2017 Dodd-Frank Act Stress Test (DFAST): Our take

The Federal Reserve (“Fed”) released the results of its Dodd-Frank Act Stress Tests (DFAST)1 that measure the potential impact of adverse or severely adverse economic conditions on the performance and condition of the 34 banks subject to the rule.  These results will be followed on June 28, 2017 by the Fed’s conclusions regarding the adequacy of bank capital plans as evaluated through the Comprehensive Capital Analysis and Review (CCAR).

Key takeaways for the severely adverse scenario results include:

Continue reading “2017 Dodd-Frank Act Stress Test (DFAST): Our take”

Key points from the CDRH and FDA draft guidance under 21 CFR part 11

In June 2017, the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA or Agency) issued a draft guidance document titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  While focused on the use of electronic records and signatures for clinical trial documents, the concepts and requirements outlined in the guidance reflect the Agency’s latest thinking on this topic and should be considered when implementing electronic records and signatures across the medical product lifecycle.  At 28 pages, the document has a lot of content in keeping with FDA’s current policy of providing guidance documents that include more practical examples to help industry comply with the requirements.

Some key points from the draft guidance include:

Continue reading “Key points from the CDRH and FDA draft guidance under 21 CFR part 11”

SWIFT Customer Security Program: Implementation considerations

The 2016 Bangladesh Bank cyber-attack and multiple other cyber events connected to the Society for Worldwide Interbank Financial Telecommunication (SWIFT) have brought renewed attention to the effectiveness of SWIFT security and fraud controls.

SWIFT’s Customer Security Program (CSP)1 is a set of core security standards intended to help mitigate specific cybersecurity risks that SWIFT clients face due to the cyber threat landscape.  The CSP, which is based on three objectives, eight strategic security principles, and a common set of 27 security controls (16 mandatory and 11 advisory), is aimed at reducing these fraud and cyber incidents. All SWIFT customers must comply with the mandatory controls under the CSP and provide a detailed annual attestation with respect to their compliance, the first of which is due in December 2017.

Continue reading “SWIFT Customer Security Program: Implementation considerations”

Getting started with RegTech

As financial services firms look for ways to harness the power of risk & regulatory technologies (RegTech), one of the first questions that comes to mind is where to start. Different parts of the business present very different challenges and opportunities, and the activity areas you choose to focus on can have a big impact on the results. Here are some tips for getting started:

Continue reading “Getting started with RegTech”

House-passed health care bill would increase uninsured by 23 million in 2026, nonpartisan analysis projects

The number of uninsured people in the US would increase by 23 million by 2026 if the American Health Care Act (AHCA, HR 1628) as passed by the House of Representatives were enacted, the nonpartisan Congressional Budget Office (CBO) projected in a report issued late Wednesday, May 24, 2017.1 A CBO analysis of a previous version of the AHCA projected that enactment of the legislation would have increased the number of uninsured by 24 million in 2026.

The House on May 4, 2017, narrowly approved the bill.

The release of the CBO report clears the way for the bill to move to the Senate for consideration under the budget reconciliation process, which would make it possible for the Senate to pass the AHCA with a simple majority of 51 votes, rather than 60 votes generally needed to bring legislation up for a vote under Senate rules. Significant changes may be under consideration in the Senate.

Overall, the AHCA would:

  • Reduce federal health care spending;
  • Redesign advanceable, refundable tax credits for individuals who do not have access to employer-sponsored coverage;
  • Restructure and cap federal Medicaid funding to the states;
  • Repeal most taxes and fees enacted under the Affordable Care Act (ACA);
  • Provide $138 billion over 10 years in federal funding for state programs intended to help stabilize and reduce health insurance premiums in the non-group market.

Organizations representing hospitals, physicians, health plans and consumers have issued statements critical of the bill.

Key highlights of the CBO’s analysis of the AHCA as passed by the House are provided below.

Continue reading “House-passed health care bill would increase uninsured by 23 million in 2026, nonpartisan analysis projects”

CMS releases final Medicare audit protocol updates

The Centers for Medicare and Medicaid Services (CMS) has released the final protocols for 2017 audits of Medicare Parts C and D plans. This is the latest step in a process RegPulse has reported on during the initial release and as draft protocols underwent updates during the last year.

The audit protocol revisions affect the ways in which plan sponsors—such as Medicare Advantage Organizations (MAOs), Prescription Drug Plans (PDPs), and Medicare-Medicaid Plans (MMPs)—prepare and present information about their data universes to CMS. Sponsors that take part in these programs should review the changes and continue or update their programs assessments to identify the changes that affect them and plan appropriate responses.

Here is a summary of the relevant changes to the audit protocols in the final release, listed by program type:

Continue reading “CMS releases final Medicare audit protocol updates”

House approves bill to replace key provisions of the Affordable Care Act; All eyes turn to the Senate

The House of Representatives on May 4, 2017, narrowly voted 217-213 to pass the American Health Care Act (AHCA, H.R. 1628). No Democrat voted in favor of the bill and 20 Republicans voted against the bill. As many recall, the House on March 24, 2017, cancelled a planned vote on the AHCA due to a lack of support in the Republican conference.

In the ensuing weeks, three amendments to the AHCA were drafted by House members in an effort to win additional votes for the underlying bill. This ultimately paved the way toward passage in the House today on a slim majority vote. Following the vote, the House went into recess until May 16, 2017.

The AHCA now goes to the Senate for its consideration and likely modification in the coming weeks. Based on the next steps in the process, it may take well into the summer months before a final piece of legislation could be signed into law by President Trump.

The House bill seeks to repeal key provisions of the Affordable Care Act (ACA) and enact alternative health care policies that in general would:

  • Redesign advanceable, refundable tax credits for individuals who do not have access to employer-sponsored coverage
  • Restructure and cap federal Medicaid financing to the states
  • Repeal most taxes and fees enacted under the ACA; and
  • Provide $138 billion over 10 years in federal funding for state programs intended to help stabilize and reduce health insurance premiums in the non-group market.

Next week, Deloitte will produce a detailed summary of the AHCA as amended and passed by the House.

Continue reading “House approves bill to replace key provisions of the Affordable Care Act; All eyes turn to the Senate”

Amidst ongoing debate over future of ACA Exchanges, CMS finalizes rule for 2018 and a timeline for submission of plans

The Centers for Medicare and Medicaid Services (CMS) last week released a final rule on the 2018 benefit year for Exchanges established under the Affordable Care Act (ACA), as well as a final timeline for health insurers to submit products for federally-facilitated Exchanges and other tools plans will need to submit products for ACA Exchanges for 2018. Notably, the final rule was published in the Federal Register on the same day that health insurers met with CMS Administrator Seema Verma and other Administration officials about the ACA Exchanges.

The final rule is intended to reduce volatility in the non-group and small group health insurance markets, and it finalizes with few changes policies included in a proposed rule published in the Federal Register on February 17, 2017. The final rule was published in the Federal Register on Tuesday, April 18, 2017, and its provisions take effect June 19, 2017. The policies in the final rule include changes requested by health insurers in previous years.

Continue reading “Amidst ongoing debate over future of ACA Exchanges, CMS finalizes rule for 2018 and a timeline for submission of plans”

CY 2018 changes and policy updates for Medicare health and drug plans

Summary of provisions and impacts

The Centers for Medicare and Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Draft Call Letter on February 1, 2017.

The purpose of the Advance Notice and draft Call Letter was to notify Medicare Advantage Organizations (MAO) and Part D sponsors of proposed changes to the Part C and Part D programs for the following plan year, including but not limited to:

  • Planned changes in the MA capitation rate methodology and risk adjustment methodology applied under Part C for CY 2018
  • Proposed changes in the Part D payment methodology for CY 2018
  • Proposed changes to the quality rating system and information the MAOs and Part D sponsors should consider while preparing their 2018 bids

CMS received many submissions in response to the request for comments on the Advance Notice and released final updates to MA and Part D Prescription Drug Programs for 2018 on April 3, 2017.
Continue reading “CY 2018 changes and policy updates for Medicare health and drug plans”

FRB finalizes public disclosure requirement for LCR

Introduction

On December 19, 2016, the Federal Reserve Board (FRB) finalized a rule requiring covered institutions to publicly disclose their Liquidity Coverage Ratio (LCR), including quantitative and qualitative information underlying the LCR.1 Relative to the proposal, the final rule did not revise the reporting frequency or quantitative data requirements.   However, it did amend the qualitative information requirements.

Continue reading “FRB finalizes public disclosure requirement for LCR”