On October 15, 2018, the Centers for Medicare & Medicare Services (“CMS”) in the Department for Health and Human Services proposed a rule to require prescription drug manufacturers to post the Wholesale Acquisition Cost (“WAC”) for drugs and biological products covered by Medicare or Medicaid in direct-to-consumer television advertisements. The WAC reflects the manufacturer’s list price for a drug to direct purchasers, not inclusive of any discounts or rebates. CMS is proposing this rule in the context of broadcast advertisements, an area in which the Supreme Court has recognized that the government may take special steps to help ensure that viewers receive appropriate information.[1]

CMS stated that 47 percent of Americans have high-deductible health plans and that many patients may pay the list price of the drug until they meet their deductible. The proposed rule aims to provide greater transparency into the prices charged by prescription drug manufacturers. The theory is that markets operate more efficiently with greater transparency, and that increased exposure of the list price will also provide a moderating force to discourage price increases. While wholesale prices do not equate to the patient’s out-of-pocket obligation, CMS asserts that benefit designs are impacted by WACs, and patients in high-deductible plans may pay the full list price until meeting their deductible – thus, the WAC may still be relevant to many patient and impact their decisions and market dynamics. The price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a thirty day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad and would not apply where the list price for a thirty day supply or typical course of treatment of a prescription drug was less than $35.

Overall, the agency has taken action designed to promote transparency in healthcare this year. In the drug pricing arena, CMS released a redesigned version of the Drug Spending Dashboards which identifies manufacturers that have increased their prices, along with year-over-year information on drug prices. Outside of the drug pricing space, CMS recently launched the eMedicare initiative to allow customers to find and compare Medicare coverage options and quickly see estimates on what the coverage would cost, among other features. CMS has also included requests for information on cost transparency and expanded patient access to data in recent payment rules, and is expected to propose more new policies in an upcoming regulation currently under OMB review.

CMS’s proposal is part of an ongoing effort by the Trump administration to bring down prescription drug prices and out-of-pocket costs, as signaled by the release in May of American Patients First, the administration’s drug pricing blueprint. This is also the latest in a series of steps focused on increasing data access and price transparency in healthcare. Although Congress was not successful in its attempt to address direct-to-consumer advertising this summer through a provision that would have allocated $1 million to the Food and Drug Administration to implement regulations requiring drug companies to list their prices in TV ads, Congress passed and the President signed into law legislation to improve transparency and lower health care costs for patients across the country. This law effectively paves the way for pharmacists to advise their patients on the cost of various medications and different payment methods, free from restrictions imposed by take-it-or-leave-it contracts with insurers.

In the present proposal CMS seeks public feedback on a variety of questions, including:

  • How providing consumers with the list price of a medication may influence interactions with prescribers, the selection of drug products, and the perceived efficacy of the prescribed drug.
  • How benefit design influences these choices.
  • Whether compliance with rule should be a condition of payment by a federal health care program.
  • Whether WAC is the amount that best reflects the “list price” for the stated purposes of price transparency and comparison shopping
  • Whether 30-day supply and typical course of treatment are appropriate metrics for a consumer to gauge the cost of the drug.
  • How to treat an advertised drug that must be used in combination with another non-advertised drug or device.
  • Whether the cost threshold of $35 to be exempt from compliance with this rule is the appropriate level and metric for such an exemption.
  • Whether rule should be extended to advertisements in other media forms, including radio, magazines, websites, etc.

This rulemaking presents a major opportunity for pharmaceutical companies, insurers, and patients alike to make their voices heard in an area that is critically important. Electronic comments can be submitted until December 17, 2018. For further assistance, please contact Jodi Daniel (jdaniel@crowell.com), Barbara Ryland (bryland@crowell.com), and Maya Uppaluru (muppaluru@crowell.com).

[1] See Red Lion Broad. Co. v. FCC, 395 U.S. 367, 390, 394 (1969) (“It is the right of the viewers and listeners, not the right of the broadcasters, which is paramount.”)

On October 3rd, the United States Senate passed a bipartisan opioids package with a sweeping vote of 98 to 1, after the U.S. House of Representatives passed the final version of the bill with a vote of 393 to 8. One of its components, the “Fighting the Opioid Epidemic with Sunshine Act,” expands the scope of reporting requirements under the Physician Payment Sunshine Act (known as the “Sunshine Act”), which will have immense implications for the pharmaceutical and medical device and supply industries.

Enacted at section 6002 of the Affordable Care Act in 2010 to increase transparency around the financial relationships between health care providers and drug manufacturers, the Sunshine Act requires “applicable group purchasing organizations” and “applicable manufacturers,” including pharmaceutical and medical device or supply companies with operations in the United States, to track and report payments and transfers of value that they make to “covered recipients,” currently defined to include physicians and teaching hospitals. These transfers of value include items such as consulting fees, honoraria for speaking events, and research grants.

The opioids legislation package expands the definition of “covered recipients” to include other types of health care professionals: physician assistants, nurse practitioners, clinical nurse specialists, registered nurse anesthetists, and certified nurse midwives. The new legislation additionally sunsets a prohibition in the Sunshine Act that prevents the inclusion of the National Provider Identifier on the CMS Open Payments website.

Given the Administration’s focus on the opioid crisis, identified as a “national emergency,” the expansion of the Sunshine Act reflects the reality that prescriptions of opioids and other drugs to individuals may come from health professionals who are not physicians. State “sunshine laws” that imposed reporting requirements on payments to these professionals have existed for a number of years, but the changes passed in the opioids package would make this standard the baseline for reporting covered payments nationwide. By the time these changes would be effective on January 1, 2022, applicable group purchasing organizations and manufacturers will need to update their Sunshine Act compliance and monitoring activities to account for the greatly enlarged scope of individual health care professionals to whom they may be providing direct or indirect transfers of value.

The expansion of the Sunshine Act’s covered recipient definition was introduced in the Senate version of the opioids package, and remained in the overall legislation despite vigorous opposition. To become law, the bill requires the signature of President Trump.

Federal agencies are signaling closer oversight of Medicaid managed care organizations (“MCOs”). On August 21, 2018, the U.S. Comptroller General Gene Dodaro and Centers for Medicare and Medicaid Services (“CMS”) Administrator Seema Verma testified to the Senate Homeland Security and Governmental Affairs Committee about combating Medicaid fraud and urged additional oversight of Medicaid MCOs and a larger restructuring of the Medicaid program. This testimony follows other steps taken by the Governmental Accountability Office (“GAO”) and CMS earlier this year to encourage increased scrutiny of Medicaid managed care programs.

GAO Reports Recommend Improved Oversight

           Over the past few months, GAO has released several reports focused on program integrity issues in Medicaid and urging increased oversight, including in the managed care context.

           In May, the GAO released the results of a study it conducted to determine whether the methodology used by CMS to calculate program integrity risks adequately measured the risks in the Medicaid managed care context. Using the Payment Error Rate Measurement (“PERM”) methodology, CMS had estimated that $37 billion in improper Medicaid payments were made in fiscal year 2017, equaling about 10.1 percent of the $364 billion in federal spending on Medicaid. For Medicaid managed care, which constitutes about half of total federal Medicaid expenditures, the improper payment rate determined under the PERM methodology was only 0.3 percent ($500 million in improper payments out of $171 billion in expenditures). In its study, the GAO found that the PERM methodology may not account for key program integrity risks such as unidentified overpayments and unallowable costs. GAO recommended that CMS take steps to mitigate program risks not measured in the PERM, consider revising the PERM methodology, or focus additional audit resources on managed care.

           In July, GAO released another report analyzing payment risks in Medicaid managed care, based on interviews with state program integrity stakeholders in ten states. The study identified six payment risks, four of which relate to the payments made by Medicaid agencies to MCOs and two of which relate to payments by MCOs to providers. The report identified two of the payment risks as being the most significant: (1) incorrect fee-for-service payments from managed care organizations to providers, and (2) inaccurate state payments to managed care organizations due to payments being determined on incorrect data. GAO recommended that CMS expedite planned guidance on Medicaid managed care program integrity, address impediments to managed care audits, and ensure that states account for overpayments when setting future capitation rates.

           The GAO has also released several other reports on Medicaid program integrity not specific to managed care. For instance, in June, GAO released a report highlighting the major program integrity risks for the Medicaid program generally. In August, GAO released reports assessing CMS’s oversight of state-reported Medicaid expenditures and recommending additional actions CMS could take to improve oversight of Medicaid.

CMS Increases Oversight

           CMS has taken steps to increase overall Medicaid program integrity oversight. On June 26, 2018, CMS announced several new initiatives and increased emphasis on existing initiatives intended to improve Medicaid program integrity and maintain sustainability of the program. In its press release on the initiatives, CMS noted that Medicaid spending has rapidly increased over recent years due to several factors, with specific mention of the Medicaid expansion. Three of the main initiatives aim to

  1. Emphasize program integrity in audits of state claims for federal match funds and medical loss ratios (MLRs).
  2. Conduct new audits of state beneficiary eligibility determinations.
  3. Optimize state-provided claims and provider data.

The initiatives enhance audit functions, oversight of state contracts with private payers, beneficiary eligibility oversight, and enforcement of state compliance.

Senate Testimony

           On August 21, 2018, Comptroller General Dodaro and Administrator Verma testified before the Senate Homeland Security and Governmental Affairs Committee on the topic of combatting Medicaid fraud. As committee members questioned Dodaro and Verma about oversight of Medicaid managed care programs, all parties appeared to support greater scrutiny.

           Notably, both Dodaro and Verma urged the senators to increase auditors’ review of managed care organizations. Administrator Verma specifically discussed a recent action by CMS to recoup an anticipated $9.5 billion in improper payments made by the State of California to managed care organization. Her written testimony echoed “concerns that managed care rates resulted in significant profits for insurance companies . . . .”

           Comptroller General Dodaro recommended that CMS utilize state auditors to reduce improper Medicaid payments and hold Medicaid programs accountable. He suggested that it would be a “game changer” to involve state auditors in a “substantive, ongoing way.” He noted that Medicaid is projected to cost the federal government and states nearly $1 trillion annually by 2025 and that the program accounts for one-third of many state budgets.

           Verma and Dodaro also directed particular criticism at the use of federal Medicaid funds on the Medicaid expansion population, as provided for under the Patient Protection and Affordable Care Act (the “ACA”). Dodaro criticized the Obama administration for not increasing oversight of Medicaid managed care plans upon the increased Medicaid enrollment caused by the expansion.

           In her testimony, Verma emphasized her support for structural changes to the Medicaid program, which she described as an “open-ended entitlement.” Administrator Verma attributed some of the government’s overspending to the high match rates that states receive for the Medicaid expansion population and urged for a new system that would make states accountable for outcomes. For example, she noted that the high match rate may have incentivized states to improperly keep pregnant women enrolled in the expansion population rather than appropriately transition them to traditional Medicaid when they become pregnant, as traditional Medicaid has a lower match rate.

           Overall, the committee members, Comptroller General Dodaro, and Administrator Verma all agreed that increased oversight is necessary under Medicaid managed care programs.

Conclusion

           Taken together, the reports, announcements, and testimony discussed here provide a clear signal from the Administration that Medicaid managed care is likely to become subject to increasing scrutiny. CMS and federal and state auditors have not yet taken significant concrete action, but MCOs may be well served to proactively evaluate and address program integrity risks related to their payments to providers and their premium rate payments from states.

Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation of a start-up, protection of intellectual property, FDA and product safety requirements, and how to commercialize a product through government and commercial reimbursement. Specifically, the bootcamp will feature the following presentations:

  • Building an Investible Health Tech Company;
  • IP Basics for Health Tech;
  • Navigating The Existing Regulatory and Product Safety Landscape In A New Digital World;
  • Healthcare Reimbursement:  Commercialization Strategies and Approaches; and
  • Adding Value: Managed Care Contracting Issues.

The bootcamp is a co-sponsored event with the Inova Center for Personalized Health (“ICPH”). Following the bootcamp, there will be a networking reception and panel presentation on the State of Heathcare Investing. For more information, contact a participant listed below or your regular Crowell & Moring contact.

Crowell & Moring Participants:

A. Xavier Baker

Troy A. Barsky

Lex Eley

Michael H. Jacobs

Lisa A. Adelson

Rebecca Baden Chaney

Joe Records

Roma Sharma

Maya Uppaluru

Chalana N. Williams

Danielle Winston

 

The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:

  1. Multi-Function Device Draft Guidance. FDA’s new draft guidance, “Multiple Function Device Products: Policy and Considerations,” explains the FDA’s regulatory approach to multi-function digital health devices—where some functionalities fall under the FDA’s definition of a medical device, and other functionalities do not. The guidance, mandated by the 21st Century Cures Act, provides examples in which the FDA will review certain functional software capabilities in a medical device. Consistent with previous guidance and risk-based frameworks from the FDA, the agency’s enforcement focus will be on medical device functions that diagnose and treat patients. For example, data analysis will be considered a device function for which the FDA would enforce compliance, but data tracking and trending will not.
  2. Software Precertification Pilot Program Expansion and “Pre-Cert 1.0” Roll-Out. Gottlieb outlined three updates to the Software Pre-Cert Pilot Program, originally announced last Fall. The FDA will hold a “user session” on May 10, 2018 to discuss the agency’s general progress on the pilot program, and to conduct an in-depth discussion of the three updates:
    • Draft Working Model – An initial framework and vision which outlines the program’s key components: Excellence Appraisal and Determining Precertification Level, Review Pathway Determination, Streamlined Premarket Review Process, and Monitoring Real-world Performance.
    • Challenge Questions – Key questions about various components of the Pre-Cert program for stakeholders to consider with regard to the areas outlined in the Draft Working Model.
    • Roadmap – An overview of the program’s milestones and timeline toward launching the first version of the program (“PreCert 1.0”).
  3. Expansion of Digital Health Tools for Drug Development. The FDA announced its intention to establish clear policies for integrating the review and validation of digital health tools into drug development programs. The FDA will publish a policy framework, through new guidance, and seek public input on the best practices to incorporate software intended for use with prescription drugs.
  4. Precertification Approach to Artificial Intelligence (AI). Gottlieb recognized the novel role that AI and machine learning can have on the medical device submission process (obviating the need to make multiple submissions) and new software validation tools. Gottlieb also discussed “employing the Pre-Cert approach to AI.” This suggests the FDA’s interest in a more effective approach to regulation of medical devices that use AI. This announcement expands upon the FDA’s brief mention of regulatory oversight of devices using “proprietary algorithms,” included in December’s Draft Clinical Decision Support and Patient Decision Support Guidance. (See our prior blog post analyzing the guidance.)
  5. Premarket Digital Safety Program Launch. Gottlieb announced the creation of a Premarket Digital Safety Program, which would allow for electronic submissions of premarket safety reports for an Investigational New Drug Application.
  6. Information Exchange and Data Transformation Incubator. Gottlieb announced the agency’s new digital health/technology incubator, to be known as the Information Exchange and Data Transformation (INFORMED). The incubator will initially be launched in the cancer context, with fellowship collaborations between the FDA and the National Cancer Institute, as well as with Harvard on AI and machine learning. Crowell & Moring’s Digital Health team is ready to assist with the submission of industry input, as well as strategic counseling on these issues.

The various initiatives, guidance, and calls for industry input reflect the FDA’s quest to be flexible in the face of digital health opportunity and innovation. Not only will the FDA’s newest initiatives support its quest to advance safe, patient-centered care, but these initiatives will provide the regulatory predictability critical to encouraging business investment in innovative technologies and products.

Crowell & Moring’s Digital Health team is ready to assist with the submission of industry input, as well as strategic counseling on these issues.

Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients.

Continue Reading The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

On March 22, 2018, the Centers for Medicare and Medicaid Services (CMS) announced a notice of proposed rulemaking (NPRM) that would, if finalized, exempt states with high rates of Medicaid beneficiaries in managed care plans from monitoring and reporting requirements related to Medicaid service access set forth in 42 C.F.R. §§ 447.203 and 447.204. The regulations currently require states to analyze and document the impact of Medicaid fee-for-service (FFS) payment amounts on beneficiary access to covered health care services in access monitoring review plans (AMRPs) submitted to CMS.

States’ AMRPs must, using a data-driven process, address the impact of Medicaid FFS payments on beneficiaries’ access to the following categories of Medicaid services: primary care services, physician specialist services, behavioral health services, pre- and post-natal obstetric services, and home health. The state must update and submit the AMRP related to these service categories to CMS at least every three years. If a state reduces Medicaid FFS rates for services outside of these categories, the state must include those additional services in the AMRP and publicly monitor the rate reductions for three years.

Since the adoption of these requirements, several states have complained that the scheme imposes an undue administrative burden and that it is not an efficient use of limited state program resources. In response, the proposed rule’s changes to the regulations would allow the following:

  • An exemption from most access monitoring requirements for states with an overall Medicaid managed care penetration rate of 85% or greater (currently, 17 States).
  • An exemption from the specific access analysis for reductions to provider payments below the “nominal payment rate change” of 4% in overall service category spending during a state fiscal year (and 6% over two consecutive years).
  • A state to submit an assurance that its baseline data “indicates current access is consistent with requirements of the Social Security Act,” rather than be required to predict the effects of proposed Medicaid FFS rate reductions or restructurings on access to care.

This NPRM aligns with the Trump Administration’s push to “cut the red tape” and to generally reduce states’ administrative burdens under federal programs. The proposed changes are also consistent with CMS’s other efforts to enable states to focus on patient outcomes rather than processes in administering their Medicaid programs, as quantified in the agency’s estimates that the proposed changes will eliminate 561 administrative hours and save a total of $1.66 million for the affected states.

Comments on the proposed rule are due to CMS no later than May 22, 2018.

Alex Azar assumed office as HHS Secretary on January 29, 2018, and has hit the ground running.  Among discussions on stabilization bills (see blog post discussion here and how these proposals further the Administration’s efforts on Trump’s Inauguration Day Executive Order here), Secretary Azar has been a vocal advocate for, in his own terms, “state experimentation” under both the Medicaid and health insurance exchanges (“Exchanges”).

Secretary Azar has not provided detail as to what type of experimentation he would like to see from states, but in his remarks at HHS headquarters on Tuesday, February 20, he stated that he was working with the Centers for Medicare and Medicaid Services (CMS) Administrator, Seema Verma, to give states “a menu of options” to decrease the restrictions under the Affordable Care Act (ACA).  In particular, Secretary Azar noted that he was exploring ways to allow states greater flexibility through federal waivers.

Continue Reading Will Secretary Azar Waive(r) Away the ACA?

First 100 Days LogoOn Tuesday, April 18, 2017, our Health Care Group will hold a webinar on the health care policy and transition challenges still at play as the Trump Administration nears the end of its 100 days in power.  During the webinar, participants will hear important insights and predictions on what a Trump-led Executive Branch will mean for health care industry stakeholders from:

  • Partner Xavier Baker, whose practice focuses on the regulatory and compliance aspects of commercial insurers’ participation in Medicare Advantage, Medicaid managed care, and the health insurance exchanges;
  • Counsel Gary Baldwin, the former deputy director of Plan and Provider Relations at the California Department of Managed Health Care (DMHC), with expertise in state insurance regulatory issues for commercial plans;
  • Partner Laura Cordova, the former assistant chief in the Fraud Section of the Criminal Division at the U.S. Department of Justice, who focuses primarily on counseling health care companies and executives in criminal, civil and administrative enforcement actions, which may still increase under a Trump administration; and
  • Counsel Stephanie Willis, who counsels health care entities in licensure and regulatory matters related to participation in health care reform incentive programs such as the Medicare Shared Savings Program and Meaningful Use.

Register for the webinar here.

On January 20, 2017, hours after being sworn in as the 45th president of the United States, President Donald Trump issued Executive Order 13765 that aims to “minimize the unwarranted economic and regulatory burdens” of the Affordable Care Act (ACA) while its repeal is “pending.” 

The one-page Executive Order declares that it is the policy of the Trump Administration to seek a “prompt repeal” of the ACA and directs that the executive branch “take all actions consistent with law to minimize the unwarranted economic and regulatory burdens” of the ACA.  The Executive Order also mandates that all federal agencies, including the Department of Health and Human Services (HHS), “shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of” any provision of the ACA that imposes a financial or regulatory burden on any stakeholder including patients, physicians, hospitals and other providers, as well as insurers, medical device manufacturers, and pharmaceutical companies.  Federal agencies are also required to “exercise all authority and discretion available to them to provide greater flexibility to States.”  The Executive Order further instructs agencies “to create a more free and open healthcare market” consistent with ACA replacement proposals to permit the sale of health insurance products across state lines. 

By signing the Executive Order, President Trump signals that his Administration will prioritize changes to federal health care policy in order to lessen the economic impact of the ACA.  The Executive Order could be a signal for HHS to expand hardship waivers to permit individuals to avoid the ACA’s tax penalties for individuals who fail to maintain coverage.  HHS also may provide greater flexibility to states for the administration of Medicaid programs, including by more readily granting waivers under section 1115 of the Social Security Act, 42 U.S.C. § 1315.

The practical impact of the Executive Order remains unclear and is limited to agency discretion for now.  The Executive Order does not diminish the authority of federal agencies established by the ACA and requires agencies to implement the Order’s mandates in a manner consistent with current law.  Thus, HHS and other agencies must continue to comply with the requirements of prior legislation while exercising their discretion to minimize the financial burdens of the ACA.  In addition, the Executive Order does not provide a mechanism for private parties to enforce the Trump Administration’s new policy and states that it “is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against” the federal government.  The Executive Order appears to give lawmakers the ability to proceed more deliberately and the spotlight will now be on Congress to agree on a plan to repeal and replace the ACA.