The OIG has issued a report on its findings that Medicare in some cases continued to make payments to physicians who have delinquent Medicare debts that have been referred to Treasury for collection. For instance, CMS paid a total of $10.7 million to 23 individual physicians who collectively owed CMS a total of $8.84 million. The OIG recommended that CMS take a series of steps to ensure that it does not pay individual physicians with delinquent debts after referring their Medicare debts to Treasury for collection; CMS concurred. For more information, see the full report, “CMS Made Payments Associated With Providers After Referring Individual Providers' Debts to the Department of the Treasury for Collection.”
CMS has released the Medicare Part A inpatient hospital deductible and hospital and extended care services coinsurance amounts for 2015. Specifically, the 2015 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,260, followed by $315 per day for days 61-90 and $630 per day for stays beyond the 90th day in a benefit period. The daily skilled nursing facility coinsurance for days 21 through 100 in a benefit period will be $157.50 in 2015. CMS also published the 2015 Medicare Part A premium amounts for the uninsured aged and disabled individuals who have exhausted other entitlement. Finally, CMS has announced that Medicare Part B premiums and deductibles will be unchanged in 2015, for the second consecutive year. Specifically, the 2015 premium varies by income from $104.90 to $335.70 per month, and the Part B deductible is $147.00 for all Part B beneficiaries.
CMS has published corrections to its August 22, 2014 final update to the Medicare Hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System for FY 2015. Among other things, CMS made technical errors in its calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, operating standardized amounts, capital federal rates, and impacts. CMS also made errors in determining the FY 2015 readmissions payment adjustment factors; CMS has revised the estimated savings under the Hospital Readmissions Reduction Program to $428 million, from $424 million in the final rule.
CMS has published a final rule that updates prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for FY 2015. Under the final rule, the federal per diem base rate will be increased by 2.1%, reflecting a market basket increase of 2.9%, offset by a 0.3 percentage point reduction and a productivity adjustment reduction of 0.5 percentage points (both reductions were mandated by the ACA). CMS also anticipates that the final update to the outlier fixed-dollar loss threshold amount will provide an additional 0.4% boost in overall payments to IPFs. In light of all payment policies, CMS estimates that total payments to IPFs under the final rule will increase by $120 million (2.5%) compared to FY 2014 payments. The final rule also, among other things, establishes a new methodology for updating the cost of living adjustment (consistent with the inpatient hospital methodology), expands quality measures under the IPF Quality Reporting Program, adopts coding changes related to comorbidity categories and unspecified codes, and discusses CMS’s future plans to propose an IPF-specific market basket. The final rule was published August 6, 2014.
CMS has announced a new “Medicare Intravenous Immune Globulin (IVIG) Demonstration” that will evaluate the potential benefits of providing payment for items and services needed for in-home administration of IVIG for the treatment of primary immune deficiency disease (PIDD). Under this demonstration, which will last three years, Medicare will provide a bundled Part B payment for items and services that are necessary to administer IVIG in the home to enrolled beneficiaries who are not otherwise homebound and receiving home health care benefits. The demonstration only applies to situations where the beneficiary requires IVIG for the treatment of PIDD, or is currently receiving subcutaneous immune globulin to treat PIDD and wants to switch to IVIG. The demonstration is limited to 4,000 Medicare beneficiaries nationwide, and the statute authorizes up to $45 million to pay for services and administrative costs. Beneficiaries who want to participate in the demonstration must submit an application signed by the beneficiary and his or her physician and meet specified eligibility requirements. The initial enrollment period ends on September 12, 2014; applications received after that date will be considered on a space-available basis only. Services will be covered under the demonstration beginning October 1, 2014.
On June 13, 2014, the Medicare Payment Advisory Commission (MedPAC) released its June 2014 Report to the Congress on Medicare and the Health Care Delivery System. Among other things, MedPAC addresses ways to align Medicare fee-for-service (FFS), Medicare Advantage, and accountable care organization policies on payment, risk adjustment, and quality measurement. MedPAC also discusses various FFS reforms, including post-acute care reforms to promote payment consistency across settings and bonus payments to support primary care. Finally, MedPAC discusses changing income eligibility standards for the Medicare Savings Programs to help low-income Medicare beneficiaries afford out-of-pocket costs, and it examines the impact of medication adherence on health spending.
On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG’s expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted.
Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG’s proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.
The Client Alert is available here.
In early April, Reed Smith hosted an enlightening, industry-leading conference on post-acute care in Washington, D.C. The conference, entitled “Reed Smith 2014 Washington Health Care Conference: Focus on Post-Acute Care," brought together a panel of experts to discuss episodic care, bundling models, and alternative payment and delivery systems. The conference also featured other speakers who presented from the perspective of investors and Capitol Hill, along with a keynote address from American Enterprise Institute resident scholar Dr. Norman Ornstein.
Policy Discussion on Payment Models
The conference started with a panel discussing bundling initiatives and other alternative payment models. The panel featured Barbara Gage, Ph.D., Fellow and Managing Director of Engelberg Center for Health Care Reform at the Brookings Institution; Judy Feder, Ph.D., Professor at Georgetown University; Vincent Mor, Ph.D., Professor at Brown University School of Medicine; and James Michel, Director for Medicare Research & Reimbursement at the American Health Care Association (“AHCA”). The panel brought with them decades of experience in health care policy and research, and a deep knowledge of post-acute care providers’ current reimbursement systems, in addition to models expected to reform payment for post-acute services in the future.
Dr. Gage spoke first, and introduced bundling by discussing the triple aim adopted by the Centers for Medicare & Medicaid Services (“CMS”): achieve better care for patients, better communities’ health, and lower costs by improving the health care system. She explained how new payment models—including bundled payment initiatives and accountable care organizations—strive to accomplish the above-mentioned triple aim. Gage discussed whether the post-acute setting in which a patient receives treatment distinguishes the patient’s outcome and the level of resources that different post-acute settings (e.g., home health, skilled nursing facilities (“SNF”), inpatient rehabilitation facilities (“IRF”), or long-term acute care hospitals (“LTCH”)) furnish to patients. Gage described in great detail the arguments in favor of bundled payments, emphasizing that one of the benefits of a bundled payment model is that it forces communication across all care settings.
Dr. Feder, on the other hand, urged caution as reimbursement moves to new models. She stressed that bundled payment models, for example, create powerful incentives to potentially reduce or limit the care furnished to patients, and therefore could result in reduced quality of care. Feder explained that bundling is not new, and that, e.g., payers have bundled in the inpatient hospital setting for 30 years. Feder pointed out that when Medicare implemented diagnosis-related groups in the inpatient hospital prospective payment system, hospital length of stay “dropp[ed] like a stone.” Feder underscored that the biggest challenges arise from patients whose health is deteriorating, and explained that the number of home health visits, for instance, are the lowest when patient acuity is the highest. In order to ensure adequate, appropriate, and high-quality care for patients, Feder suggested that policymakers thoughtfully develop and implement any new payment system over time, and incorporate quality mechanisms that serve to protect patients. Feder suggested that good patient data and strong accountability measures are essential to any bundled payment program.
After Feder spoke, Dr. Mor took the podium and analogized capitation versus fee-for-service as being “between the devil and the deep blue sea.” He further explained that fee-for-service reimbursement models have encouraged runaway costs and increased utilization, and that there is a lack of provider accountability and responsibility. In contrast, he explained that in capitation reimbursement models, there is an inherent incentive to deny care. Mor discussed how policymakers can ensure patients receive quality care from providers, and raised a number of thought-provoking questions, such as whether a SNF or other post-acute provider should be responsible for rehospitalization after the discharge of a patient, and whether low rehospitalization reflects overall high-quality care. Mor urged the development of a common assessment tool that includes hospital assessment data in order to more accurately measure post-acute quality and case-mix. He also recommended that CMS use the “Welcome to Medicare” assessment and other periodic beneficiary assessments to obtain risk profiles for patients. Mor ended his presentation by suggesting that while capitation models—such as bundling—are preferable to fee-for-service because one entity is responsible for patients’ care, capitation models face challenges as well, including how to properly measure case-mix and outcomes.
James Michel from AHCA noted the operational challenges associated with bundled payments. For example, it is difficult for post-acute providers to assume the responsibility for patients after the post-acute provider discharges a given beneficiary. Michel also stated that the Center for Medicare & Medicaid Innovation Bundled Payments for Care Improvement initiative’s models incentivize low-cost providers to participate, but providers who recognize they have higher costs than the community average will not participate because of the risk that they will miss the spending target, resulting in a payment to the government. Michel noted that AHCA has developed its own bundled payment proposal, in part to preserve a process in which patients and their families can decide where the patient should be treated after an acute stay. The AHCA bundled payment proposal includes four proposed episodes (e.g., major respiratory condition and septicemia) that would account for approximately 60 percent of all SNF care and more than 50 percent of all post-acute care.
Wall Street Perspective
Jay Barnes, a Senior Vice President for Healthcare Investment Banking at Jefferies, LLC, spoke from the Wall Street perspective, addressing the current appetite for deals in the post-acute space. He described a tepid outlook for post-acute investment stemming from the uncertainty of the future payment models and the changing regulatory landscape, particularly with regard to LTCHs. He informed attendees that the private equity market has been non-existent in the post-acute space because it is challenging to create projection models when future reimbursement for post-acute care remains murky. He explained that the post-acute transactions occurring are largely driven by real estate. For example, Barnes described the recently announced Emeritus Senior Living and Brookdale Senior Living merger as driven by real estate.
Cate McCanless, Senior Policy Analyst at Brownstein Hyatt Farber Schreck, provided an insightful overview of Medicare activity on Capitol Hill. She explained that Congress has focused on post-acute care because of the perceived “comfortable” margins achieved by post-acute providers (according to the Medicare Payment Advisory Commission). McCanless also described the outlook for the discussion draft of the Improving Medicare Post-Acute Care Transformation (“IMPACT”) Act of 2014, released by the House Ways and Means Committee Chairman Dave Camp (R-Mich.) and Ranking Member Sandy Levin (D-Mich.), along with Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Orrin Hatch (R-Utah), March 18, 2014. The IMPACT Act draft includes one measure discussed by Mor during the bundling panel: the reporting of common data across post-acute providers, and the required reporting by acute-care hospitals of patient assessment data gathered in advance of discharge. McCanless also explained that while there has been some Congressional momentum in eliminating Medicare's sustainable growth-rate (“SGR”) formula in order to move to an alternative payment model, such momentum may lose steam this year now that a temporary patch has been enacted, because eliminating the SGR would be expensive, and it is an election year. McCanless pointed out certain post-acute policy proposals that would result in cost savings, such as reducing the SNF payment update by 1.1 percent, which would save an estimated $12 billion, and equalizing certain payments for SNFs and IRFs, which would save an estimated $1 billion; these provisions could be targets for offsets for future Medicare reforms.
Impact of Political Polarization on Health Policy
Dr. Norman Ornstein, noted observer of Congress and politics, and keynote speaker at Reed Smith’s inaugural Health Care Conference, closed the session with a thoughtful discussion regarding the current state of American politics. He described not just the polarization, but also the tribalism, of American politics today, depicting a broken American political system where opposing parties have adopted a mantra of, “if you support it, I am against it.” Despite Ornstein’s bleak description of the current state of politics, he offered some suggestions for reform, including incentivizing citizens to vote. He argued that if more of the American public is engaged, politicians must meet in the middle on at least some policy debates.
In all, the inaugural Reed Smith Health Care Conference led to provocative discussions and a deeper understanding of the political climate and policy recommendations likely to impact—or even transform—post-acute care in the not-so-distant future. We look forward to next year’s conference.
CMS is instructing Medicare providers and suppliers that the updated version of the Medicare claim form (CMS 1500 form version 02/12) must be used for all Medicare paper claims received on and after April 1, 2014. The new form includes indicators to differentiate between ICD-9 and ICD-10 codes, identifies whether certain providers have performed an ordering, referring, or supervising role in the furnishing of the service, and expands the number of possible diagnosis codes on a claim to 12, among other changes. The old version of the Medicare claims form, version 08/05, will only be accepted through March 31, 2014.
GAO Report Confirms Insurance Coverage Prior to Medicare Linked to Better Health, Lower Program Spending
This post was written by Nancy Sheliga.
The Government Accountability Office (GAO) has released a report examining the effect of prior health insurance coverage on Medicare beneficiaries. The report specifically focuses on the health status, program spending, and use of services by Medicare beneficiaries with and without continuous health insurance coverage before Medicare enrollment. According to the GAO, Medicare beneficiaries with prior insurance initially used fewer or less costly medical services than those without prior insurance. Because the difference in total spending was the greatest during the first year in Medicare, the GAO hypothesizes that beneficiaries without prior continuous insurance may have had a pent-up demand for medical services in anticipation of coverage at age 65. In addition, the report finds that beneficiaries without prior continuous insurance have higher total and institutional outpatient spending but not higher spending for physician and other noninstitutional services, suggesting that they require more costly and intensive medical services or that they are continuing prior patterns of visiting hospitals more than physician offices. Finally, in line with previous research, the GAO found that beneficiaries with continuous health insurance coverage for approximately six years before enrolling in Medicare were more likely than those without prior continuous insurance to report being in good health during their first six years in Medicare.
Citing a “rapid and overwhelming increase in claim appeals,” the HHS Office of Medicare Hearings and Appeals (OMHA) has temporarily suspended the assignment of most new provider requests for an Administrative Law Judge (ALJ) hearing. In a memorandum to high-volume appellants dated December 24, 2013, Chief ALJ Nancy Griswold announced that the suspension, which was effective July 15, 2013, is expected to last at least 2 years, during which the OMHA will work through a backlog of appeals involving almost 357,000 Medicare claims and entitlements already assigned to the 65 ALJs. Note that notwithstanding the suspension, OMHA will continue to assign and process requests filed directly by Medicare beneficiaries. As previously reported, the OMHA is hosting a Medicare Appellant Forum on February 12, 2014 to provide additional information to appellants and providers on efforts to make the appeals process work more efficiently.
The OIG has issued a report focusing on individual clinicians who generated high cumulative Medicare Part B payments (defined for purposes of this report as more than $3 million in Part B services) in 2009. Out of 303 such clinicians identified by the OIG, 34% had been identified for improper payment reviews, and as of December 31, 2011, they were tied to $34 million in overpayments, three of the clinicians had their medical licenses suspended and two were indicted. Since existing procedures may not always identify clinicians responsible for high cumulative payments in a timely manner, the OIG recommends that CMS: (1) establish a cumulative payment threshold above which a clinician’s claims would be selected for review, and (2) implement a procedure for timely identification and review of clinicians’ claims that exceed the cumulative payment threshold. While CMS noted that “[h]igh cumulative payments are not necessarily indicative of improper payments or fraud,” the agency partially concurred with the OIG recommendations and stated that it would work with its contractors to develop an appropriate, cumulative payment threshold.
On January 9, 2014, the House Energy and Commerce Health Subcommittee is holding a hearing on “The Extenders Policies: What Are They and How Should They Continue Under a Permanent SGR (Sustainable Growth Rate) Repeal Landscape?” The so-called extenders are measures that secure the continuation of various temporary Medicare payment and policy revisions impacting hospitals, physicians, therapy providers, and certain other provider types that are routinely extended by Congress (most recently as part of the Pathway for SGR Reform Act).
CMS has announced the 2014 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location (unless a hardship exemption applies). The fee for 2014 is $542, up from $532 in 2013. CMS uses a broad definition of institutional entities subject to the application fee; it applies to “any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S or associated Internet-based PECOS enrollment application,” along with additional categories of Medicaid-only and CHIP-only institutional providers.
CMS published notices on October 30, 2013 announcing the 2014 Medicare inpatient hospital deductible and hospital and extended care services coinsurance amounts. The 2014 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,216, followed by $304 per day for days 61-90 and $608 per day for stays beyond the 90th day in a benefit period. The daily skilled nursing facility coinsurance for days 21 through 100 in a benefit period will be $152 in 2014. CMS also released the 2014 Medicare Part A premium amounts for the uninsured aged and disabled individuals who have exhausted other entitlement. Finally, CMS has announced that for 2014, Part B premium rates and the Part B deductible are the same as the respective amounts for 2013. Specifically, the 2014 premium varies by income from $104.90 to $335.70 per month, and the Part B deductible is $147.00 for all Part B beneficiaries.
The ongoing partial federal government shutdown that began on October 1, 2013 due to the government funding impasse is having a varied impact on health care provider operations. CMS has ordered Medicare Administrative Contractors (MACs) to continue to perform all Medicare claims processing and payment functions during the government shutdown. Some providers may experience the impact of the shutdown, however, in the form of curtailed survey and certification activities. In short, CMS is directing state survey agencies to continue to investigate and enforce only complaints involving immediate jeopardy or harm to individuals and revisit surveys necessary to prevent provider termination. Many other survey activities are being suspended during the federal government shutdown, including Medicare recertification surveys, revisits that are not required to prevent termination of Medicare participation, Medicare initial surveys, validation surveys, complaint investigations that do not allege immediate jeopardy or actual harm, Patient Safety Initiative Pilot Surveys, MDS or OASIS activities, informal dispute resolutions, or new improvement projects funded by collected civil monetary penalty funds. The shutdown also has hampered federal rulemaking activities; a lengthy shutdown could throw a wrench into CMS efforts to finalize annual Medicare payment rules for systems updated on calendar year basis (including the Medicare physician fee schedule, the hospital outpatient prospective payment system, and the ambulatory surgical center payment system), increasing uncertainty about major proposed policy changes. The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is continuing Medicare and Medicaid oversight and enforcement activities, including maintaining its fraud and abuse hotline, while most other OIG activities will be suspended during this period. In other areas, the HHS shutdown contingency plan estimates that the shutdown will result in 52% of HHS employees being furloughed, with the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Agency for Healthcare Research and Quality having the vast majority of their staff on furlough. A wide range of HHS activities are also being curtailed, including payments under the Children’s Hospital GME Program and Vaccine Injury Compensation Claims, most new National Institutes of Health admissions and grant awards, the Centers for Disease Control and Prevention annual seasonal influenza program, and routine Food and Drug Administration activities not funded through user fees, among many other programs. There is no clear sign of when a deal on a funding bill will be reached.
The House Ways and Means Committee is seeking comments on three bipartisan proposals intended to “modernize” Medicare cost-sharing policies. The proposals, which were included in President Obama’s proposed FY 2014 budget, include: (1) reducing premium subsides for wealthier seniors in Medicare Parts B and D (10-year savings of at least $50 billion); (2) increasing the annual Medicare Part B deductible (10-year savings of $3.3 billion); and (3) establishing a home health co-payment (10-year savings of $700 million - $730 million). The Committee is seeking comments on these proposals through August 16, 2013.
On May 31, 2013, the Medicare Board of Trustees released its annual assessment of the financial condition of the Social Security and Medicare trust funds. The Board projects that the Medicare hospital insurance trust fund will remain solvent until 2026, which is two years later than forecast last year. The Board attributes the improved outlook in part to lower-than-expected Medicare Part A spending in 2012 (particularly for skilled nursing facilities) and lower projected Medicare Advantage costs. The Board points out, however, that projections of Medicare costs are highly uncertain due to a number of factors, including questions about whether Congress will continue to override the Medicare physician fee schedule/sustainable growth rate (SGR) formula and how the ACA will impact spending.
The OIG has discovered that Medicare has paid millions of dollars in benefits for aliens who are not lawfully present in the country and for incarcerated beneficiaries, contrary to program rules. Specifically Medicare made $91.6 million in payments to health care providers for services to approximately 2,600 unlawfully present beneficiaries during calendar years 2009 through 2011 because CMS did not always receive the unlawful presence information promptly. Likewise, because CMS did not always receive incarceration information promptly, Medicare paid $33.6 million for services to approximately 11,600 incarcerated beneficiaries during 2009 through 2011, even though prisons generally are responsible for paying for care (Medicare will make payments for incarcerated patients if state or local law requires the individuals to repay the cost of the services, but providers must submit such claims with an "exception code"). The OIG recommends that CMS ensure that its contractors recoup any improper payments, implement various policies and procedures to detect and recoup future improper payments, and standardize contractor processing of exception codes for incarcerated beneficiaries. Additional details can be found in the complete reports, Medicare Improperly Paid Providers Millions of Dollars for Unlawfully Present Beneficiaries Who Received Services During 2009 Through 2011 and Medicare Improperly Paid Providers Millions of Dollars for Incarcerated Beneficiaries Who Received Services During 2009 Through 2011.
On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas. The Federal Register version of the agenda includes only a portion of the regulations in the pipeline, however; the full agenda has been posted on the Office of Management and Budget (OMB) web site. Major Department of Health and Human Services (HHS) regulations are highlighted after the jump.
- An HHS Office of Inspector General (OIG) proposed rule that would add new/modify existing safe harbors under the anti-kickback statute; add new/revise existing regulations governing OIG's authority to impose civil money penalties and assessments; add new/revise existing regulations governing OIG's exclusion authority; and codify new exceptions to the beneficiary inducement prohibition (expected July 2013);
- A final Centers for Medicare & Medicaid Services (CMS) rule implementing Affordable Care Act (ACA) provisions related to Medicaid reimbursement for covered outpatient drugs (expected in August 2013);
- A CMS proposed rule to establish Medicare payment safeguards to prevent providers and suppliers that do not meet Medicare requirements from remaining enrolled in or submitting claims to Medicare (expected May 2013);
- Proposed emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers (expected in July 2013);
- A final CMS rule establishing requirements for disclosure of skilled nursing facilities' ownership (expected May 2013);
- A final rule on long-term care facility agreements with hospice agencies (expected October 2013);
- A proposed rule to establish a prospective payment system for Federally Qualified Health Centers (expected June 2013);
- Annual Medicare payment update rules (various dates);
- Various rules implementing insurance-related provisions of the ACA (various dates);
- A final rule modifying HIPAA privacy, security, enforcement, and breach notification rules (expected but not released in December 2012);
- An advance notice of proposed rulemaking to establish a methodology allowing an individual harmed by an offense punishable under HIPAA to receive a percentage of any civil money penalty or monetary settlement collected (expected March 2013);
- A final rule to enhance human subjects research protections (expected April 2013); and
- A Food and Drug Administration (FDA) final rule establishing a unique device identification system for medical devices (expected May 2013).
There are also some surprises on the Administration’s list of “long-term actions” – including the long-overdue final ACA “Sunshine Act” rule requiring applicable manufacturers of drugs, devices, biologicals, or medical supplies to annually report certain payments to physicians or teaching hospitals (“final action” listed as December 2014). Other long-term actions include a final rule implementing ACA requirements related to reporting and returning of overpayments (February 2015); a variety of rules dealing with the 340B discount drug program (timing listed as “to be determined”); and a final HIPAA privacy rule on accounting for disclosures under the Health Information Technology for Economic and Clinical Health Act (TBD).