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Lauren Moldawer is an Associate in the firm’s Washington, DC office. She counsels health care providers, PBMs, and managed care organizations on regulatory issues. Lauren is admitted to practice in New Jersey and is practicing under the supervision and guidance of Members in the DC office. Before joining Mintz Levin, Lauren was with the Centers for Medicare & Medicaid Services in the Medicare-Medicaid Coordination Office, where she worked with states and health plans implementing the Financial Alignment Demonstration.

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.  Last month, the Health Care Leadership Council released a White Paper entitled “Health System Transformation: Revisiting the Federal Anti-Kickback Statute and Physician Self-Referral (“Stark”) Law to Foster Integrated Care Delivery and Payment Models” (“HCL White Paper”), identifying current fraud and abuse laws as impeding transformation of the healthcare system.  Pharmaceutical and device manufacturers have also taken advantage of the OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts (“OIG Solicitation”) to advocate for more flexible fraud and abuse laws with respect to value-based arrangements. Continue Reading Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”).  For the majority of the letter’s provisions, CMS is proposing to continue its current course of action and is refraining from introducing new policies.  With that said, however, CMS is proposing several notable updates, including updates to the use of encounter data for risk adjustment and the 2018 Star Ratings.  This blog is to highlight some key provisions and changes as MA and Part D plans prepare and finalize comments.

Continue Reading CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies

Next Tuesday, January 12th, Mintz Levin and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.

Join my Mintz Levin and ML Strategies colleagues Tom CraneEllen Janos, and Rodney Whitlock, and moderator Bethany Hills, as they provide an introduction to the Cures Act.  Specific topics for this first webinar will include:

  • The political path taken to accomplish the Act, the compromises made, and the key implementation issues facing the Trump administration
  • Health information policies related to Electronic Health Records
  • Medicare delivery reform, coverage/payment changes, and OIG authorities
  • Mental health parity and new funding opportunities for substance use disorder prevention and improved mental health access and services
  • The “sense of Congress” on telehealth expansion and changes to HIPAA

Click here to register!  For more information on the Cures Act check out our prior blog posts covering provisions related to: (i) the role of Real World Evidence; (ii) the accelerated approval pathway for regenerative medicine; and (iii) drug and biologic manufacturers’ ability to promote their products to payors and health plans through well-developed “health care economic information.

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

The demonstration was intended to test new reimbursement methods for Medicare Part B drugs and to promote value-based and cost-effective drug purchasing.  Despite its intentions, major patient, pharmaceutical, and physician groups criticized the scope of the rule and the speed in which CMS was implementing it.  Many worried it would restrict or limit access to certain drugs.  It also drew sharp criticism from several members of Congress, including President-elect’s nominee for the Secretary of Health and Human Services, Rep. Tom Price. Continue Reading The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016.  As we await the release of the final rule, the fate of this demonstration will be in the hands of a Republican-held Congress and President-Elect Trump.  To move forward, not only will CMMI need to finalize the implementing regulations, but the Part B payment demonstration will also need to survive review under the Congressional Review Act (CRA). Continue Reading The Future of the Medicare Part B Payment Demo under a Republican-held Congress

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.

The ACA created CMMI to test innovative payment and service delivery models to reduce program expenditures and improve care.  To carry out this goal, the ACA allows CMMI to waive any Medicare provision of the Social Security Act, as well as select Medicaid provisions, that may be necessary to carry out and evaluate demonstration policies.  If the demonstrations prove effective, CMS may implement the program nationally.

Over the past few years, CMS has implemented numerous demonstration projects under CMMI’s authority.  These include delivery reform demonstrations such as the Medicare Shared Savings Program and Pioneer ACO program, as well as the Financial Alignment Initiative, which integrates care for dual-eligible individuals in select states. Demonstrations such as the Medicare Advantage Value-Based Insurance Design Model have focused on encouraging the use of high-value clinical services, while others, such as the Diabetes Prevention Program, have focused on preventive service models.  In July of this year, CMS proposed expanding the Diabetes Prevention Program nationally.

While there have been successes, CMS’s use of this authority has not been without controversy and criticism.  Continue Reading Will Republicans Embrace CMMI’s Authority?

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”).  The Protocols have been updated based on the over 500 comments CMS received in response to the draft released in June.  The Protocols are open for comments until December 5, 2016.

A review of the crosswalk detailing the changes made to 2016’s Audit Protocols and Data Requests shows that CMS largely retained the same elements as in years past and made a few notable changes.

  • CMS is no longer asking for “self-identified issues.”  Self-identified issues were issues that had been discovered by the plan but not reported to CMS prior to the audit.  Practically speaking, this now means that plans only receive “credit” for reporting issues to CMS, whereas previously plans received some favorable treatment for reporting self-identified issues through the audit.
  • CMS added language to provide plans more instruction regarding what documentation and detail expected for tracer cases.
  • The Protocols added more emphasis on fraud, waste, and abuse policies and operations as applied to a plan’s first tier, downstream and related entities (“FDR”).
  • The Protocols asked plans in multiple areas to identify whether they classify actions as compliance or FWA.
  • CMS modified (edited, deleted, and added) many questions that appear in the Protocols questionnaires.  Some changes include:
    • Providing more detail to plans about what should be produced when conducting a formal audit under the plan’s compliance program.
    • Asking for examples of issues the plan had to deal with that involved an FDR and impacted a significant number of enrollees.
    • Asking for an example of when communicating compliance issues to the senior management/governing body was challenging.
    • Asking for a plan to share best practices.

All plans should carefully review the Protocols, consider how they would perform under the updated structure, and consider how they would update their internal audit and monitoring activities to reflect changes that CMS is considering.  As all plans know, undergoing a CMS audit requires an enormous amount of time and resources and CMS’s audit findings can greatly impact plans in many ways, including how a plan performs in the Star ratings system.

Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019.  Under the Medicare Part D Prescriber Requirements, Medicare Advantage and Part D plans must deny coverage of drugs prescribed by providers who are not enrolled in Medicare or who have not validly opted out of Medicare (except under limited circumstances).  This represents the third delay since the requirements were finalized.

In an HPMS memo addressed to Part D Sponsors, CMS stated that this delay is in recognition of the need to minimize disruption to beneficiaries and to ensure that they have continued access to the care they need.  It also provides Part D sponsors, their pharmacy benefit managers, and Medicare Advantage plans “sufficient time” to finalize system enhancements necessary to comply with these requirements.  Continue Reading CMS Delays Enforcement of Part D Prescriber Enrollment Requirements

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”).  This much anticipated rule represents the first major update of these regulations in 25 years – setting new staffing, patient protections, and compliance requirements for LTC facilities.  CMS estimates that these changes will not necessarily be inexpensive for facilities, costing an average of $62,900 per facility in the first year and $55,000 in each subsequent year.  In response to the estimated financial burden and the complexity of the Final Rule, CMS has adopted a phased approach for the rollout, spreading out implementation of the various requirements over the next three years.  The implementation dates are November 28, 2016 for Phase 1, November 28, 2017 for Phase 2, and November 28, 2018 for Phase 3.  The three phases have been categorized based on CMS’s assessment of each revision’s complexity and the extent to which interpretive guidance and survey processes will need to be revised.

We highlight key provisions of the Final Rule below:

Prohibition against Pre-Dispute Binding Arbitration Agreements

In an effort to strengthen resident rights, under the Final Rule, CMS will prohibit LTC facilities from entering into pre-dispute binding arbitration agreements with residents or their legal representatives.  While the initial Proposed Rule set forth specific criteria to be met by LTC providers seeking to make use of pre-dispute binding arbitration agreements, the Final Rule bans them altogether.  CMS cites doubts about residents’ ability to understand the implications of such agreements as well as concerns about the arbitration process in general.  In response to comments regarding CMS’s legal authority to ban arbitration agreements, the agency clarified that the Final Rule would have no effect on existing pre-dispute arbitration agreements between LTC facilities and residents, and that any such existing agreements could still be enforced.  The prohibition against pre-dispute binding arbitration agreements is included in Phase 1. Continue Reading CMS releases Final Rule Overhauling Long-Term Care Facility Requirements

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years.  With several insurers withdrawing from the Marketplace and others still threatening their departure, CMS is releasing this proposed Notice nearly two months early with significant proposals seeking to strengthen the program.

At the core of CMS’s proposals to strengthen the Marketplace are updates to the HHS risk adjustment model and methodology.  Specifically, CMS is proposing: (1) an adjustment for members who are only enrolled for part of the year; (2) the inclusion of select prescription drug utilization data in the risk adjustment model; and (3) modifications to establish transfers for costs associated with high-cost enrollees so a portion of the costs exceeding $2 million for an individual would be shared among all issuers. Continue Reading 2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model