Trump Administration Launches Multi-Pronged Effort to “Transform Care Delivery for Patients with Chronic Kidney Disease”

The Trump Administration has announced a number of policy goals and innovation models that seek to “improve the lives of Americans suffering from kidney disease, expand options for American patients, and reduce healthcare costs,” according to the Department of Health and Human Services (HHS).  The broad policy framework was outlined in an executive order on “Advancing American Kidney Health” signed by President Trump on July 10, 2019.  The executive order includes as federal priorities:  preventing kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care; expanding affordable treatment alternatives for end stage renal disease (ESRD); encouraging the development of artificial kidneys, and updating the organ transplant system.

HHS is launching five new Medicare ESRD innovation models to jump-start the Advancing American Kidney Health initiative.  One model, a proposed ESRD Treatment Choices Model, would be mandatory for dialysis providers in randomly-selected geographic areas that account for about 50% of adult ESRD beneficiaries.  This model promotes home dialysis and kidney transplants by adjusting ESRD prospective payment system (PPS) payments upward or downward based on home dialysis and transplant rates, and increasing certain payments for home dialysis services.  This model is subject to a public comment period through September 16, 2019.  CMS also announced four optional models:  the Kidney Care First (KCF) Model, and three Comprehensive Kidney Care Contracting (CKCC) Models.  These models include incentives for coordinating care for beneficiaries with chronic kidney disease or ESRD and reducing total care costs, and for successful transplants.  Details about these models are available here.

CMS Proposes Easing State Requirements for Demonstrating Medicaid Beneficiary Access to Care

The Centers for Medicare & Medicaid Services (CMS) has proposed rescinding current procedural standards that must be met for states to demonstrate that Medicaid fee-for-service (FFS) payments are sufficient to assure beneficiary access to covered services.

As we previously reported, regulations adopted in 2015 require states to establish and periodically update access monitoring review plans (AMRPs) for certain categories of Medicaid services provided through a FFS delivery system to demonstrate the sufficiency of provider payment rates.  The regulations also include administrative requirements for states proposing to reduce or restructure Medicaid provider payments.  These regulations apply to the following categories of services:  primary care; physician specialist services; behavioral health; pre- and post-natal obstetric services including labor and delivery; home health; any services for which the state has submitted a state plan amendment to reduce or restructure provider payments that could result in diminished access; and additional services as determined necessary by the state or CMS.

Citing state concerns about the administrative burden associated with the current regulations, in March 2018 CMS proposed exempting states with high rates of Medicaid managed care enrollment from the AMRP requirements.  CMS did not finalize this plan.  Instead, in a proposed rule published July 15, 2019, CMS now proposes to rescind the regulatory process requirements for states to develop and update an AMRP and to submit certain access analysis when proposing to reduce or restructure provider payment rates.  However, states would not be exempt from the statutory requirements “to ensure access is consistent with the Act generally, and especially when seeking to reduce or restructure Medicaid payment rates.”  CMS will accept comments on the proposed rule until September 13, 2019.

Concurrent with release of the proposed rule, CMS issued an informational bulletin to states announcing CMS plans “to develop a new data-driven strategy to understand access to care in the Medicaid program across fee-for-service and managed care delivery systems, as well as in home and community-based services (HCBS) waiver programs.”  In the coming months, CMS expects to convene workgroups comprised of state and federal stakeholders to identify measures, benchmarks, and data that could be used as access indicators across Medicaid programs.

CMS Proposes CY 2020 Medicare Home Health PPS Update, Infusion Therapy Benefit Policies

The Centers for Medicare & Medicaid Services (CMS) has issued the proposed calendar year (CY) 2020 update to Medicare home health prospective payment system (HH PPS) rates and policies.  The proposed rule also would update transitional home infusion therapy rates for CY 2020 and institute permanent infusion therapy payment reforms beginning in CY 2021.

With regard to home health policy, CMS projects that aggregate CY 2020 HH PPS payments would increase by 1.3%, or $250 million, compared to 2019 levels under the proposed rule.  As established in the CY 2019 final rule, CMS will implement its new case mix methodology, the “Patient-Driven Groupings Model” (PDGM), effective January 1, 2020.  The proposed CY 2020 HH PPS update reflects the transition to the PDGM methodology and a new 30-day payment unit, with CMS proposing downward adjustments for certain anticipated “behavior changes” such as modifications to documentation and coding practices.  The proposed update also makes other adjustments, including to incorporate a new rural add-on policy, updated wage index data, and an updated fixed-dollar loss ratio for outlier payments.  The proposed 2020 national, standardized 30-day payment for an HHA that submits required quality data is $1,791.73 (compared to the CY 2019 national, standardized 60-day episode payment of $3,154.27). The proposed rate for an HHA that does not submit required quality data is $1,756.42.

In addition to the HH PPS rate update, CMS proposes to make a number of HHA policy changes, including:  streamlining home health plan of care content requirements; allowing physical therapy assistants to furnish maintenance therapy; modifying the split percentage payment policy (with elimination of split-percentage payments beginning in CY 2021); and updating Home Health Quality Reporting Program and Home Health Value-Based Purchasing Model requirements.

The proposed rule also continues to implement refinements to Medicare payment policy for home infusion therapy services, as mandated by the 21st Century Cures Act.  In the final 2019 rule, CMS established a new temporary transitional payment for home infusion therapy services in 2019 and 2020, in advance of implementation of a new home infusion therapy benefit in 2021.  The proposed 2020 rule would update the temporary transitional payment rates for 2020 based on corresponding CY 2020 Physician Fee Schedule (PFS) amounts (which are expected to be released in the near future).  For 2021, CMS proposes fully implementing the new home infusion therapy benefit, with home infusion drugs classified into three payment categories, each of which would have a single unit of payment based on PFS amounts (such amounts would be adjusted by the geographic adjustment factor).  CMS proposes establishing higher payment amounts for the first home infusion therapy visit; for subsequent visits, CMS would apply a small decrease to the payment amounts to maintain budget neutrality.

CMS will accept comments on the proposed rule until September 9, 2019.

CMS Proposes New Mandatory Medicare Radiation Oncology Payment Innovation Model

The Centers for Medicare & Medicaid Services (CMS) has proposed a new Radiation Oncology (RO) innovation model (RO Model) to test whether prospective site neutral, episode-based payments for radiotherapy (RT) episodes of care would reduce Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.  Importantly, the RO Model would be mandatory for providers and suppliers that furnish RT services within randomly selected Core Based Statistical Areas (CBSAs), with very limited exceptions.  CMS estimates that the RO Model would cover about 40% of Medicare RO episodes and reduce Medicare spending by $250 million – $260 million during the five-year program.

Key features of the proposed RO Model are summarized below.  CMS will accept comments on the model until September 16, 2019.

RO Provider/Supplier Participation

Medicare-participating physician group practices (PGPs), hospital outpatient departments (HOPD), and freestanding radiation therapy centers that furnish RT services in designated CBSAs generally would be required to participate in the RO Model.  CMS proposes exempting a provider or supplier that:

(1)    furnishes RT services only in Maryland, Vermont, or the U.S. territories;

(2)    is classified as an ambulatory surgery center (ASC), critical access hospital (CAH), or prospective payment system-exempt cancer hospital; or

(3)    is eligible to participate the Pennsylvania Rural Health Model.

In a proposed rule to be published on July 18, 2019; CMS expresses its view that mandatory participation “is necessary to obtain a diverse, representative sample of RT providers and RT suppliers and to help support a statistically robust test of the prospective episode payments made under the RO Model.”  CMS notes that because hospital outpatient prospective payment system (OPPS) rates are projected to increase substantially more than physician fee schedule (PFS) rates during the period of 2019 through 2023, it “would result in few to no HOPDs electing to voluntarily participate in the Model.”  CMS also expects that a voluntary program would attract only those freestanding radiation therapy centers with historically lower RT costs compared to the national average.

Providers and suppliers would participate in the RO Model as either a Professional participant, Technical participant, or Dual participant. Continue Reading

HHS Scraps Pending Rule to Remove Anti-Kickback Safe Harbor Protection for Drug Rebates to Health Plans, PBMs

The Trump Administration has decided against finalizing a controversial proposed Office of Inspector General (OIG) regulation that would have modified Federal Anti-Kickback Statute safe harbor protection for certain prescription drug rebates to health plans and pharmacy benefit managers (PBMs).  As we previously reported, the proposed rule would have (i) removed safe harbor protection for drug manufacturer rebates to Part D plans, Medicaid managed care organizations, and PBMs acting under contract with either type of entity, (ii) establish a new safe harbor protecting manufacturer “point of sale” price reductions on Part D and Medicaid managed care drug utilization, and (iii) establish a new safe harbor protecting certain service fees paid by drug manufacturers to PBMs.  

According to the White House Office of Management and Budget (OMB), the OIG officially withdrew the pending final rule on July 10, 2019.  Action to end consideration came after release of a Congressional Budget Office estimate that the rule as proposed would increase federal spending by about $177 billion over the 2020–2029 period while increasing beneficiary Part D drug plan premiums.

HHS “Quality Summit” to Focus on Overhauling Federal Quality Programs

The Department of Health and Human Services (HHS) has announced plans to hold a “Quality Summit” to foster dialogue between government leaders and health care industry stakeholders on how HHS quality programs “can be further evaluated, adapted, and ultimately streamlined to deliver a value-based care model focused on improving outcomes for American patients.”  Ultimately, the initiative is intended to help HHS formulate a “Health Quality Roadmap,” as directed by President Trump’s recent executive order on health care price and quality transparency.  In announcing the Quality Summit, HHS Deputy Secretary Eric Hargan observed that current HHS quality programs are “uncoordinated among the various agencies and inconsistent in their demands on healthcare providers.”  Through an external, systemic review, HHS believes the Quality Summit will both strengthen the protections offered to patients and improve value by reducing costs and onerous requirements for providers.

Summit participants will include government representatives and approximately 15 non-government health care industry leaders.  Nominations for participation in the summit will be accepted through July 31, 2019.

Congressional Committees Advance Multiple Bills Addressing Surprise Medical Billing, Prescription Drug Policy, and Other Health Policy Issues

Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including:  surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others.  The following are highlights of recent action.  Note that none of the bills has yet been considered by the full House or Senate, and all are subject to change during the legislative process.

Senate HELP Committee

The Senate Health, Education, Labor and Pensions (HELP) Committee approved S 1895, the Lower Health Care Costs Act of 2019.  This high-profile, bipartisan legislation would hold patients harmless from “surprise” medical bills for out-of-network services provided at an in-network facility, with payment to out-of-network providers set at the median contracted rate for in-network providers in the geographic area (a controversial “benchmark rate” proposal).  The bill contains separate protections regarding costs for emergency room and air ambulance services.  Additionally, S 1895 seeks to improve health care transparency by, among other things, banning what are described as “anticompetitive” terms in contracts between insurers and providers; providing patients with additional information on out-of-pocket costs; and regulating certain pharmacy benefit manager (PBM) pricing practices.  The legislation also includes numerous provisions intended to promote generic drug and biosimilar biological product innovation; improve health information exchange and strengthen health entity cybersecurity practices; and authorize various public health programs.  The Committee approved the bill on June 26, 2019 on a vote of 20-3.  Committee Chairman Lamar Alexander expressed hope for full Senate consideration of the bill in July.

During the same markup, the HELP Committee also approved S 1173, the Emergency Medical Services for Children Program Reauthorization Act, and S 1199, the Poison Center Network Enhancement Act of 2019.

Senate Judiciary Committee

The Senate Judiciary Committee approved the following four bills that are intended to help reduce prescription drug prices:

  • S 1227, the Prescription Pricing for the People Act of 2019, which would require the Federal Trade Commission (FTC) to study the role of PBMs in the pharmaceutical supply chain and provide Congress with related policy recommendations.
  • S 440, the Preserving Access to Cost Effective Drugs Act, which would bar patent owners from asserting sovereign immunity, including the sovereign immunity accorded to an Indian tribe, in certain drug patent disputes.
  • S 1224, the “Stop STALLING Act,” to authorize the FTC to take action against entities that file “sham” citizen petitions to attempt to interfere with approval of a competing generic drug or biosimilar.
  • S 1416, Affordable Prescriptions for Patients Act of 2019, which would authorize the FTC to challenge certain brand manufacturer practices (e.g., “product hopping” and “patent thickets”) that could discourage generic drug and biological use.

House Ways and Means Committee

The House Ways and Means Committee recently passed the following health policy bills: Continue Reading

States Banding Together on HIPAA Enforcement

In the first settlement of its kind, a medical software provider has agreed to pay $900,000 to 16 state attorneys general for alleged violations of state and federal privacy laws. The settlement, stemming from a federal lawsuit in the U.S. District Court for the Northern District of Indiana, demonstrates the resolution of the first-ever multistate data breach suit based on alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as state deceptive trade practices acts, state personal information protection acts, and state breach notifications acts. The settlement is a result of a 2015 data breach resulting in compromised user ID and password data of the electronic protected health information of approximately 3.5 million individuals. The settlement was finalized shortly after the medical software provider agreed to pay $100,000 to the Office of Civil Rights (OCR), the agency tasked with enforcing HIPAA, for alleged HIPAA violations associated with the same breach.

To read more, please visit our Life Sciences Legal Update blog.

Supreme Court Decides Important Agency-Deference Question

As we reported back in March 2019, the Supreme Court of the United States was reexamining what level of deference, if any, courts must show to a federal agency in cases challenging an agency’s interpretation of its own regulations. Today, in Kisor v. Wilkie, No. 18-15, a narrow majority of the Supreme Court relied on principles of stare decisis in refusing to overrule the Court’s past rulings addressing the deference question. After doing so, however, the majority purported to “reinforce [the] limits” of the test courts must apply when evaluating an agency’s interpretation of its own regulations.

Much ink will be spilled over Kisor given the issues involved and the intensity of the disagreeing views expressed by four Justices. For now, let us focus on what constitutes the opinion of the Court that lower federal courts must follow on a going-forward basis. (The opinion of the Court was authored by Justice Kagan and joined by Chief Justice Roberts and Justices Ginsburg, Breyer, and Sotomayor.)

The refined test is as follows:

First, a court should not afford deference to an agency’s interpretation of its own regulation unless the regulation is “genuinely ambiguous.” In deciding whether such ambiguity exists, a court must carefully consider the text, structure, history, and purpose of the regulation. The Kisor majority specifically cautioned that a court “cannot wave the ambiguity flag just because it found the regulation impenetrable on first read. Agency regulations can sometimes make the eyes glaze over. But hard interpretive conundrums, even relating to complex rules, can often be solved.”

Second, even if the regulation is genuinely ambiguous, the agency’s interpretation must still be “reasonable.” “In other words,” the Kisor majority explained, “it must come within the zone of ambiguity the court has identified [in step one] after employing all its interpretive tools.”

Third, even if the agency’s interpretation of the ambiguous regulation is reasonable, a court “must make an independent inquiry into whether the character and context of the agency interpretation entitles it to controlling weight.” This, in turn, involves three elements. First, the “regulatory interpretation must be one actually made by the agency. In other words, it must be the agency’s ‘authoritative’ or ‘official position,’ rather than [an] ad hoc statement not reflecting the agency’s views.” Second, the agency’s interpretation “must in some way implicate [the agency’s] substantive expertise.” Finally, an agency’s interpretation of a regulation “must reflect fair and considered judgment” to receive deference. For example, Kisor instructs that a court “should decline to defer to a merely convenient litigating position or post hoc rationalization advanced to defend past agency action against attack. . . . And a court may not defer to a new interpretation, whether or not introduced in litigation, that creates unfair surprise to regulated parties.”

Only time will tell if the test as refined by Kisor actually results in more court decisions rejecting agency regulatory interpretations and/or a change in agency behavior when drafting regulations.

President Trump’s Issues Executive Order on Health Care Price Transparency, but Key Details are TBD

On June 24, 2019, President Trump signed an executive order (EO) intended to improve health care price and quality transparency, boost tax-preferred health savings accounts, and protect patients from surprise medical bills.  This is not the first time the Trump Administration has tacked health price disclosure.  For instance, new hospital price transparency rules went into effect October 1, 2019, and the Administration has issued rules (challenged in court) to require drug manufacturers to include certain pricing information in direct-to-consumer television advertising.  This attempt is more ambitious, however.  In signing the measure, the President remarked that if the Administration’s action “is half as big as some people are saying it will be, it will be one of the biggest things ever done in this world, in this industry, in this profession.”  That said, assessing the potential impact of this EO is a challenge given that (1) the EO is short on actual policy changes, deferring action to future regulations and reports, and (2) the realities of the health marketplace prevent “transparency” from being a panacea.

The EO sets in motion three parallel initiatives to provide patients with more health care pricing information, each of which will require additional policy development:

  • The EO directs the Secretary of Health and Human Services (HHS) to propose regulations to require hospitals to publicly post standard charge information, including charges based on negotiated rates and for common or “shoppable” items and services (defined as “common services offered by multiple providers … which patients can research and compare before making informed choices based on price and quality”).  The charge information, which will cover services, supplies, or other fees billed by the hospital or provided by hospital employees, must be provided “in an easy-to-understand, consumer-friendly, and machine-readable format … that will meaningfully inform patients’ decision making and allow patients to compare prices across hospitals,” and must be regularly updated.  The regulation must be issued within 60 days of the order; there is no deadline for the Secretary to issue a final rule or for the regulation to go into effect.
  • The EO requires the Secretaries of HHS, Treasury, and Labor to issue an advance notice of proposed rulemaking (ANPR) “on a proposal to require healthcare providers, health insurance issuers, and self-insured group health plans to provide or facilitate access to information about expected out-of-pocket costs for items or services to patients before they receive care.” The ANPR must be proposed within 90 days; no other deadlines are established.
  • The EO instructs the HHS Secretary, in consultation with the Attorney General and the Federal Trade Commission (FTC), to “issue a report describing the manners in which the Federal Government or the private sector are impeding healthcare price and quality transparency for patients, and providing recommendations for eliminating these impediments in a way that promotes competition.” Furthermore, this report – which must be issued within 180 days – “should describe why, under current conditions, lower-cost providers generally avoid healthcare advertising.”

In other provisions, the EO seeks to:  align quality measures across federal health programs and eliminate low-value or counterproductive measures; expand researcher and other stakeholder access to de-identified claims data; and expand access to tax-preferred health savings accounts and make other tax-related policy changes (potentially including direct primary care arrangements and healthcare sharing ministries).  Finally, the EO requires the HHS Secretary to submit a report on ways to address surprise medical billing; the report is due within 180 days.

The full impact of the EO will not be felt unless associated regulatory policies are promulgated and enacted.  Industry players are already warning, however, that price transparency does not necessarily equate with lower out-of-pocket costs.  For instance, the American Hospital Association contends that “publicly posting privately negotiated rates could, in fact, undermine the competitive forces of private market dynamics, and result in increased prices.”  Even the FTC has observed that if disclosures allow competitors to figure out what their rivals are charging, it “dampens each competitor’s incentive to offer a low price, or increases the likelihood that they can coordinate on higher prices.”  Furthermore, while the EO targets “shoppable” health care (which the Administration states makes up a significant share of the market), many health care decisions would not necessarily be different in light of additional pricing data, given patients’ established provider relationships, insurance network rules, and numerous other factors.

We will be reporting on the progress of the Administration’s transparency initiative as future policy milestones are achieved.

Legislation to Modify Medicaid Drug Rebate Policies, Extend Medicaid Health Provisions Advances in Congress

The House of Representatives has overwhelmingly approved H.R. 3253, the Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act, which would finance extension of various Medicaid-related health programs by increasing manufacturer Medicaid drug rebate obligations.  In terms of health programs, the legislation also would, among other things:

  • Extend the “Money Follows The Person Rebalancing Demonstration” and the Medicaid demonstration program for certified community behavioral health clinics.
  • Authorize state Medicaid fraud control units to review complaints of abuse or neglect involving patients in noninstitutional or other settings.
  • Extend through March 31, 2024 the applicability of current Medicaid spousal impoverishment protections for recipients of home- and community-based services.
  • Increase funding for the Medicaid Improvement Fund.

To offset the costs of these provisions, H.R. 3253 would make two changes to Medicaid drug rebate rules.  First, the legislation would prohibit manufacturers from blending the average manufacturer price of a brand drug and any authorized generic of the drug for Medicaid drug rebate purposes.  Second, the bill would exclude manufacturers from the definition of “wholesalers” for purposes of rebate calculations.  The Congressional Budget Office (CBO) estimates that the Medicaid drug rebate provisions would save the federal government $1.17 billion over 5 years (FYs 2020-2024) and $3.08 billion over 10 years (FYs 2020-2029).

The legislation was passed on a bipartisan vote of 371 to 46.  It now moves to the Senate.

OMB Reviewing OIG Proposed Rule Amending Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care.  The proposed rule presumably builds on the related request for information (RFI) on this topic issued by the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) in August 2018.  As discussed in a Reed Smith client alert, the RFI sought information on, among other things, changes needed in current safe harbors and beneficiary inducement CMPs to promote beneficial care coordination, patient engagement, and value-based arrangements.

The OIG sent the safe harbor proposed rule to OMB for review on June 5, 2019.  The text of the rule is not yet available, and regulatory review can take anywhere from hours to months.  The latest Trump Administration regulatory agenda projects that the proposed rule will be released in July 2019.  While such projections are not always accurate, the notation on the agenda indicates that the wait for this highly-anticipated proposed rule may be coming to a close, and the beginning of the comment period may be on the horizon.   We will be closely monitoring developments.

CMS Looking for More Ways to Cut Medicare & Medicaid Red Tape

As part of its continuing “Patients over Paperwork” initiative, the Centers for Medicare & Medicaid Services (CMS) has released another request for information (RFI) on regulatory or subregulatory changes the agency could make to “reduce unnecessary administrative burdens for clinicians, providers, patients and their families.”  In particular, CMS seeks new ideas for:

  • Streamlining reporting requirements, documentation requirements, or processes to monitor compliance with CMS rules and regulations;
  • Aligning Medicare, Medicaid and other payer coding, payment, and documentation requirements and processes;
  • Enabling operational flexibility, feedback mechanisms, and data sharing that would enhance patient care, support the clinician-patient relationship, and facilitate individual preferences; and
  • Determining how and when CMS issues regulations and policies, and how CMS can simplify rules and policies for beneficiaries, clinicians, and providers.

Additionally, CMS solicits recommendations regarding ways the agency could: Continue Reading

Upcoming Congressional Hearings to Focus on Health Coverage, Surprise Billing, and Vertical Integration

On June 12, 2019, three Congressional committees have scheduled hearings on health care policy topics:

Health Fraud Recoveries Continue to Dip in FY 2018, According to Latest OIG/DOJ Fraud Report

Federal health care fraud judgments and settlements totaled $2.3 billion in fiscal year (FY) 2018 – down from $2.6 billion in recoveries in FY 2017 and $3.3 billion in FY 2016 — according to latest Health Care Fraud and Abuse Control (HCFAC) Program Annual Report.  During FY 2018, the Department of Justice (DOJ) opened 1,139 new criminal health care fraud investigations, filed criminal charges in 572 cases involving 872 defendants, and launched 918 new civil health care fraud investigations.  Investigative efforts by the Federal Bureau of Investigation resulted in more than 812 “operational disruptions of criminal fraud organizations,” plus “the dismantlement of the criminal hierarchy of more than 207 health care fraud criminal enterprises,” during this period.  Furthermore, HHS Office of Inspector General (OIG) investigations resulted in 679 criminal actions and 795 civil actions related to Medicare and Medicaid, along with 2,712 exclusions of individuals and entities from federal health care programs.  The HCFAC report also includes highlights of significant criminal and civil investigations, including the results of concentrated efforts to combat opioid fraud and abuse.

CMS Accelerates Investigations of EMTALA Complaints, Surveys of Hospital Deaths in Restraint or Seclusion

The Centers for Medicare & Medicaid Services (CMS) has instructed state survey agencies that they must conduct onsite complaint investigations related to Emergency Medical Treatment and Labor Act (EMTALA) complaints and surveys of death in restraint or seclusion in hospitals and critical access hospitals within two business days instead of five.  This change brings these two categories of complaint investigations in line with other potential immediate jeopardy investigations in Medicare-participating non-long term care facilities.  The June 4, 2019 guidance to states also updates how CMS Regional Offices may triage EMTALA complaints and makes other revisions to the survey process.  The changes are effective immediately.

CMS Plans June 27 “Listening Session” on Draft Hospital Co-Location Guidance

CMS has scheduled a June 27, 2019 listening session to get public feedback on its recent draft guidance on how state surveyors should evaluate hospital co-location arrangements for compliance with the Medicare hospital conditions of participation (COPs).  In particular, CMS is looking for input on how the guidance addresses staffing, contracted services, emergency services, and distinct and shared spaces.  The agency is accepting comments and questions in advance of the listening session (note that the comment deadline on the draft guidance is CMS July 2, 2019).  The target audience for the listening session includes hospitals, hospital associations, accreditation organizations, state survey agencies, and other interested stakeholders. For Reed Smith’s analysis of the draft guidance, please see our client alert.

Medicare OPPS Advisory Panel to Meet August 19-20, 2019

The annual Advisory Panel on Hospital Outpatient Payment meeting will be held on August 19-20, 2019, the Centers for Medicare & Medicaid Services (CMS) has announced.  The Panel is charged with advising CMS on outpatient prospective payment system (OPPS) ambulatory payment classification clinical integrity and weights, along with hospital outpatient therapeutic services supervision issues.  The deadline for the submission of presentations and comments is July 22, and meeting registration runs through July 29.

Congress Continues Focus on Health Care Costs

The House of Representatives has approved H.R. 987, the “Strengthening Health Care and Lowering Prescription Drug Costs Act,” which packages seven prescription drug and insurance-related bills recently approved by the House Energy and Commerce Committee.  The legislation is intended to:  increase generic drug competition; fund Affordable Care Act “Navigator” outreach and enrollment programs and state-based insurance marketplaces; and reverse Trump Administration policies on short-term, limited duration insurance (STLDI).  The bill was approved on a largely party-line vote of 234 – 183.  While voicing support for the bill’s provisions to help speed the availability of generic drugs, the Trump Administration has announced its opposition to the bill in its current form, primarily because of the STLDI provision.

Congressional committees also have held hearings this month to highlight various health policy topics, including the following:

  • A Senate Judiciary Committee hearing entitled “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition.”
  • A Senate Finance Committee hearing entitled “Medicare Physician Payment Reform after Two Years: Examining MACRA Implementation and the Road Ahead.”
  • A Senate Health, Education, Labor and Pensions Committee hearing on “Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers.”
  • A House Ways and Means Committee hearing on “Protecting Patients from Surprise Medical Bills.”
  • A House Budget Committee hearing on “Key Design Components and Considerations for Establishing a Single-Payer Health Care System.”
  • Energy and Commerce Committee hearings on drug cost transparency and the drug supply chain.  Looking ahead, a June 4, 2019 Energy and Commerce hearing will focus on proposals to reauthorize various federal health care programs (so-called “extenders”).

Surprise Medical Billing:  Bipartisan Consensus on the Problem, but Finding an Effective Fix May be Harder

In a rare display of unity, President Donald Trump and bipartisan Congressional leaders have highlighted their shared commitment to tackling “surprise” medical billing – when an insured patient is subject to unexpectedly high out-of-pocket costs for out-of-network care that is beyond their control.  Such surprise billing can occur when a patient receives emergency care from an out-of-network provider but they could not choose their provider, or when a patient is treated at an in-network hospital but the anesthesiologist or another provider is out of network.

On May 9, 2019, the White House held an event to highlight the economic burden surprise billing can have on patients and set the following forth principles for a legislative solution, including:

  • Patients receiving emergency care should not be forced to shoulder extra costs billed by a care provider but not covered by their insurer. In emergency situations, balance billing for amounts above the in-network allowed amount should be prohibited.
  • Patients receiving scheduled care should have information about whether providers are in or out of their network and what costs they may face.
  • Patients should not receive surprise bills from out-of-network providers they did not choose.
  • Federal healthcare expenditures should not increase.

President Trump indicated in his remarks that the Administration would be releasing a more detailed “transparency” proposal over the next two weeks or so.  In response to the Administration’s announcement, key lawmakers in both parties expressed support for legislative action on this issue.  For instance, House Energy and Commerce Chairman Frank Pallone, Jr and Ranking Member Greg Walden released a joint statement committing to crafting bipartisan legislation to address surprise billing, and Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander stated his goal of having a bipartisan solution on the Senate floor by July.

Yet even with bipartisan recognition of the problem, crafting a federal solution is expected to be complex.  In addition to determining how to balance state and federal roles in regulation of insurance practices, it will be important for legislators to understand how reimbursement rates are set in the private sector, how charges may differ from actual costs, the complicated dynamics of negotiations between payers and hospital-based physicians, and the role cost shifting continues to play in the health care system as a whole.  Moreover, stakeholders – which include employers, patients, physicians, hospitals and insurers — are likely to be sharply divided on potential remedies, such as holding patients harmless for charges, banning balance billing, limiting reimbursement rates for out-of-network providers, prohibiting out-of-network/in-network distinctions for emergency care, and requiring binding arbitration to resolve disputes between payers and providers.  Even with the political will to act quickly, finding a legislative cure may take a more methodical approach.

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