not received conditional approval do not have the option of operating only a SHOP in the 2014 plan year. However, for plan years 2015 and beyond, CMS will consider new Blueprints from states wanting to operate only the SHOP.
The proposed rule also makes the following two notable “technical” changes:
- Amends the applicable definitions of “small employer” and “large employer” for purposes of the Exchanges. This change is significant in that the definitions, as revised, differ from those used under the Public Health Service Act, the Internal Revenue Code, and the Employee Retirement Income Security Act (ERISA).
- Makes a “technical correction” to clarify that coverage sold through associations is considered individual coverage under the PHS Act, affecting the application of the Affordable Care Act’s insurance-related consumer protections.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017