Category: Affordable Care Act

The Continuing Viability of the Obamacare Medicaid Expansion

Resilient if nothing else, the Patient Protection and Affordability Care Act (“ACA”) continues in force. On June 29, 2018, Judge James E. Boasberg of the United States District Court for the District of Columbia rejected the attempt by the United States Department of Health and Human Services (“HHS”) to defend the grant of a waiver of Medicaid standards to the State of Kentucky for a demonstration program that would have required recipients to work or participate in other qualifying activities for at least 80 hours a month in order to be eligible for coverage.  In Stewart v. Azar, 2018 WL 3203384 (D.D.C. 2018), Judge Boasberg denied the defendants’ motion for summary judgment and granted the plaintiffs’ cross-motion for summary judgment to vacate the Secretary of HHS’ approval of the entire program that had been presented by Kentucky.  This ruling is likely to impact other states, including Arkansas, New Hampshire, Michigan, Alabama, and Indiana, which have received waivers to include work requirements of various sorts.

The United States Supreme Court had upheld the constitutionality of the requirement in the ACA that all Americans have affordable health insurance coverage in National Federation of Independent Business v. Sebelius, 567 U.S. 519 (2012). While seven justices had at first declared the mandatory Medicaid eligibility expansion unconstitutional, Chief Justice John Roberts in a portion of the opinion supported by five justices prevented the outright elimination of the expansion by fashioning a remedy that simply limited the federal government’s enforcement powers over its provisions and allowed states not to proceed with expanding Medicaid without losing all of their federal Medicaid funding.  Before the ACA, the Medicaid program was designed to cover medical services for four particular categories of the needy: the disabled, the blind, the elderly, and needy families with dependent children. With the enactment of the ACA, Medicaid became a program to meet the health care needs of the entire nonelderly population with income below 133 percent of the poverty level.  Judge Boasberg described the Medicaid expansion as “a central component of that statute” which, as was noted in the NFIB opinion of the Chief Justice, allowed states to provide “‘health care to all citizens whose income falls below a certain threshold.’”  With the enactment of the ACA, Medicaid was “transformed” and was “no longer a program to care for the neediest among us, but rather an element of a comprehensive national plan to provide universal health insurance coverage.”

Whether or not to adopt the Medicaid expansion has continued to be a matter of dispute across the country. Since the 2010 enactment of the ACA, according to the Kaiser Family Foundation, as of July 2018, expansion programs were adopted in 32 states, including New Jersey.

Kentucky adopted the Medicaid expansion by executive order of the governor issued in 2014. This had the effect of reducing the uninsured rate from 17% in 2013 to just under 7% in 2015 and providing for a number of preventive services.  However, with the change in presidential administrations, the then Secretary of HHS and the Administrator of the Centers for Medicare and Medicaid Services encouraged states to submit applications for waiver from some of the Medicaid program’s coverage requirements, especially with regard to the expansion populations and the implementation of work requirements for beneficiaries. Section 1115 of the Social Security Act had long permitted the Secretary to approve “experimental, pilot, or demonstration programs” that would otherwise be outside of the requirements of Medicaid.  In July 2017, Kentucky submitted an experimental plan that included “Kentucky HEALTH” which imposed the 80-hour monthly work requirement on the expansion population as well as an increase in premiums to be paid, reporting requirements, and penalties for non-emergency use of emergency department facilities.

The plaintiffs in Stewart were 15 Kentucky residents enrolled in the state Medicaid program.  They filed a class action complaint challenging many aspects of the program.  The evidential record before the court estimated that 95,000 people in Kentucky would lose their Medicaid coverage under the program.

In analyzing the claims for relief, Judge Boasberg emphasized that pursuant to 42 U.S.C. § 1315(a), the Secretary could only approve those demonstration projects that were “likely to assist in promoting the objectives of [Medicaid].” The court addressed the standard of review to be employed.  While acknowledging that the Secretary’s judgment concerning waivers was entitled to deference, Judge Boasberg demonstrated that use of the “arbitrary and capricious” standard could be a deft and exacting analytical tool.  He emphasized that agency action could be characterized as “arbitrary and capricious” if the agency failed to examine relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.  “Courts, accordingly, ‘do not defer to the agency’s conclusory or unsupported suppositions.’”   And no deference is due to an agency’s post hoc rationalizations advanced as a litigation position.

The court noted that one of the primary objectives of the Medicaid program was “providing medical assistance.” It continued: “The Medicaid statute ‘defines “medical assistance” as “payment of part or all of the cost” of medical “care and services” for a defined set of individuals.’” Using that definition, it found a congressional intent to enable each state, as far as practicable, to provide “payment of part or all of the cost of medical care and services.”   With the enactment of the ACA in 2010, Congress expanded the Medicaid program to provide medical assistance for a new population:  low-income adults under 65 who would not otherwise qualify.

But the Secretary did not address these factors. Rather, the supposed justifications were that the project “would improve health outcomes, promote increased upward mobility and improved quality of life, increase individual engagements in health decisions, and prepare individuals who transition to commercial health insurance coverage to be successful in this transition.”  Accepting that those might be “worthy goals,” Judge Boasberg commented that there was “a notable omission from the list.”  Namely, whether the program “would help provide health coverage for Medicaid beneficiaries.”   Furthermore, the Secretary had failed to analyze whether the program would cause recipients to lose coverage or whether it would promote coverage.  Judge Boasberg found the congressional intent in these circumstances to be self-evident:

Here, the Medicaid statute — taken as a whole — confirms that Congress intended to provide medical assistance to the expansion population. The ACA amended Section 1396a(a)(10)’s mandatory population to include all individuals whose income fell below prescribed levels. In so doing, it placed this group on equal footing with other “vulnerable” populations, requiring that states afford them “full benefits.” … Under this regime, states must provide “medical assistance for all services covered under the State plan under this subchapter that is not less in amount, duration, or scope, or is determined by the Secretary to be substantially equivalent, to the medical assistance available for [other individuals]” covered under the Act. … Regardless of whether the Secretary can ultimately waive that requirement, he must start with the presumption that the expansion group is on par with other protected populations.

At the end of the day, even if the Secretary could properly consider other factors — such as health, cost, or self-sufficiency — his “failure to address” a “salient factor” in the Act — i.e., furnishing medical assistance — renders his approval arbitrary and capricious.

The court determined that the appropriate remedy was to vacate the Secretary’s approval of the program with its work requirement and other provisions and to remand the matter to the agency.

The adequacy of the modest reimbursement from the Medicaid program continues to be a matter of controversy. But the positive impact of the Medicaid expansion is well documented.  With the increased access to medical care, there are better health outcomes as a result of primary and preventive care services. The amount of uncompensated and charity care provided by hospitals has been reduced.  R. Rudowitz & L. Antonisse, Implications of the ACA Medicaid Expansion: A Look at the Data and Evidence (May 2018). Hospitals in states that have adopted the Medicaid expansion are less likely to close for financial reasons because of the revenue flow. See generally R.C. Lindrooth, M.C. Perraillon, R.Y. Hardy & G.J. Tung, Understanding the Relationship Between Medicaid Expansions And Hospital Closures, 37 Health Affairs 111 (2018).

Trump Provides Leeway to Employers to Withhold Birth Control Coverage

On October 6, 2017 President Donald Trump signed an executive order calculated to provide employers more opportunities in denying coverage concerning contraceptives. Under the Affordable Care Act (“ACA”), most health plans are required to cover all methods of birth control approved by the Food and Drug Administration without charging women for them. Although religious employers and some private employers with strong religious objections are exempt, very few met the requirements and had to provide the contraception.

President Trump’s executive order officially opens the door for many companies or nonprofit organizations with religious or moral objection to contraception to stop offering it. The move has been long anticipated given the fact that President Trump issued an executive order on “religious liberty” in May 2017. Over 55 million US women have birth control coverage with zero out-of-pocket costs, according to the National Women’s Law Center. Moreover, according to the center, Obamacare saved women an estimated $1.4 billion on birth control pills alone in 2013. To further efforts against the executive order experts have relied on the fact that many women use contraception methods for more than pregnancy prevention. On the other side, Health and Human Services officials claim the new rule would have no impact on “99.9% of women” in the United States. The agency calculated that at most, 120,000 women would be affected: mainly those who work at the roughly 200 entities that have been involved in 50 or so lawsuits over birth control coverage.

Notwithstanding what the early headlines may have inferred, the executive order does not eliminate the ACA’s contraceptive coverage guarantee. This issue is the unknown factor of how many individuals will lose coverage because an employer will claim a religious or moral exemption. A 2015 study from the Henry J. Kaiser Family Foundation estimated that 3% of all nonprofits and 10% of the largest nonprofits have been using the accommodation. There are more than 1.4 million nonprofits in the United States and thousands consist of hospitals, long-term care facilities, schools, and charities—are affiliated with the Catholic church, the hierarchy of which objects to contraception.

Time will tell whether these religious based nonprofits will continue to use the accommodation or whether they will instead actively deny contraceptive coverage to all of those employees, dependents, and students.

The Senate Continues to Shape Its Version of A Health Care Insurance Bill

Recently Republican Senate Majority Leader Mitch McConnell released the Senate’s updated version of the Better Care Reconciliation Act (“BCRA”). Although a similar version of the bill passed in the House, the BCRA failed to obtain the necessary support in the Senate, leaving Republican leaders and the American people asking the question of “what next?” A summary of the key provisions of the BCRA are below. While this list is not exhaustive, it serves as the Republican party “wish list” of changes to the Affordable Care Act. Any further legislation will most likely have all, if not many, of the below provisions included.

  • The BCRA eliminates Employer and Individual Mandate Penalties enacted under the Affordable Care Act (“ACA”). The Individual Mandate Penalty has been a hot topic since the ACA was enacted.
  • The BCRA repeals taxes that were enacted under the ACA such as the excise tax on medical devices, the health insurance tax, the Medicare surcharge tax, the net investment tax, the branded prescription tax, the health insurance executive tax, the Medicare tax on high income taxpayers and the tanning tax. The bill would also temporarily repeal the “Cadillac tax” through 2026.
  • The BCRA ends the exclusion of coverage for over-the-counter medications from HSA or FSA funds, allows individuals to use HSA funds to pay insurance premiums, allow individuals to use HSA funds to cover health care related expenses incurred up to 60 days before HSA coverage becomes effective, and increase the amount that an individual can contribute annually to an HSA.
  • The BCRA eliminates the ACA’s small business tax credit by the year 2020.
  • The BCRA amends the IRS code to allow small business health plans to be treated as a group health plan.
  • The BCRA provides $45 million in federal funding to combat the current opioid crisis.
  • The BCRA will restructure the premium tax credits beginning in year 2020. Subsidies will be available to those below 350% of poverty. Subsidies are geared to a plan with an actuarial value of 58%, just below a bronze-level plan. The current subsidies are tied to the silver plans, which cover 70% of costs for most customers.
  • Cost Sharing Reduction (“CSR”) payments will be fully repealed by year 2020.
  • An additional $70 billion in stabilization funding will be provided to insurers as a way of reducing premiums and reducing out of pocket costs. This is an increase from the first version of the Senate’s BCRA, which provided for $112 billion dollars in stabilization funding.
  • The BCRA begins to phase out the enhanced federal match for Medicaid expansion over a three year period beginning in calendar year 2021.
  • Medicaid payments to beneficiaries will be capped for each Medicare beneficiary beginning the calendar year 2020. Blind and disabled children are not subject to the cap.
  • BCRA provides safety-net funding over a five years period to states that did not expand Medicaid under the ACA.
  • The BCRA has an incentive program in the form of a bonus payment for states in if states can demonstrate that on a set of child and adult quality measures, they were able to achieve results while also showing lower-than-expected aggregate Medicaid expenditures during an annual performance year.
  • The BCRA, like the AHCA will impose more frequent eligibility redeterminations. Although the BCRA makes this an optional exercise, the Senate bill would increase by 5 percentage points the federal contribution to state costs in connection with a more frequent eligibility redetermination process.
  • The BCRA allows the states to impose work requirements on non-disabled, nonelderly, and non-pregnant adults using the TANF work rules as the basis of a new Medicaid work policy.
  • The BCRA allows states to offer Medicaid coverage of “qualified inpatient psychiatric hospital services” to persons age 21 through 65. Under this provision, qualifying stays cannot exceed 30 consecutive days in a month or 90 total days in any calendar year.
  • As with the AHCA, the BCRA prohibits using tax credits to purchase health plans that cover abortion.
  • Also the same as the AHCA, the BCRA prohibits for one year any Medicaid, CHIP, Maternal and Child Health Services Block Grant, and Social Services Block Grant funding for Planned Parenthood.
  • The BCRA loosens 1332 waiver requirements.

Ted Cruz’s amendment to the BCRA will allow consumers to buy health insurance plans that do not meet the current requirements for health plans under the ACA. In essence, these plans would be cheaper and offer less coverage. Insurers could offer these plans if the insurer also offers a plan that does include all of the current ACA requirements, allowing those with pre-existing conditions to obtain coverage at a reasonable rate. This is a heated topic in the discussions surrounding the passage of the BCRA. One of the most population functions of the ACA is that individuals with pre-existing conditions can obtain affordable health insurance.  Because all Americans are currently required to purchase health insurance, risk shifting takes place between those with preexisting conditions and those who are generally healthy but still paying high premiums. Opponents of the Cruz legislation argue that all Americans will purchase the bare bones plan, essentially making health insurance costs rise for those purchasing the more comprehensive plans. With less being collected by insurance companies in the form of premiums, the funds will have to be recaptured elsewhere.

After the failure of the BCRA, Senate Republicans attempted a “skinny repeal” of the Affordable Care Act, repealing only some of the provisions of the ACA, allowing further legislation to be passed in the future. The skinny repeal would have included repealing the unpopular individual mandate, defund planned parenthood while diverting funds to community health centers, eliminate the medical device tax for three (3)  years, allow for increased contribution to Health Savings Accounts, allow states to have more flexibility in determining waivers for essential health benefits, and eliminate the employer mandate for eight (8) years. The hot button topic of Medicaid was not discussed in the skinny repeal. Even without some of the more controversial topics being included, the skinny repeal of the ACA did not pass. Again, Republicans and the American people are asking themselves the question of what will happen next. Regardless of what side of the political spectrum you fall, health care and health insurance affects every American.

There is great uncertainty surrounding the Republican effort to repeal and replace the Affordable Care Act. Thus, it is unclear whether the Republican “wish list” outlined above or any other version can ultimately muster up sufficient votes to make it through both chambers of Congress to get to the President’s desk.

The State of Health Insurance After President Obama

In President Obama’s weekly address on December 10, 2016, the President encouraged Americans who do not currently have healthcare, to enroll in a health insurance plan under the Affordable Care Act (ACA). In the address, the President likely also wanted to remind everyone listening that the threat of Republicans in Congress repealing this law was now a real possibility. President Obama stated “that if Congress repeals Obamacare as they’ve proposed, nearly 30 million Americans would lose their coverage. Four in five of them would come from working families. More than nine million Americans who would receive tax credits to keep insurance affordable would no longer receive that help.” Now that President-elect Trump will take office in a matter of days, what is the fate of healthcare in America?

“The first order of business is to keep our promise to repeal Obamacare and replace it with the kind of healthcare reform that will lower the cost of health insurance without growing the size of government,” Vice President Elect Pence told a news conference recently. Pence also said that Trump would work with congressional leaders for a “smooth transition to a market-based healthcare reform system” through legislative and executive action. House Speaker Paul Ryan said that lawmakers would take action that did not “pull the rug out from anybody” and that the party had “plenty of ideas.” Democrats and many health-care experts are warning that a swift repeal could lead insurers to stop selling policies to individuals on federally mandated exchanges. More than 12 million Americans are covered under those policies.

The current Health and Human Services Secretary, Sylvia Mathews Burwell, briefed Senate Democrats on December 8, 2016, on the expected unraveling of Obamacare’s insurance exchanges. As previously discussed on the MDM&C blog, Trump’s selection of Representative Tom Price to the position of Secretary of Health and Human Services seems to be Trump’s first step towards repealing the ACA. Price has been a regular voice in opposition to the ACA. Price’s philosophy on fixing Obamacare is rooted in “clear[ing] out the bureaucratic impediments” to health-care providers so that the marketplace can figure out the best way to get people health insurance.

Some commentators have stated that a possible less drastic route Congress may go is to replace the ACA rather than an all-out repeal. Congress could pass a plan that doesn’t call for repeal for several years. Between now and then, there would need to be some kind of transition to whatever replaces Obamacare that did not just dump people off coverage with no alternative. However, others still believe that the Republican Congress will swiftly replace ACA’s ban on health status underwriting and pre-existing condition exclusions, as well as its individual mandate, with a continuous coverage guarantee and high-risk pools. This could mean that if individuals were initially uninsured or if they had to drop coverage because of financial hardship, they may face a penalty when they seek coverage significantly greater than the repealed individual mandate penalty. Many argue that these Republican plans would fall far short of the assistance lower-income Americans need, who are currently being helped by ACA.

However, in his recent 60 Minutes interview, President-Elect Trump assured the public that he agrees with certain parts of ACA. Trump plans to keep the ACA policy that allows young adults to stay on their parents’ insurance plans until age 26, as well as the provision that insurers must cover people with pre-existing conditions.

We are likely to know more in the coming months as Congress and the President-Elect begin to take action.

The Future Is Uncertain For the Patient Protection and Affordable Care Act

With the election of Donald Trump to the office of President of the United States, Republicans and their supporters began implementing plans for the repeal and replacement of President Obama’s signature legislation, the Patient Protection and Affordable Care Act (“ACA”). President-Elect Trump’s selection of Representative Tom Price (R-GA) to the position of Secretary of Health and Human Services signaled the next step in those efforts.

Dr. Price, an orthopedic surgeon, has been a regular voice in opposition to the ACA and many in Congress and the media see this selection as confirmation that every effort will be made to replace the ACA. Several Democrats have already come forth indicating they plan to challenge Dr. Price’s selection as they see any threat to the ACA as a threat to thousands of patients that have only received insurance as a result of the ACA.

While a repeal of the ACA is still not guaranteed and many are already challenging whether it could even be effectuated without significant impacts on the health insurance industry and millions of Americans, it is nevertheless important to understand what a replacement program might look like. Dr. Price has previously submitted one of the more detailed Republican plans to replace the ACA. His previously proposed legislation is known as the Empowering Patients First Act.

Unlike the ACA, Dr. Price’s legislation seeks to minimize government’s role in health care. The following are five key elements of Dr. Price’s prior proposal:

  1. Fixed tax credits that rise with age so that patients can purchase their own insurance on the private market, including across state lines. The tax credits would not fluctuate based on income.
  2. Expand health savings accounts to further incentivize patients to contribute to such accounts to pay co-pays and deductibles.
  3. Preexisting conditions would continue to be excluded as a basis to deny coverage but only if the patient has had continuous insurance for eighteen months prior to selecting a new policy. If not, coverage might be denied for up to eighteen months under the new policy.
  4. Limiting the amount of money companies can deduct from their taxes for employee health insurance expenses.
  5. States would be paid federal funds to set up high risk pools to assist those with preexisting conditions that cannot afford insurance on the private market.

While Dr. Price has indicated his willingness to negotiate and compromise on what the ultimate replacement looks like, it remains to be seen how flexible he and the Republicans will be on a substitute for the ACA. Regardless of the final form, one cannot forget that as Secretary of HHS, Dr. Price would ultimately control the authoring of the enabling regulations to implement the new legislation.

It is anticipated that during President-Elect Trump’s first 100 days in office this issue will be addressed.

CMS Brings Clarity to ACA’s 60-Day Overpayment Rule

Part of the antifraud provisions of the Affordable Care Act (ACA) requires any person who receives an “overpayment” of Medicare or Medicaid funds to “report and return” said overpayment to HHS, the State, or another party if appropriate within sixty (60) days of the “date on which the overpayment was identified.” See, 42 U.S.C. § 1320a-7k(d)(1).  A violation of this so-called “Sixty-Day Rule” is a per se violation of the False Claims Act (FCA) which may lead to treble damages, fines of between $5,500 – $11,000 per claim, and possible imprisonment. Id. § 1320a-7k(d).   See, 31 U.S.C. § 3729(a).

Since the ACA’s enactment there have been serious questions raised by providers regarding when an “overpayment” is “identified” for purposes of starting the clock under the Sixty-Day Rule. Finally, on February 11, 2016, CMS released a final rule, effective March 14, 2016, (the “Final Rule”) which clarifies that : (1) the 60 day window for refunding overpayments is not triggered until both the fact and amount of an overpayment are known; (2) the standard for knowledge is not “actual knowledge,” but when the provider would have identified the overpayment had it exercised reasonable diligence; and (3) the manner in which the refund must be made.

Prior to this Final Rule, it was unclear when the 60-day period began to run, leaving courts to interpose their own interpretation of the ACA in this regard. As we have previously discussed on this blog, U.S. ex rel. Kane v. Continuum Health Partners, No. 11 Civ. 2325, 2015 WL 4619686 (S.D.N.Y. Aug. 3, 2015), addressed that very issue.  In Kane, three hospitals received payment for Medicaid claims that should never have been submitted.  In September 2010, auditors from the New York State Comptroller’s office raised the potential overpayments and determined that these claims were caused by a third-party’s software glitch. The glitch was fixed in December 2010.  The hospitals’ management asked relator Robert Kane to identify claims potentially implicated by the glitch. On February 4, 2011, Kane wrote an email to management attaching a spreadsheet of approximately 900 claims totaling over $1 million that had potentially been affected by the glitch.  Four days later, Kane was terminated, allegedly in retaliation.

Kane filed an FCA and wrongful termination suit on April 5, 2011, which is exactly 60 days after he provided his spreadsheet. In June 2014, the United States government and New York Attorney General intervened on Kane’s behalf, alleging that by failing to further investigate the potential overpayments identified by Kane and delaying repayment for over two years, the hospitals improperly withheld “overpayments” in violation of the Sixty-Day Rule.

The hospitals moved to dismiss, stating that Kane’s spreadsheet had not identified any overpayment for purposes of the ACA, but was merely preliminary. Further, they claimed that because the overpayments had not been definitively ascertained, the sixty-day clock did not start and that they had no obligation to begin repayment for claims until they determined with certainty that those claims had, in fact, been overpaid, and to what extent.

The District Court rejected this argument, and held that the 60-day period begins to run when a provider is put “on notice of a potential overpayment, rather than the moment when an overpayment is conclusively ascertained.” If left as precedent, this would have dramatically lowered the knowledge requirement to sustain a violation of the Sixty-Day Rule, potentially exposing Medicaid providers and suppliers to a myriad of liability under the FCA for “overpayments” not repaid within sixty days.  CMS’s Final Rule changes this, clarifying that the 60-day period for refunding overpayments is not triggered until both the fact and amount of an overpayment are known. The CMS final rule also stated that the standard for knowledge is not “actual knowledge,” but when the provider would have identified the overpayment had it exercised reasonable diligence.  While providers must act with due alacrity to investigate possible overpayments, they need not fear that mere possibility of an overpayment will lead to liability under the FCA unless it is repaid within sixty days.

Although it remains to be seen how the court will apply the Final Rule under the facts and circumstances of Kane, it seems likely that the defendants will renew their motion to dismiss armed with CMS’s new interpretation set forth in the Final Rule.

Supreme Court of the United States to Decide Fate of Federal ACA Subsidies

The Affordable Care Act’s future is again before the U.S. Supreme Court. Today, the Court agreed to review the Fourth Circuit’s decision in King v. Burwell, which this past July upheld the provision of taxpayer-funded subsidies for low income families and individuals seeking to purchase health insurance on one of the thirty-four federally-run exchanges. Approximately 4.7 million people, or 86 percent of all enrollees, qualified for a subsidy in 2014.  The sixteen state-run exchanges will not be affected by this decision.

King was decided the same day as Halbig v. Burwell.  In that case, a three-judge panel of the D.C. Court of Appeals found that the IRS exceeded its authority by establishing the federal exchanges.  This split between the D.C. and Fourth Circuits was resolved in September when the D.C. Circuit vacated the three-judge panel’s ruling and agreed to rehear the case with all eleven judges of the court on December 17, 2014.

As we previously discussed, at issue in both cases is the ACA’s statutory language that authorizes subsidies in the form of tax credits for health insurance bought “through an exchange established by the State.” (emphasis added).

Four justices must agree for a case to be reviewed by the Supreme Court.  In this situation where there is no obvious split among the lower courts on the issue, the fact that four justices voted to take this case may indicate skepticism of the Fourth Circuit’s decision upholding the subsidies.   A decision is expected by June 30, 2015 when the Court’s term officially ends.

CMS to Propose Revisions to the Safe Harbors under the Anti-Kickback Statute, and to the Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing

It is anticipated that today the Center for Medicare and Medicaid Services (“CMS”) will publish in the Federal Register a set of proposed rules that would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (“CMP”) rules under the authority of the Office of Inspector General.

The proposed rules will seek to add new safe harbors consistent with statutory provisions of the Medicare Prescription Drug, Improvement and Modernization Care Act, Pub. L. No. 111-148, and the Patient Protection and Affordable Care Act, Pub. L. No. 111-152.  In particular, CMS seeks to amend 42 C.F.R. 1001.952 to make the following changes:

  • a technical correction to the existing safe harbor for referral services;
  • protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries; and waivers of cost-sharing for emergency ambulance services furnished by State- or municipality owned ambulance services;
  • protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • protection for free or discounted local transportation services that meet specified criteria.

Additionally, CMS seeks to amend the definition of “remuneration” under the CMP regulations at 42 C.F.R. 1003 by adding certain exceptions for:

  • copayment reductions for certain hospital outpatient department services;
  • certain remuneration that poses a low risk of harm and promotes access to care;
  • coupons, rebates, or other retailer reward programs that meet specified requirements;
  • certain remuneration to financially needy individuals; and
  • copayment waivers for the first fill of generic drugs.

CMS also propose to codify the gainsharing CMP set forth in section 1128A(b) of the Social Security Act.

For further information please refer to the Proposed Rule which is available here and which it is anticipated will be officially published to the Federal Register on October 3, 2014. Comments on the proposed amendments will be due within 60 days of the publication of the proposed rules.

D.C. Circuit to Reconsider Key ACA Subsidy Provision En Banc, Any Possible Review by SCOTUS Unlikely Until 2015 at the Earliest

As we discussed approximately six weeks ago, two separate federal appeals courts reached opposite conclusions regarding a key provision of the Affordable Care Act (ACA) that makes subsidies available to individuals who purchase coverage through federally-run exchanges in thirty-six states.  Opponents of the ACA have argued that the tax credits and other subsidies are only authorized in exchanges “established by the State,” not the federal government.

On July 22, 2014, in Halbig v. Burwell, the D.C. Circuit Court of Appeals agreed with the challengers’ position, concluding that “the ACA “unambiguously restricts” the section 36B subsidy to insurance purchased on Exchanges ‘established by the State.’”    Later that same day, the Fourth Circuit Court of Appeals issued a unanimous contradictory ruling in King v. Burwell, a separate case that raised the same challenge to subsidies provided through federally-run exchanges.  In King, the court remarked that challengers could not “rely on our help to deny to millions of Americans desperately-need health insurance through a tortured, nonsensical construction of a federal statute whose manifest purpose, as revealed by the wholeness and coherence of its test and structure, could not be more clear.”

On September 4, 2014, the D.C. Circuit Court of Appeals granted the Government’s request that the entire eleven-judge panel (composed of seven Democratic and four Republican appointees) rehear the case.  Argument is scheduled for December 17, 2014.  A decision can be expected sometime in early/mid-2015.  In addition to Halbig and King, identical challenges to the ACA subsidy provision are before courts in Oklahoma and Indiana.

This recent order by the D.C. Circuit diminishes the immediate likelihood of a review by the Supreme Court, which is unlikely to intervene unless there is an obvious clash among Courts of Appeals.  If the D.C. Circuit aligns itself with the Fourth Circuit, there would be no obvious reason for the Supreme Court to take up this issue unless the other cases raising this challenge to the ACA create a split with the Seventh (which includes Indiana) or Tenth (which includes Oklahoma) Circuit.  On the other hand, if the D.C. Circuit affirms its earlier ruling sometime in the first half of 2015, that issue would not likely reach the Supreme Court this term which ends June 30, 2015, but might be considered during the 2015-2016 Term.  This has the potential to once again propel the ACA into the spotlight just in time for the November 2016 Presidential election.

The Affordable Care Act – Proof of Eligibility

One of the most significant provisions in the Patient Protection and Affordable Care Act (a/k/a “Obamacare”) is the requirement that every citizen or legal resident of the United States, with few exceptions, have suitable health coverage. For persons not covered by employer-provided healthcare, coverage can be obtained from the Health Benefit Exchange in their state of residence, primarily through

As everyone knows, suffered numerous technical difficulties during the initial 90 days of operation. Certain problems continue including the ability to verify whether a person is eligible to obtain coverage from a Health Benefit Exchange. When the initial enrollment period ended in April 2014, approximately 1,000,000 people had insurance applications with inconsistencies.

Many of these cases have been resolved, but a significant number of persons have not responded to requests for documents to verify their eligibility. On August 12, 2014, letters were mailed to 310,000 persons by the Center for Medicare and Medicaid Services (“CMS”) requesting documentation by September 5. Officials at CMS stated that beginning on September 30, CMS would start to notify insurers to discontinue the policies of persons who fail to provide the requested documentation. With the passage of today’s deadline the coming weeks will tell whether CMS carries out their threat and begins contacting insurers to discontinue policies.