Author: Belmont Health Law

CVS and Aetna Merger

By Brandon Huber, Class of 2019

According to the Wall Street Journal, CVS and Aetna are reportedly in serious talks over a
potential merger between the two healthcare giants. With the potential buyout price in the
ballpark of $70 billion, the deal would not only set the record for the largest merger of any two
companies in 2017, it would easily be considered the largest health provider merger of all time,
shattering Express Scripts’ $29 billion merger with Medco back in 2012.
The deal would combine CVS, currently the largest pharmacy retail chain, with Aetna, the third
largest health insurer provider in the United States. Although both companies have declined to
comment on the negotiations of the deal, there have been reports that a deal could be reached
by the two companies as soon as December. Despite the growing pressure over the last few
years on healthcare providers to consolidate, due in large part to soaring medical costs, a
merger of this size promises to send a shockwave across the entire healthcare industry.
The merger comes on the heels of news that Amazon, the online retail giant, almost certainly
will enter the prescription-drug market as soon as 2019. Although Amazon has not yet
announced any official plans to enter the pharmacy retail business, there can be little doubt
that even rumors of such plans would be enough to motivate CVS, and other pharmacy retail
chains, to find creative ways to expand and grow.
CVS’ buyout of Aetna, at least from the outset, seems to present the perfect opportunity for
both companies to benefit from the deal. On the other hand, however, whether consumers
stand to gain any benefit from the merger remains to be seen. From Aetna’s perspective, the
merger affords the opportunity to provide better care management. Insurers have long
believed that the best way to control rising healthcare costs is to ensure they have more access
into the lives of their beneficiaries. The deal would help Aetna ensure its beneficiaries were
staying on their medicines, getting the care they need at more cost-effective locations—like a
CVS health clinic—as opposed to a more expensive and perhaps unnecessary hospital visit.
Conversely, not only would CVS be able to expand its reach within the healthcare market, the
deal would drive more traffic to its stores as more of Aetna’s insured beneficiaries would seek
preventive care and treatment for less serious medical issues at the clinics located within CVS
stores. Additionally, CVS could expect an influx of customers because Aetna’s beneficiaries
would likely use CVS to get their prescriptions filled.
With that said, however, despite the near guarantee that both parties would benefit
significantly from such a deal, there are some who remain skeptical as to whether the deal will
benefit consumers. According to Amanda Starc, associate professor of strategy at
Northwestern's Kellogg School of Management, CVS’ position as a pharmacy benefit manager would allow the merged companies to negotiate lower drug prices with pharmaceutical
manufacturers. It is unlikely, however, that these newly acquired drug-rates, now available to
Aetna as a result of its newly acquired market power, would translate into lower prices for
customers and not into profits for the company.

Combatting the Opioid Crisis

By Andy Cole, Class of 2018

Florida Governor Rick Scott announced on September 26, 2017, plans to introduce legislation that would limit opioid prescriptions to only three days unless a set of very strict standards are met. If the standards are met, then a seven day supply would be permitted. Currently, this bill has not been filed in the House or Senate, but a similar seven day limit bill has been filed.
This legislation follows President Donald Trump declaring the opioid epidemic as a national emergency and many other states and pharmaceutical retailers taking similar stances. Less than a week before Gov. Scott’s announcement, pharmaceutical retailer CVS announced that beginning next February it will limit opioid prescriptions to seven days for patients who are new to pain therapy. Additionally, the Pharmaceutical Research and Manufacturers of America has announced its support for a seven day limit on opioid prescriptions with exceptions for certain conditions such as cancer.
It is unclear if this legislation will pass as it is currently planned. If so, it will be the strictest opioid limitations in the country. Many states have passed seven day limits for first time opioid patients.
In Massachusetts, Governor Charlie Baker proposed a similar 72 hour limit on opioids for first time users. This proposal was met with much criticism from many doctors and advocacy groups who called the proposal “draconian.” The final product of the bill had overwhelming support from both parties. Baker, a Republican, signed the final bill after it passed unanimously through the Democrat controlled legislature.
Many state legislatures have found it hard to balance the need for doctors to maintain discretion and to curb a national crisis. Many doctors and organizations are calling for tighter restrictions that prevent overprescribing of opioids to patients who do not need the medication.
Dr. Steven Stanos, president of American Academy of Pain Medicine, said the academy “supports any initiative that would help limit the effects of over prescribing medications or leading to excessive unused medicines that could lead to harm to a patient or family members or their community.”
The trend of states seeking to regulate the amounts of opioids doctors are allowed to prescribe will continue to grow until the epidemic can be helmed. As many states look to begin drafting their legislative initiatives for 2018 and many politicians prepare for midterm elections, combating opioid addictions will undoubtedly be a bipartisan effort.
There is a possibility that many states will push for law similar to the law enacted in Massachusetts, which requires practitioners to take more steps to combat opioid misuse. The first point of the law is to limit opioid prescriptions to seven days for any new opioid prescription. This applies to all opiates Schedule II through Schedule VI. There are exceptions to this limit. Physicians can prescribe for more than seven days if the prescription is designed for the treatment of substance use disorder or opioid dependence, for inpatient prescriptions, for pain related to an acute medical condition, for chronic pain management, for pain associated with a cancer diagnoses, or for palliative care.
If a first time opiate prescription is being written for greater than a seven-day supply pursuant to an exception, the prescriber must document in the medical record the specific exception for which the opiate is being prescribed; and provide brief information about the actual condition or treatment that necessitates more than seven days; and indicate whether there were known and available non-opiate alternatives. The state has added an additional requirement for prescribing opioids to minors under the age of eighteen. For minors, the prescriber must also document that there was a discussion with the parent/guardian of the known risks with the specific prescription and why it is necessary for that condition/treatment. Additionally, prescribers must document in the medical record each and every time an outpatient opioid prescription is being issued to anyone.
This law moves beyond the prescription limit and also requires prescribers to check the Prescription Monitoring Program every time he or she schedules a Schedule II or III narcotic. The law also requires prescribers to complete training in pain management and addiction. In addition, it requires prescribers and patients to enter into a written pain management treatment agreement for prescriptions for extended-release long-acting opioids.
Finally, this law also places a new burden on pharmacists. If a patient requests a partially filled opioid prescription, the pharmacist must notify the prescriber within seven days. Then the prescriber is responsible for discussing with the patient the quantity of the prescription and the option to partial fill.
From an attorney’s point of view, it is important to make sure your client is aware of all of these changes and their new obligations under the law. While Tennessee has not enacted this type of law yet, combatting the opioid crisis in the state will be high on the legislative agenda for the next few years. A piece of legislation similar to this is bound to be at least be discussed by lawmakers as a potential route to take. At the moment it is difficult to tell how difficult it will be to monitor providers who may abuse the system.

District Court Upholds First Application of “Escobar Materiality Standard”

By Chase Doscher, Class of 2018; Emmie Futrell, Class of 2018; Alexander H. Mills, Associate at Waller

On March 15, 2017, the U.S. District Court for the Western District of Pennsylvania issued an opinion in United States ex rel. Emanuele v. Medicor Assocs. applying the materiality standard from Universal Health Services v. United States ex rel. Escobar to the “writing requirement” utilized throughout various exceptions to the Stark Law. The District Court found that this requirement, and the signature requirement specifically, represents a material component of the Stark Law for purposes of establishing liability under the federal False Claims Act (FCA). On August 25, 2017, the court denied the defendant’s motion for reconsideration, affirming its initial interpretation.

The Stark Law

The Stark Law exists for the purpose of prohibiting a physician (or an immediate family member of the physician) from making referrals for “designated health services” to an entity with which the referring physician (or immediate family member) has a financial relationship unless the parties comply with one of the exceptions set forth in the federal regulations. Additionally, Stark prohibits entities like hospitals from submitting claims for payment to Medicare or Medicaid for items or services that result from the prohibited referrals. Although the concept of a “financial relationship” may seem simple, Stark defines the term broadly and includes both ownership and investment interests and compensation arrangements between physicians (and their immediate families) and entities. Violation of the Stark Law can incur significant civil liability under the False Claims Act, civil monetary penalties, and exclusion from all federal healthcare programs. Included in the framework of the Stark Law are numerous exceptions to civil liability. One common theme among them is the requirement that any arrangement must be evidenced by signed writing.

Materiality Under Escobar

In 2016, the United States Supreme Court set out in Escobar that generally, when submitting a claim for payment from a government payor, a healthcare provider makes certain implied representations regarding the goods and services which are the subject of the claim. The Court held that when a provider fails to disclose certain critical information, the offense is actionable if it results in a material misrepresentation affecting the government’s payment decision. The Court noted that a misrepresentation is not material for the mere fact that the government designates compliance with a particular requirement as a condition of payment. Factors that are considered in determining materiality include:

  • Whether the violation goes to the “essence of the bargain” or is instead a “minor or insubstantial” detail
  • Whether the government has expressly identified a particular requirement as a condition of payment (which would weigh in favor of materiality); and
  • Whether the government has consistently refused to pay claims due to noncompliance with a requirement (which would also suggest materiality), or has regularly paid claims despite actual knowledge that the requirement was violated (which represents “strong evidence” that the requirement is not material).

The Pennsylvania Court’s Analysis

The Western District of Pennsylvania further clarified the boundaries of the FCA materiality bar for healthcare providers. While Escobar may have left healthcare providers with a murky picture of the intended definition of materiality, the Emanuele court outlined the reach of this requirement, especially with respect to the interconnection of other fraud and abuse statutes.

In November 2016, the Centers for Medicare & Medicaid Services (CMS) codified amendments to the Stark Law to make it easier for healthcare providers to meet the writing requirement. Many of the Stark exceptions require a written agreement between a referring physician and an entity with which the physician has a financial relationship. This requirement was originally interpreted to be a writing in the form of a single signed agreement, but CMS amended language across the statute to relax this exacting standard. The amendments instead allowed for the writing to be codified in an “arrangement” or various contemporaneous documents evidencing the conduct between the parties. CMS explained:

In most instances, a single written document memorializing the key facts of an arrangement provides the surest and most straightforward means of establishing compliance with the applicable exception. However, there is no requirement under the physician self-referral law that an arrangement be documented in a single formal contract. Depending on the facts and circumstances of the arrangement and the available documentation, a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement of the leasing exceptions and other exceptions that require that an arrangement be set out in writing.

Despite relaxing the standard for what constitutes a writing sufficient to meet a Stark exception, however, the Emanuele court illustrates that the writing requirement remains significant. The court initially noted that the Stark Law expressly prohibits payment on Medicare claims that do not satisfy each element of an applicable exception. As such, all claims submitted by healthcare providers to CMS inherently imply compliance with the requirements of any relevant Stark exception. The court, quoting Escobar, cautioned that although “statutory, regulatory, and contractual requirements are not automatically material, even if they are labeled conditions of payment,” they nevertheless represent “relevant” evidence in favor of materiality.”

The court went on to ultimately conclude that the Stark writing and signature requirements are material, after satisfying several of the factors of materiality from Escobar. A signed writing allows reviewers to consider whether agreements vary with the volume or value of services based on the timeframe, compensation and exact services that they contain and whether both parties consent to the agreement. These elements, therefore, go to the basis of the bargain between the government and healthcare providers, because of the role that they play in preventing fraud and abuse. Therefore, the court concluded, the writing requirement is “important, mandatory, and material to the government’s payment decisions.”

Emanuele represents the first time that a federal court has had the opportunity to interpret and enforce CMS’s 2016 amendment as to the writing requirement. It can’t be overstated that the writing requirement is essential to ensure compliance with exceptions and avoid liability under Stark. Although the linguistic shift to an “arrangement” intended to relieve healthcare providers from the necessity of strictly maintaining and updating written agreements, the collection of contemporaneous writings still must contain the minimum requirements set forth in the regulations, notably a signature. Without meeting these requirements, healthcare providers may be exposed to liability under both Stark and the FCA, since federal courts will likely continue to interpret the writing requirement to go to the “basis of the bargain” between healthcare providers and CMS.

Pain-Capable Unborn Child Act

By Andy Cole, Class of 2018

The United States House of Representatives voted to approve H.R. 36, Pain-Capable Unborn Child Protection Act, a bill that would ban abortions in the country after 20 weeks of gestation because some scientific studies show that fetuses can feel pain at 20 weeks. Similar legislation passed in the House in 2015, but failed in the Senate. Even though the legislation probably faces a similar fate this year, it is important to look at the legislation and determine what would happen if this legislation did pass in the Senate and was signed by the President.

Most people point to the landmark case of Roe v. Wade to talk about abortion constitutionality. However, nearly twenty years after Roe, the Supreme Court largely affirmed its ruling from Roe in Planned Parenthood v. Casey. Casey offered the Supreme Court an opportunity to overturn Roe. Instead of overturning Roe, the Court created an undue burden test. This test continued to allow states to prohibit post-viability abortions, with the exception of cases where the life and health of the mother are at stake, but changed the rest of the analysis. Under the Casey framework before a fetus reaches viability, a woman has the right to have an abortion without an undue burden. This changes slightly from Roe. The idea of an undue burden test still exists today.

Many pro-life groups argue that these bills are constitutional, or alternatively pain capable standard is a better standard than viability standard.This option has been met with some controversy. The bill passed by the House, would make it a crime to perform abortions after 20 weeks with exceptions for rape, incest, and to save the life of the mother.

Many states have passed similar statutes, and some of these have been challenged in court based on the fact that they are unconstitutional because they violate the viability standard. Currently, there are very few cases of fetuses surviving if born at 20 weeks, which is problematic under the viability standard.

Some of the early versions of these bills have started making their way through the judicial system. In Isaacson v. Horne, the Ninth Circuit held that an Arizona law that prohibited abortions beginning at 20 weeks with a medical emergency exception. Both parties in the case agreed that a fetus is typically not viable at 20 weeks. The Court held that the State’s interests were not strong enough to prevent pre-viability abortions. However, a pain cable bill has never actually been argued in front of the Supreme Court.

Attorneys representing critics of these bills can argue that the bills are unconstitutional based on the viability standard and that the science behind the pain capable testing is disputed and controversial. Additionally, they can argue that pain capable acts restrict a woman’s right to an abortion at a time when the fetus would not be able to live outside of the womb. Many can argue that the science behind these bills is not strong enough to overturn the viability standard. The critics say that there is truly no way to know if a fetus is feeling pain in the womb or just experiencing a flinch or reaction to something that doctors and researchers could be mistaking as the sensing of pain.

Attorneys representing legislatures and pro-life groups can point to the fact that there are recently documented cases of fetuses surviving outside of the womb at 20 weeks. In fact, one child who survived at 20 weeks was present during the introduction of the bill in the House. Attorneys can also point to the rapid advance in medical technology that allows premature children to live at even earlier points in the gestation cycle. Additionally, attorneys can argue for a change in the viability standard and by the time this bill would reach the Supreme Court, there is likely to be changes on the court.

Senator Lindsey Graham has introduced the bill in the United States Senate. In the unlikely event this bill does pass the Senate, it is more than likely unconstitutional based on current standards. However, things could definitely change in the event of a change on the Supreme Court.

CHOW Time: Change of Ownership Changes

By Chase Doscher, Class of 2018; Colbey B. Reagan, Partner at Waller; Daniel Patten, Associate at Waller

Last April, the Center for Medicare & Medicaid Services (CMS) issued a change request making revisions to Chapter 15 (Medicare Enrollment) of the Medicare Program Integrity Manual. Specifically, this change request made significant alterations to Section 15.7.7.1.5 – Electronic Funds Transfer (EFT) Payment and CHOWs. Prior to the change request, when dealing with a change of ownership (CHOW), Medicare Administrative Contractors (MACs) continued to pay the Seller of a healthcare provider or facility until they received the tie-in notice from the CMS Regional Office. MACs would reject any application submitted by either the Seller or the Buyer to change the EFT account or special payment address prior to receiving approval from CMS. The ultimate responsibility for determining payment arrangements was left to the Buyer and Seller while the MAC and CMS processed the CHOW application.

Effective May 15, 2017, when the Seller and the Buyer initiate a CHOW, the provider agreement in existence, alongside the CMS Certification Number (CCN), is assigned automatically from the Seller to the Buyer effective on the transfer date. It is important to note that the Buyer retains the ability to reject the automatic assignment prior to the transfer date. To reject the automatic assignment of the provider agreement, the Buyer must file an initial participation application with the Medicare program. The assigned provider agreement is still subject to all applicable statutes and regulations as well as the terms and conditions under which it was issued. Any contractor will continue to adjust payments to the provider to account for both prior overpayment and underpayment, even if the claims relate to services provided before the CHOW. Additionally, the Buyer in a CHOW may obtain a new National Provider Identifier (NPI) or maintain the existing NPI. Once the CHOW processing is complete, the Seller will no longer be allowed to bill for services furnished after CHOW processing, and only the Buyer is permitted to submit claims using the existing CCN. It is important for parties undergoing CHOW processing to understand that under the implemented changes, any payment arrangement for services furnished during the CHOW processing period is left up to the parties to work out. One primary implication of this is that the Buyer will have some long-term responsibility to bill for services provided by the Seller during CHOW processing.

 

CMS Proposes Change to Joint, Episodic, and Cardiac Rehabilitation Payment Models

By Emmie Futrell, Class of 2018; Patsy Powers, Partner at Waller; Daniel Patten, Associate at Waller

On August 17, 2017, CMS published a proposed rule that could bring about significant changes to some of its Innovation Center’s major payment models. Specifically, the Proposed Rule would:

  • reduce the number of mandatory geographic area participants of the Comprehensive Care for Joint Replacement (CJR) model;
  • cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model; and
  • increase the pool of practitioners that qualify under the Advanced Alternative Payment Model.

These changes may be surprising to some as these models are still in their infancy. The CJR model started last year, and the EPMs and CRs were not scheduled to begin until January 1, 2018.

Perhaps the most striking element of the Proposed Rule is the removal of 33 geographic areas (of the currently 64 geographic areas) where participation in the CJR model has been mandatory. Instead, CMS proposes that such hospitals participate in the CJR model on a voluntary basis, especially hospitals with low volume or those located in rural areas. These hospitals are provided with a one-time option whereby continued participation in the CJR model will be left to their discretion. CMS believes that moving the CJR model away from a mandatory requirement will increase the likelihood that providers will participate in future voluntary initiatives. Hospitals that choose to continue participation in the CJR model will receive a target price for these procedures from CMS each year, and the proposed rule includes refinements and clarifications to this payment process.

CMS is accepting public comments on these revisions, which can be electronically submitted here, until October 16, 2017.

CMS Modernizes Conditions of Participation for Home Health Agencies

By Will Blackford, Class of 2017

On January 13, 2017, the Centers for Medicare and Medicaid Services (“CMS”) published in the Federal Register its Final Rule pertaining to the Conditions of Participation (“CoPs”) for home health agencies (“HHAs”). The rule represents the first modernization in over two decades of the fundamental requirements for HHA participation in Medicare and Medicaid, despite efforts in 1997 to revise the entire set of HHA CoPs. With enforcement of the new provisions beginning July 13, 2017, CMS has given HHAs a six-month window for adapting their policies, procedures, and practices to comply with the new standards.

The most significant changes under the Final Rule revolve around four categories:

  • Patient Rights. CMS added an expansive CoP that sets forth the specific rights that HHAs owe each patient and the steps they must take to protect such rights.
  • Care Planning. The final rule updates the comprehensive patient assessment requirement to focus on all aspects of patient wellbeing. It also requires that a HHA provide its patients with a written copy of the plan of care and utilize an integrated communication system to identify and coordinate care between the HHA and the patient’s physicians.
  • Quality Assessment and Performance Improvement. To ensure continual evaluation and improvement of care for patients, CMS will now require that HHAs initiate a data-driven, agency-wide quality assessment and performance improvement (QAPI) program that is capable of measuring improvement in indicators that are linked to improvement in patient outcomes, safety and care quality.
  • Infection and Prevention Control. The new infection prevention and control requirement that focuses on the use of standard infection control practices, and patient/caregiver education and teaching.

In addition to the modified care standards, CMS also refined the definition of “Representative” to expressly distinguish between a patient-selected representative and a legal representative with legal decision-making authority under the law. There are numerous updates throughout the Final Rule that are shaped by this two-tiered approach to representation.

To meet these new requirements, HHAs need to familiarize themselves with the Final Rule and analyze their current policies and procedures to formulate a plan for tackling implementation of these significant changes. Agencies that fail to comply with any of the new CoPs by the July 13, 2017 deadline are at risk of penalties ranging from imposition of sanctions for marginal issues, to program termination for major infractions.

The Trump Administration Shores Up Health Insurance Marketplace Pending Possible ACA Repeal

By Will Blackford, Class of 2017

Recently, the Trump administration put forth two key initiatives to ease the burden of the Affordable Care Act (“ACA”) and to stabilize the Obamacare marketplace.

First, the Internal Revenue Service (“IRS”) quietly updated its website with a statement indicating that the agency will not reject 2016 tax filings that fail to indicate whether a taxpayer complied with the ACA’s individual mandate. Second, the Centers for Medicare & Medicaid Services (“CMS”), now overseen by Tom Price, the new Secretary of the Department of Health and Human Services, submitted a new proposed rule aimed at making health insurer plans under the Obamacare exchange more profitable.

Both changes come on the cusp of significant insurer uncertainty, with Humana announcing its departure from the exchange market in 2018, and other insurers—such as Aetna and Anthem—threatening to cease future participation in the absence of meaningful modifications to the system.

 

New IRS Individual Mandate Policy

Following the signing of an executive order by President Trump on Jan. 20, 2017, which directed federal agencies to reduce the burden of the ACA, the IRS retreated from its previous policy that would have required an indication of health insurance coverage on tax returns. The system the IRS initially developed would have automatically rejected tax returns that failed to indicate whether the individual maintained health insurance, allowing the agency to efficiently enforce the ACA’s assessment of a penalty on those lacking coverage.

Under the newly announced policy, this mechanism for handling so-called “silent returns” will not be implemented. Instead, the IRS will continue to accept and process electronic and paper returns, even in the absence of an indication of coverage status. However, the IRS will still be enforcing the individual mandate if people volunteer on their 1040s that they lacked health coverage in 2016. While the agency reserves the right request additional information from individuals that file “silent returns,” the policy shift will undeniably lead to a lesser degree of enforcement under the mandate.

 

CMS Market Stabilization Proposed Rule

As Congress continues its debate over repealing, repairing, or replacing the ACA, a recent CMS notice of proposed rulemaking (“NPRM”) is intended to calm insurer anxieties over the long-term viability of the health insurance exchange. The NPRM offers numerous policy and operational tweaks geared toward stabilizing the marketplace, including:

  • Shortened 2018 Open Enrollment Period. The NPRM would reduce the open enrollment period for 2018 to 45 days (November 1 to December 15, 2017). This would allow insurers to collect a full year’s premium for 2018 from regular enrollees and limit adverse selection by those individuals who discover health issues during the months of December and January.
  • Special Enrollment Periods. The NPRM would target special enrollment periods (“SEP”) by tightening up eligibility, restricting the upgrade ability of existing marketplace enrollees, and limiting overall use of the “exceptional circumstances” SEP.
  • New Guaranteed Availability Requirement Interpretation. To address insurer concerns over potential abuses, the NPRM would add flexibility to the guaranteed availability requirement for allowing an issuer to collect premiums for prior unpaid coverage before enrolling a patient in the next year’s plan with the same issuer. This is meant to incentivize patients to avoid coverage lapses.
  • Reduced Essential Community Providers Requirement. The NPRM proposes that for 2018, plans be required to include only 20 percent of Essential Community Providers (e.g., community health centers, family planning clinics, safety-net hospitals) within their network, rather than the current requirement of at least 30 percent.
  • Network Adequacy Delegated to States. Starting with the 2018 plan year, CMS proposes deferring to the state regulators to ensure network adequacy, provided that the state has adequate authority and resources to ensure reasonable access to providers.

Unlike the traditional 30-day minimum for feedback, the NPRM has an unusually short comment period—only 20 days—for CMS to consider public comments prior to issuing a final rule. This expedited timeframe is intended to accommodate insurers who are frantically working to finalize their forms and rates for 2018.

SAMHSA Final Rule Updates the 42 C.F.R. Part 2 Substance Abuse Confidentiality Requirements

By Will Blackford, Class of 2017

After four decades of anticipation, the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published on January 18 a Final Rule modernizing the laws governing how providers share data about individuals with a substance use disorder (“SUD”). The affected regulations, known as 42 C.F.R. Part 2 (“Part 2”), were updated to meet the demands of the electronic age. The Final Rule is meant to facilitate broader data delivery and electronic exchange while safeguarding the privacy of the patient information.

Revisions to Part 2 under the Final Rule include:

  • Consent. Rather than requiring the identification of a specific information recipient, patients are now allowed, in certain circumstances, to consent to a “general disclosure” to intermediate entities (e.g., “my current and future treating providers”).
  • Disclosure. Any patient who opts for this general designation consent may request in writing (paper or electronic) a list of entities to which their information has been disclosed (“List of Disclosures”), and the disclosing entity named on the general consent form must respond within 30 days with a brief description of each disclosure made within the past two years.
  • Description. All patient consent forms are required to include an explicit description of the amount and kind of information that may be disclosed.
  • Scope. The applicability of restrictions on disclosures under Part 2 is expanded to include individuals or entities receiving patient records from “other lawful holders of patient identifying information.”
  • Security. Part 2’s security requirements now apply to both electronic and paper records, as well as require Part 2 programs and “other lawful holders” to have formal security policies and procedures in place.
  • Exclusions. Simply providing screening, brief intervention, or referral to treatment, within the scope of general healthcare, does not subject a provider to classification as a Part 2 program.
  • Qualified Service Organizations. The definition of a Qualified Service Organization (“QSO”) is expanded to include an entity that provides population health management (“PHM”) services to a Part 2 program; however, disclosures under QSO agreements are limited to specific offices or units that actually carry out PHM and such agreements may not be used to circumvent patient consent.
  • Re-disclosure. As a clarification, the prohibition on re-disclosure under Part 2 now applies only to information that would identify a patient as having been diagnosed, treated, or referred for a SUD, unless the patient expressly authorizes such disclosure.
  • Other Disclosures. The Final Rule also relaxes requirements in specific areas, such as disclosure without consent for certain scientific research, medical emergencies, and audits or evaluations.
  • Payment and Operations Disclosures. Due to commenter concerns, SAMHSA issued, alongside the Final Rule, a Supplemental Notice of Proposed Rulemaking (“SNPRM”) to seek comment on disclosures to contractors for payment and operations facilitations, as well as disclosures for Medicare, Medicaid, and other federal program audits or evaluations.

 

Although the Final Rule was scheduled to go into effect on February 17, 2017, President Trump’s 60-day hold on all rules published in the Federal Register that are not yet effective will likely delay the effective date until at least March 21, 2017. But even with the delay, those providers subject to Part 2 have a very limited timeframe to thoroughly review the new provisions and implement necessary changes.

Specifically, Part 2 providers should implement or update security procedures to address both paper and electronic records. Security measures should also clarify internal policies for creating, maintaining, transferring, destroying, and de-identifying such records. Should providers choose to utilize the new general designation consents for disclosures, there will need to be adequate recordkeeping processes in place to ensure compliance with any List of Disclosure requests. Additionally, providers working with QSO vendors should review relevant contractual documentation to confirm that such vendors are correctly categorized as a QSO under the new definition.

Stay tuned as we continue to monitor the implementation of this Final Rule and analyze its legal consequences.

Proposed Telehealth Bill

By Ann Hogan, Class of 2018

After years of debate, on Wednesday, March 29, 2017, the Texas Senate unanimously passed Bill 1107, legalizing telehealth and telemedicine in the state of Texas and is to take effect immediately. Telemedicine is a health care service delivered by a licensed physician or health professional to a patient at a different physical location than the physician or health professional using telecommunications or information technology.

Bill 1107 removes the requirement of a face-to-face consultation between a patient and physician providing a telemedicine medical service within a certain number of days following an initial telemedicine service in order to create the physician-patient relationship. Now, a physician-patient relationship can be created through telephone or video.

Bill 1107 delegates the authority for the Texas Medical Board to create rules to effectuate appropriate quality care, the prevention of fraud and abuse, and the supervision of the healthcare professionals. It also requires the physician to comply with the standard of care that would apply to the provision of the same health care service or procedure in an in-person setting. Mental health services are excluded from this provision. Also noteworthy, physicians are not permitted to prescribe an abortifacient or any other drug or device that terminates a pregnancy through telemedicine.

The passing of this bill will likely have a significant effect for rural provider areas. For Texans who live in rural areas, telemedicine will allow them to seek care from providers via phone or video and have prescriptions called in to their local pharmacy. This will increase the efficiency of health care for Texans and save them time and money.