Another Delay in Implementation of the Medicare Part D Prescriber Enrollment Rule

The Centers for Medicare and Medicaid Services finalized a rule in March 2014 that required healthcare providers prescribing medication, where the prescription is paid for by a Medicare Part D plan, to enroll in Medicare as a prescriber. The enforcement date has been delayed several times and was slated to take effect on February 1, 2017, but has recently been delayed again until January 1, 2019.

 

Under the final rule, if a provider is not enrolled in Medicare as a prescriber, the patient’s prescribed drugs will not be covered by the Part D plan. Part D plans will be required to notify patients that the prescriber is not enrolled and the plan will not cover prescriptions from that provider. The most recent delay is aimed at ensuring that prescribers are aware of the rule and reduce the immediate burden placed on the estimated 250,000 prescribers not enrolled in Medicare and the 5.25 million beneficiaries that would be impacted.  

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Healthcare Entities Required to Post New Non-Discrimination Notice

The Patient Protection and Affordable Care Act (ACA) prohibits health care entities from discriminating on the basis of race, color, national origin, sex, age, or disability. The ACA prohibition on discrimination applies to covered entities, which means those healthcare entities that receive federal financial assistance through the Department of Health and Human Services (HHS). For example, a covered entity includes a physician or pharmacy that accepts Medicare or Medicaid, health insurers that offer a plan on the healthcare exchange, and any entity that offers a Medicare part D plan.

In an effort to enforce the non-discrimination law, HHS issued a new rule in May of 2016 that requires all covered entities to post new non-discrimination notices. Although the rule was finalized in May of 2016, health care entities had until October 16, 2016 to post a new notice of non-discrimination. The new notice must state that the health care entity does not discriminate, that language assistance for the patient is available, and delineate how an individual can file a discrimination complaint with HHS. The new notice is intended to decrease discrimination by helping consumers become more aware of their rights.

For further information or to find example HHS non-discrimination notices, visit the following link:
http://www.hhs.gov/civil-rights/for-individuals/section-1557/translated-resources/index.html

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Final Regulations Issued for Non-Discrimination in Health Programs

Section 1557 of the Patient Protection and Affordable Care Act (ACA) allows the Secretary of Health and Human Services (HHS) to issue regulations pertaining to non-discrimination. Earlier in May of 2016, the Secretary of HHS issued such regulations, which bans the denial of healthcare or health coverage to individuals on the basis of race, color, national origin, sex, age, or disability.

This final rule, the first federal civil rights law that broadly prohibits discrimination on the basis of sex, applies to any federally funded health plan. Although the law prohibits discrimination based upon sex, HHS failed to fully define certain issues, such as whether this covers discrimination based upon sexual orientation. However, HHS’s Office for Civil Rights (OCR), the agency tasked with enforcement, has stated an intention to review all claims in this area to determine whether the discrimination can be addressed under the regulations.

This rule will become effective on July 18, 2016, and will be enforced by OCR. Although OCR is tasked as a primary regulator, compliance burdens will fall to all entities covered by the new regulations, as well as individual citizens because the regulations include a private right of action for violations. Further details can be found at the following link. https://federalregister.gov/a/2016-11458

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Pending Increases for False Claims Act Civil Penalties

The False Claims Act (“FCA”) creates a civil penalty for any person that knowingly submits for payment a false or fraudulent claim to the federal government. This usually includes any government contractor, but will often arise in the healthcare industry. In 2015, for example, the federal government collected over $3.5 billion resulting from these civil penalties, with approximately $1.9 billion from the healthcare industry.

In December of 2015, the Bipartisan Budget Act was enacted and it included a section titled the Federal Civil Penalties Inflation Adjustment Act Improvements Act (“Act”). This Act amends a prior 1990 act, requiring inflation adjustments to the civil penalties in the False Claims Act. Due to the length of time between the last adjustment, the Act requires a catch-up adjustment and annual adjustments thereafter. The Act is slated to be implemented at all federal agencies by July 1st, with the new rates to take effect by August 1st of 2016.

The first federal agency to issue an interim final rule to implement the catch up adjustment was the Railroad Retirement Board, doing so on May 2, 2016. The interim rule changed the minimum FCA civil penalty from $5,500 per violation to $10,781 per violation, nearly doubling the per violation penalty. As the other agencies look to implement this rule, such as the Centers for Medicare and Medicaid, similar increase are expected. For those working on a government contract, especially those submitting claims to the government in the healthcare industry, taking due care in compliance efforts will be magnified because of the pending increases in FCA civil penalties.

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Delay Announced in CMS Star Rating System for Hospitals

Originally, the Centers for Medicare and Medicaid Services (CMS) intended to release a star rating system on hospitals, beginning April 21, 2016. However, CMS recently announced plans to delay the rating system until July, or potentially later. The exact timing will depend upon the development of the methodology for rating a hospital.

When the star rating system was designed, the purpose was to create a simple tool for consumers to evaluate hospitals. This system largely incorporated the previous, more complicated, performance measures that follows more than 100 quality measures. While the new star system will not replace the more complicated system, it will be in addition to the prior measures and make the review process simpler for consumers. The new star system incorporates factors such as readmission rates, mortality rates, timeliness of care, safety of care, and other patient driven statistics.

The delay is largely attributed to hospital and lawmaker complaints that the new rating system will impact consumer perceptions, when it may not have a direct bearing on the specific services sought. Moreover, a concern regarding the quality of the data, including the methodology for ensuring accuracy, remained a significant worry for the hospitals. It is unclear when the star rating system will be implemented, but hospitals and consumers should expect further information, if not the unveiling of the star rating system, this summer.

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Moratorium on Health Insurance Tax

As part of the omnibus budget bill passed by Congress and signed by the President in December of 2015, Congress implemented several delays for pending taxes under the Patient Protection and Affordable Care Act (PPACA). These delays impact the medical device tax, the “Cadillac” tax on high-cost employer health plans, and tax on health insurers.

The tax on health insurers has been delayed for one year and this moratorium is aimed at reducing the potential premium increases to consumers. This delay is for the tax due in 2017, but will have no impact on either the amount or the timing of the tax due in 2018, for calendar year 2017. The “Cadillac” tax and the medical device tax were both delayed for two years.

The health insurance industry reported that the insurer tax could have forced the health insurers to raise premiums by 3% to 4% every year. However, this delay should temporarily help keep premiums relatively stable for those receiving plans from the health exchanges, employer-based insurance, and Medicare advantage plans.  The Centers for Medicaid and Medicare Services issued a Frequently Asked Questions Memorandum on the delay, which can be found at the following link: https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FINAL_9010_FAQ_2-29-16.pdf

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Final rule on Medicaid Prescription Drug Programs

In January of 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on covered outpatient drugs. The rule changes the Medicaid Drug Rebate Program by the Patient Protection and Affordable Care Act (PPACA) and the overall Medicaid drug reimbursement program.  These changes have several goals, including reducing the cost to the federal and state governments and improving beneficiary access to covered outpatient drugs.

CMS claims the changes implemented will help the government save money in the Medicaid Drug Rebate Program, which had been subject to sustainability issues. One key change in the final rule is a definition of the Average Manufacture Price, which in turn gets used to determine rebates and pharmacy reimbursements subject to the federal upper limit. Similarly, the changes to the federal upper limit formula will incentivize pharmacies to use certain generic drugs. The final rules clarify many of the ambiguous sections of the Medicaid Drug Rebate Program by the PPACA, including the manufacturer reporting requirements. The rule also aligns the pharmacy reimbursement system with the actual acquisition cost of the drug.

Overall, the new incentives and changes should improve the reimbursement system and help manage drug costs. This rule becomes effective April 1, 2016, although CMS is allowing comment for 60 days after publication on certain elements of the rule. The new rule can be found at the following link:

https://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol4/pdf/CFR-2014-title42-vol4-part447.pdf

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IRS issues final regulations on employer sponsored health insurance

In December of 2015, the Internal Revenue Service (IRS) issued final regulations that addressed some of the questions pertaining to whether employer sponsored health insurance meets the Patient Protection and Affordable Care Act minimum value requirements.  Amongst a variety of miscellaneous items pertaining to minimum value, the final regulations clarify the impact of a health reimbursement arrangement (HRA) on affordability. The regulations also clarify some of the rules regarding eligibility for the health insurance premium tax credit.

Under the final regulations, the new amounts made available by an employer to an employee in a HRA that can be used to pay health insurance premiums, when the employer also offers qualifying health coverage, will be counted towards affordability. Similarly, if the new amounts are available to an employee in a HRA integrated with qualified employer coverage, and the new amount can only be used to reduce cost-sharing, that new amount will be counted for minimum value purposes.

The health insurance premium tax credit had rules finalized in the same regulations. One rule includes the eligibility of a household that has income from a child. The premium tax credit is based on household income and when a parent includes a child’s income on their income tax return for tax credit eligibility purposes, the amount used is the child’s modified adjusted gross income, not the gross income reported on the child’s tax return.

The final regulations also addressed the impact of wellness incentives on the health insurance premium tax credit. The regulations clarify that wellness incentives that reduce the cost of health insurance premiums to an employee will not be included in the calculation for minimum value or affordability, instead the regulations assume the employee will not qualify for the incentive. This rule has one exception, which is if the incentive is based on tobacco use. If so, the regulations assume that the employee will qualify for the incentive and the incentive can be used in the minimum value and affordability calculation. Thus, only tobacco use wellness incentives can be used in the minimum value and affordability calculation for purposes of premium tax credit eligibility.

Overall, a variety of miscellaneous rules regarding health insurance were finalized in the regulation. The entirety of the IRS regulation can be found at the following link: https://www.federalregister.gov/articles/2015/12/18/2015-31866/minimum-value-of-eligible-employer-sponsored-plans-and-other-rules-regarding-the-health-insurance

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Physician Conflict of Interest Reporting Requirements

The Physician Payments Sunshine Act was adopted as part of the Patient Protection and Affordable Care Act in 2010. The act allows patients to know if their physician may have an outside motivation when providing care, such as incentives provided by medical product manufacturers. These incentives could include simple monetary payments or any type of transfer of valuable goods. By making this information public, the hope is to ensure that physicians make the best possible decisions for their patients, not their own personal interests.

The Act requires physicians to disclose to the Centers for Medicare and Medicaid Services (CMS) any payment or “transfer of value” made to the physician or teaching hospital by a medical product manufacturers. This Act also requires a group purchasing organization or medical manufacturer to disclose any physician ownership. The information is then published online for patients and others to research, with the first set of data published in 2014. Despite the initial publication, CMS withheld some information due to technical difficulties and the outcome of this publicity remains unclear. For 2015 and 2016, CMS implemented changes to the reporting process for physicians as a result of the first release.

Despite the lack of clarity surrounding the outcome of making this information public, some lawmakers are trying to expand the law to include nurse practitioners and others that have prescribing authority. However, at the current time, the law remains limited to physicians, medical product manufacturers, and group purchasing organizations. To view the information and search for physicians, please visit the following website: https://www.cms.gov/openpayments/

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Clarity Emerges for Employer Sponsored Health Insurance Auto-Enrollment Requirement

In early November, 2015, the President officially signed the federal budget that included a repeal of the auto-enrollment mandate contained with the Patient Protection and Affordable Care Act (PPACA) for employers with over 200 employees.

Originally under the PPACA, an employer with 200 or more employees would be required to automatically enroll new employees into the employer-sponsored health coverage. This mandate had never been implemented and was indefinitely suspended due to problems at the Department of Labor in issuing regulations. It was unclear whether it would eventually be implemented, but the official legislative repeal ends this potential issue for employers.

Many aspects of the PPACA continue to change and evolve. As more of the law continues to be implemented, be sure to monitor the evolving requirements for both individuals and health insurance providers.

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