Regulatory Alert: CMS Announces New Flexibilities

Originally published on March 31, 2020 in MGMA’s Washington Connection
Reprinted with permission from MGMA

Last night, the Centers for Medicare & Medicaid Services (CMS) issued a series of temporary regulatory waivers to further support the ability of the nation’s healthcare system to respond to COVID-19. The changes outlined below will take effect immediately across the entire country:

• New telehealth codes. CMS will pay for 80 additional telehealth codes, including home visits, emergency department visits, and therapy services. Providers can waive copayments for all telehealth services for Original Medicare beneficiaries.
• Virtual check-ins. Clinicians can provide virtual check-in services (HCPCS G2012, G2010) to both new and established patients. Previously, these services were limited to established patients only.
• Telephone codes. CMS will reimburse for telephone evaluation and management services provided by a physician (CPT 99441-99443) and telephone assessment and management services provided by a qualified nonphysician healthcare professional (CPT 98966-98968). These codes are only available to established patients but may be furnished using audio-only devices.
• E-visits. Licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists can provide e-visits (HCPCS G2061-G2063). These codes are only available to established patients and must be initiated by the patient.
• Removal of frequency limitations on Medicare telehealth. Subsequent inpatient visits (CPT 99231-99233), subsequent skilled nursing visits (CPT 99307-99310), and critical care consult codes (CPT G0508-G0509) no longer have limitations on the number of times they can be billed.
• Medicare physician supervision requirements. Physician supervision can be provided virtually using real-time audio/visual technology for services requiring direct supervision by a physician or other practitioner.
• “Stark Law” waivers. CMS is implementing waivers that exempt providers from sanctions for noncompliance of certain Stark Law rules, permitting certain referrals and the submission of related claims that would otherwise violate the Stark Law.
• MIPS flexibilities. CMS will allow clinicians adversely affected by COVID-19 to submit an application to request reweighting of the MIPS performance categories for the 2019 performance year.

MGMA Government Affairs will continue to educate medical groups as the Administration releases additional waivers and further guidance on COVID-19 related regulatory changes. For a comprehensive list of Medicare telehealth waivers and regulatory developments, please click here.

Can an Audit or Regulatory Proceeding Really Happen to You? Yes it can.

By Stephanie Dozier and Austin Marshall

2019 Alliance sponsor feature article courtesy of MagMutual

Regulation of the healthcare industry is increasing. Almost every aspect of a medical practice is now regulated, including interactions with patients, employees, vendors, and even how you bill for your services.

Though the headlines are filled with articles about million dollar settlements between the government and providers, hospitals, or pharmaceutical companies, no one thinks it will happen to him or her.

What if it does? Do you have a plan in place for when you receive a large audit demand, subpoena or civil investigative demand (CID)? What will you do if you receive a six-figure recoupment demand for billing errors from a government auditor?

Don’t wait until it happens to have a plan in place.

You’re Being Audited, Now What?

Understanding how the audit process works and having a knowledgeable person guide you through it is essential. The government and its audit contractors do not discriminate on specialty, size or location when mining your billing data for possible errors. The auditors are looking for a wide variety of mistakes or intentional deceit. These items include things like upcoding, (using a higher paid code in place of a lower code), incorrect or inadvertent mistakes in coding, or lack of documentation.

Routine audits can quickly turn into large repayment demands from payers. These demands should not be paid automatically. You may want to consider the appeals process.

There are five steps in the appeals process:

1. Redetermination – Typically, this can be done in-house if the organization or provider has trained personnel to prepare the appeal; however, it’s recommended that you engage counsel as soon as you get the audit.
2. Reconsideration – This is a request by the organization or provider to have the data reviewed by a Qualified Independent Contractor who was not involved in the redetermination. It is advisable at this stage to obtain the help of an experienced healthcare attorney. The reason for the appeal and all supporting data should be presented.
3. Administrative Law Judge (ALJ) Hearing – At this level, the case will be heard by an administrative law judge. There are significant delays at this level due to the backlog of cases. It could take two to three years for the case to be to be heard. Only certain cases which meet the dollar amount threshold can be appealed at this level.
4. Appeals Council Review – At this level a Medicare appeal council will review the ALJ decision and make a decision.
5. Judicial Review in Federal Court – Only certain cases with a minimum dollar amount make it to this level, the court will review the Appeals Council’s Review and make a determination.

The appeal process can be timely and costly and there are time constraints involved in each step. These steps must be followed or you could inadvertently lose the ability to appeal to the next level. Be prepared and have a team in place that is ready to respond should you receive a demand for repayment.

What to do When You Receive a CID

A subpoena or CID typically comes from the US Department of Justice or HHS-OIG and is a formal legal inquiry that must be responded to appropriately and timely. These are typically related to allegations pertaining to the False Claims Act, Stark Law, or Anti-Kickback Statute. Your organization should immediately contact legal counsel and your insurance carrier upon receipt of a subpoena or CID. If you receive a CID or subpoena you must preserve all data and documents or your defense could be jeopardized.

If documents or data are destroyed, additional penalties may apply.

Having a knowledgeable attorney is key to a successful response to a subpoena or CID.

Staying Ahead of a False Claims Act Investigation

Many times a False Claims Act (FCA) investigation may have already begun by the government long before you become aware. If there is a whistleblower, (also known as a Relator), then the case must be kept confidential for a set time to allow the government time to investigate before you are notified.

Some of the common types of FCA cases in the healthcare industry involve:

• Billing for items or services not provided
• Billing for items or services (not medically necessary)
• Inflated billing (upcoding)
• Stark Law or Anti-Kickback Statute violations

These matters can result in significant recoupment amounts and fines and penalties imposed by the government. Penalties can range from $11,181 to $22,363 for each false claim plus three times the amount of damages because of the false claims.

There are some steps you can take to minimize your risk for an audits or regulatory proceedings:

1. Have a billing and coding compliance program that is continually reviewed
2. Provide yearly coding education
3. Hire properly trained and certified billing and coding staff and ensure that they have access to continuing education
4. Have open communication with staff and a process for reporting any improper billing
5. Engage a consultant to do an audit of the billing and address any deficiencies that are found
6. Work with legal counsel to prepare a voluntary self-disclosure if errors are found
7. Have all contracts reviewed by an experienced healthcare attorney to ensure compliance with all laws and regulations, including the Stark Law and Anti-Kickback Statute
8. Consider purchasing insurance to transfer some of the financial risk for billing errors proceedings and other regulatory proceedings

References:

AAPC. Dustman, Renee. Respond to a Payer Audit: Not so fast! https://www.aapc.com/blog/27005-respond-to-a-payer-audit-not-so-fast/ March 1, 2014.

Sheppard Mullin. Loveland, Christopher and Couvillon, Christine. You’ve Been Served – What to Do When You Receive an Agency Subpoena or CID (Part II). https://www.fcadefenselawblog.com/2016/10/youve-been-served-what-to-do-when-you-receive-an-agency-subpoena-or-cid-part-ii/ October 24, 2016.

American Bar Association Health Law Section. Navigating the Perilous Waters of the False Claims Act from Medical Necessity to the Anti-Kickback Statute and Beyond. https://www.americanbar.org/content/dam/aba/events/health_law/2015_Meetings/DocLaw/Slides/12_panel_01.authcheckdam.pdf

Medical Practice Issues to Watch in 2019

Originally published in the January 9, 2019 issue of MGMA’s Washington Connection
Reprinted with permission from MGMA

2019 promises to be another busy year in healthcare. The 2018 midterm elections shifted the balance of power in Washington as Democrats now hold the gavel in the U.S. House of Representatives, creating a divided Congress with the Republican-held Senate. MGMA has identified the following legislative and regulatory issues critical for medical practices in the coming year. We will keep members apprised of key developments in these areas and their impact on medical practices and will continue to advocate for policies that enable practices to thrive in their mission to furnish high-quality, cost-effective patient care.

1. HHS doubles down on risk

Despite an anemic pipeline of new voluntary Medicare alternative payment models (APMs) trickling out of the Department of Health and Human Services (HHS), Secretary Alex Azar is planning a new approach to accelerate participation in risk-based APMs. Forgoing incremental implementation, the Secretary is expected to unveil new mandatory models in 2019 and to emphasize performance-based risk as a necessary component of any new APM.

MGMA strongly supports voluntary participation in APMs when it makes financial sense for individual practices and disagrees with the Secretary that the way to expedite the move to value-based care is to mandate participation. We will continue to advocate for new opportunities for practices to participate in voluntary APMs and for development of more physician-led models.

2. Regulatory relief from government burdens

It is expected that Congress and the Administration will continue to work toward reducing the regulatory burden on medical practices participating in government healthcare programs. The Centers for Medicare & Medicaid Services’ (CMS’) “Patients Over Paperwork” initiative is one such example. However, this has translated into only modest relief for practices thus far, as 88% of MGMA members polled reported an increase in overall regulatory burden last year. MGMA will continue to make regulatory relief a top advocacy priority in 2019. Keep up with our efforts at mgma.com/regrelief.

3. Kicking back the Stark Law

As part of the effort to accelerate payment innovation, HHS leaders pledge to revisit antiquated fraud and abuse rules such as the Stark Law and Anti-Kickback Statute. In 2019, watch for proposed rules that expand exceptions and safe harbors to protect value-based arrangements and benefit providers willing to take on performance-based risk.
While a push to simplify Medicare compliance rules is welcomed, it is likely that congressional intervention will be necessary to achieve meaningful reform. It remains to be seen if Congress will also prioritize this issue in 2019.

4. Surprise! Here is a medical bill you didn’t expect

Medical practices can expect to see a push to curb surprise medical bills, including efforts to empower patients and consumers through improved access to healthcare cost information. The sticker shock of surprise hospital bills continues to make headlines and draw bipartisan attention in Congress, making this issue ripe for legislative action in 2019.

5. A spoonful of new regulations to help drug prices go down

With a new Congress and support from the Administration, reducing Medicare drug prices is on the action list for 2019. For physician-administered drugs, one proposal seeks to curb the price of drugs in Part B by tying prices to a new International Price Index, create new private-sector vendors to supply practices with drugs, and set drug administration cost as a flat fee. CMS is also looking to give Part D drug plans greater flexibility to negotiate drug prices in protected classes.

6. The stakes are higher in MIPS

Implementation of the Merit-based Incentive Payment System (MIPS) continues to ramp up. In 2019, MIPS performance will determine whether clinicians receive a positive or negative payment adjustment of up to 7% on 2021 Medicare reimbursement. Medicare is accelerating cost accountability for MIPS clinicians by increasing the cost component to 15% of the overall MIPS score and introducing episode-based measures. The performance threshold required to avoid a payment penalty also doubles from 15 to 30 points in 2019. With more on the line this year, it is critical that MGMA members prepare their practices for success. Visit mgma.com/macra for helpful resources.

7. Data interoperability a priority for feds

The Office of the National Coordinator for Health Information Technology (ONC) is expected to release regulations to meet requirements of the 21st Century Cures Act and facilitate improved data sharing between healthcare entities. ONC will define and seek to discourage “information blocking,” develop a framework to facilitate data movement between heath information exchange entities, and release specifications for the use of apps to foster data exchange between different providers and between providers and patients. The goal of using apps, a component of MIPS and Stage 3 Meaningful Use, is to permit practices to efficiently and securely move administrative and clinical data via their EHR.

8. Cybersecurity continues to be a top practice concern

Medical practices can be a prime target for phishing and other cybersecurity attacks because they possess valuable information assets (patient clinical and financial data) and often have inadequate cybersecurity protections. HHS’ HIPAA enforcement arm is expected to ramp up audits and fines in 2019. Medical practices should protect both their data and business continuity by completing a comprehensive risk assessment, identifying vulnerable areas of the organization, and taking the steps necessary to mitigate risk. Check out MGMA security resources to prepare your practice this year.

9. Site-of-service payment differentials remain a target

Policymakers will continue the trend toward site-neutral payments with the goal of equalizing Medicare payments for the same services across clinical sites. Medicare expanded this policy through 2018 rulemaking by phasing-in payment reductions for clinic visits at hospital outpatient departments (HOPDs), including HOPDs excepted from previous site-neutral payment rules. In addition to saving money for patients and the government, site-neutral payments are viewed as a policy lever for increasing market competition, eliminating the incentive for hospitals to purchase freestanding clinics and leveling the playing field.

10. “Repeal and replace” is out, “Medicare for all” is in

This shift in power within Congress will recast the role the federal government plays in healthcare in 2019. With “Medicare for all” a key platform for many progressives during the 2018 primaries, the politicized debate over a single-payer health system shows no signs of slowing down and will likely gain steam ahead of 2020 elections.
Passage of any major health reform bill is highly unlikely anytime soon. However, as presidential contenders begin campaigning for the 2020 primaries, universal healthcare will almost certainly become a point of debate.

Washington Report from MGMA

The following information was originally published in the February 3, 2016 issue of MGMA’s Washington Connection
We are reprinting with permission from MGMA

Why all practices should submit a hardship exception to avoid the 2017 Meaningful Use penalty
MGMA updated its member-benefit resource, Overview of the Final Requirements for Meaningful Use – 2015 through 2017, to assist members applying for the 2017 hardship exception. MGMA encourages all eligible professionals (EPs) subject to the 2017 Medicare Meaningful Use penalty to apply for the hardship exception. The Centers for Medicare & Medicaid Services (CMS) recently stated that it will broadly accept hardship exceptions due to the delayed publication of program regulations and will require no supporting documentation if the application is submitted by March 15, 2016. In addition, CMS is now permitting group practices to submit one application for all of its EPs. As a reminder, applying for the hardship exception will not prevent an EP from earning an incentive, and EPs attesting that they have met the requirements for the 2015 Meaningful Use reporting period should still apply for the hardship exception.

For more information, access the CMS hardship exception instructions and application form.

MGMA to Congress: Fix Stark Law
Last week, in response to a solicitation for comments on the Stark Law, MGMA called on the Senate Committee on Finance and the House Committee on Ways and Means to seriously consider full repeal of the law, or, at a minimum, repeal of the confusing compensation relationship provisions. The notoriously complex law impacts the ability of practices to deliver ancillary services and regulates how physicians are compensated within group practices. In the letter, the Association emphasizes the inherently confusing nature of the law and how it never accomplished its original purpose of establishing clear compliance standards for the federal Anti-Kickback Statute and creating “bright line” standards that could be generally understood, easily implemented and equitably enforced. MGMA also questions whether such stringent regulation of physician financial incentives remains relevant or necessary in today’s modern, more value-based Medicare reimbursement environment. MGMA will continue to iterate its concerns with the Stark Law to Congress and track progress closely, reporting any updates through the Washington Connection.

CMS issues proposed changes to update Shared Savings ACO cost benchmarks
Last week, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would, among other changes, modify the methodology used to measure performance in the Medicare Shared Savings Program (MSSP) for Accountable Care Organizations (ACOs).

In the MSSP, ACOs can share in savings earned if they meet certain cost and quality benchmarks. One of the common criticisms with the current methodology is that CMS measures an ACO’s cost performance by comparing its historical cost performance to a benchmark based on national spending trends. Under the proposed rule, CMS would instead use regional spending trends to establish the benchmark. The MSSP’s current methodology of comparing savings to the same historic baseline also makes it difficult for ACOs to continue achieving high cost savings and meet cost benchmarks over time. The proposed rule would instead base the benchmark on a percentage difference between ongoing fee-for-service spending and the ACO’s historical spending, making it easier for ACOs to meet benchmarks and achieve continued success in the program.

The MSSP is currently in its fourth program year and up to this point has yielded mixed results. While it has grown gradually in size each year to 434 participants in 2016, over one-third of ACOs in the program exited in 2015. MGMA is reviewing the proposed rule and plans to respond to CMS within the 60-day comment period.