Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate.  Continue Reading CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud.  I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with colleagues from all sides of the aisle.  And I always come away with a few nuggets to share with those who did not attend.

Here are my seven top takeaways from this year’s Institute. Continue Reading Seven Takeaways from the ABA National Institute On Health Care Fraud

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an allegation that the Clinic violated the Stark Law by compensating twelve Clinic physicians in a manner that took into account the volume and value of the physicians’ referrals to the Hospital’s infusion center.  The U.S. contended that the defendants’ Stark Law violations caused their reimbursement claims to Medicare for infusion services to violate the False Claims Act. Continue Reading Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated the Stark Law

On May 23, the White House released its 2018 budget proposal, outlining its priorities for the upcoming fiscal year. In health care, the President has proposed cuts to several agencies and programs. The Administration’s annual budget is seen as a statement of policy, not necessarily a legislative proposal certain to become law. That said, ML Strategies has summarized the highlights from the Health and Human Services Budget that are worth monitoring as Congress begins its work on the FY 2018 budget.  The summary is available here. ML Strategies will continue its coverage here of ongoing health care issues on Capitol Hill that will need to be addressed later this year, such as the FY18 budget and the Health Care Minibus.

Our ML Strategies colleagues have published a preview for another big week in health care. The American Health Care Act (AHCA) continues to be a big story as the Senate works on its version. This week we watch for updates on these items and how they might impact AHCA discussions:

  1. Cost-sharing reductions (CSRs) litigation on Monday
  2. President Trump’s anticipated budget proposal on Tuesday
  3. The Congressional Budget Office (CBO) score on the House AHCA on Wednesday
  4. Scheduled hearings in the House and Senate on Tuesday (Zika response), Wednesday (FY 2018 budget) and Thursday (budget proposals for Treasury and Tax Reform)

Despite reports last Friday that President Trump may seek to stop the CSRs paid to insurers, on Monday the Administration requested another 90 day extension in the House v. Price case. In a joint filing, the House and the Department of Justice requested the extension as they consider measures that might remove the need for the payments, including legislation to repeal the Affordable Care Act.

On Tuesday, President Trump’s budget proposal will be released. We anticipate major cuts to Medicaid, and to supplemental income and nutritional assistance programs. Then on Wednesday, the CBO will release its score of the AHCA. We don’t anticipate major changes from the original results, but stay tuned for updates.

We will continue to monitor each of these items. Stay tuned for additional coverage on this blog at https://www.healthlawpolicymatters.com/

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

The current policy requires all biosimilars that are related to a reference product to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. Continue Reading CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline.

Each year, CMS releases Proposed Part D DIR Reporting Requirements for interested parties to review and comment on. The DIR Reporting Requirements tend to change slightly from year-to-year as the Part D program has developed and CMS gains further understanding of rebates and price concessions that a Part D plan sponsor may receive or pay.  Additionally, some changes in DIR Reporting Requirements are the result of changes to Part D regulations.  After reviewing the comments, CMS publishes the Final Part D DIR Reporting Requirements, typically in late May, and then plan sponsors submit their DIR Report by June 30th.

These Proposed DIR Reporting Requirements are the first that reflect the change in the definition of “negotiated prices” as set forth at 42 C.F.R. § 423.100. Although the discussion regarding changing the definition of negotiated prices started multiple years ago and was finalized in 2014, the change was not effective until January 1, 2016.  CMS’s proposed changes related to the updated definition of negotiated prices are captured in Summary DIR Report columns DIR #8 and DIR #9.

The deadline for submitting comments is June 2, 2017.

Typically, Part D plan sponsors must submit their DIR reports to CMS by June 30th of the year following the close of the plan year (June 30, 2017 for 2016 DIR).  CMS is postponing the deadline for 2016 DIR submission so that it has time to review the comments it receives and so that Part D plan sponsors have adequate time to analyze and categorize their data in the manner required by the upcoming Final Part D DIR Reporting Requirements.  CMS will announce the 2016 DIR submission deadline in the Final Part D DIR Reporting Requirements for 2016 and it appears that plan sponsors will have approximately 30 days to analyze and categorize their data.

Press ReleaseThe U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit health system in southeast Texas.  Memorial Hermann agreed to pay $2.4 million and to comply with a corrective action plan after publicly disclosing a patient’s name in the title of a press release regarding an incident at one of its clinics.  In a week that has been filled with high-tech cybersecurity issues (see our recent blog posts on the WannaCry attack here and here), this settlement is a good reminder of HIPAA obligations unrelated to technology.

Continue Reading Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

Our ML Strategies colleagues, Eli GreenspanKatie Weider, and Rodney Whitlock, have published a new edition of the Health Care Weekly Preview.

This edition covers upcoming hearings in the House, including one before the House Ways & Means Committee regarding expiring Medicare programs, as well as changes to Medicare’s payment system.  It also covers an upcoming hearing before the Senate Finance Committee regarding The (CHRONIC) Care Act of 2017, which has been co-sponsored by Democrats and Republicans.

The ML Strategies team also comments on the possibility of a bipartisan bill designed to fix the Affordable Care Act.

Click HERE to read this week’s edition and stay tuned for additional Previews!

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.  The committee voted almost unanimously to move the bipartisan bill forward, with only Senator Bernie Sanders (I-Vt.) and Senator Rand Paul (R-Ky.) voting against it.  And in an interesting overlap of FDA-related news, the Agency’s brand-new Commissioner, Dr. Scott Gottlieb, was also sworn in on May 11th following a speedy (albeit politically controversial and party-line) confirmation process and Senate vote.  With less than a week on the job, Dr. Gottlieb is already receiving pressure from varied stakeholders to ensure the user fee legislation is enacted in a timely manner in order to avoid disrupting the Agency’s work. Continue Reading FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board