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Health Headlines – April 3, 2017


03 Apr 2017
NEWSLETTER

CMS Announces New Standardized Voluntary Self-Referral Disclosure Protocol Forms - On March 27, 2017, CMS posted a new set of standardized forms for disclosure of potential violations of the Stark Law under the Self-Referral Disclosure Protocol (“SRDP”).  The forms instruct disclosing entities to follow certain new requirements, including requirements to update CMS upon certain changes to the disclosing entity and to file separate disclosures for each Medicare-enrolled entity.  The new forms obligate disclosing entities to fill in information into the blank fields of a pdf file in order to standardize SRDP submissions.  Many of the fields are prefaced with detailed discussion of the information that should be included in the submission based on the type of noncompliance that is being disclosed.  The new forms will become mandatory on June 1, 2017. 

The SRDP is a process that enables providers to self-disclose actual or potential violations of the federal physician self-referral statute commonly referred to as the “Stark Law.”  The SRDP was created in 2010 by section 6409 of the Affordable Care Act. 

The previous version of the SRDP guidance (now identified by CMS as “retired”) required the inclusion of certain information in each submission, without the use of a standardized submission form.  The new set of forms standardizes the submission process by providing a single pdf file with blank fields to be completed by the disclosing party. 

The new set of forms includes four mandatory components:

  • SRDP Disclosure Form.  This form contains information about the disclosing party, including any history of abuse, pervasiveness of noncompliance, and steps to prevent future noncompliance.
  • Physician Information Form.  This form, which must be submitted for each physician included in the disclosure, requires details regarding the noncompliant financial relationship between the physician and the disclosing party.
  • Financial Analysis Worksheet.  This worksheet quantifies the overpayment for each physician included in the disclosure who made referrals in violation of the Stark Law.  The worksheet must be submitted in Microsoft Excel-compatible format.
  • Certification.  A certification must be signed by the disclosing party or, in the case of an entity, its chief executive officer, chief financial officer, or another authorized individual.

In addition to these four mandatory components, the disclosing party may submit a cover letter containing any additional information that is relevant to CMS’s evaluation of the disclosure.

The forms are intended to provide a more detailed discussion regarding the information that is sought by CMS.  As a new obligation, the forms require the disclosing party to inform CMS by email within 30 days of the occurrence of the following changes to the disclosing party: filing for bankruptcy, undergoing a change of ownership, or changing the designated representative.  Additionally, CMS instructs in the forms that, if multiple entities from a single network or system are involved, each entity that is separately enrolled in Medicare must submit a separate disclosure. 

The new SRDP forms are available here.

Reporter, Igor Gorlach, Houston, +1 713 276 7326, igorlach@kslaw.com.

Upcoming Cost Report Filings for FYE 12/31/2016 Subject to More Stringent Rules Prohibiting Payment of Items that Are not Claimed or Protested  – The CY 2016 OPPS Final Rule, issued on October 30, 2015, instituted new cost reporting rules prohibiting MACs from paying items that a provider has not claimed or protested on its as-filed cost report.  Importantly, these changes apply to cost reporting periods beginning on or after January 1, 2016, i.e., to cost reporting periods ending on or after December 31, 2016.  As the cost reports for FYE December 31, 2016 are due to be filed in the coming weeks, the purpose of this article is to remind providers of the increased need to ensure that all applicable items are either claimed or protested on those cost reports. 

For a full discussion of the Final Rule, please reference a previous Health Headlines report here. Notably, in the Final Rule, CMS finalized revisions to the cost reporting rules requiring providers to include an appropriate claim for a specific item on their cost reports – either by affirmatively claiming reimbursement or expressly self-disallowing the cost by filing a cost report item under protest – to be eligible to potentially receive Medicare reimbursement.  In other words, the so-called “protest requirement” has effectively gone from being a condition for Provider Reimbursement Review Board (PRRB) jurisdiction to a condition of payment altogether.  While the PRRB will now have jurisdiction to hear appeals of items that have not been claimed or protested, the PRRB will presumably find in favor of the MAC in such situations since the PRRB is bound by CMS regulations and the condition of payment has not been met.   

One important but not necessarily obvious consequence of CMS’s rule change is that providers will no longer be able to avoid CMS’s protest requirement by filing appeals when their notices of program reimbursement (NPRs) have not been issued within 12 months of the filing of their cost reports. 

Since upcoming cost report filings for FYE December 31, 2016 are the first to fall under these new rules, providers should make extra efforts to ensure that those and future cost reports are 100 percent accurate and that every appropriate item is either claimed or protested.   Providers should also consider including a “catch-all” protest item on their cost reports to help insure against unfair disallowances later. 

The Final Rule is available here (see 80 Fed. Reg. at 70552-70564).

Reporters, Daniel Hettich, Washington D.C., +1 202 626 9128, dhettich@kslaw.com and Lauren Gennett, Atlanta, + 1 404 572 3592, lgennett@kslaw.com.

OIG Releases “Resource Guide” Regarding Measuring Compliance Program Effectiveness –  On March 27, 2017, in conjunction with the Health Care Compliance Association annual Compliance Institute, HHS OIG released a Resource Guide for the healthcare industry to facilitate the consideration of potential options for benchmarking and measuring the effectiveness of various key elements of corporate compliance programs.  The Resource Guide was released on the same day that HHS Inspector General Daniel Levinson, the longest tenured HHS inspector general, delivered the keynote address which similarly focused on Compliance 2.0 and the agency’s renewed focus on compliance program maturation and effectiveness.  The Resource Guide, titled Measuring Compliance Program Effectiveness: A Resource Guide, was developed in follow up to an important roundtable on January 17, 2017, which included seasoned compliance representatives from the OIG and industry (including providers, suppliers, and payors). The purpose of the January roundtable was for industry representatives and the OIG to confer about the expectations and strategies being employed to actively assess and gauge whether a compliance program is functioning well and growing.

The purpose of the Resource Guide is to provide examples of potential approaches to measuring the effectiveness of certain elements of a compliance program for organizations of varying size, operational complexity, and resources.  Importantly, “the purpose of this [Resource Guide] is to give health care organizations as many ideas as possible, be broad enough to help any type of organization, and let the organization choose which ones best suit its needs.”  However, the Resource Guide makes clear that this list is not a “checklist” that should be “applied wholesale to assess a compliance program.”  The Resource Guide further acknowledges the impracticality of using all or even a large number of the measurement options outlined.

The Resource Guide is structured to provide tools regarding both “what to measure” and “how to measure” with respect to the following seven elements of a compliance program first established by the U.S. Sentencing Guidelines Manual:  

  1. Standards, Policies, and Procedures
  2. Compliance Program Administration
  3. Screening and Evaluation of Employees, Physicians, Vendors, and other Agents
  4. Communication, Education, and Training on Compliance Issues
  5. Monitoring, Auditing, and Internal Reporting Systems
  6. Discipline for Non-Compliance
  7. Investigations and Remedial Measures

The Resource Guide focuses on, among other things:

  • Compliance Culture
  • Individual Accountability
  • Risk Assessments
  • Self-Disclosure
  • Oversight of Third Parties

The focal points in the Resource Guide are of no surprise given the U.S. Department of Justice’s current priorities. The Resource Guide is available here.

Reporters, Sara Kay Wheeler, Atlanta, +1 404 572 4685, skwheeler@kslaw.com, and

Stephanie F. Johnson, Atlanta, +1 404 572 4629, sfjohnson@kslaw.com.

Senate Finance Committee May Tackle Medicare Appeals Backlog – According to Kimberly Brandt, Chief Oversight Counsel for the Senate Finance Committee’s majority staff, the Senate Finance Committee could reintroduce the Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2015 (AFIRM Act), which is intended to address the Medicare appeals backlog.  Ms. Brandt offered this insight at the Health Care Compliance Association’s Compliance Institute in Washington, D.C. on March 28, 2017.

The AFIRM Act was originally introduced on December 9, 2015, by Senate Finance Committee Chairman, Orrin Hatch (R-Utah) and Ranking Member, Ron Wyden (D-Ore).  It would have appropriated an additional $127 million annually to clearing the Medicare appeals backlog, with an additional $125 million going to the Office of Medicare Hearings and Appeals (OMHA) and $2 million to the Departmental Appeals Board (DAB). 

It also would have created new Medicare magistrate positions within OMHA to handle reviews with amounts in controversy between $150 and $1,500 and reserved reviews with amounts in controversy greater than $1,500 for administrative law judges (ALJs). The AFIRM Act, notably, would also have created a process whereby an ALJ could certify an appeal for expedited judicial review where there are no material issues of fact in dispute and neither the ALJ nor the DAB has the authority to decide the questions of law or regulation presented.

According to Ms. Brandt, the Committee could also introduce legislation that would amend the Stark Law by the end of 2017.  Senator Hatch previously released a white paper addressing Stark Law reform on June 30, 2016, and the Committee held a hearing to discuss potential changes to the Stark Law following the white paper’s release.  

A copy of the AFIRM Act introduced in 2015 is available here, and a copy of the white paper is available here.

Reporter, Kate Stern, Atlanta, +1 404 572 4661, kstern@kslaw.com.

National Academy of Medicine Issues Discussion Paper on Healthcare Reform – On March 21, 2017, the National Academy of Medicine (NAM) released a discussion paper entitled Vital Directions for Health and Health Care Priorities from a National Academy of Medicine Initiative.  The discussion paper identifies eight “vital directions” to advance healthcare policy.  The report was the subject of a recent column by David Ignatius of The Washington Post, available here

This discussion paper is the culmination of an initiative launched by NAM to determine a set of healthcare policy directions that could address concerns over inefficiencies, costs, and inequities in healthcare delivery.  In 2016, NAM convened a bipartisan steering committee and 19 working groups to analyze policy issues impacting the U.S. healthcare system and infrastructure.  The eight vital directions identified in this discussion paper were the elements common across the nineteen working groups.

The discussion paper divides the eight vital directions into four “action priorities” and four “essential infrastructure needs.”  The action priorities address “the greatest contributors to deficiencies” in the healthcare system but are likely to result in the greatest impact and progress.  The four action priorities are:

  • “Pay for value – deliver better health and better results for all”;
  • “Empower people – democratize action for health”;
  • “Activate communities – collaborate to mobilize resources for health progress”; and
  • “Connect care – implement seamless digital interfaces for best care.”

According to the discussion paper, the four essential infrastructure needs are the necessary underpinnings that will help “strengthen the impact” and “ensure the success” of the action priorities.  The essential infrastructure needs are: 

  • “Measure what matters most – use consistent core metrics to sharpen focus and performance”;
  • “Modernize skills – train the workforce for 21st century health care and biomedical science”;
  • “Accelerate real-world evidence – derive evidence from each core experience”; and
  • “Advance science – forge innovation-ready clinical research processes and partnerships.”

Additional information and resources related to this initiative can be found here.

Reporter, Brittany Strandell, Atlanta, +1 404 572 2796, bstrandell@kslaw.com

ALSO IN THE NEWS 

Upcoming Webinar on Managed Care Contracting for Pharmaceutical Companies – Please join us on Thursday, April 6, 2017 12:00 p.m. to 1:00 pm ET for Managed Care Contracting Risks: An Antitrust, Government Pricing, and Fraud and Abuse Analysis. This Webinar will take an inter-disciplinary approach to evaluating the legal risks associated with managed care contracting by pharmaceutical companies and provides practical advice regarding antitrust laws, government pricing laws, and fraud and abuse laws. More information is available here. 

King & Spalding Roundtable on Compliance Enforcement and Post-Acute Care Providers – Please join us for on Wednesday April 19, 2017 from 1:00 p.m. to 2:30 p.m. ET for a Roundtable webinar that will explore recent enforcement trends and current industry scrutiny on post-acute providers, including hospice, home health, inpatient rehabilitation facility, and skilled nursing providers. In addition, this webinar will also highlight strategies for providers to consider in order to manage risk proactively and promote compliance with federal healthcare program requirements.  There is no charge to participate.  Please register here. 

King & Spalding’s 2017 Cybersecurity & Privacy Summit – On Monday, April 24, 2017, make plans to join the cybersecurity and privacy experts from King & Spalding and PwC, as well as representatives from the U.S. Department of Justice, the Federal Trade Commission, Georgia Institute of Technology, The Home Depot, and TSYS, to learn about the latest strategies for protecting your company against the legal and financial risks of cybersecurity breaches and other privacy incidents. Click here for more information regarding session topics and featured speakers.

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