Category: Affordable Care Act

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Graham-Cassidy Proposal Falls Short on Votes While Other Deadlines Loom

Efforts to replace the Affordable Care Act (ACA) with the Graham-Cassidy legislation were unsuccessful as lawmakers rushed to meet the September 30th deadline when the Senate would have lost its current reconciliation vehicle.  Changes to the bill were incorporated in order to gain Republican support from a number of holdouts, but with Senator Susan Collins (R-ME) announcing she will not vote for the current proposal, Senate Republicans conceded today since they were short of the 50 votes required to pass the measure.  Senate Republicans are currently discussing potential paths forward, including future reconciliation vehicles that would allow for ongoing efforts to repeal and replace the ACA. Efforts to stabilize the insurance exchanges were  thwarted by Senator Mitch McConnell (R-KY) in order to advance Graham-Cassidy.

Status of CHIP Program

While all eyes have been on the Graham-Cassidy legislation, funding for the Children’s Health Insurance Program (CHIP) is set to expire on September 30, 2017. Last week, Senators Orrin Hatch(R-UT)) and Ron Wyden (D-OR) of the Finance Committee agreed to a five year reauthorization of CHIP.  However, there is no guarantee that the House will support their proposal. CHIP has been introduced as a part of the “Keep Kids Insurance Dependable and Secure Act of 2017” and, if passed, would fund the CHIP Program through federal fiscal year 2022.

We will continue to monitor all efforts this week as the September 30th deadline looms.

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Senate Sets Timeline to Take up Repeal and Replace Legislation on ACA

With Congress returning to Washington, D.C. from its Memorial Day work period, Senators are focusing heavily on the timeline and details of legislation that would significantly alter the Affordable Care Act (ACA). Over the last week, many senior Senators have expressed skepticism regarding whether they can pass a bill, but Senate Republican Leader Mitch McConnell (R-KY) has laid out an aggressive timeline. Specifically, he would like the chamber to vote on a bill before the July 4th recess and use the rest of July to reconcile the House and Senate versions, leading to a final vote before the August recess. Congressional Republicans are eager to move beyond health care in order to take up tax reform and FY2018 federal government funding.

The Great Medicaid Expansion Divide

Senate Republicans are in agreement that their bill will be significantly different from what the House passed earlier this year, but that is where consensus ends. The main sticking point is how to appease Senators on both sides of the expansion – states that expanded and those that did not – in order to cobble together 50 votes (with Vice President Pence delivering the 51st). Those that did expand their Medicaid population don’t want to see their expansion population lose coverage, and those that did not expand, believe they are entitled to an additional financial benefit so they are not at a disadvantage as compared to the expansion states.

Achieving the required savings under reconciliation, while appeasing both factions, is proving extremely difficult. At this point, Democrats are not expected to vote for any Senate bill that significantly modifies the ACA so Republicans must rely entirely on their own Conference. Senators are also concerned about the alarming number of Americans projected to lose coverage under the House passed bill, and are developing a plan that would provide more generous tax subsidies for purchasing coverage. At this point, there is very little interest in including changes to the Essential Health Benefits package as was done in the House bill.

Still Awaiting the House-Passed Bill

In an interesting twist, the Senate parliamentarian is still in the process of reviewing the House-passed bill to make sure it does not violate Senate rules. Therefore, the legislative vehicle has still not officially been delivered to the Senate from the House. A ruling is expected this week.

Stay tuned for further updates as we eagerly await the first draft of the Senate bill, which could come as early as this week.

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Republican Health Care Bill Moves Forward to the Senate

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In a surprising reversal, last week the U.S. House of Representatives passed legislation that would significantly modify the Affordable Care Act. The legislation, known as the American Health Care Act (the “AHCA”, H.R. 1628), passed on Thursday with a 217-213 party line vote.  After cancelling an expected vote on AHCA in March, the House Republicans developed additional amendments to the AHCA which ultimately led enough House Republicans to support the bill.

While the AHCA would not fully repeal the Affordable Care Act, it does make significant changes to the insurance markets developed under the Affordable Care Act, and also includes numerous tax provisions and significant modifications to the Medicaid program. A summary of the initial AHCA legislation from early March is available here. The version of the legislation approved by the House of Representatives last week also includes key amendments that were introduced to help secure the votes to move the bill forward:

Amendments that Impact the Insurance Markets

  • Beginning January 1, 2018, would allow states to waive the ACA’s “community rating” (or medical underwriting) prohibitions, thereby permitting insurance companies to charge higher premiums for more complex health conditions.
  • Beginning January 1, 2020, would allow states to modify the ACA’s essential health benefits for plans offered in the state on the individual or group market, allowing such plans to offer more limited benefits, and potentially allowing all plans (including employer-sponsored insurance) to impose lifetime caps on benefits that are not essential health benefits.
  • Modifies the AHCA’s required premium increases for individuals who do not maintain continuous health insurance coverage (defined as all but 63 days in the last twelve months) to allow plans to instead consider the health status of such individuals when setting premiums for one year, but only if the state establishes a high-risk pool or other program to stabilize individual health market insurance premiums.
  • Additional funding for the Patient and State Stability Fund, including $8 billion per year from 2018 to 2023 to states who have applied for and been granted a waiver from the ACA’s community rating requirements. These funds must be used to provide assistance to reduce premiums or other out-of-pocket costs to individuals that:
    • reside in states with an approved waiver,
    • have a pre-existing condition,
    • are uninsured due to not maintaining continuous coverage, and
    • have purchased health care in the individual market.

Medicaid Amendments

  • New option for states to be paid a block grant for adult beneficiaries with dependents and child beneficiaries. The block grant would allow states to draw down the federal block grant funds at an enhanced rate, and would allow the state increased flexibility to reduce eligibility standards, benefits, and other Medicaid requirements.
  • New options for states to condition availability of Medicaid beneficiaries on satisfaction of a work requirement.
  • In addition to phasing out the enhanced federal matching funds for the Medicaid expansion for all states beginning in 2020, would include language prohibiting states that elect to expand after January 1, 2017 from receiving the enhanced matching funds.

Looking Forward

Now that the House has passed the AHCA attention turns to the U.S. Senate. Early Senate reactions indicate they will take some time to decide the best path forward and will write their own bill, rather than work off of the House bill.  While the House and Senate Republicans were working closely together on legislative language when the earlier version of the AHCA was released, that effort was abandoned in recent weeks once the House began to include changes to the ACA’s essential health benefits package and provisions related to coverage for people with pre-existing conditions. Those provisions have been met with opposition from some Republican Senators and are unlikely to be included in a Senate bill, in part because they do not have a federal budgetary impact, which is required when moving a bill under the chamber’s reconciliation rules. Moreover, Republican Senators have publicly stated their opposition to the AHCA’s changes to the Medicaid program and repealing funding for Planned Parenthood. To complicate matters further, Congress loses the ability to use the FY17 reconciliation vehicle once they pass a conferenced FY18 budget resolution. Just this week they have turned their attention to the FY18 budget so the clock is ticking.

Last week’s vote puts many House Republicans in districts which were won by Secretary Clinton on the hot seat for their re-election in 2018.  The dynamic is eerily similar to what occurred in 2009 and 2010 when Democrats passed the Affordable Care Act.

Stay tuned for further updates as we watch the Senate to see what happens to the AHCA and to the ACA.

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Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

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Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that it should result in cost savings as treatment that is unlikely to work for that patient is avoided.

The lack of standardized reimbursement codes and definitions covering precision medicine treatments and services, particularly molecular genetic laboratory tests — when the industry hasn’t even settled on a standard definition of “personalized medicine” — make it difficult for providers to get reimbursed, especially for new or innovative offerings. In order to secure payment from insurers, personalized medicine providers must prove not only the clinical efficacy of their treatments or genetic testing, but also the value they offer to payers. Doing so requires a deep understanding of health care economics.

That formidable landscape provided the backdrop for panel discussion at the Business of Personalized Medicine Summit on March 28 in San Francisco. Moderated by Foley partner Judith Waltz, the discussion carried the title “Moving Targets,” an apt description of a market in the midst of dramatic structural and philosophical change. Even in light of the recent failure of a sweeping health care bill in Congress, the market remains mired in uncertainty. The Affordable Care Act, and other government and payer initiatives, pushed the industry toward value-based reimbursement, and the Obama administration provided vocal support for personalized medicine. Thus far the Trump administration has yet to signal whether it will support continued movement in those directions.

In that environment, Waltz said, the imperative for personalized medicine providers is to recognize and fully understand, at the earliest possible stage, how they’ll make money. “Every personalized medicine business strategy has to identify who the payer will be, and how pricing and reimbursement will work,” she said. “And it has to articulate the product differentiation – because payers often won’t cover it unless it’s better or cheaper than what they’re already doing.”

They’ll also need to have a plan for demonstrating clinical utility in order to meet payers’ evidentiary requirements for coverage, said Mark McCoy, Senior Director, Reimbursement at Guardant Health. In most cases that means building a body of clinical literature, since most payers want to see published data proving either cost savings or cost effectiveness of outcomes.

That has ramifications for sales and marketing, McCoy said. It’s vital to work with providers to set up clinical tests with appropriate utilization and other elements that payers will expect to see – and to keep in mind that providers [physicians who order and rely upon the test that is reimbursed by payers] have little if any financial incentive to use your test. That means, as the business and product evolve, changes must be carefully communicated to providers – who can’t be expected to take pains. “We’ve found you can get good early adoption, but if you change your ordering process a year or two in providers will get frustrated and just drop you,” he said.

Providers also require a lot of education on not only personalized medicine treatments or tests, but on how to apply new evidence to specific patients and how to articulate the results. Amber Trivedi, Senior Vice President, Market Development and Innovation at InformedDNA, said payers want to see that providers are involved, and that puts the impetus on companies to ensure that providers understand how payers define clinical utility and that they document that utility in encounter notes.

Trivedi advised taking a very hands-on approach in dealing with physicians. “You might even have to teach them how to write letters of medical necessity to secure coverage,” she said. “There’s a lot of variation out there in understanding of even the most basic terms.”

Evidence-based review through one of the four established programs also proves extremely helpful when seeking reimbursement, said Anita Chawla, Managing Principal at Analysis Group. The MoIDX program, developed and administered by Palmetto GBA, helps determine Medicare reimbursement – making its determination of clinical utility among the most influential in the industry.

Given that influence, it makes sense for personalized medicine providers to factor in MoIDX criteria and processes when designing clinical studies. “It can save a lot of time downstream,” Chawla said. She pointed to the MoIDX hierarchy – which sets randomized, prospectively controlled trials as the gold standard – as an important road map for companies in the testing-design stage.

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What To Know About New HHS OIG Exclusion Regs

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On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort  a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary penalty (CMP) regulations, 81 Fed. Reg. 88,334 (Dec. 7, 2016), and safe harbors under the anti-kickback statute and beneficiary inducement prohibitions, 81 Fed. Reg. 88,368 (Dec. 7, 2016).

The final rule codifies the OIG’s expanded authority to impose exclusions under the Affordable Care Act and the Medicare Prescription Drug, Improvement and Modernization Act of 2003, including discretionary exclusions for obstructing an audit and for making false statements, omissions, or misrepresentations in an enrollment or similar application to participate in a Federal health care program.

The final rule notices an effective date of Feb. 13, 2017. However, on Jan. 20, 2017, the new administration postponed for 60 days the effective date of all federal regulations that have not yet taken effect. Although agencies may propose additional rulemaking, for regulations that “raise no substantial questions of law or policy,” agencies are not required to take any additional action. Thus, this rule will likely take effect following the 60-day freeze, which ends on March 21, 2017.

The effect of exclusion is far-reaching. Until an individual or entity that has been excluded is reinstated into the federal health care programs, no payment will be made by Medicare, including Medicare Advantage and Prescription Drug Plans, Medicaid or any other federal health care program for any item or service furnished, on or after the effective date. Additionally, private payers frequently refuse to contract with excluded persons.

Although the majority of exclusion are derivative of other actions (such as convictions or licensure actions), exclusions can be pursued affirmatively and initiated by the OIG, often by the OIG’s recently established (2015) administrative litigation team.

Like the two rules before it, this final rule provides important guidance on the OIG’s administrative enforcement authorities and expands and clarifies existing provisions, including aggravating and mitigating factors used to determine the length of exclusions.

Refresher on Exclusions

Before discussing the new provisions, the following is a brief overview of the OIG’s exclusion authorities. The majority of the OIG’s exclusion authorities are set forth in Section 1128 of the Social Security Act, 42 U.S.C. 1320a–7, and are implemented by regulations at 42 C.F.R. part 1001.

Mandatory Exclusions: There are four mandatory authorities and nearly 20 permissive exclusion authorities. As the name suggests, mandatory exclusions must be imposed by the OIG when individuals or entities (persons) are convicted of crimes related to certain conduct, namely: (1) misdemeanor or felony convictions related to the federal health care programs; (2) misdemeanor or felony convictions relating to patient abuse in connection with the delivery of a health care item or service; (3) felony convictions relating to health care fraud (i.e., relating to fraud, theft, embezzlement, breach of fiduciary responsibility or other financial misconduct); and (4) felony conviction relating to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance.

Permissive Exclusions: Sixteen permissive exclusions are listed in Section 1128 and a handful of others can be found in other sections of the Social Security Act. The OIG has discretion as to whether to pursue an exclusion under its permissive authorities.

Convictions and Enforcement Actions Lead to Derivative Exclusions: Even when it is not required to do so, the OIG is likely to exclude a person who has been convicted of a crime or when another government agency, such as a state medical board, has taken action. These derivative exclusion actions are easy for the OIG to impose and defend, making them an efficient way to protect the programs.

Definition of a Conviction: Because a large number of derivative exclusions, whether mandatory or permissive, are based on convictions, it is worth noting that the term “conviction” is broadly defined in the statute at 1128(i), 42 U.S.C. 1320a–7(i). The term includes convictions where conviction or other records have been expunged, pleas of nolo contendere, findings of guilt by a court, and participation in deferred adjudication and similar arrangements where judgment of conviction has been withheld.

Length of Exclusion: Base exclusion periods for the most frequently used exclusion authorities, including those based on convictions or licensure actions, are set forth in the exclusion statute at 1128(c)(3), 42 U.S.C. 1320a–7(c)(3). Mandatory exclusions must be, at a minimum, five years. Permissive exclusions based on convictions have a base period of three years. Permissive exclusions based on licensure or state actions are coterminous with the underlying state sanction. The OIG uses aggravating and mitigating factors to adjust the period of exclusion, but not below five years for mandatory exclusions.

Major Provisions in the Final Rule

In the final rule, the OIG adopted the majority of the provisions included in its proposed rule, 79 Fed. Reg. 26,810 (May 9, 2014), but revised some of its proposals, generally in response to public comment. Like the OIG’s other recent rulemakings, this final rule offers insight into how the OIG may use its exclusion authorities as key components of its administrative enforcement efforts.

The final rule:

  1. Expands permissive exclusion authority, pursuant to the ACA, for convictions related to obstructing an investigation to include “audits,” a term the OIG interprets broadly.
  2. Adds permissive exclusion authority from the ACA for making false statements, omissions or misrepresentations in an enrollment or similar application to participate in the federal health care programs, including Medicare Advantage organizations, Medicare prescription drug plan sponsors, Medicaid-managed organizations, and entities that apply to participate as providers or suppliers in organizations or plans.
  3. Expands the OIG’s authority to exclude a person for failing to supply (or allow the examination of) payment information by the secretary or a state health care program to apply not only to persons who furnishing services, but also to those referring or certifying the need for items or services.
  4. Expands the OIG’s authority to grant waivers of certain exclusions that are requested by the administrator of a federal health care program.
  5. Adds a process for requesting early reinstatement when a health care license has been lost and not reinstated.
  6. Adds a 10-year statute of limitations for exclusion actions.

Enrollment Exclusions Merit Oral Argument: For the newly added exclusion authority for false statements in an enrollment application, the OIG finalized its proposal to allow the presentation of oral argument to an OIG official before the exclusion is imposed, which is consistent with its practice in exclusion actions brought under Section 1001.701 or Section 1001.801, two other exclusions that also are not based on a conviction or other official action and go into effect within 20 days if not contested and prior to an administrative law judge hearing.

Early Reinstatement for License Revocations: The OIG also finalized its proposed process for early reinstatement, which, when certain conditions are met, is available to those that have been excluded based on the loss of a health care license that has not been reinstated. Normally, a person who is excluded due to a loss of license may not be considered for reinstatement until the person has regained the license in the state where it was originally revoked. Historically, that requirement has led to much longer periods of exclusion for persons subject to licensure actions than those who have been convicted of a crime, including convictions mandating exclusion. However, the OIG decided to prohibit persons who lost their licenses for reasons related to abuse or neglect from applying for early reinstatement.

Changes From the Proposed Rule in the Final Rule

Aggravating Factors: In keeping with changes made in its two final rules issued in December, the OIG raised the dollar amount for the aggravating factors related to financial loss from $5,000 and $1,500 to $50,000. The OIG initially proposed to raise the threshold only to $15,000. This change to $50,000 keeps the financial loss aggravating factors consistent among the OIG’s various authorities with one important exception. For exclusions under Section 1128(b)(6) of the act, 42 U.S.C. 1320a–7(b)(6), the OIG retained its proposed $15,000 threshold because those exclusions are based on unnecessary or substandard care, not convictions.

Statute of Limitations: The OIG scrapped its proposal to implement its position that there is no time limitation to exclusions imposed under Section 1128(b)(7) of the act. Many commenters objected to the OIG’s interpretation that no statute of limitations exists for such exclusions. Some argued that even when a statute is silent on periods of limitations, courts often apply some period of limitation. Other commenters noted the administrative burden this would place on providers because they would be required to retain documentation relevant to OIG authorities indefinitely. In the final rule, the OIG adopted a 10-year period, which it notes is grounded in the False Claims Act’s period of limitations, and which it believes will provide certainty to the industry while preserving the OIG’s ability to protect federal health care programs and beneficiaries from untrustworthy persons identified in FCA cases or otherwise.

Convictions Related to Controlled Substances: The OIG also decided against a proposed limit on its exclusion authority for convictions related to controlled substances. The OIG had proposed to limit the exclusion to those who were convicted for conduct that occurred during a time when they were employed in the health care industry. The OIG was persuaded to make the change based on comments noting that the proposal would not protect beneficiaries from those who leave the health care industry before committing a crime but then re-enter the industry shortly thereafter. The OIG also decided not to remove aggravating and mitigating factors associated with the exclusion authority or the exclusion authority related to exclusion from a state health care program.

Ownership and Control Interest in Sanctioned Entities: Several commenters complained that the proposed rule’s language for the exclusion of individuals with ownership or control interest in sanctioned entities exceeded the OIG’s statutory authority. The OIG modified the regulatory text to clarify that in cases where the sanctioned entity has been excluded, the individual’s exclusion will remain in effect for as long as the term of the entity’s exclusion. 82 Fed. Reg. at 4106.

Key Points for Future Exclusion Enforcement

This final rule shows that the OIG continues to evaluate and update its enforcement authorities with an eye toward increased affirmative enforcement actions but that it is also willing to make practical changes to its enforcement policies.

  1. New early reinstatement process is available for those who have been excluded for loss of license, if certain conditions are met, so long as the loss of license was not due to patient abuse or neglect.
  2. The OIG has updated several aggravating factors in the exclusions regulations.
  3. Despite proposing to codify its interpretation that 1128(b)(7) exclusions do not have a statute of limitations, the OIG was receptive to comments that there should be some statute of limitations, and in the final rule adopted a 10-year statute of limitations.
  4. In line with the December updates to the CMP regulations, the OIG included provisions in this rule that highlight the importance it places on protecting beneficiaries. It increased most financial loss aggravating factors to $50,000, except for exclusions based on unnecessary or substandard care, which were increased to a $15,000 threshold. The OIG also finalized a prohibition in its early reinstatement process providing that those who lost a license for reasons related to abuse or neglect are not eligible for early reinstatement.

The final rule, and the underlying exclusion regulations, should be reviewed closely by any individuals or entities that are facing enforcement actions that, depending upon characterization of the underlying conduct, may give rise to mandatory or permissive exclusions. The “Health Care Fraud and Abuse Control Program Annual Report” for fiscal year 2016 (released in January 2017) reports 3,635 exclusions, indicating that OIG is actively applying its exclusion authorities.

Judith A. Waltz is a partner and health lawyer with Foley & Lardner LLP in San Francisco in the firm’s health care practice. Jill S. Wright is a special counsel and health care lawyer with Foley & Lardner in Washington, D.C., in the firm’s health care practice.

Click here for the original article which appeared in Law360.  

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Obamacare in the Cross Hairs — but Procedural Hurdles Loom

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President-elect Trump and congressional Republicans have promised to “repeal and replace” the Affordable Care Act (ACA), but there is deep division regarding which provisions will be rescinded and around the details of the replacement and the length of any transition period.

Last week the U.S. House and U.S. Senate took the first steps toward achieving repeal by passing a budget resolution with reconciliation instructions related to ACA repeal. The reconciliation process allows the Senate to bypass a filibuster and pass legislation with a simple majority. However, only budget-impacted provisions of the ACA can be repealed this way. Further, this year’s budget resolution stipulates that changes must save $1 billion over a ten-year period to be enacted through reconciliation.   While the budget resolution calls for committees to develop language to achieve this by January 27, it may take much longer given the complexity around repeal and replace.

The policy stakes are extremely high, not only because millions of Americans stand to lose coverage if the exchanges and Medicaid expansion are eliminated with no replacement, but also because developing a newly designed system which will inevitably pit health care stakeholders against one another creates significant political ramifications.

While the situation remains fluid, there are a few issues we are watching in the first few weeks of a Trump presidency.

Rolling Back Regulations

Congressional Republicans can also use the appropriations process to de-fund certain parts of the ACA, and President-elect Trump may modify portions of the law by Executive Order. This would jeopardize regulatory actions taken by President Obama, including pilot programs created by the ACA and developed within the Center for Medicare and Medicaid Innovation, which Republicans have accused of exceeding its authority. Other health-related regulations, particularly those finalized in the weeks following the election, may also be on the chopping block.

Carryover of ACA Provisions

While the GOP targets what it believes to be the ACA’s most onerous provisions, many popular insurance reforms — including the prohibition on denials of coverage for pre-existing conditions — are likely to survive. President-elect Trump has voiced support for maintaining some of these so-called insurance reforms, but some Republicans argue that their elimination would give insurers more flexibility in setting prices. Keeping those requirements intact without a coverage mandate would cause severe market disruption.

HHS Confirmation

Mr. Trump’s pick of Representative Tom Price (R-GA) faced severe scrutiny during a courtesy hearing before the Senate Health, Education, Labor and Pensions Committee on January 18. He must clear the Senate Finance Committee, which he will face on January 24, before proceeding to a vote on the Senate floor to secure his confirmation.

Rep. Lamar Alexander (R-TN), chairman of the Senath Health, Education, Labor and Pensions Committee, indicated the Senate  wouldn’t officially confirm Price until mid to late February, so it is unlikely there will be significant legislative movement until March.

Other “Must Pass” Health Care Legislation

While there is a strong impetus to address the ACA, it is not the only game in town. Key health priorities include reauthorizing the Children’s Health Insurance Program (CHIP), set to expire this year. CHIP enjoys bi-partisan support and no one wants to risk getting caught in the political blowback if it is allowed to lapse. While CHIP was not part of the ACA, its reauthorization could get tied up with ACA-related measures, either attached as amendments or following in subsequent bills.

Uncertainty Surrounding Drug Prices

Contrary to what Wall Street and the pharmaceutical industry believed would happen in the wake of the presidential election, President-elect Trump said last week that drug companies were “getting away with murder,” and that the United States — the largest buyer of drugs in the world — doesn’t “bid properly, and we’re going to save billions of dollars.”

The statements roiled markets and stand in stark contrast to the historical position of his party, which has been a reliable ally of the pharmaceutical industry. We will be watching closely to see how he and majority leadership will reconcile their views on drug pricing, if at all.

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